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
Derogations from the requirement on operators to apply to the competent authority for approval of aquaculture establishments
1. By way of derogation from Article 176(1)(a) of Regulation (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)
aquaculture establishments where aquaculture animals are kept solely for release into the wild;
(b)
extensive ponds where aquaculture animals are kept for direct human consumption or for release into the wild;
(c)
purification centres which:
(i)
are approved in accordance with Article 4 of Regulation (EC) No 853/2004; and
(ii)
receive molluscs only from within the epidemiological area in which the establishment is located;
(d)
dispatch centres which:
(i)
are approved in accordance with Article 4 of Regulation (EC) No 853/2004; and
(ii)
receive molluscs only from within the epidemiological area in which the establishment is located;
(e)
relaying areas which:
(i)
are approved in accordance with Article 4 of Regulation (EC) No 853/2004; and
(ii)
receive molluscs only from within the epidemiological area in which the establishment is located.
2. Derogations from the requirement to apply to the competent authority for approval provided for in paragraph 1 of this Article shall only 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)
taking into account at least the risk factors set out in points (a) and (b) of Chapter 2 of Part I of Annex VI to Commission Delegated Regulation (EU) 2020/689; and
(b)
which 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.
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)
quarantine establishments for aquaculture animals;
(b)
aquaculture 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)
aquaculture establishments which are closed facilities keeping aquaculture animals for ornamental purposes, which because of their movement patterns, create a significant disease risk;
(d)
aquaculture establishments keeping aquaculture animals for ornamental purposes in open facilities;
(e)
vessels 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
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 Articles 9 to 19, or groups of aquaculture establishments referred to in Article 8, if their operators have developed and documented a biosecurity plan, which complies with the following requirements:
(a)
it identifies 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 considers or takes into account, where appropriate, the elements set out in point 1(a) of Parts 1 to 7 and Parts 9 to 12, and in point 1(b) of Part 8 of Annex I, when this plan for the aquaculture establishment or group of aquaculture establishments is being developed.
Requirement for approved aquaculture establishments and groups thereof to participate in a risk-based surveillance scheme
1. The 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 Regulation (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 Annex II to this Regulation.
2. The competent authority shall only approve groups of aquaculture establishments referred to in Article 8 of this 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 Annex II to this Regulation.
3. When granting approval of aquaculture establishments or groups thereof as provided for in paragraphs 1 and 2, the competent authority shall take account of the following elements, and include them in the risk-based surveillance scheme:
(a)
the outcome of the surveillance conducted by the operator in accordance with Article 24 of Regulation (EU) 2016/429;
(b)
the 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.
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 to 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)
Article 6(1), in relation to risk-based surveillance;
(b)
point 1 of Part 1 of Annex I, in relation to biosecurity measures;
(c)
point 2 of Part 1 of Annex I, in relation to facilities and equipment.
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)
Article 6(2), in relation to risk-based surveillance;
(b)
point 1 of Part 2 of Annex I, in relation to biosecurity measures for the aquaculture establishments in the group;
(c)
point 2 of Part 2 of Annex I, in relation to facilities and equipment.
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)
Article 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 Annex I, in relation to biosecurity measures;
(c)
point 2 of Part 3 of Annex I, in relation to surveillance and control;
(d)
point 3 of Part 3 of Annex I, in relation to facilities and equipment.
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 arrangements to perform veterinary post-mortem examinations in appropriate facilities in the confined aquaculture establishment or in a laboratory;
(b)
secure by contract or by another legal instrument, the services of an establishment veterinarian who shall be responsible for:
(i)
the supervision of the activities of the confined aquaculture establishment and compliance with the requirements for approval laid down in Article 9;
(ii)
the review of the disease surveillance plan referred to in point 2(a) of Part 3 of Annex I at least annually.
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 Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 4 of Annex I, in relation to facilities and equipment.
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 Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 5 of Annex I, in relation to facilities and equipment.
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 Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 6 of Annex I, in relation to facilities and equipment.
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 Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 7 of Annex I, in relation to facilities and equipment.
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 Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 8 of Annex I, in relation to surveillance and control measures;
(c)
point 3 of Part 8 of Annex I, in relation to facilities and equipment.
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 longer regarded as vectors, comply with the requirements set out in:
(a)
point 1 of Part 9 of Annex I, in relation to biosecurity measures;
(b)
point 2 of Part 9 of Annex I, in relation to surveillance and control measures;
(c)
point 3 of Part 9 of Annex I, in relation to facilities and equipment.
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)
Article 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.
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)
Article 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.
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
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 Regulation (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)
the unique registration number assigned to it by the competent authority;
(b)
the date of registration by the competent authority;
(c)
the address and geographical coordinates (latitude and longitude) of the location of the aquaculture establishment;
(d)
a description of its facilities and equipment;
(e)
categories of aquaculture animals which are kept in the aquaculture establishment;
(f)
the approximate number or the maximum biomass or both, of the aquaculture animals which may be kept in the aquaculture establishment;
(g)
the 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)
the 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
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)
the unique approval number assigned to it by the competent authority
(b)
the date of approval granted by the competent authority or of any suspension or withdrawal of approval by the competent authority;
(c)
the address and geographical coordinates (latitude and longitude) of the location of the approved aquaculture establishment or group of aquaculture establishments;
(d)
a description of its relevant facilities and equipment;
(e)
categories of aquaculture animals which are kept in the aquaculture establishment or in the group of aquaculture establishments;
(f)
the 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)
the 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)
the 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 that 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)
whether 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)
any 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
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)
the unique registration number assigned to the aquaculture establishment by the competent authority;
(b)
details of any investigations that were carried out following the occurrence of increased mortality or suspicion of the presence of disease;
(c)
self-declaration documents issued in accordance with Article 218 of Regulation (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 relevant, any other documents accompanying aquatic animals.
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 to 34 of this Regulation, shall record and keep the following information:
(a)
the unique approval number issued to the aquaculture establishment by the competent authority;
(b)
the current risk categorisation of the aquaculture establishment, as assigned by the competent authority;
(c)
details of the implementation and results of the risk-based surveillance provided for in Article 6(1);
(d)
details of movements to the aquaculture establishment including:
(i)
the 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)
the location of the habitat from which wild aquatic animals have been collected before being dispatched to the aquaculture establishment;
(e)
details of movements from the aquaculture establishment including:
(i)
aquaculture 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)
the name and address of transporters who deliver aquatic animals to or collect aquaculture animals from the establishment;
(g)
the biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h)
self-declaration documents issued in compliance with Article 218 of Regulation (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 relevant, any other documents accompanying aquatic animals.
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 to the information required by Article 186(1) of Regulation (EU) 2016/429, operators of aquaculture establishments in a group of aquaculture establishments approved in accordance with point (a) of Article 177 of Regulation (EU) 2016/429 shall record and keep the following information:
(a)
the unique approval number issued to the aquaculture establishment by the competent authority;
(b)
the current risk categorisation of the group of aquaculture establishments, as assigned by the competent authority;
(c)
details of the implementation and results of the risk-based surveillance provided for in Article 6(2);
(d)
details of movements to the aquaculture establishment including:
(i)
the 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)
the location of the habitat from which wild aquatic animals have been collected before being dispatched to the aquaculture establishment;
(e)
details of movements from the group of aquaculture establishments including:
(i)
aquaculture 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)
the name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the aquaculture establishment;
(g)
details of the biosecurity plan employed and evidence of its implementation;
(h)
self-declaration documents issued in compliance with Article 218 of Regulation (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 relevant, any other documents accompanying the aquatic animals.
2. The operator of a group of aquaculture establishments approved in accordance with point (b) of Article 177 of Regulation (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.
Record-keeping obligations of operators of approved confined aquaculture establishments
In addition to the information required by Article 186(1) of Regulation (EU) 2016/429, operators of approved confined aquaculture establishments shall record and keep the following information:
(a)
the unique approval number issued to the confined aquaculture establishment by the competent authority;
(b)
details 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)
the name and address of transporters who deliver aquaculture animals to, or collect aquaculture animals from, the confined aquaculture establishment;
(d)
details of the implementation and results of the disease surveillance plan provided for in point 2 of Part 3 of Annex I;
(e)
the 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 relevant, details of the vaccination or treatment of aquaculture animals provided for in point 2(c) of Part 3 of Annex I;
(g)
details 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)
the biosecurity plan for the confined aquaculture establishment;
(i)
where relevant, any other documents accompanying the aquaculture animals.
Record-keeping obligations of operators of disease control aquatic food establishments
In addition to the information required by Article 187(1) of Regulation (EU) 2016/429, operators of disease control aquatic food establishments shall record and keep the following information:
(a)
the unique approval number issued to the disease control aquatic food establishment by the competent authority;
(b)
the biosecurity plan for the disease control aquatic food establishment and evidence of its implementation;
(c)
maintenance records for the waste water treatment system used in the disease control aquatic food establishment;
(d)
records to verify the efficacy of the water treatment system;
(e)
the name and address of transporters who deliver aquatic animals to the disease control aquatic food establishment;
(f)
where relevant, any other documents accompanying the aquatic animals.
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)
the unique approval number issued to the approved purification centre by the competent authority;
(b)
the biosecurity plan for the approved purification centre and evidence of its implementation;
(c)
maintenance records for the waste water treatment system used in the approved purification centre;
(d)
records to verify the efficacy of the water treatment system;
(e)
where relevant, any other documents accompanying aquatic animals.
Record-keeping obligations of operators of approved dispatch centres
In addition to the information required by Article 186(1) of Regulation (EU) 2016/429, operators of approved dispatch centres shall record and keep the following information:
(a)
the unique approval number issued to the approved dispatch centre by the competent authority;
(b)
the biosecurity plan for the approved dispatch centre and evidence of its implementation;
(c)
maintenance records for the waste water treatment system used in the approved dispatch centre;
(d)
records to verify the efficacy of the water treatment system;
(e)
where relevant, any other documents accompanying aquatic animals.
Record-keeping obligations of operators of approved relaying areas
In addition to the information required by Article 186(1) of Regulation (EU) 2016/429, operators of approved relaying areas shall record and keep the following information:
(a)
the unique approval number issued to the approved relaying area by the competent authority;
(b)
the biosecurity plan for the approved relaying area and evidence of its implementation;
(c)
where relevant, any other documents accompanying aquatic animals.
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)
the unique approval number issued to the quarantine establishment by the competent authority;
(b)
details of movements to the approved quarantine establishment including:
(i)
the unique registration or approval number of the aquaculture establishment of origin of all aquaculture animals received from another aquaculture establishment; or
(ii)
the location of the habitat from which aquatic animals have been collected before being dispatched to the approved quarantine establishment;
(c)
details of movements from the approved quarantine establishment including:
(i)
the unique registration or approval number of the aquaculture establishment of destination; or
(ii)
the location of the habitat into which aquaculture animals have been released into the wild;
(d)
the name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved quarantine establishment;
(e)
details of the implementation and results of the disease surveillance provided for in point 2 of Part 8 of Annex I;
(f)
the results of clinical and laboratory tests and of post-mortem examinations provided for in point 2 of Part 8 of Annex I;
(g)
instructions, if any, of the competent authority as regards observations made during any isolation or quarantine period;
(h)
the biosecurity plan for the approved quarantine establishment and evidence of its implementation;
(i)
evidence 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 relevant, any other documents accompanying the aquatic animals.
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 longer 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)
the unique approval number issued to the aquaculture establishment by the competent authority;
(b)
details of movements to the approved aquaculture establishment including:
(i)
the unique registration or approval number of the aquaculture establishment of origin of all aquaculture animals received from another aquaculture establishment; or
(ii)
the location of the habitat from which aquatic animals have been collected before being dispatched to the approved aquaculture establishment;
(c)
details of movements from the approved aquaculture establishment including:
(i)
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;
(d)
the name and address of transporters who deliver aquatic animals to, or collect aquaculture animals from, the approved aquaculture establishment;
(e)
details of the implementation and results of the disease surveillance provided for in point 2 of Part 9 of Annex I;
(f)
the results of clinical and laboratory tests and of post-mortem examinations provided for in point 2 of Part 9 of Annex I;
(g)
instructions, 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 Annex I;
(h)
the biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(i)
where relevant, any other documents accompanying the aquatic animals.
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)
the unique approval number issued to the aquaculture establishment by the competent authority;
(b)
the current risk categorisation of the approved aquaculture establishment, as assigned by the competent authority;
(c)
details of the implementation and results of the risk based surveillance provided for in Article 6(1), where relevant;
(d)
details 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)
details 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)
the 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)
the biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h)
self-declaration documents issued in accordance with Article 218 of Regulation (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 relevant, any other documents accompanying aquaculture animals.
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)
the unique approval number issued to the aquaculture establishment by the competent authority;
(b)
the current risk categorisation of the approved aquaculture establishment, as assigned by the competent authority;
(c)
details of the implementation and results of the risk based surveillance provided for in Article 6(1), where relevant;
(d)
details 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)
details 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)
the 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)
the biosecurity plan for the approved aquaculture establishment and evidence of its implementation;
(h)
self-declaration documents issued in accordance with Article 218 of Regulation (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 relevant, any other documents accompanying aquatic animals.
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 Regulation (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)
the unique approval number issued to the vessel or other mobile premises by the competent authority;
(b)
the dates and times of loading of aquaculture animals at the approved vessel or other approved mobile premises;
(c)
where relevant, the name, address and unique registration or approval number of each aquaculture establishment where aquaculture animals were loaded and unloaded;
(d)
the 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 relevant, details of the route taken between one aquaculture establishment and another;
(f)
details of each treatment or husbandry-related procedure which takes place in the approved vessel or other approved mobile premises;
(g)
the biosecurity plan for the approved vessel or other approved mobile premises and evidence of its implementation;
(h)
where relevant, any other documents accompanying aquaculture animals.
CHAPTER 2 — Records to be kept by transporters
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)
the dates and times of loading of aquatic animals at the aquaculture establishment or habitat of origin;
(c)
the name, address and unique registration or approval number of each aquaculture establishment visited;
(d)
the location of each habitat from which wild aquatic animals were collected;
(e)
the dates and times of unloading of aquatic animals at the aquaculture establishment or habitat of destination;
(f)
the dates, times and places of water exchange, when this has occurred;
(g)
the biosecurity plan for the means of transport and evidence of its implementation;
(h)
the reference numbers of the documents accompanying the consignments of aquatic animals.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
