3 6 2020 Official Journal of the European Union L 174/345 EN
COMMISSION DELEGATED REGULATION (EU) 2020/ 691
of 30 January  2020
supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for 
aquaculture establishments and transporters of aquatic animals
(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 
Articles  176(4), 181(2), 185(5), 189(1) and 279(2) thereof,
Whereas:
(1) R egulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to 
animals or humans, including, inter alia, rules for aquaculture establishments, and for transporters of aquatic animals   
Regulation (EU) 2016/429 also provides for the Commission to adopt delegated acts in order to supplement certain 
non-essential elements of that Regulation   It is therefore necessary to lay down supplementing rules in order to ensure 
the smooth functioning of the system established within the new legislative framework of Regulation (EU) 2016/429  
(2) More par ticularly, the rules laid down in this Regulation should supplement those already laid down in Chapter  1 
of Title  II of Part  IV of Regulation (EU) 2016/429, as regards the approval of aquaculture establishments keeping 
aquaculture animals posing a significant animal health risk, the registers of aquaculture establishments to be kept by 
competent authorities, and the record-keeping obligations of operators of aquaculture establishments and transporters 
of aquatic animals  
(3) In addition, t his Regulation takes into account the repeal of Council Directive 2006/88/EC  (2) by Regulation (EU) 
2016/429 with effect from 21 April  2021   Regulation (EU) 2016/429 provides that establishments and operators 
registered or approved in accordance with that Directive, before the date of application of Regulation (EU) 2016/429, 
are to be deemed to be registered or approved, as required, in accordance with that Regulation, and subject to the 
relevant obligations laid down therein  
(4) A ccordingly, the rules laid down in this Regulation should supplement the rules laid down in Part  IX of Regulation (EU) 
2016/429, as regards the necessary transitional measures to protect the acquired rights and legitimate expectations 
of stakeholders resulting from pre-existing Union acts with regard to aquaculture establishments  
(5) As t he rules laid down in this Regulation all relate to aquaculture establishments and transporters of aquatic animals 
and are to be applied in tandem, they should be set out in a single act rather than in separate acts with numerous 
cross-references, in order to facilitate their application, in the interests of transparency, and to avoid a duplication of 
rules   This is also in keeping with the approach adopted by Regulation (EU) 2016/429  
(6) Ar ticle  176(1) of R egulation (EU) 2016/429 provides that operators of aquaculture establishments are to apply to the 
competent authority for approval where they keep aquaculture animals with a view to those animals being moved 
therefrom, either alive or as products of aquaculture animal origin   As a wide variety of aquaculture establishments fall 
within that category, Article  176(2) of R egulation (EU) 2016/429 provides that Member States may exempt operators 
of specific types of aquaculture establishments from the requirement for approval provided that such aquaculture 
establishments do not pose a significant disease risk   In addition, Article  176(4) of that Regulation provides that the 
Commission may adopt delegated acts concerning derogations from the requirement for approval for certain types 
of aquaculture establishments, again on the condition that those aquaculture establishments do not pose a significant 
risk 
(1) OJ L 84, 31  3 2016, p   1 
(2) 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) Official Journal of the European Union L 174/346 EN 3 6 2020
(7) Th e level  of risk posed by an aquaculture establishment, depends on the activity of that aquaculture establishment 
and the destination and intended use of the aquaculture animals or products of aquaculture animal origin produced 
therein   Some aquaculture establishments have already been approved for different purposes, such as aquaculture 
establishments which have been approved under the hygiene rules in accordance with Regulation (EC) No  853/2004 
of the European Parliament and of the Council  (3)  In certain situations, aquaculture establishments such as purification 
and dispatch centres or relaying areas only receive molluscs from within the epidemiological area in which the 
aquaculture establishment is itself located   These aquaculture establishments therefore, pose an insignificant risk from 
an animal health perspective   Other aquaculture establishments are also engaged in low risk activities, such as keeping 
aquaculture animals solely for release into the wild after having produced them from broodstock which originated 
from the water body on which the aquaculture establishment is located, or keeping aquaculture animals in extensive 
ponds for human consumption or for release into the wild  
(8) It is necessary to lay down in this Regulation, the specific conditions under which derogations from the requirement 
for approval should be permitted for aquaculture establishments   In certain cases, derogations should only apply to 
aquaculture establishments which move aquaculture animals within their own Member State and not to aquaculture 
establishments which move aquaculture animals between Member States   In all cases, however, derogations from 
the requirement for an aquaculture establishment to be approved should only be considered when the competent 
authority has completed a risk assessment which takes into account at least the risk of aquaculture animals on the 
aquaculture establishment contracting or spreading an aquatic disease via water or via movements and where the risk 
has been found to be insignificant   Details of additional risk factors which the competent authority may take into 
account in this risk assessment are set out in Chapter  2 of P art I of Annex  VI to Commission Delegated Regulation 
(EU) 2020/689  (4)  Therefore, the supplementing rules laid down in this Regulation should be consistent with those 
laid down in that Delegated Regulation  
(9) A t the same time, certain other types of aquaculture establishments represent a significant risk for the spread of aquatic 
animal diseases   Such types of aquaculture establishment should be specifically described in this Regulation, and the 
requirement for the operators of these aquaculture establishments to be approved should be detailed in this Regulation   
These include aquaculture establishments keeping ornamental aquaculture animals in open facilities and also in closed 
facilities where the movement patterns are such that trade within the Union or with third countries potentially present 
a disease risk   Other types of aquaculture establishments where the risk of disease spread should be mitigated through 
the requirement for approval by the competent authority, are quarantine establishments, establishments which keep 
vector species in isolation until such time as they are no  long er considered to be vectors, and vessels and other mobile 
premises where aquaculture animals are treated or undergo other husbandry-related procedures  
(10)  Ar ticle  177  of Regulation (EU) 2016/429 provides for the competent authority to grant approval of operators for 
groups of aquaculture establishments   The supplementing rules laid down in this Regulation should therefore apply to 
such groups where appropriate, and should set out the details of how the rules should apply directly to, and within, 
the group  
(11)  Op erators of all aquaculture establishments or groups of aquaculture establishments are required to provide information 
to the competent authority with a view to obtaining approval in compliance with Article  180 of R egulation (EU) 
2016/429   In that regard, operators should provide the competent authority with a written biosecurity plan which will 
be considered during the approval process   This requirement should apply to both individual aquaculture establishments 
and groups of aquaculture establishments regardless of their size, but the complexity of the biosecurity plan should 
depend upon the specificities of the individual aquaculture establishment or group thereof, and on the measures which 
are required to mitigate the associated disease risks  
(12)  Cer tain aquaculture establishments and groups of aquaculture establishments should, on the basis of the rules 
laid down in Chapter  1 of Part  I to Annex  VI of Delegated Regulation (EU) 2020/ 689 , participate in a risk-based 
surveillance scheme which is put in place by the competent authority in accordance with Article  26 of R egulation 
(EU) 2016/429   Without such participation, aquaculture establishments or groups of aquaculture establishments 
should not be approved   In line with Article  27 of R egulation (EU) 2016/429, risk-based surveillance may take into 
account the surveillance conducted by operators themselves in accordance with Article  24, including t he animal health 
visits referred to in Article  25 of that Regulation   Risk-based surveillance may also be carried out at the same time as 
surveillance connected with particular listed diseases, in order to maximise resources  
(3) R egulation (EC) No  853/2004 of the European Parliament and of the Council of 29 Apr il  2004  laying down specific hygiene rules for food 
of animal origin ( OJ L 139, 30  4 2004, p   55) 
(4) Commission Deleg ated 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 (see page  211 of this Official Journal)  3 6 2020 Official Journal of the European Union L 174/347 EN
(13)  T he frequency of risk-based surveillance should be based on the ranking of the aquaculture establishment by the 
competent authority as ‘high ’, ‘medium ’ or ‘low ’ risk, following an assessment of the circumstances of the establishment   
Factors to be taken into account and considered by the competent authority when risk ranking establishments, as well 
as the frequency of surveillance which attaches to each risk ranking are set out in Part  I of Annex  VI to Delegated 
Regulation (EU) 2020/ 689   The objective of including aquaculture establishments which keep non-listed species but 
which participate in a significant amount of trade and which are therefore ranked as ‘high ’ risk, in the risk- based 
surveillance scheme, is to maximise the chances of identifying and controlling emerging diseases, should they appear 
in aquaculture animals of those non-listed species  
(14)  As risk-based surveillance is also carried out in approved groups of aquaculture establishments, it is important to set out 
how this should be completed at group level  so that the outcome of the surveillance is epidemiologically meaningful   
Accordingly, this Regulation should lay down rules concerning the approach which the competent authority should 
take to carrying out such surveillance  
(15)  Ap art from the requirement for operators to present a biosecurity plan to the competent authority as part of the 
approval process, and for certain aquaculture establishments to participate in a risk-based surveillance scheme, the 
aquaculture establishments that are required to be approved should also meet certain requirements in relation to their 
facilities and equipment   The particular combination of requirements with regard to biosecurity, surveillance, and 
facilities and equipment which apply to a specific category of aquaculture establishment or to a specific category of 
group of aquaculture establishments should therefore, be set out in this Regulation  
(16)  Ar ticle  178 of Regulation (EU) 2016/429 provides that operators of aquaculture establishments wishing to obtain 
the status of a confined aquaculture establishment may only move aquaculture animals to or from their aquaculture 
establishments after they have obtained the approval of that status from the competent authority in accordance with 
the rules laid down in that Regulation   As these aquaculture establishments may exchange aquaculture animals amongst 
themselves with fewer movement requirements than for other types of aquaculture establishments, it is appropriate 
that they should have a contracted veterinarian who will supervise the activities of the aquaculture establishment and 
be responsible for its health surveillance, so they can provide robust health guarantees to each other   Article  181(2) 
of Regulation (EU) 2016/429 provides for the Commission to adopt delegated acts laying down supplementing rules 
for the approval of such aquaculture establishments, and such rules should be laid down in this Regulation  
(17)  Ar ticle  179 of Regulation (EU) 2016/429 provides for the approval of disease control aquatic food establishments   
These aquaculture establishments facilitate the sanitary slaughter and sanitary processing of aquatic animals, which 
may be infected with a listed or emerging disease   Therefore, they represent a significant disease risk and should be 
approved by the competent authority   During the periods when these aquaculture establishments are receiving aquatic 
animals which are infected or suspected of being infected with a listed or emerging disease, they should comply with 
stringent biosecurity measures with the aim of ensuring that disease agents are not released into open waters without 
appropriate treatment   Article  181 (2) of that Regulation provides for the Commission to adopt delegated acts laying 
down supplementing rules for the approval of these aquaculture establishments and accordingly those supplementing 
rules should be laid down in this Regulation  
(18)  Cer tain purification centres, relaying areas, and dispatch centres for live molluscs should be considered as aquaculture 
establishments which require approval in accordance with Article  176(1) of R egulation (EU) 2016/429   Those 
establishments which receive live molluscs from outside their own epidemiological area, represent a higher risk of 
spreading listed or emerging diseases and should be treated as such during the approval process   This Regulation 
should therefore lay down supplementing rules in that respect  
(19)  Commission Im plementing Regulation (EU) 2018/1882  (5) lays down definitions for categories A, B, C, D and E 
diseases, and it provides that the disease prevention and control rules for listed diseases referred to in Article  9(1) of 
Regulation (EU) 2016/429 are to apply to the categories of listed diseases for the listed species, and groups of listed 
species referred to in the table  set out in the Annex  to Implementing Regulation (EU) 2018/1882   That table  provides 
that certain species of aquatic animals which are listed in column 4 thereof are only to be considered as vectors when 
they are kept in an aquaculture establishment where the species listed in column 3 thereof are also kept, or in the 
case of wild aquatic animals, when they have been exposed to species listed in column 3 in a wild habitat   However, 
if these species are subsequently kept in isolation from the species listed in column 3 and from infected water sources 
for an appropriate period of time, they are no  long er to be regarded as vectors   If this period of isolation cannot 
be carried out in a quarantine establishment approved in compliance with Article  15 of t his Regulation, then such 
(5) 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) Official Journal of the European Union L 174/348 EN 3 6 2020
 aq uatic animals may instead be kept in another type of aquaculture establishment which does not have all of the 
biosecurity measures which are required for quarantine establishments, but where they are kept in isolation from 
potential pathogens until such time as they are no  long er to be regarded as vectors   Article  181(2) of R egulation (EU) 
2016/429 provides for the Commission to adopt delegated acts laying down supplementing rules for the approval of 
such aquaculture establishments taking into account those requirements   Accordingly, those requirements should be 
laid down in this Regulation  
(20)  Ar ticle  185(5) of Regulation (EU) 2016/429 empowers the Commission to adopt delegated acts regarding additional 
information to be included in the registers of registered and approved aquaculture establishments kept by the competent 
authority and public access to those registers   Subject to the data protection requirements laid down in Regulation 
(EU) 2016/679 of the European Parliament and of the Council  (6), the information which should be made publicly 
available by the competent authority should reflect the requirements set out in Article  185(2)(a),(c),(e) and (f) of 
Regulation (EU) 2016/429 which in turn, largely reflect the details which Member States have already provided in a 
public register in compliance with Commission Decision 2008/392/EC  (7) 
(21)  More sp ecific information should, however, also be included in the public register of the competent authority regarding 
the health status of each approved establishment in order to facilitate safe trade and to ensure stakeholders know whether 
or not a given aquaculture establishment is free from a specific category  B or C disease, is subject to an eradication 
programme for a specific category  B or C disease, is in a surveillance programme for a specific category  C disease, or 
if it has none of those health statuses   Given the scope of the requirements which are set out in this Regulation with 
regard to the public availability of information on approved aquaculture establishments, this Regulation should repeal 
Decision 2008/392/EC  
(22)  Ar ticles  186 and  187 of Regulation (EU) 2016/429 lay down the minimum record- keeping obligations for operators 
of aquaculture establishments   As aquatic animals are generally not individually identifiable, record-keeping in relation 
to their production and movement is crucial   Whilst there are some common elements between the records kept by 
operators of different types of aquaculture establishments, specific types of aquaculture establishments should keep 
records which are particular to them and the type of aquaculture activity they are engaged in   As Article  189(1) of 
that Regulation provides for the Commission to adopt delegated acts laying down supplementing rules for the record-
keeping obligations, different record-keeping requirements should therefore, be set out in this Regulation for each type 
of approved aquaculture establishment  
(23)  Ar ticle  188 of R egulation (EU) 2016/429 lays down the minimum record-keeping obligations for transporters of 
aquatic animals intended for aquaculture establishments and of aquatic animals which are moved between habitats   
Transporters of aquatic animals represent a particular risk for the spread of disease and it is crucial that these operators 
keep records to ensure the traceability of the aquatic animals they transport, as well as to provide documentary 
evidence that they are employing appropriate biosecurity measures   Accordingly, this Regulation should lay down 
supplementing rules for their record-keeping obligations  
(24)  Th is Regulation should apply from 21 Ap ril  2021  in accordance with the date of application of Regulation (EU) 
2016/429,
HAS ADOPTED THIS REGULATION:
PART  I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article  1
Subject matter and scope
1  T his Regulation supplements the rules laid down in Regulation (EU) 2016/429 as regards registered and approved 
aquaculture establishments keeping aquaculture animals and transporters of aquatic animals  
(6) R egulation (EU) 2016/679 of the European Parliament and of the Council of 27 April  2016  on the protection of natural persons with 
regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection 
Regulation) ( OJ L 119, 4  5 2016, p   1 )
(7) Commission Decision 2008/392/EC of 30 April  2008  implementing Council Directive 2006/88/EC as regards an internet-based 
information page to make information on aquaculture production businesses and authorised processing establishments available by 
electronic means ( OJ L 138, 28  5 2008, p   12) 3 6 2020 Official Journal of the European Union L 174/349 EN
2  P art  II lays down requirements in:
(a) Chap ter  1 of T itle I, on the approval by the competent authority of aquaculture establishments posing a significant risk 
for diseases affecting aquatic animals, and certain derogations for operators of establishments that pose an insignificant 
risk for those diseases;
(b) Chap ter  2 of T itle I, on the requirements for aquaculture establishments and groups thereof, and the granting of approval 
by the competent authority;
(c) Chap ter  1 of T itle II, on the information obligations of the competent authority as regards registers of aquaculture 
establishments registered in accordance with Article  173 of Regulation (EU) 2016/429;
(d) Chap ter  2 of T itle II, on the information obligations of the competent authority as regards registers of approved aquaculture 
establishments;
(e) Chap ter  1 of Title  III, for the record-keeping obligations of operators of aquaculture establishments and disease control 
aquatic food establishments registered or approved by the competent authority, in addition to those provided for in 
Articles  186(1) and 187(1) of Regulation (EU) 2016/429;
(f) Ch apter  2 of T itle III, on the record-keeping obligations of transporters of aquatic animals, in addition to those provided 
for in Article  188(1) of Regulation (EU) 2016/429  
3  P art  III lays down certain transitional measures as regard to Directive 2006/88/EC and Decision 2008/392/EC in relation 
to the registration and approval of aquaculture establishments  
Article  2
Definitions
For the purposes of this Regulation, the definitions set out in Article  1 of Im plementing Regulation (EU) 2018/1882 shall apply  
The following definitions shall also apply:
 (1) ‘extensive pond’ means a traditional pond or lagoon which is natural or artificial and where the food source for the 
animals kept in these ponds or lagoons is natural other than in exceptional circumstances, and where no  measures are 
taken to increase the production beyond the natural capacity of the environment;
 (2) ‘purification centre ’ means an establishment with tanks fed by clean seawater in which molluscs are placed for the time 
necessary to reduce contamination to make them fit for human consumption;
 (3) ‘dispatch centre ’ means an on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, 
grading, wrapping and packaging of molluscs intended for human consumption;
 (4) ‘relaying area ’ means any freshwater, sea, estuarine or lagoon area with boundaries clearly marked and indicated by 
buoys, posts or any other fixed means, and used exclusively for the natural purification of molluscs;
 (5) ‘in isolation ’ means keeping aquaculture animals in an aquaculture establishment where they do not come into contact 
with any other species of aquatic animals either directly through co-habitation or indirectly through the water supply;
 (6) ‘closed facility ’ means an aquaculture establishment, the waste water from which, is subjected to treatment which is 
capable of inactivating agents of listed diseases or emerging diseases, before it is discharged into open waters;
 (7 )  ‘open facility ’ means an aquaculture establishment, the waste water from which, is discharged directly into open waters 
without being treated to inactivate agents of listed diseases or emerging diseases;
 (8) ‘epidemiological area ’ means a defined geographical area where the aquatic animals have the same health status and 
are exposed to the same risk of contracting a listed disease or an emerging disease;
 (9 )  ‘biosecurity plan ’ means a documented plan which identifies the routes by which a disease agent can enter an aquaculture 
establishment, spread within it and transfer from it; it takes account of the specificities of the establishment and identifies 
measures which will mitigate the biosecurity risks which have been identified;
 (10)  ‘common biosecurity measures ’ means the measures included in a biosecurity plan which has been devised for, and 
implemented by, each aquaculture establishment in a group of aquaculture establishments which has been approved 
by the competent authority in accordance with Article  177 of Regulation (EU) 2016/429;Official Journal of the European Union L 174/350 EN 3 6 2020
 (11)  ‘unique registration number ’ means a number assigned to a registered aquaculture establishment or group of aquaculture 
establishments as referred to in Article  173 of Regulation (EU) 2016/429;
 (12)  ‘unique approval number ’ means a number assigned by the competent authority to an aquaculture establishment or 
group of aquaculture establishments approved by it in accordance with Article  173 of Regulation (EU) 2016/429;
 (13)  ‘IMO ship identification number ’ means a unique number assigned to sea-going vessels by the International Maritime 
Organisation (IMO);
 (1 4)  ‘hygiene barrier ’ means footbaths, hand washes, changes of clothing or other biosecurity measures, the effects of which 
are to create barriers to the spread of disease into, within or from an aquaculture establishment;
 (15)  ‘production units ’ means troughs, ponds, raceways, tanks, cages, pens, or similar structures which contain groups of 
aquaculture animals in an aquaculture establishment;
 (16)  ‘increased mortality ’ means unexplained mortalities above the level  considered nor mal for the aquaculture establishment 
or group of aquaculture establishments in question, under prevailing conditions;
 (17)  ‘surveillance programme ’ means a voluntary programme of testing and control measures undertaken in relation to a 
category  C disease at an aquaculture establishment which is not participating in an eradication programme to achieve 
disease-free status, but where testing indicates that the aquaculture establishment is not infected with that category  C 
disease  
PART  II
REGISTRATION, APPROVAL, REGISTERS AND RECORD-KEEPING
TITLE  I
APPROVAL OF OPERATORS OF AQUACULTURE ESTABLISHMENTS BY THE COMPETENT AUTHORITY
CHAPTER 1
Approval of aquaculture establishments posing a significant risk for the spread of disease and derogations 
from the requirement for approval
Article  3
Derogations from the requirement on operators to apply to the competent authority for approval of 
aquaculture establishments
1  By wa y of derogation from Article  176(1)(a) of R egulation (EU) 2016/429, operators of the following types of aquaculture 
establishments shall not be required to apply to the competent authority for approval of their aquaculture establishments:
(a) aq uaculture establishments where aquaculture animals are kept solely for release into the wild;
(b) e xtensive ponds where aquaculture animals are kept for direct human consumption or for release into the wild;
(c) pur ification centres which:
 (i) are appr oved in accordance with Article  4 of R egulation (EC) No  853/2004; and
 (ii) receiv e molluscs only from within the epidemiological area in which the establishment is located;
(d) dispatc h centres which:
 (i) are appr oved in accordance with Article  4 of R egulation (EC) No  853/2004; and
 (ii) receiv e molluscs only from within the epidemiological area in which the establishment is located;
(e) rela ying areas which:
 (i) are appr oved in accordance with Article  4 of R egulation (EC) No  853/2004; and
 (ii) receiv e molluscs only from within the epidemiological area in which the establishment is located  3 6 2020 Official Journal of the European Union L 174/351 EN
2  Der ogations from the requirement to apply to the competent authority for approval provided for in paragraph  1 of t his 
Article  shall onl y apply to aquaculture establishments from which aquaculture animals are not moved to another Member 
State, other than molluscs for direct human consumption and when the competent authority has completed a risk assessment:
(a) t aking into account at least the risk factors set out in points  (a) and (b) of Ch apter  2 of P art I of Annex  VI to Commission 
Delegated Regulation (EU) 2020/ 689 ; and
(b) whic h has found the risk of the aquaculture animals on the aquaculture establishment either contracting or spreading 
a listed disease or an emerging disease to be insignificant  
Article  4
Types of aquaculture establishments required to be approved by the competent authority
Operators of the following types of aquaculture establishments shall apply to the competent authority for approval in 
accordance with Article  176(1)(b) of Regulation (EU) 2016/429:
(a) q uarantine establishments for aquaculture animals;
(b) aq uaculture establishments keeping aquaculture animals of listed species which are vectors in isolation, until such time 
as they are no  longer regarded as being vectors;
(c) aq uaculture establishments which are closed facilities keeping aquaculture animals for ornamental purposes, which 
because of their movement patterns, create a significant disease risk;
(d) aq uaculture establishments keeping aquaculture animals for ornamental purposes in open facilities;
(e) v essels or other mobile premises where aquaculture animals are kept temporarily to be treated or to undergo another 
husbandry-related procedure  
CHAPTER 2
Requirements and granting of approval of aquaculture establishments
Article  5
Requirement for approved aquaculture establishments and groups thereof to have a biosecurity plan
The competent authority shall only approve aquaculture establishments referred to in Article  7 and Ar ticles  9 to 19, or groups 
of aquaculture establishments referred to in Article  8, if t heir operators have developed and documented a biosecurity plan, 
which complies with the following requirements:
(a) it identif ies the routes whereby a disease agent can enter the aquaculture establishment or group of aquaculture 
establishments, spread within it and transfer from it to the environment or to other aquaculture establishments;
(b) it takes account of the specificities of the individual aquaculture establishment or group of aquaculture establishments 
and identifies risk-mitigation measures for each biosecurity risk which has been identified;
(c) it consider s or takes into account, where appropriate, the elements set out in point  1(a) of P arts 1 to 7 and Parts  9 to 
12, and in point  1(b) of Part  8 of Annex  I, when t his plan for the aquaculture establishment or group of aquaculture 
establishments is being developed  
Article  6
Requirement for approved aquaculture establishments and groups thereof to participate in a risk-based 
surveillance scheme
1  T he competent authority shall only approve aquaculture establishments referred to in Articles  7, 17 and 18 of this 
Regulation if the operators comply with risk-based surveillance conducted by the competent authority in accordance with 
Article  26 of R egulation (EU) 2016/429, in the form of a risk-based surveillance scheme as set out in Part  1 and in point  1 
of Part  2 of Anne x II to this Regulation  Official Journal of the European Union L 174/352 EN 3 6 2020
2  T he competent authority shall only approve groups of aquaculture establishments referred to in Article  8 of t his 
Regulation when operators comply with risk based surveillance conducted by the competent authority in accordance with 
Article  26 of Regulation (EU) 2016/429, in the form of a risk- based surveillance scheme as set out in Part  1 and in point  2 
of Part  2 of Anne x II to this Regulation  
3  Wh en granting approval of aquaculture establishments or groups thereof as provided for in paragraphs  1 and 2, t he 
competent authority shall take account of the following elements, and include them in the risk-based surveillance scheme:
(a) t he outcome of the surveillance conducted by the operator in accordance with Article  24 of R egulation (EU) 2016/429;
(b) t he information obtained through the animal health visits carried out by a veterinarian in accordance with Article  25 
of Regulation (EU) 2016/429, when the operators make such information available  
Article  7
Requirements for granting approval of aquaculture establishments where aquaculture animals are kept 
with a view to being moved therefrom either alive or as products of aquaculture animal origin, other 
than those aquaculture establishments for which specific requirements are laid down in Articles  12 t o 19
When granting approval, the competent authority shall ensure that aquaculture establishments where aquaculture animals 
are kept with a view to being moved therefrom either alive or as products of aquaculture animal origin, other than those 
aquaculture establishments referred to in Articles  12 to 19, comply with the requirements set out in:
(a) Ar ticle  6(1), in relation to risk-based surveillance;
(b) point  1 of Part  1 of Anne x I, in relation to biosecurity measures;
(c) point  2 of Part  1 of Anne x I, in relation to facilities and equipment  
Article  8
Requirements for granting approval of groups of aquaculture establishments where aquaculture animals 
are kept with a view to being moved therefrom either alive or as products of aquaculture animal origin
When granting approval, the competent authority shall ensure that groups of aquaculture establishments where aquaculture 
animals are kept with a view to being moved therefrom either alive or as products of aquaculture animal origin comply with 
the requirements set out in:
(a) Ar ticle  6(2), in relation to risk-based surveillance;
(b) point  1 of Part  2 of Anne x I, in relation to biosecurity measures for the aquaculture establishments in the group;
(c) point  2 of Part  2 of Anne x I, in relation to facilities and equipment  
Article  9
Requirements for granting approval of confined aquaculture establishments
When granting approval, the competent authority shall ensure that confined aquaculture establishments comply with the 
requirements set out in:
(a) Ar ticle  10, in relation to arrangements for facilities where post-mortem examinations are carried out and securing the 
services of an establishment veterinarian;
(b) point  1 of Part  3 of Anne x I, in relation to biosecurity measures;
(c) point  2 of Part  3 of Anne x I, in relation to surveillance and control;
(d) point  3 of Part  3 of Anne x I, in relation to facilities and equipment  3 6 2020 Official Journal of the European Union L 174/353 EN
Article  10
Obligations of operators of confined aquaculture establishments
Before approval is granted by the competent authority, operators of confined aquaculture establishments shall:
(a) put in place ar rangements to perform veterinary post-mortem examinations in appropriate facilities in the confined 
aquaculture establishment or in a laboratory;
(b) secure b y contract or by another legal instrument, the services of an establishment veterinarian who shall be responsible 
for:
 (i) t he supervision of the activities of the confined aquaculture establishment and compliance with the requirements 
for approval laid down in Article  9;
 (ii) t he review of the disease surveillance plan referred to in point  2(a) of Part  3 of Anne x I at least annually  
Article  11
Requirements for granting approval of disease control aquatic food establishments
When granting approval, the competent authority shall ensure that disease control aquatic food establishments comply with 
the requirements set out in:
(a) point  1 of Part  4 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  4 of Anne x I, in relation to facilities and equipment  
Article  12
Requirements for granting approval of purification centres other than those referred to in Article  3(1)(c)
When granting approval, the competent authority shall ensure that purification centres other than those referred to in 
Article  3(1)(c) comply with the requirements set out in:
(a) point  1 of Part  5 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  5 of Anne x I, in relation to facilities and equipment  
Article  13
Requirements for granting approval of dispatch centres other than those referred to in Article  3(1)(d)
When granting approval, the competent authority shall ensure that dispatch centres other than those referred to in 
Article  3(1)(d) comply with the requirements set out in:
(a) point  1 of Part  6 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  6 of Anne x I, in relation to facilities and equipment  
Article  14
Requirements for granting approval of relaying areas other than those referred to in Article  3(1)(e)
When granting approval, the competent authority shall ensure that relaying areas other than those referred to in Article  3(1)(e) 
comply with the requirements set out in:
(a) point  1 of Part  7 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  7 of Anne x I, in relation to facilities and equipment  Official Journal of the European Union L 174/354 EN 3 6 2020
Article  15
Requirements for granting approval of quarantine establishments
When granting approval, the competent authority shall ensure that quarantine establishments comply with the requirements 
set out in:
(a) point  1 of Part  8 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  8 of Anne x I, in relation to surveillance and control measures;
(c) point  3 of Part  8 of Anne x I, in relation to facilities and equipment  
Article  16
Requirements for granting approval of aquaculture establishments keeping aquaculture animals of listed 
species which are vectors in isolation, until such time as they are no  longer regarded as vectors
When granting approval, the competent authority shall ensure that aquaculture establishments keeping aquaculture animals 
of listed species which are vectors in isolation, until such time as they are no  long er regarded as vectors, comply with the 
requirements set out in:
(a) point  1 of Part  9 of Anne x I, in relation to biosecurity measures;
(b) point  2 of Part  9 of Anne x I, in relation to surveillance and control measures;
(c) point  3 of Part  9 of Anne x I, in relation to facilities and equipment  
Article  17
Requirements for granting approval of aquaculture establishments which are closed facilities keeping 
aquaculture animals for ornamental purposes which, because of their movement patterns, create a 
significant disease risk
When granting approval, the competent authority shall ensure that aquaculture establishments which are closed facilities 
keeping aquaculture animals for ornamental purposes which, because of their movement patterns, create a significant disease 
risk, comply with the requirements set out in:
(a) Ar ticle  6(1), in relation to risk-based surveillance;
(b) point  1 of Part  10 of Annex  I, in relation to biosecurity measures;
(c) point  2 of Part  10 of Annex  I, in relation to facilities and equipment  
Article  18
Requirements for granting approval of aquaculture establishments which are open facilities keeping 
aquaculture animals for ornamental purposes
When granting approval, the competent authority shall ensure that aquaculture establishments which are open facilities 
keeping aquaculture animals for ornamental purposes comply with the requirements set out in:
(a) Ar ticle  6(1), in relation to risk-based surveillance;
(b) point  1 of Part  11 of Annex  I, in relation to biosecurity measures;
(c) point  2 of Part  11 of Annex  I, in relation to facilities and equipment  3 6 2020 Official Journal of the European Union L 174/355 EN
Article  19
Requirements for granting approval of vessels or other mobile premises where aquaculture animals are 
kept temporarily to be treated or to undergo another husbandry-related procedure
When granting approval, the competent authority shall ensure that vessels or other mobile premises where aquaculture animals 
are kept temporarily to be treated or to undergo another husbandry-related procedure comply with the requirements set out in:
(a) point  1 of Part  12 of Annex  I, in relation to biosecurity measures;
(b) point  2 of Part  12 of Annex  I, in relation to facilities and equipment  
TITLE  II
REGISTERS TO BE KEPT BY THE COMPETENT AUTHORITY OF REGISTERED AND APPROVED AQUACULTURE 
ESTABLISHMENTS
CHAPTER 1
Registers of aquaculture establishments kept by the competent authority
Article  20
Information obligation of the competent authority as regards the register of registered aquaculture 
establishments
In addition to the information required by Article  185(2) of R egulation (EU) 2016/429, the competent authority shall include 
the following information in the register of aquaculture establishments provided for in Article  185(1)(a) of that Regulation, 
for each aquaculture establishment it registers:
(a) t he unique registration number assigned to it by the competent authority;
(b) t he date of registration by the competent authority;
(c) t he address and geographical coordinates (latitude and longitude) of the location of the aquaculture establishment;
(d) a descr iption of its facilities and equipment;
(e) cat egories of aquaculture animals which are kept in the aquaculture establishment;
(f) t he approximate number or the maximum biomass or both, of the aquaculture animals which may be kept in the 
aquaculture establishment;
(g) t he period during which aquaculture animals are kept in the aquaculture establishment if it is not continuously occupied, 
including when relevant, information on seasonal occupation or occupation during particular events;
(h) t he date of any cessation of activity when the operator has informed the competent authority thereof  
CHAPTER 2
Registers of aquaculture establishments approved by the competent authority
Article  21
Information obligation of the competent authority as regards the register of approved aquaculture 
establishments
1  In addition to the information required by Article  185(2) of Regulation (EU) 2016/429, the competent authority shall 
include the following information in the register of approved aquaculture establishments provided for in Article  185(1)(b) 
and (c) of that Regulation, for each aquaculture establishment or group of aquaculture establishments it approves:
(a) t he unique approval number assigned to it by the competent authorityOfficial Journal of the European Union L 174/356 EN 3 6 2020
(b) t he date of approval granted by the competent authority or of any suspension or withdrawal of approval by the competent 
authority;
(c) t he address and geographical coordinates (latitude and longitude) of the location of the approved aquaculture establishment 
or group of aquaculture establishments;
(d) a descr iption of its relevant facilities and equipment;
(e) cat egories of aquaculture animals which are kept in the aquaculture establishment or in the group of aquaculture 
establishments;
(f) t he approximate number or the maximum biomass, or both, of the aquaculture animals which may be kept in the 
aquaculture establishment or in the group of aquaculture establishments;
(g) t he period during which aquaculture animals are kept in the aquaculture establishment or group of aquaculture 
establishments if not continuously occupied, including when relevant, information on seasonal occupation or occupation 
during particular events;
(h) t he date of any cessation of activity when the operator has informed the competent authority thereof  
2  In addition to the information required by Article  185(3) of Regulation (EU) 2016/429, the competent authority shall 
include up-to-date information on the health status of the aquaculture animals kept in aquaculture establishments or groups 
of aquaculture establishments which are approved in accordance with Article  181(1) of t hat Regulation, in an internet-based 
information page which is publicly available  
That up-to-date health information shall at least set out the health status of the aquaculture establishment or group of 
aquaculture establishments for each relevant listed disease and for each relevant category thereof, as follows:
(a) whe ther it is free from a category  B disease or category  C disease;
(b) if it is in an eradication programme for a category  B disease or category  C disease;
(c) if it is in a voluntary surveillance programme for a category  C disease; or
(d) an y other information which pertains to a category  B, category  C or category  D disease, other than the information 
which is set out in points  (a), (b) and (c)  
TITLE  III
RECORD-KEEPING OBLIGATIONS OF OPERATORS IN ADDITION TO THOSE PROVIDED FOR IN REGULATION 
(EU) 2016/429
CHAPTER 1
Records to be kept by operators of registered or approved aquaculture establishments
Article  22
Record-keeping obligations of operators of registered aquaculture establishments
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of registered aquaculture 
establishments shall record and keep the following information:
(a) t he unique registration number assigned to the aquaculture establishment by the competent authority;
(b) de tails of any investigations that were carried out following the occurrence of increased mortality or suspicion of the 
presence of disease;
(c) self-declar ation documents issued in accordance with Article  218 of R egulation (EU) 2016/429, received with 
consignments of aquaculture animals which have arrived at the aquaculture establishment or which have been sent 
with such consignments which have been dispatched from the aquaculture establishment, as relevant;
(d) where rele vant, any other documents accompanying aquatic animals  3 6 2020 Official Journal of the European Union L 174/357 EN
Article  23
Record-keeping obligations of operators of approved aquaculture establishments where aquaculture 
animals are kept with a view to their being moved therefrom, either alive or as products of aquaculture 
animal origin other than those which are referred to in Articles  27 to  34
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved aquaculture 
establishments where aquaculture animals are kept with a view to being moved therefrom either alive or as products of 
aquaculture animal origin other than those aquaculture establishments referred to in Articles  27 t o 34 of this Regulation, 
shall record and keep the following information:
(a) t he unique approval number issued to the aquaculture establishment by the competent authority;
(b) t he current risk categorisation of the aquaculture establishment, as assigned by the competent authority;
(c) de tails of the implementation and results of the risk-based surveillance provided for in Article  6(1);
(d) de tails of movements to the aquaculture establishment including:
 (i) t he unique approval or registration number of the aquaculture establishment of origin of all aquaculture animals 
which have been received from another aquaculture establishment; or
 ( ii) t he location of the habitat from which wild aquatic animals have been collected before being dispatched to the 
aquaculture establishment;
(e) de tails of movements from the aquaculture establishment including:
 ( i) aq uaculture animals and products of aquaculture animal origin and, in the case of movements of aquaculture animals, 
including the unique registration or approval number of the aquaculture establishment of destination; or
 (ii) in the case of movements into the wild, details of the habitat into which the aquaculture animals will be released;
(f) t he name and address of transporters who deliver aquatic animals to or collect aquaculture animals from the establishment;
(g) t he biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h) self-declar ation documents issued in compliance with Article  218 of R egulation (EU) 2016/429 received with consignments 
of aquaculture animals which have arrived at the aquaculture establishment or which have been sent with consignments 
which have been dispatched from the aquaculture establishment, as relevant;
(i) where rele vant, any other documents accompanying aquatic animals  
Article  24
Record-keeping obligations of operators of an approved group of aquaculture establishments where 
aquaculture animals are kept with a view to being moved therefrom either alive or as products of 
aquaculture animal origin
1  In addition t o the information required by Article  186(1) of R egulation (EU) 2016/429, operators of aquaculture 
establishments in a group of aquaculture establishments approved in accordance with point  (a) of Ar ticle  177 of R egulation 
(EU) 2016/429 shall record and keep the following information:
(a) t he unique approval number issued to the aquaculture establishment by the competent authority;
(b) t he current risk categorisation of the group of aquaculture establishments, as assigned by the competent authority;
(c) de tails of the implementation and results of the risk-based surveillance provided for in Article  6(2);
(d) de tails of movements to the aquaculture establishment including:
 (i) t he unique approval or registration number of the aquaculture establishment of origin for all aquaculture animals 
which have been received from an aquaculture establishment outside the group; or
 ( ii) t he location of the habitat from which wild aquatic animals have been collected before being dispatched to the 
aquaculture establishment;Official Journal of the European Union L 174/358 EN 3 6 2020
(e) de tails of movements from the group of aquaculture establishments including:
 ( i) aq uaculture animals and products of aquaculture animal origin from aquaculture animals and, in the case of 
movements of aquaculture animals, including the unique registration or approval number of the establishment of 
destination, where aquaculture animals are dispatched to another establishment outside the group; or
 (ii) in the case of movements into the wild, details of the habitat into which the aquaculture animals will be released;
(f) t he name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the aquaculture 
establishment;
(g) de tails of the biosecurity plan employed and evidence of its implementation;
(h) self-declar ation documents issued in compliance with Article  218 of R egulation (EU) 2016/429, received with 
consignments of aquaculture animals which have arrived at the aquaculture establishment or which have been sent 
with consignments which have been dispatched from the aquaculture establishment, as relevant;
(i) where rele vant, any other documents accompanying the aquatic animals  
2  T he operator of a group of aquaculture establishments approved in accordance with point  (b) of Ar ticle  177 of R egulation 
(EU) 2016/429 shall record or keep the information set out in paragraph  1(a) to (i) of this Article  on behalf of each aquaculture 
establishment in the group  
Article  25
Record-keeping obligations of operators of approved confined aquaculture establishments
In addition to the information required by Article  186(1) of R egulation (EU) 2016/429, operators of approved confined 
aquaculture establishments shall record and keep the following information:
(a) t he unique approval number issued to the confined aquaculture establishment by the competent authority;
(b) de tails of movements to and from the confined aquaculture establishment including the unique registration or approval 
number of the aquaculture establishment of origin or destination of all aquaculture animals received from or dispatched 
to another aquaculture establishment;
(c) t he name and address of transporters who deliver aquaculture animals to, or collect aquaculture animals from, the 
confined aquaculture establishment;
(d) de tails of the implementation and results of the disease surveillance plan provided for in point  2 of Part  3 of Anne x I;
(e) t he results of clinical and laboratory tests and of post-mortem examinations completed when increased mortalities or 
suspicion of the presence of disease are investigated;
(f) where rele vant, details of the vaccination or treatment of aquaculture animals provided for in point  2(c) of P art 3 of 
Annex  I;
(g) de tails of isolation or quarantine of incoming aquaculture animals, instructions, if any, of the competent authority as 
regards isolation and quarantine and relevant observations made during any isolation or quarantine period;
(h) t he biosecurity plan for the confined aquaculture establishment;
(i) where rele vant, any other documents accompanying the aquaculture animals  
Article  26
Record-keeping obligations of operators of disease control aquatic food establishments
In addition to the information required by Article  187(1) of R egulation (EU) 2016/429, operators of disease control aquatic 
food establishments shall record and keep the following information:
(a) t he unique approval number issued to the disease control aquatic food establishment by the competent authority;
(b) t he biosecurity plan for the disease control aquatic food establishment and evidence of its implementation;3 6 2020 Official Journal of the European Union L 174/359 EN
(c) maint enance records for the waste water treatment system used in the disease control aquatic food establishment;
(d) recor ds to verify the efficacy of the water treatment system;
(e) t he name and address of transporters who deliver aquatic animals to the disease control aquatic food establishment;
(f) where rele vant, any other documents accompanying the aquatic animals  
Article  27
Record-keeping obligations of operators of approved purification centres
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved purification 
centres shall record and keep the following information:
(a) t he unique approval number issued to the approved purification centre by the competent authority;
(b) t he biosecurity plan for the approved purification centre and evidence of its implementation;
(c) maint enance records for the waste water treatment system used in the approved purification centre;
(d) recor ds to verify the efficacy of the water treatment system;
(e) where rele vant, any other documents accompanying aquatic animals  
Article  28
Record-keeping obligations of operators of approved dispatch centres
In addition to the information required by Article  186(1) of R egulation (EU) 2016/429, operators of approved dispatch 
centres shall record and keep the following information:
(a) t he unique approval number issued to the approved dispatch centre by the competent authority;
(b) t he biosecurity plan for the approved dispatch centre and evidence of its implementation;
(c) maint enance records for the waste water treatment system used in the approved dispatch centre;
(d) recor ds to verify the efficacy of the water treatment system;
(e) where rele vant, any other documents accompanying aquatic animals  
Article  29
Record-keeping obligations of operators of approved relaying areas
In addition to the information required by Article  186(1) of R egulation (EU) 2016/429, operators of approved relaying areas 
shall record and keep the following information:
(a) t he unique approval number issued to the approved relaying area by the competent authority;
(b) t he biosecurity plan for the approved relaying area and evidence of its implementation;
(c) where rele vant, any other documents accompanying aquatic animals  
Article  30
Record-keeping obligations of operators of approved quarantine establishments for aquaculture animals
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved quarantine 
establishments for aquaculture animals shall record and keep the following information:
(a) t he unique approval number issued to the quarantine establishment by the competent authority;Official Journal of the European Union L 174/360 EN 3 6 2020
(b) de tails of movements to the approved quarantine establishment including:
 (i) t he unique registration or approval number of the aquaculture establishment of origin of all aquaculture animals 
received from another aquaculture establishment; or
 ( ii) t he location of the habitat from which aquatic animals have been collected before being dispatched to the approved 
quarantine establishment;
(c) de tails of movements from the approved quarantine establishment including:
 (i) t he unique registration or approval number of the aquaculture establishment of destination; or
 (ii) t he location of the habitat into which aquaculture animals have been released into the wild;
(d) t he name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved 
quarantine establishment;
(e) de tails of the implementation and results of the disease surveillance provided for in point  2 of Part  8 of Anne x I;
(f) t he results of clinical and laboratory tests and of post-mortem examinations provided for in point  2 of P art 8 of Annex  I;
(g) ins tructions, if any, of the competent authority as regards observations made during any isolation or quarantine period;
(h) t he biosecurity plan for the approved quarantine establishment and evidence of its implementation;
(i) e vidence showing that the environmental parameters in the approved quarantine establishment are conducive to the 
expression of the relevant listed or emerging disease(s);
(j) where rele vant, any other documents accompanying the aquatic animals  
Article  31
Record-keeping obligations of operators of approved aquaculture establishments keeping aquaculture 
animals of listed species which are vectors in isolation, until such time as they are no  long er regarded as 
vectors
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved aquaculture 
establishments keeping aquaculture animals of listed species which are vectors in isolation, until such time as they are 
no longer regarded as vectors, shall record and keep the following information:
(a) t he unique approval number issued to the aquaculture establishment by the competent authority;
(b) de tails of movements to the approved aquaculture establishment including:
 (i) t he unique registration or approval number of the aquaculture establishment of origin of all aquaculture animals 
received from another aquaculture establishment; or
 ( ii) t he location of the habitat from which aquatic animals have been collected before being dispatched to the approved 
aquaculture establishment;
(c) de tails of movements from the approved aquaculture establishment including:
 (i) t he unique registration or approval number of the aquaculture establishment of destination; or
 (ii) in the case of movements into the wild, details of the habitat into which the aquaculture animals will be released;
(d) t he name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved 
aquaculture establishment;
(e) de tails of the implementation and results of the disease surveillance provided for in point  2 of Part  9 of Anne x I;
(f) t he results of clinical and laboratory tests and of post-mortem examinations provided for in point  2 of P art 9 of Annex  I;
(g) ins tructions, if any, of the competent authority as regards observations made during the 90  day isolation period referred 
to in point  2 of Part  9 of Anne x I;
(h) t he biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(i) where rele vant, any other documents accompanying the aquatic animals  3 6 2020 Official Journal of the European Union L 174/361 EN
Article  32
Record-keeping obligations of operators of approved aquaculture establishments which are closed 
facilities keeping aquaculture animals for ornamental purposes
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved aquaculture 
establishments which are closed facilities keeping aquaculture animals for ornamental purposes shall record and keep the 
following information:
(a) t he unique approval number issued to the aquaculture establishment by the competent authority;
(b) t he current risk categorisation of the approved aquaculture establishment, as assigned by the competent authority;
(c) de tails of the implementation and results of the risk based surveillance provided for in Article  6(1), where relevant;
(d) de tails of movements to the approved aquaculture establishment including the unique registration or approval number 
of the aquaculture establishment of origin of all aquaculture animals received from another aquaculture establishment;
(e) de tails of movements from the approved aquaculture establishment, including the unique registration or approval number 
of the aquaculture establishment of destination other than when these movements take place to households;
(f) t he name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved 
aquaculture establishment, other than when these movements take place to households;
(g) t he biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h) self-declar ation documents issued in accordance with Article  218 of R egulation (EU) 2016/429, received with consignments 
of aquaculture animals which have arrived at the approved aquaculture establishment or which have been sent with 
consignments which have been dispatched from the approved aquaculture establishment, as relevant;
(i) where rele vant, any other documents accompanying aquaculture animals  
Article  33
Record-keeping obligations of operators of approved aquaculture establishments which are open facilities 
keeping aquaculture animals for ornamental purposes
In addition to the information required by Article  186(1) of Regulation (EU) 2016/429, operators of approved aquaculture 
establishments which are open facilities keeping aquaculture animals for ornamental purposes shall record and keep the 
following information:
(a) t he unique approval number issued to the aquaculture establishment by the competent authority;
(b) t he current risk categorisation of the approved aquaculture establishment, as assigned by the competent authority;
(c) de tails of the implementation and results of the risk based surveillance provided for in Article  6(1), where relevant;
(d) de tails of movements to the approved aquaculture establishment including the unique registration or approval number 
of the aquaculture establishment of origin of all aquaculture animals which have been received from another aquaculture 
establishment;
(e) de tails of movements from the approved aquaculture establishment including the unique registration or approval number 
of the aquaculture establishment of destination except when these movements take place to households;
(f) t he name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved 
aquaculture establishment, other than when these movements take place to households;
(g) t he biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h) self-declar ation documents issued in accordance with Article  218 of R egulation (EU) 2016/429, received with consignments 
of aquaculture animals which have arrived at the approved aquaculture establishment or which have been sent with 
consignments which have been dispatched from the approved aquaculture establishment, as relevant;
(i) where rele vant, any other documents accompanying aquatic animals  Official Journal of the European Union L 174/362 EN 3 6 2020
Article  34
Record-keeping obligations of operators of approved vessels or other approved mobile premises where 
aquaculture animals are kept temporarily to be treated or to undergo another husbandry-related procedure
In addition to the information required by Article  186(1) of R egulation (EU) 2016/429, operators of approved vessels or other 
approved mobile premises where aquaculture animals are kept temporarily to be treated or to undergo another husbandry-
related procedure, shall record and keep the following information:
(a) t he unique approval number issued to the vessel or other mobile premises by the competent authority;
(b) t he dates and times of loading of aquaculture animals at the approved vessel or other approved mobile premises;
(c) where rele vant, the name, address and unique registration or approval number of each aquaculture establishment where 
aquaculture animals were loaded and unloaded;
(d) t he dates and places at which the vessel or other mobile premises was filled with water before loading and where relevant, 
exchanged between loading and unloading;
(e) where rele vant, details of the route taken between one aquaculture establishment and another;
(f) de tails of each treatment or husbandry-related procedure which takes place in the approved vessel or other approved 
mobile premises;
(g) t he biosecurity plan for the approved vessel or other approved mobile premises and evidence of its implementation;
(h) where rele vant, any other documents accompanying aquaculture animals  
CHAPTER 2
Records to be kept by transporters
Article  35
Record-keeping obligations of transporters of aquatic animals
In addition to the information required by Article  188 of Regulation (EU) 2016/429, transporters of aquatic animals shall 
record and keep the following information for each means of transport used to move aquatic animals:
(a) its licence plate number in the case of transport by land, its IMO ship identification number in the case of transport by 
sea, or any other means of identification which uniquely identifies other means of transport in which aquatic animals 
are transported;
(b) t he dates and times of loading of aquatic animals at the aquaculture establishment or habitat of origin;
(c) t he name, address and unique registration or approval number of each aquaculture establishment visited;
(d) t he location of each habitat from which wild aquatic animals were collected;
(e) t he dates and times of unloading of aquatic animals at the aquaculture establishment or habitat of destination;
(f) t he dates, times and places of water exchange, when this has occurred;
(g) t he biosecurity plan for the means of transport and evidence of its implementation;
(h) t he reference numbers of the documents accompanying the consignments of aquatic animals  
PART  III
TRANSITIONAL AND FINAL PROVISIONS
Article  36
Repeal
Decision 2008/392/EC is repealed with effect from 21 Apr il  2021  
References to the repealed act shall be construed as references to this Regulation  3 6 2020 Official Journal of the European Union L 174/363 EN
Article  37
Transitional measures regarding the information in the registers of existing aquaculture establishments 
and operators kept by competent authorities
Member States shall ensure that, for the existing aquaculture establishments and operators referred to in Article  279(1) of 
Regulation (EU) 2016/429 which fall within the scope of Articles  20 and 21 of this Regulation, the information required 
by Articles  20 and 21 has been included for each such aquaculture establishment and operator in the registers of registered 
and approved aquaculture establishments kept by competent authorities before 21 Apr il  2021  
Article  38
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, 30 Januar y  2020  
For the Commission
The President
Ursula VON DER LEYENOfficial Journal of the European Union L 174/364 EN 3 6 2020
ANNEX  I
REQUIREMENTS FOR GRANTING APPROVAL OF AQUACULTURE ESTABLISHMENTS, AS REFERRED TO IN 
CHAPTER 2 OF TITLE  I OF PART  II
PART 1
Requirements for granting approval of aquaculture establishments where aquaculture animals are kept 
with a view to being moved therefrom either alive or as products of aquaculture animal origin as referred 
to in Article  7
1  T he requirements in relation to biosecurity measures of aquaculture establishments where aquaculture animals are kept 
with a view to being moved therefrom either alive or as products of aquaculture animal origin as referred to in point  (b) 
of Article  7, shall be the following:
(a) oper ators shall implement a biosecurity plan in accordance with Article  5, which must take the following elements 
into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the aquaculture establishment;
 (ii) wh ere the following functional units exist within the same aquaculture establishment, they must be separated 
using appropriate hygiene barriers:
— hatc hery units,
— f attening units,
— pr ocessing units,
— dispatc h centre;
 (iii) w ork clothing and footwear for personnel must be kept solely for use at the aquaculture establishment and 
cleaned and disinfected regularly;
 ( iv)  eq uipment must not be shared between aquaculture establishments but where this is unavoidable, an appropriate 
protocol for cleaning and disinfection of the equipment must be followed;
 ( v)  visit ors to the aquaculture establishment must be controlled in cases where they pose a disease risk; these 
visitors must either:
— w ear protective clothing and footwear provided at the aquaculture establishment, or
— clean and dis infect any protective clothing and footwear they bring onto the aquaculture establishment 
on arrival and in the case of non-disposable clothing and footwear, on departure;
 ( vi)  dead animals mus t be removed from all production units at a frequency that ensures infective pressure is kept 
to a minimum but which is practicable given the production method used, and disposed of in compliance with 
Article  13 of Regulation (EC) No  1069/2009 of the European Parliament and of the Council  (1);
 (vii) as f ar as possible, equipment in the aquaculture establishment must be cleaned and disinfected at the end of 
each production cycle;
 ( viii)  wh ere aquaculture establishments receive fertilised eggs from other establishments, and where biologically 
feasible, these eggs must be disinfected appropriately on arrival and all packaging must be disinfected or 
disposed of in a biosecure manner;
 ( ix)  t he cleaning and disinfection records of transporters must be verified before aquatic animals are loaded or 
unloaded at the aquaculture establishment;
(b) oper ators shall nominate a named person to be in charge of implementing the biosecurity plan for the aquaculture 
establishment with other personnel reporting to that individual in relation to biosecurity matters  
(1) 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) 3 6 2020 Official Journal of the European Union L 174/365 EN
2  T he requirements in relation to facilities and equipment of aquaculture establishments as referred to in point  (c) of 
Article  7, shall be the following:
(a) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the aquaculture animals kept on the aquaculture establishment;
(b) t he aquaculture establishment must provide for good standards of hygiene and allow adequate health monitoring to 
be carried out;
(c) as far as possible, equipment and facilities must be made from materials which can be appropriately cleaned and 
disinfected;
(d) ap propriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose and the environmental constraints of the aquaculture establishment;
(e) appr opriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of 
transport  
PART 2
Requirements for granting approval of groups of aquaculture establishments where aquaculture animals 
are kept with a view to being moved therefrom either alive or as products of aquaculture animal origin 
as referred to in Article  8
1  T he requirements in relation to biosecurity measures of groups of aquaculture establishments where aquaculture animals 
are kept with a view to being moved therefrom as referred to in point  (b) of Article  8, shall be the following:
(a) oper ators shall implement a biosecurity plan in accordance with Article  5, and in de veloping their biosecurity plan, 
the operators must take the following elements into consideration:
 (i) disinf ection points  mus t be installed at critical locations in each aquaculture establishment in the group;
 (ii) wh ere the following functional units exist within the same aquaculture establishment, they must be separated 
using appropriate hygiene barriers:
— hatc hery units,
— f attening units,
— pr ocessing units,
— dispatc h centre;
 (iii) w ork clothing and footwear for personnel must be kept solely for use at each aquaculture establishment and 
cleaned and disinfected regularly;
 ( iv)  eq uipment must not be shared between aquaculture establishments but where this is unavoidable, an appropriate 
protocol for cleaning and disinfection of the equipment must be followed;
 ( v)  visit ors to the aquaculture establishment must be controlled where they pose a disease risk; these visitors must 
either:
— w ear protective clothing and footwear provided at each aquaculture establishment, or
— clean and dis infect any protective clothing and footwear they bring onto the aquaculture establishment 
on arrival and in the case of non-disposable clothing and footwear, on departure;
 ( vi)  dead aq uaculture animals must be removed from all production units at a frequency that ensures infective 
pressure is kept to a minimum but which is practicable given the production method used, and disposed of 
in compliance with Article  13 of Regulation (EC) No  1069/2009;
 (vii) as f ar as possible, equipment in each aquaculture establishment must be cleaned and disinfected at the end of 
each production cycle;Official Journal of the European Union L 174/366 EN 3 6 2020
 ( viii)  wh ere aquaculture establishments receive fertilised eggs from other establishments, and where biologically 
feasible, these eggs must be disinfected appropriately on arrival and all packaging must be disinfected or 
disposed of in a biosecure manner;
 (ix) t he cleaning and disinfection records of transporters must be verified before aquaculture animals are loaded 
or unloaded at the aquaculture establishment;
(b) responsibility for the implementation of the measures set out in the biosecurity plan shall be with:
 ( i) t he operator of each individual aquaculture establishment in a group of aquaculture establishments approved in 
accordance with point  (a) of Article  177 of Regulation (EU) 2016/429;
 (ii) t he operator of a group of aquaculture establishments approved in accordance with point  (b) of Article  177 of 
Regulation (EU) 2016/429  
2  T he requirements in relation to facilities and equipment of groups of aquaculture establishments as referred to in point  (c) 
of Article  8, shall be the following:
(a) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the aquaculture animals kept in each aquaculture establishment in the group;
(b) eac h aquaculture establishment in the group must have good standards of hygiene and allow health monitoring to 
be carried out;
(c) eq uipment and facilities in each aquaculture establishment in the group must be made from materials which can be 
readily cleaned and disinfected;
(d) appr opriate predator control measures must be put in place in each aquaculture establishment in the group, taking 
into account the risk of disease spread these predators pose and the environmental constraints of the aquaculture 
establishment;
(e) ap propriate equipment must be available in each aquaculture establishment in the group for cleaning and disinfection 
of facilities, equipment and means of transport  
PART 3
Requirements for granting approval of confined aquaculture establishments referred to in Article  9
1  T he requirements in relation to the biosecurity measures of confined aquaculture establishments as referred to in point  (b) 
of Article  9, shall be the following:
(a) op erators shall implement the biosecurity plan in accordance with Article  5, whic h must take the following elements 
into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the confined aquaculture establishment;
 (ii) where dif ferent functional units exist within the same confined aquaculture establishment, they must be kept 
separate using hygiene barriers;
 ( iii)  w ork clothing and footwear for personnel must be kept at the confined aquaculture establishment and cleaned 
and disinfected regularly;
 (iv) visit ors must wear protective clothing and footwear provided by the operator;
 (v) eq uipment shall not be shared with other aquaculture establishments;
 ( vi)  dead animals must be removed at a frequency that ensures infective pressure is kept to a minimum, and disposed 
of in compliance with Article  13 of Regulation (EC) No  1069/2009;
 (vii) t he equipment in the confined aquaculture establishment must be cleaned and disinfected at an appropriate 
frequency;3 6 2020 Official Journal of the European Union L 174/367 EN
 ( viii)  where conf ined aquaculture establishments receive fertilised eggs from other establishments, where biologically 
feasible and where it does not interfere with research objectives, these eggs must be disinfected appropriately 
on arrival, and all packaging must be disinfected or disposed of in a biosecure manner;
 (ix) t he cleaning and disinfection records of transporters must be verified before aquaculture animals are loaded 
or unloaded at the establishment;
(b) op erators shall nominate a named person to be in charge of implementing the biosecurity plan for the confined 
aquaculture establishment with other personnel reporting to that individual in relation to biosecurity matters  
2  T he requirements in relation to surveillance and control measures of confined aquaculture establishments as referred to 
in point  (c) of Article  9, shall be the following:
(a) a disease sur veillance plan must be implemented, which must include appropriate controls for diseases of aquaculture 
animals, and it must be updated according to the number and species of the aquaculture animals present in the 
confined aquaculture establishment, and to the epidemiological situation in and around the confined aquaculture 
establishment as regards listed and emerging diseases;
(b) aq uaculture animals suspected of being infected with listed or emerging disease agents must be subjected to clinical, 
laboratory or post-mortem testing;
(c) t he vaccination and treatment of aquaculture animals against transmissible diseases is carried out as appropriate  
3  T he requirements in relation to facilities and equipment of confined aquaculture establishments as referred to in point  (d) 
of Article  9, shall be the following:
(a) t he boundaries of the confined aquaculture establishments must be clearly demarcated and the access of aquatic 
animals and humans to animal facilities must be controlled;
(b) where necessar y, adequate facilities suited for the quarantine of aquaculture animals introduced from other 
establishments must be available;
(c) adeq uate means for isolating aquaculture animals must be available;
(d) t anks and other holding facilities must be of a suitable standard and constructed so that:
 ( i) cont act with aquatic animals outside is prevented and that inspections and any necessary treatments can be 
easily carried out;
 (ii) f loors, walls and all other material or equipment can be readily cleaned and disinfected;
(e) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the aquaculture animals kept in the confined aquaculture establishment;
(f) t he confined aquaculture establishment must provide for good standards of hygiene and allow adequate health 
monitoring to be carried out;
(g) ap propriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of 
transport;
(h) appr opriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose;
(i) ap propriate disinfection equipment must be in place to ensure that all wastewater which is discharged from the 
confined aquaculture establishment is treated to a level  which ensures that any infectious agents of listed or emerging 
diseases which are present are fully inactivated before discharge  Official Journal of the European Union L 174/368 EN 3 6 2020
PART 4
Requirements for granting approval of disease control aquatic food establishments referred to in 
Article  11
1  Th e requirements in relation to biosecurity measures of disease control aquatic food establishments as referred to in 
point  (a) of Article  11, shall be the following:
(a) ope rators shall implement the biosecurity plan for the disease control aquatic food establishment in accordance with 
Article  5, whic h must take account of at least the following elements when animals which are infected with a listed 
or emerging disease are slaughtered or processed on the premises:
 (i) visit ors to the establishment must be avoided, but when such visits are unavoidable, they must be controlled 
and protective clothing and footwear must be provided by the operator which are safely disposed of or cleaned 
and disinfected after use;
 (ii) t he personnel of the disease control aquatic food establishment must wear work clothing and footwear which 
must be cleaned and disinfected at an appropriate frequency;
 (iii) an ap propriate disinfection system must be in place to ensure that waste water from the disease control aquatic 
food establishment is appropriately treated so that any disease agents which are present are inactivated before 
the water is discharged;
 ( iv) an ap propriate system must be in place to ensure the collection and appropriate disposal of animal by-products; 
such by-products shall be processed as Category  1 or Category  2 material in compliance with Article  12 or 
Article  13 of Regulation (EC) No  1069/2009;
 ( v) appr opriate cleaning and disinfecting operations must be completed prior to the arrival of any new consignment 
of aquatic animals for processing;
 ( vi) ap propriate measures must be in place to ensure that all means of transport and their containers which are used 
to deliver aquatic animals to a disease control aquatic food establishment are cleaned and disinfected before they 
leave the establishment  
2  T he requirements in relation to facilities and equipment of disease control aquatic food establishments as referred to in 
point  (b) of Article  11, shall be the following:
(a) f loors, walls and all other material or equipment must be easily cleaned and disinfected;
(b) ap propriate disinfection equipment must be in place to ensure that all waste water which is discharged from the 
disease control aquatic food establishment is treated to a level  whic h ensures that any infectious agents of listed or 
emerging diseases which are present are fully inactivated before discharge;
(c) ap propriate equipment, compatible with the type of production activities conducted, must be available for the 
cleaning and disinfection of facilities, equipment and means of transport;
(d) ap propriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose  
PART 5
Requirements for granting approval of purification centres as referred to in Article  12
1  Th e requirements in relation to biosecurity measures of purification centres as referred to in point  (a) of Ar ticle  12, shall 
be the following
(a) op erators shall implement the biosecurity plan in accordance with Article  5, whic h must take the following elements 
into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the purification centre;
 ( ii) t he work clothing and footwear for personnel must be kept solely for use at the purification centre and cleaned 
and disinfected regularly;
 (iii) eq uipment must not be shared between establishments but where this is unavoidable, an appropriate protocol 
for cleaning and disinfection of the equipment must be put in place;3 6 2020 Official Journal of the European Union L 174/369 EN
 ( iv) visit ors to the purification centre must be controlled where they pose a risk for the spread of disease; these 
visitors must either:
— w ear protective clothing and footwear provided at the purification centre; or
— clean and disinfect any protective clothing and footwear they bring onto the purification centre on arrival 
and in the case of non-disposable clothing and footwear, on departure;
 (v) eq uipment in the purification centre must be cleaned and disinfected at the end of the purification cycle;
 ( vi) was tewater from the purification centre must not be discharged without appropriate treatment directly into 
water bodies when the health status of aquatic animals may be jeopardised with respect to listed or emerging 
diseases  
2  T he requirements in relation to facilities and equipment of purification centres as referred to in point  (b) of Article  12, 
shall be the following:
(a) t he purification centre must provide for good standards of hygiene;
(b) eq uipment and facilities must be made from materials which can be appropriately cleaned and disinfected;
(c) ap propriate equipment must be available for cleaning and disinfection of facilities, equipment and means of transport;
(d) ap propriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose;
(e) ap propriate disinfection equipment must be put in place to ensure that wastewater which is discharged from the 
purification centre is treated when required to ensure that any agents of listed or emerging diseases which are present 
are inactivated prior to discharge  
PART 6
Requirements for granting approval of dispatch centres as referred to in Article  13
1  T he requirements in relation to biosecurity measures of dispatch centres as referred to in point  (a) of Ar ticle  13, sh all be 
the following:
(a) op erators shall implement the biosecurity plan in accordance with Article  5, whic h must take the following elements 
into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the dispatch centre;
 (ii) w ork clothing and footwear for personnel must be kept solely for use at the dispatch centre and cleaned and 
disinfected regularly;
 (iii) eq uipment must not be shared between establishments but where this is unavoidable, an appropriate protocol 
for cleaning and disinfection of the equipment must be put in place;
 ( iv) visit ors to the dispatch centre must be controlled in cases where they pose a risk for the spread of disease; these 
visitors must either:
— w ear protective clothing and footwear provided at the establishment, or
— clean and disinfect any protective clothing and footwear they bring onto the establishment on arrival and 
in the case of non-disposable clothing and footwear, on departure;
 (v) eq uipment in the dispatch centre must be cleaned and disinfected at the end of the dispatch operation;
 (vi) was tewater from the dispatch centre must not be discharged without appropriate treatment directly into water 
bodies when the health status of aquatic animals may be jeopardised with respect to listed or emerging diseases  
2  T he requirements in relation to facilities and equipment of dispatch centres as referred to in point  (b) of Ar ticle  13, sh all 
be the following:
(a) t he dispatch centre must provide for good standards of hygiene;
(b) eq uipment and facilities must be made from materials which can be appropriately cleaned and disinfected;Official Journal of the European Union L 174/370 EN 3 6 2020
(c) ap propriate equipment must be available for cleaning and disinfection of facilities, equipment and means of transport;
(d) ap propriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose;
(e) ap propriate disinfection equipment must be in place to ensure that waste water which is discharged from the 
dispatch centre is treated when required to ensure that any agents of listed or emerging diseases which are present 
are inactivated prior to discharge  
PART 7
Requirements for granting approval of relaying areas as referred to in Article  14
1  T he requirements in relation to biosecurity measures of relaying areas as referred to in point  (a) of Ar ticle  14, shall be 
the following:
(a) op erators shall implement the biosecurity plan in accordance with Article  5, whic h must take the following elements 
into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the relaying area;
 ( ii) w ork clothing and footwear for personnel must be kept solely for use at the relaying area and cleaned and 
disinfected regularly;
 (iii) eq uipment must not be shared between aquaculture establishments but in cases where this is unavoidable, an 
appropriate protocol for cleaning and disinfection of the equipment must be put in place;
 (iv) visit ors to the relaying area must be controlled in cases where they pose a risk for the spread of disease; these 
visitors must either:
— w ear protective clothing and footwear provided at the relaying area, or
— clean and dis infect any protective clothing and footwear they bring onto the relaying area on arrival and 
in the case of non-disposable clothing and footwear, on departure;
 (v) as far as possible, equipment in the relaying area must be cleaned and disinfected at the end of the purification 
cycle  
2  T he requirements in relation to facilities and equipment of relaying areas as referred to in point  (b) of Article  14, shall 
be the following:
(a) as f ar as possible, the relaying area must provide for good standards of hygiene;
(b) as f ar as possible, equipment and facilities must be made from materials which can be appropriately cleaned and 
disinfected;
(c) appr opriate equipment must be available for cleaning and disinfection of facilities where relevant, and equipment 
and means of transport;
(d) ap propriate predator control measures must be put in place, taking into account the risk of disease spread these 
predators pose and the environmental constraints of the relaying area  
PART 8
Requirements for granting approval of quarantine establishments as referred to in Article  15
1  T he requirements in relation to biosecurity measures of quarantine establishments for aquatic animals as referred to in 
point  (a) of Article  15 shall be the following:
(a) t he quarantine establishment must be located at a secure distance from other quarantine establishments, aquaculture 
establishments or groups of aquaculture establishments by a distance specified by the competent authority on the 
basis of a risk assessment which must take into account the epidemiology of the relevant listed and emerging diseases;3 6 2020 Official Journal of the European Union L 174/371 EN
(b) t he operator shall implement the biosecurity plan which is provided for in Article  5 and whic h must include at least 
the following elements:
 (i) disinf ection points  mus t be installed at critical locations as identified in the biosecurity plan;
 ( ii)  where t hey exist within the same quarantine establishment, measures must be taken to ensure that quarantine 
units remain epidemiologically separate from each other;
 ( iii)  w ork clothing and footwear for personnel must be kept at the quarantine establishment and cleaned and 
disinfected regularly;
 ( iv)  eq uipment must not be shared between quarantine units within the quarantine establishment, but in cases 
where this is unavoidable, an appropriate protocol for cleaning and disinfection of the equipment must be 
put in place; equipment must not be shared with other establishments;
 (v) onl y authorised persons may enter the quarantine establishment;
 (vi) per sons entering the quarantine establishment must wear the protective clothing and footwear provided and 
these must be safely disposed of or cleaned and disinfected after use;
 ( vii)  dead animals mu st be removed from all quarantine units at a frequency that ensures infective pressure is kept to 
a minimum and disposed of as Category  1 or Category  2 material in compliance with Article  12 or Ar ticle  13 
of Regulation (EC) No  1069/2009;
 (viii)  all eq uipment in the quarantine establishments must be cleaned and disinfected at the end of each quarantine 
period;
 ( ix)  t he required quarantine period must start when the last aquatic animal in the cohort to be quarantined is 
introduced;
 (x) eac h quarantine unit must be emptied of animals, cleaned and disinfected at the end of the quarantine period 
and be kept free of animals for a period of at least seven  days before new aquatic animals are introduced;
 (xi) pr ecautions must be taken to prevent cross-contamination between incoming and outgoing consignments of 
aquatic animals;
 ( xii)  animals released fr om the quarantine establishment must meet the requirements for movements of aquaculture 
animals between Member States;
(c) a named per son must be in charge of implementing the biosecurity plan for the quarantine establishment with other 
personnel reporting to that individual in relation to biosecurity matters, where necessary  
2  Th e requirements in relation to surveillance and control measures of quarantine establishments for aquaculture animals, 
as referred to in point  (b) of Article  15, shall be the following:
(a) en vironmental conditions which are conducive to the clinical expression of the relevant listed or emerging disease 
must be kept in the quarantine establishment throughout the entire quarantine period;
(b) all aq uaculture animals that die or show symptoms of disease during the quarantine period must be clinically inspected 
by a veterinarian and testing of samples must be carried out at a laboratory designated by the competent authority 
for that purpose;
(c) f ish, molluscs and crustaceans of listed species must be quarantined under the conditions set out in point  (a) f or a 
period of at least 90  days;
(d) wit hin a period of 15  days from the date of expiry of the quarantine period, samples must be taken from a number 
of aquaculture animals that will ensure the detection of the relevant pathogen with a 95  % conf idence if the target 
prevalence is 2  %  These aquaculture animals may be taken from the cohort which is undergoing quarantine or from 
co-habiting sentinel aquaculture animals which are susceptible to the relevant listed or emerging disease and which 
are used as a diagnostic aid during the quarantine period  
3  T he requirements in relation to facilities and equipment of quarantine establishments for aquaculture animals, as referred 
to in point  (c) of Article  15, shall be the following:
(a) t he water supply to the quarantine establishment must be free of agents of the relevant listed or emerging disease;Official Journal of the European Union L 174/372 EN 3 6 2020
(b) t he waste water from the quarantine establishment must be treated appropriately to ensure that the infectious agent(s) 
of listed and emerging diseases are inactivated before discharge;
(c) t he waste water treatment system must be fitted with a fail-safe backup mechanism to ensure its continuous operation 
and the complete containment of the relevant infectious agent(s);
(d) t he quarantine establishments must be clearly demarcated and the access of animals and humans must be controlled;
(e) s taff responsible for carrying out veterinary checks must have sufficiently equipped premises at their disposal, where 
necessary, including changing rooms and showers;
(f) adeq uate means for isolating aquaculture animals must be available for use when required;
(g) f loors, walls and all other material or equipment must be constructed so that they can be adequately cleaned and 
disinfected;
(h) an appr opriate system must be in place to ensure the collection and appropriate disposal of animal by-products in 
compliance with Article  13 of Regulation (EC) No  1069/2009;
(i) appr opriate predator control measures are put in place, taking into account the risk of disease spread that these 
predators pose;
(j) t he part of the quarantine establishment accommodating the aquaculture animals must be of a suitable standard 
and so constructed that contact with water and animals outside is prevented and that inspection and any necessary 
husbandry procedures can be easily carried out  
PART 9
Requirements for granting approval of aquaculture establishments keeping aquaculture animals of vector 
species in isolation, until such time as they are no  long er regarded as vectors, as referred to in Article  16
1  T he requirements in relation to biosecurity measures of aquaculture establishments keeping aquaculture animals of listed 
species which are vectors in isolation until such time as they are no  long er regarded as vectors, as referred to in point  (a) 
of Article  16 shall be the following:
(a) oper ators shall implement the biosecurity plan in accordance Article  5, whic h must include at least the following 
elements:
 (i) disinf ection points  mus t be installed at critical locations in the aquaculture establishment;
 (i i)  wh ere different isolation units exist within the same aquaculture establishment, appropriate measures must 
be taken to ensure they remain epidemiologically separate from each other;
 (iii) w ork clothing and footwear for personnel must be kept solely for use at the aquaculture establishment and 
cleaned and disinfected regularly;
 (iv) eq uipment must not be shared between isolation units within the aquaculture establishment but where this 
is unavoidable, an appropriate protocol for cleaning and disinfection of the equipment must be put in place; 
equipment must not be shared with other establishments;
 (v) onl y authorised persons must enter the aquaculture establishment;
 (vi) p ersons entering the aquaculture establishment must wear the protective clothing and footwear provided and 
these must be safely disposed of or cleaned and disinfected after use;
 ( vii)  dead animals mus t be removed from all production units in the establishment at a frequency that ensures 
infective pressure is kept to a minimum, and must be disposed of in compliance with Article  13 of R egulation 
(EC) No  1069/2009;
 ( viii)  all eq uipment in the aquaculture establishment, or in the relevant isolation unit, if the aquaculture establishment 
consists of more than one such unit, must be cleaned and disinfected at the end of each isolation period;
 (ix) t he isolation period referred to in point  2 shall onl y start when the last animal in the cohort is introduced to 
the aquaculture establishment, or when there are a number of isolation units in the aquaculture establishment, 
the isolation period shall only start when the last animal in the cohort is introduced to the isolation unit;3 6 2020 Official Journal of the European Union L 174/373 EN
 (x) eac h isolation unit in the aquaculture establishment must be emptied of animals, and cleaned and disinfected 
at the end of the isolation period;
 (xi) pr ecautions must be taken to prevent cross-contamination between incoming and outgoing consignments of 
aquatic animals;
 (xii) animals released from the aquaculture establishment in which the isolation period has been undergone shall 
meet the requirements for movements of aquatic animals between Member States  
(b) oper ators shall ensure that a named person is charged with implementing the biosecurity plan for the aquaculture 
establishment with other personnel reporting to that individual in relation to biosecurity matters, where necessary  
2  T he requirements in relation to surveillance and control measures of establishments keeping aquaculture animals of listed 
species which are vectors in isolation until such time as they are no  long er regarded as vectors, as referred to in point  (b) 
of Article  16, shall be the following:
(a) f ish, molluscs and crustaceans of listed species shall be kept in isolation for a period of at least 90  days;
(b) all aq uaculture animals that die or show symptoms of disease during the 90  day isolation period must be clinically 
inspected by a veterinarian and testing of samples must be carried out at a laboratory designated by the competent 
authority for that purpose  
3  T he requirements in relation to facilities and equipment of aquaculture establishments keeping aquaculture animals of 
listed species which are vectors in isolation until such time as they are no  long er regarded as vectors, as referred to in 
point  (c) of Article  16, shall be the following:
(a) adeq uate means of keeping aquaculture animals in isolation must be available;
(b) t he water supply to the aquaculture establishment must be free of listed species and of agents of the relevant listed 
and emerging diseases;
(c) wh ere this is necessary so as not to jeopardise the health status of receiving waters, the waste water from the 
aquaculture establishment must be treated appropriately to ensure that the infectious agent(s) of listed and emerging 
diseases are inactivated before discharge;
(d) t he access of animals to the aquaculture establishment is controlled;
(e) f loors, walls and all other material or equipment are constructed so that they can be adequately cleaned and disinfected;
(f) an ap propriate system is in place to ensure the collection and appropriate disposal of animal by-products in compliance 
with Article  13 of Regulation (EC) No  1069/2009;
(g) ap propriate predator control measures are put in place, taking into account the risk of disease spread that these 
predators pose  
PART 10
Requirements for granting approval of aquaculture establishments which are closed facilities keeping 
aquaculture animals for ornamental purposes as referred to in Article  17
1  T he requirements in relation to biosecurity measures of aquaculture establishments which are closed facilities keeping 
aquaculture animals for ornamental purposes which, because of their movement patterns, create a significant disease 
risk, as referred to in Article  17 shall be the following:
(a) t he operator shall implement the biosecurity plan in accordance with Article  5, whic h must take the following 
elements into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the establishment;
 ( ii) w ork clothing and footwear for personnel must be kept solely for use at the aquaculture establishment and 
cleaned and disinfected regularly;Official Journal of the European Union L 174/374 EN 3 6 2020
 (iii) visit ors to the aquaculture establishment must be controlled in cases where they pose a disease risk   These 
visitors must either:
— w ear protective clothing and footwear provided at the aquaculture establishment, or
— clean and disinf ect any protective clothing and footwear they bring onto the aquaculture establishment on 
arrival and in the case of non-disposable clothing and footwear, on departure;
 (iv) dead animals  must be removed from all production units at a frequency that ensures infective pressure is kept 
to a minimum and disposed of in compliance with Article  13 of Regulation (EC) No  1069/2009  
(b) a named p erson must be in charge of implementing the biosecurity plan for the aquaculture establishment with 
other personnel reporting to that individual in relation to biosecurity matters, where necessary  
2  T he requirements in relation to facilities and equipment of the aquaculture establishments which are closed facilities 
keeping aquaculture animals for ornamental purposes which, because of their movement patterns, create a significant 
disease risk, as referred to in point  (c) of Article  17, shall be the following:
(a) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the animals kept in the establishment;
(b) t he aquaculture establishment must provide for good standards of hygiene and allow health monitoring to be carried 
out;
(c) t he equipment and facilities must be made from materials which can be readily cleaned and disinfected;
(d) ap propriate equipment must be available for cleaning and disinfection of facilities, equipment and means of transport;
(e) ap propriate predator control measures must be put in place, taking into account the risk of disease spread that these 
predators pose;
(f) an appr opriate system must be in place to ensure the collection and appropriate disposal of animal by-products in 
compliance with Article  13 of Regulation (EC) No  1069/2009  
PART 11
Requirements for granting approval of aquaculture establishments which are open facilities keeping 
aquaculture animals for ornamental purposes as referred to in Article  18
1  T he requirements in relation to biosecurity measures of aquaculture establishments which are open facilities keeping 
aquaculture animals for ornamental purposes as referred to in point  (b) of Article  18, shall be the following:
(a) t he operator shall implement the biosecurity plan in accordance with Article  5, whic h must take the following 
elements into consideration:
 (i) disinf ection points  mus t be installed at critical locations in the aquaculture establishment;
 ( ii)  wh ere they exist within the same aquaculture establishment, functional units must be kept separate using 
appropriate hygiene measures;
 ( iii)  w ork clothing and footwear for personnel must be kept at the aquaculture establishment and cleaned and 
disinfected regularly;
 (iv) eq uipment must not be shared between aquaculture establishments but in cases where this unavoidable, an 
appropriate protocol for cleaning and disinfection of the equipment must be put in place;
 ( v)  visit ors to the aquaculture establishment must be controlled in cases where they pose a disease risk   These 
visitors must either:
— w ear protective clothing and footwear provided at the aquaculture establishment, or
— clean and dis infect any protective clothing and footwear they bring onto the aquaculture establishment 
on arrival and in the case of non-disposable clothing and footwear, on departure;3 6 2020 Official Journal of the European Union L 174/375 EN
 ( vi)  dead animals mus t be removed from all production units at a frequency that ensures infective pressure is kept 
to a minimum and disposed of in compliance with Article  13 of Regulation (EC) No  1069/2009;
 (vii) as f ar as possible, equipment in the aquaculture establishment must be cleaned and disinfected at the end of 
each production cycle;
 (viii)  t he cleaning and disinfection records of transporters must be verified before animals are loaded or unloaded 
at the aquaculture establishment;
(b) oper ators shall ensure that a named person is charged with implementing the biosecurity plan for the aquaculture 
establishment with other personnel reporting to that individual in relation to biosecurity matters, where necessary  
2  T he requirements in relation to facilities and equipment of aquaculture establishments which are open facilities keeping 
aquaculture animals for ornamental purposes as referred to in point  (c) of Article  18, shall be the following:
(a) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the animals kept in the aquaculture establishment;
(b) t he establishment must provide for good standards of hygiene and allow adequate health monitoring to be carried 
out;
(c) as far as possible, equipment and facilities must be made from materials which can be appropriately cleaned and 
disinfected;
(d) appr opriate predator control measures must be put in place, taking into account the risk these predators pose and 
the environmental constraints of the aquaculture establishment;
(e) appr opriate equipment must be available for the cleaning and disinfection of facilities, equipment and means of 
transport;
(f) an ap propriate system is in place to ensure the collection and appropriate disposal of animal by-products in compliance 
with Article  13 of Regulation (EC) No  1069/2009  
PART 12
Requirements for granting approval of vessels or other mobile premises where aquaculture animals 
are kept temporarily to be treated or to undergo another husbandry related procedure as referred to in 
Article  19
1  T he requirements in relation to biosecurity measures of vessels or other mobile premises where aquaculture animals are 
kept temporarily to be treated or to undergo another husbandry related procedure as referred to in point  (a) of Ar ticle  19, 
shall be the following:
(a) t he operator shall implement the biosecurity plan in accordance with Article  5, whic h must take the following 
elements into consideration:
 ( i) t he vessel or mobile premises and all equipment used during the treatment process must be cleaned and 
disinfected when a treatment has been completed and before it moves to another aquaculture establishment;
 ( ii) w ork clothing and footwear for personnel must be kept at the aquaculture establishment and cleaned and 
disinfected regularly;
 (iii) eq uipment must not be shared with other aquaculture establishments but in cases where this is unavoidable, 
an appropriate protocol for cleaning and disinfection of the equipment must be put in place and evidence of 
its implementation kept;
 ( iv) visit ors to the aquaculture establishment must be controlled in cases where they cause a disease risk; these 
visitors must either:
— w ear protective clothing and footwear provided at the aquaculture establishment, or
— clean and disinf ect any protective clothing and footwear they bring onto the aquaculture establishment on 
arrival and in the case of non-disposable clothing and footwear, on departure;Official Journal of the European Union L 174/376 EN 3 6 2020
 ( v) t he cause of any mortality which occurs during a treatment must be recorded and dead animals must be removed 
from the aquaculture establishment at a frequency that minimises infective pressure and which is practicable 
given the treatment schedule for the aquaculture animals concerned;
 (vi) dead animals are removed at a frequency that ensures infective pressure is kept to a minimum and disposed of 
in compliance with Article  13 of Regulation (EC) No  1069/2009  
(b) op erators shall ensure that a named person is charged with implementing the biosecurity plan for the establishment, 
with other personnel reporting to that individual in relation to biosecurity matters, where necessary  
2  T he requirements in relation to facilities and equipment of vessels or other mobile premises where aquaculture animals 
are kept temporarily to be treated or to undergo another husbandry-related procedure as referred to in point  (b) of 
Article  19, shall be the following:
(a) suit able equipment and facilities must be available for the purpose of maintaining appropriate husbandry conditions 
for the aquaculture animals kept in the establishment;
(b) as f ar as possible, equipment and facilities must be made from materials which can be readily cleaned and disinfected;
(c) appr opriate equipment must be available for cleaning and disinfection of facilities and equipment;
(d) where aut omated cleaning and disinfection systems are used, their efficacy must be validated before their initial use 
and at appropriate frequencies thereafter;
(e) an ap propriate system is in place to ensure the collection and appropriate disposal of animal by-products in compliance 
with Article  13 of Regulation (EC) No  1069/2009  3 6 2020 Official Journal of the European Union L 174/377 EN
ANNEX  II
RISK-BASED SURVEILLANCE TO BE CARRIED OUT IN CERTAIN APPROVED ESTABLISHMENTS
PART 1
Risk-based surveillance in aquaculture establishments and groups thereof referred to in Articles  7, 8, 17 
and 18
Risk-based surveillance shall be implemented as follows in the aquaculture establishments, and groups thereof, which are 
referred to in Articles  7, 8, 17 and 18:
(a) aq uaculture establishments keeping listed species of aquaculture animals other than the species referred to in point  (b)(ii) 
of this Part, shall implement risk-based surveillance according to their ranking as ‘high ’, ‘medium ’ or ‘low ’ risk as a result 
of a risk assessment carried out in accordance with Part  I of Annex  VI to Delegated Regulation (EU) 2020/ 689 ;
(b) aq uaculture establishments keeping the species of aquaculture animals referred to in points  (i) and (ii) shall implement 
risk-based surveillance if they have been ranked as ‘high ’ risk as a result of a risk assessment carried out in accordance 
with Part  I of Annex  VI to Delegated Regulation (EU) 2020/ 689 :
 (i) non-lis ted species;
 (ii) lis ted species referred to in the fourth column of the table  set out in the Annex  to Implementing Regulation (EU) 
2018/1882; but those listed species must be in contact with the listed species referred to in the third column of 
that table  in order to be classified as vectors species, and that contact has not occurred  
PART 2
Content of risk-based surveillance at aquaculture establishments or groups thereof conducted in 
accordance with Article  26 of Regulation (EU) 2016/429
1  R ecord checks, clinical inspections and laboratory examinations at the approved aquaculture establishments referred to 
in Articles  7, 17 and 18 shall be carried out as follows:
(a) t he relevant records kept in accordance with the record-keeping obligations of Article  186 of R egulation (EU) 
2016/429 and with Articles  23, 32 and 33 of t his Regulation must be examined to assess if there are any indications 
of increased mortality or the presence of a listed or emerging disease in the aquaculture establishment which must 
be taken into account during the visit by a veterinarian;
(b) all p arts of the aquaculture establishment must be examined with particular attention being paid to those production 
units where increased mortalities have been indicated in the records referred to in point  (a);
(c) wh ere there are no  indications of t he presence of a listed or emerging disease either from an examination of the 
records or from the clinical inspection of all production units, there shall be no  requirement to take samples for 
laboratory examination;
(d) where recent ly dead or moribund aquaculture animals are identified, a representative selection of these aquaculture 
animals must be examined clinically, both externally and internally, to determine if pathological changes are present; 
that examination must in particular, aim at detecting listed or emerging diseases;
(e) if t he outcome of the clinical examination provided for in point  (d) leads t o a suspicion of the presence of such 
a listed or emerging disease in an aquaculture establishment in a Member State, zone or compartment in which 
an eradication programme is being implemented, or which has been declared free from that particular disease, a 
sample of aquaculture animals from that aquaculture establishment shall be collected and subjected to a laboratory 
examination in accordance with the relevant Chapter  of P art II of Annex  VI to Delegated Regulation (EU) 2020/ 689 ;
(f) if t he outcome of the clinical examination provided for in point  (d) leads to a suspicion of the presence of a listed 
disease in an aquaculture establishment in which a surveillance programme is being implemented for that particular 
category  C disease, a sample of aquaculture animals from the aquaculture establishment shall be collected and 
subjected to a laboratory examination in accordance with the relevant Chapter  of P art III of Annex  VI to Delegated 
Regulation (EU) 2020/ 689 ;Official Journal of the European Union L 174/378 EN 3 6 2020
(g) if the outcome of the clinical examination provided for in point  (d) leads to the suspicion of an emerging disease, a 
sample of aquaculture animals from the aquaculture establishment shall be collected and subjected to a laboratory 
examination with the objective of identifying the emerging disease in question  
2  R ecord checks and clinical and laboratory examinations at the approved groups of aquaculture establishments referred 
to in Article  8 shall be carried out as follows:
(a) t he relevant records kept by or on behalf of each aquaculture establishment in the group of aquaculture establishments 
in accordance with Article  186 of R egulation (EU) 2016/429 and with Article  24 of t his Regulation, must be examined 
to assess if there are indications of increased mortality or of the presence of a listed or emerging disease which must 
be taken into account when deciding which aquaculture establishment in the group is required to be visited for the 
purpose of risk-based surveillance;
(b) when t he examination of records referred to in point  (a) indicat es increased mortality or the presence of a listed or 
emerging disease in a particular aquaculture establishment within the group, that establishment must be visited for 
the purpose of risk based surveillance; the steps outlined in point  1(b) to (g) must be followed during that visit;
(c) when t he examination of records referred to in point  (a) does no t indicate increased mortality or the presence of 
a listed or emerging disease in any aquaculture establishment within the group, the risk-based surveillance visit or 
visits shall be carried out either:
 (i) af ter risk assessment, in the aquaculture establishment or aquaculture establishments within the group which 
pose the highest risk of disease introduction; or
 ( ii) t o the establishment which has had the greatest number of movements of aquaculture animals for further farming, 
since the last risk-based surveillance visit was carried out  
In either case, the steps outlined in point1 (c) to (g) must be followed during the risk-based surveillance visit