Frequently asked questions

Categories I to V which were set out in Part A of Annex III to Directive 2006/88/EC have not been replicated in the AHL or in Delegated Regulation (EU) 2020/990. 

Instead, movements within the Union of aquatic animals, which are listed in the Annex to Commission Implementing Regulation (EU) 2018/1882 (as amended by Commission Implementing Regulation (EU) 2022/925), are based on whether the establishment of destination is located in a Member State, zone or compartment which is disease-free (‘old’ Category I), or implementing an eradication programme (‘old’ Category II or IV), or alternatively, if the establishment of destination is implementing a surveillance programme for a Category C disease (modified ‘old’ Category III). 

All other establishments do not have a status per se, but are regarded as being infected (‘old’ Category V).

The main rules concerning movements of aquatic animals in the Union, which are intended for aquaculture or for release into the wild, can be summarised as follows:

• The general rules concerning all movements of aquatic animals within the Union are set out in Articles 191 to 196 of the AHL and cover general requirements for movements of aquatic animals; disease prevention measures that apply during transport; rules concerning change of intended use; obligations of operators at the place of destination and general requirements in respect of movements of aquaculture animals passing through Member States which are intended for export from the Union.
• Specific rules concerning movements of aquatic animals intended for aquaculture establishments or release to the wild are set out in Articles 197, 198 and 200 of the AHL, and in Section 1, Chapter 2, Part II of Delegated Regulation (EU) 2020/990 concerning movements of listed species of aquatic animals to Member States, zones or compartments which are either disease-free or subject to an eradication programme for a particular Category C disease.
• Additional rules concerning the movement of aquatic animals which are intended for human consumption are set out in Articles 201 and 202 of the AHL and in Section 2, Chapter 2, Part II of Delegated Regulation (EU) 2020/990.
• Specific requirements concerning movements to and from an infected establishment and other establishments located in the restricted zone within an eradication programme for a particular Category C disease are set out in Articles 60 and 61 of Commission Delegated Regulation (EU) 2020/689.
• Specific rules concerning the self-declaration documents which are issued by operators for movements of listed species of aquaculture animals between establishments in different Member States, which are participating in a surveillance programme for a particular Category C disease are set out in Article 14(2)(b) of Delegated Regulation (EU) 2020/990. This gives the operator of the place of destination the necessary assurances that regular health visits and sampling are carried out by the competent authority at the establishment of origin, and that it is not known to be infected with the Category C disease in question.

The general rules which are referred to in the first bullet point above apply in all cases. However, there are no specific rules for the movement of listed species for Category C diseases between infected establishments, which are not subject to an eradication programme.

The ‘old’ Category III health status which was referred to in Part A of Annex III to Directive 2006/88/EC, is not replicated under the AHL. Instead, a new concept of ‘surveillance programmes’ is provided for in Article 3(2)(b)(iv) of Delegated Regulation (EU) 2020/689. 

The objective of such programmes is to demonstrate that an aquaculture establishment which has not obtained disease-free status, and is not participating in an eradication programme, is not infected. 

The participation of an aquaculture establishment in such a surveillance programme, gives the operator of the place of destination of a consignment of aquaculture animals, the necessary assurances that regular health visits and sampling are carried out by the competent authority at the establishment of origin, and that it is not known to be infected with a specified Category C disease.

• The disease- specific chapters of Part III of Annex VI to Delegated Regulation (EU) 2020/689 set out the requirements to demonstrate the implementation of a surveillance programme as well as the requirements to re-start such a surveillance programme after a disease outbreak, for each Category C disease. In each case, health visits, sampling and testing are required. This is different to the situation which applied with the ‘old’ Category III establishments, where surveillance and inspections were ‘recommended’ to be carried out at a certain frequency concerning Category III establishments, whilst Delegated Regulation (EU) 2020/689 sets out requirements concerning establishments which implement a surveillance programme.
• Once an aquaculture establishment is implementing a surveillance programme for a particular Category C disease, consignments of aquaculture animals which are dispatched from that establishment to another establishment which is participating in a surveillance programme in another Member State, must be accompanied by a self-declaration document, which complies with the requirements of Article 218 of the AHL and Article 14(2) of Delegated Regulation (EU) 2020/990. In addition to other information, this self-declaration document confirms that the consignment originates from an aquaculture establishment which participates in a surveillance programme for a specified Category C disease, provides the most recent date on which a sample from the establishment was tested, and confirms that the test result was negative.

In addition to the above, consignments of aquaculture animals which are dispatched from an aquaculture establishment in one Member State to another establishment which is participating in a surveillance programme for the same disease in another Member State, must also be notified by the competent in the Member State of origin to the competent authority in the Member State of destination, using TRACES. 

In order to do that, operators at the place of origin must notify their competent authority in advance of the movement. In addition to the information which is necessary to comply with Article 219 of the AHL, advance notification of such movements must comply with the notification requirements set out in Section 4, Chapter 3, Part II to Delegated Regulation (EU) 2020/990. 

In particular, such movements should be accompanied by a TRACES document entitled “Aquatic Animals subject to surveillance” in which Part III confirms that the consignment originates from an aquaculture establishment which participates in a surveillance programme for a specified Category C disease, provides the most recent date on which a sample from the establishment was tested and confirms that the test result was negative.

Yes, in accordance with Article 199 of the AHL, Member States may require that aquatic animals are released into the wild only if they originate from a Member State/zone/compartment, which is free from one or more Category C diseases, even if the place of release of those aquatic animals is not disease free.

Supplementary rules concerning the application of this Article are set out in Article 10 of Delegated Regulation (EU) 2020/990.

For the purpose of movements of aquatic animals within the Union, the vector species, which are listed in the fourth column of the table in the Annex to Implementing Regulation (EU) 2018/1882 (as amended by Implementing Regulation (EU) 2022/925), are regarded as vectors of a specific listed disease under the conditions which are set out in Annex I to Delegated Regulation (EU) 2020/990.

With the exception of infection with HPR-deleted ISAV, for which no vector species are listed, movements of species which are listed in the fourth column of the table in the Annex to Implementing Regulation (EU) 2018/1882, shall only be regarded as vectors of the relevant Category C disease, if they originate from an aquaculture establishment where susceptible species (i.e. those species which are listed in the third column of the same table) are kept, or in the case of wild aquatic animals, if they have been exposed to susceptible species.

The competent authority has an obligation to conduct surveillance in accordance with Articles 26 and 27 of the AHL. This surveillance is further described in Part I of Annex VI to Delegated Regulation (EU) 2020/689 (risk-based surveillance). Operationally, this risk-based surveillance can be executed in several different ways, but wherever this is possible and appropriate, it should take account of the surveillance which is carried out by the private sector in compliance with Articles 24 and 25 of the AHL, thereby giving the competent authority flexibility to decide what balance of public / private participation in risk-based surveillance works best within their Member State.

In addition, according to Part I of Annex VI to Delegated Regulation (EU) 2020/689 ‘Risk-based animal health surveillance in aquaculture establishments and groups of aquaculture establishments may be combined with health visits and sampling which are carried out:

1. as part of compulsory or optional eradication programmes for one or more listed diseases; or

2. to demonstrate and maintain disease free status for one or more listed diseases; or

3. as part of a surveillance programme for one or more category C diseases.’

Therefore, carrying out risk-based surveillance when the health visits and sampling mentioned in (a), (b), and (c) above are carried out, is also an option which the competent authority can consider.

Yes, this type of surveillance is the responsibility of the competent authority, but it may be delegated to one or more delegated bodies or natural persons in accordance with Chapter III of Title II of Regulation (EU) 2017/625 (Official Controls Regulation).

The AHL does not set out a registration obligation for transporters of aquatic animals, although the AHL and Commission Delegated Regulation (EU) 2020/691 do set out certain obligations, which apply to operators who are transporters. A legal basis to register transporters of aquatic animals is however, provided in with Article 10(2) of the Official Controls Regulation.

Generally speaking, the requirement for certification when aquatic animals are moved within the Union, depends upon the species to be moved and the health status of the Member State, zone or compartment in which the establishment of destination is located.

Except in the case referred to in Article 12 of Delegated Regulation (EU) 2020/990, if the establishment of destination is located in a disease-free Member State, zone or compartment, or one which is subject to an eradication programme, and if the species to be moved is listed for the disease in question, then a certificate drawn up in accordance with the relevant model set out in Implementing Regulation (EU) 2020/2236 must accompany the consignment.

In all other cases, for movements of aquaculture animals between Member States, consignments will be accompanied by a self-declaration document issued by the operator of the establishment of origin, in accordance with Article 218 of Regulation (EU) 2016/429 and Article 14 of Delegated Regulation (EU) 2020/990.

Article 12 of Delegated Regulation (EU) 2020/990 provides a derogation from the certification requirements, which are laid down in Article 208(1) of the AHL, under certain circumstances. 

In summary, the circumstances are that the Category C disease in question has never occurred in the Member State of origin or the Member State of destination; that both competent authorities have systems in place to ensure traceability of the aquaculture animals which are moved; that the competent authority of the Member State of origin has authorized the movement, and that the competent authority of the Member State of destination has notified the Commission and the other Member States that such movements are authorized, provided that the relevant requirements are met.

The Commission is not planning to publish a model self-declaration document. Member States may therefore, choose to devise their own model, to assist operators in complying with the requirements which are set out in Article 218 of the Animal Health Law.

In compliance with Article 12(2) of the AHL, aquatic animal health professionals may undertake activities assigned to veterinarians under that Regulation, provided they are authorised to do so by the Member State concerned, under national law. This includes the signing of animal health certificates.

Concerning entry into the Union, both Article 237(2) of the AHL and Article 3(c)(i) of Commission Delegated Regulation (EU) 2020/692, require that certificates, which are issued for the entry into the Union of consignments of animals, must be signed by an official veterinarian.

An ‘establishment’, (including an aquaculture establishment) is defined as follows in the legislation:

“establishment’ means any premises, structure, or, in the case of open-air farming, any environment or place, where animals or germinal products are kept, on a temporary or permanent basis, except for:

1. households where pet animals are kept;

2. veterinary practices or clinics.

This definition is very broad, and means that any person who keeps aquaculture animals in an establishment, which complies with the above definition, is in fact, an operator of an aquaculture establishment, and thereby, assumes the responsibilities of an aquaculture operator. The competent authority may however, exempt certain very low risk aquaculture establishments from certain obligations which are set out in the legislation. The type of aquaculture establishments, which the competent authority may exempt from the requirement to be registered are set out in Article 3 of Implementing Regulation (EU) 2021/2037.

Concerning notification, in accordance with Article 3 of Commission Implementing Regulation (EU) 2020/2002, a Member State must notify the Commission and other Member States within 24 hours of the confirmation of a primary outbreak of a Category A disease, or of a primary outbreak of a Category C disease in a disease-free Member State, zone or compartment. Secondary outbreaks of such diseases must be notified on the first working day of each week. Notifications should be submitted electronically via the Animal Disease Information System (ADIS).

Concerning reporting, in accordance with Article 4 of the same Regulation, Member States must report to the Commission and to the other Member States by 30 April each year, details on the detection of Category E diseases that have been confirmed in their territory during the previous calendar year. Such reports should be submitted electronically via ADIS.

Also concerning reporting in ADIS, in accordance with Article 7 of Implementing Regulation (EU) 2020/2002, Member States must submit annual results from the implementation of their approved eradication programmes to the Commission, by 30 April each year, for the previous calendar year. It is important to note that this reporting requirement applies only to those approved eradication programmes which are listed in the relevant Annexes to Implementing Regulation (EU) 2021/620. It does not apply to eradication programmes for zones and compartments which are less than 75% of the territory of the Member State and which have been declared using the procedure set out in Article 83 of Delegated Regulation (EU) 2020/689.

Similarly, Articles 8 and 10 of Implementing Regulation (EU) 2020/2002 also concern the submission of reports and other information in ADIS concerning approved eradication programmes, which are listed in the relevant Annexes to Implementing Regulation (EU) 2021/620. These Articles do not apply to zones and compartments which are less than 75% of the territory of the Member State and which have been declared using the procedure set out in Article 83 of Delegated Regulation (EU) 2020/689.

Finally, it should be noted that Article 11 of Implementing Regulation (EU) 2020/2002 concerns the submission in ADIS of an application for the recognition of disease –freedom concerning entities, which are >75% of the territory of the Member State, or where the water catchment supplying the zone or compartment is shared with another Member State or a third country, and which will ultimately be listed as disease-free in the relevant Annex to Implementing Regulation (EU) 2021/620. Article 11 of Implementing Regulation (EU) 2020/2002 does not apply to smaller zones or compartments which may be declared disease-free in accordance with Article 83 of Delegated Regulation (EU) 2020/689.

Depending on the Category C disease in question, the following entities are listed in Annexes XII to XVIII to Implementing Regulation (EU) 2021/620:

• entire Member States which are disease free or subject to an eradication programme
• parts of Member States which comprise >75% of the territory which are either disease free or subject to an eradication programme
• zones or compartments of a Member State which are either disease free or subject to an eradication programme and where the water catchment area supplying those zones or compartments is shared with another Member State or third country

In addition, those zones and compartments, which are <75% of the territory of the Member State, which have been declared disease-free in accordance with Article 83 of Delegated Regulation (EU) 2020/689, are listed on Member States websites. 

All of the above may be accessed via the Surveillance, eradication programmes and disease-free status section of this website.

Approved eradication programmes and approved disease-free statuses for entire Member States and for zones or compartments comprising >75 % of the territory of the Member State, as well as zones or compartments where the water catchment area supplying them is shared with another Member State or a third country, are listed in the relevant Annex (XII to XVIII) to Implementing Regulation (EU) 2021/620.

On the other hand, Article 83 of Delegated Regulation (EU) 2020/689 sets out derogations from the requirement to submit eradication programmes to the Commission for approval, as provided for in Article 31(1)(b) and Article 31(2) of Regulation (EU) 2016/429, and from the requirements to obtain the approval of the Commission for disease-free status, as laid down in Article 36(4) and 37(4) of that Regulation.

In accordance with Article 83 of Delegated Regulation (EU) 2020/689, such approval for zones or compartments which cover <75 % of the territory of a Member State, and where the water catchment supplying the zone or compartment is not shared with another Member State or third country, is gained in accordance with the declaration procedure which is set out in that Article.

Disease free zones and compartments which have been declared in accordance with the declaration procedure referred to above, are listed on the websites of the declaring Member States, and can be accessed via the Surveillance, eradication programmes and disease-free status section of this website.

This is not necessarily the case. According to Annex VI, Part II, Chapter 1, Section 3, Para 2 of Regulation (EU) 2020/689, the restricted zone must be defined on a case-by-case basis. The geographical demarcation in inland areas must comprise the entire water catchment area in which the infected establishment is located, but the competent authority may however, limit the extent of the restricted zone to parts of the water catchment area, provided this limitation does not compromise the disease control measures with respect to VHS or IHN. Therefore, whilst the disease-free status of the entire zone will be withdrawn, the entire zone may not necessarily be subject to restriction measures.

Taking echinoderms as an example, the situation concerning the applicability of the AHL is as follows:

• Article 4(3) of the AHL defines ‘aquatic animals’. Echinoderms are not covered by that definition, and species of this phylum therefore, fall under the definition of ‘other animals’ as defined in Article 4(4) of the AHL.

• Rules concerning ‘other animals’ are set out in Title III of Part IV of the AHL, more specifically Articles 227 and 228. In addition, all other parts of the AHL apply to those other animals, as relevant.

Concerning Title III of Part IV of the AHL, and specifically concerning the applicability of Article 227 (which covers registration, approval, recording keeping and registers of establishments and transporters, traceability, movement requirements, certification, self-declaration), that Article would apply if ‘other animals’ were to become listed species for a listed disease as referred to in point (d) of Article 9(1) of the AHL, however, as this is not the case with Echinoderms, Article 227 does not apply.

Laboratory animals are not a special category under the AHL, therefore in general, the same movement rules apply to aquatic animals, which are used for scientific purposes, as apply to other aquatic animals of listed and non –listed species (see earlier Q/A above concerning movements).

The AHL and Delegated Regulation (EU) 2020/990 do however, provide certain flexibilities concerning aquatic animals which are to be used for scientific purposes i.e.

• Article 204 of the AHL allows the competent authority of the place of destination, to authorise the movement of aquatic animals, which do not comply with Articles 191 to 202 of the AHL, into the territory of the Member State of destination for scientific purposes, subject to the agreement of the competent authority at the place of origin. In such circumstances, the measures referred to in Articles 191(1) and (3) and Articles 192, 193 and 194 of the AHL will however, still apply.

• Another possibility is that the laboratory animals originate from a confined establishment as defined in Article 4(48) of the AHL, and they are moved in compliance with Article 203(1) of the same Regulation i.e. they originate from a confined establishment for aquaculture, they are destined for another confined establishment for aquaculture, and they do not pose a significant risk for the spread of listed diseases, except where the movement is authorised for scientific purposes.

A further possibility when moving to a confined establishment is set out in Article 6(d) of Delegated Regulation (EU) 2020/990, which provides flexibility concerning aquaculture animals which are destined for a confined establishment intended for scientific purposes, such that operators may move such animals to a Member State, zone or compartment which is free from a specific Category C disease, even if the Member State, zone or compartment of origin is not free from that particular disease.

No, model certificate AQUA-ENTRY-ESTAB/RELEASE/OTHER covers only the entry into the Union of listed species (as set out in the Annex to Implementing Regulation (EU) 2018/1882 (as amended by Implementing Regulation (EU) 2022/925)) intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding human consumption. 

The entry into the Union of non-listed species should comply with any national requirements which have been drawn up by the competent authority in the Member State of destination in accordance with Article234(4) of the AHL.

The model certificate AQUA-ENTRY-ESTAB/RELEASE/OTHER which is set out in Annex II to Implementing Regulation (EU) 2020/2236, concerns only listed species for the listed diseases. 

Harmonised certificates, declarations or other documents for the entry into the Union of non-listed species, are not foreseen.  

As previously stated, the entry into the Union of such non-listed species, will comply with the national requirements which may be drawn up by the competent authority in the Member State of destination, and different Member States may therefore, have different requirements.

In cases where the same shipment contains two different consignments, one of listed species, and the other of non-listed species, each consignment will have different requirements. 

The consignment of listed species should be accompanied by a certificate, which is drawn up in accordance with the model certificate AQUA-ENTRY-ESTAB/RELEASE/OTHER which is set out in Annex II to Implementing Regulation (EU) 2020/2236, and the consignment of non-listed species should be accompanied by the animal health certificate, declaration or other document, which complies with the national rules which the Member State of destination may apply for such commodities.

Article 7 of Implementing Regulation (EU) 2019/2122 allows the following goods which form part of passengers’ personal luggage and are intended for personal consumption to be exempted from official controls at border control posts:

• Eviscerated fresh fishery products or prepared fishery products, or processed fishery products provided that their combined quantity does not exceed the weight limit of 20kg or the weight of one fish, whichever weight is the highest
• Goods other than those referred to above and other than those referred to in Part 2 of Annex I to that Regulation, provided that their combined quantity does not exceed the weight limit of 2kg

If the above circumstances do not apply, sport-caught fish for personal use must be accompanied by a certificate which is in compliance with the model set out in Chapter 28 of Annex III to Implementing Regulation (EU) 2020/2235.

However, in accordance with the Notes concerning Part II of that certificate, if such products enter the Union ready for direct human consumption, Part II.2 of the certificate does not apply i.e. animal health attestations are not required.

Part II.2 of model FISH-CRUST-HC and MOL-HC sets out animal health attestations which apply to consignments of:

• aquatic animals of listed species which are intended for human consumption
• products of animal origin from those aquatic animals which are intended for further processing in the Union before human consumption.

It should however, be noted that wild aquatic animals of listed species and their products which are landed from fishing vessels intended for direct human consumption (i.e. aquatic animals and products of listed species which are landed from fishing vessels intended to enter the food chain), are exempted for the requirement to be accompanied by a certificate in which Part II.2. has been completed.

In all other situations, Part II.2. of the model certificates FISH-CRUST-HC and MOL-HC apply, as relevant to the commodity.

In situations where Part II.2. of FISH-CRUST-HC or MOL-HC applies, derogations from certain attestations which are set out in Part II.2, apply to certain categories of aquatic animals of listed species. These derogations can be summarised as follows:

Part II.2.3.1 (country of origin is listed in Implementing Regulation (EU) 2021/404), Part II.2.3.2 (clinical inspection carried out prior of loading) and Part II.2.4 (specific health requirements) of FISH-CRUST-HC/ MOL-HC do not apply, and should be deleted from the certificate if a consignment contains only the following molluscs/ crustaceans or fish:

1. crustaceans/molluscs which are packaged and labelled for human consumption in accordance with the specific requirements for those animals set out Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment,
2. crustaceans/molluscs which are intended for human consumption without further processing, provided that they are packaged for retail-sale in compliance with the requirements for such packages set out in Regulation (EC) No 853/2004,
3. crustaceans/molluscs which are packaged and labelled for human consumption in compliance with the specific requirements for those animals set out in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing,
4. fish (other than live fish) intended for further processing in the Union, which were slaughtered and eviscerated prior to dispatch to the Union.

In such situations where Parts II.2.3.1, II.2.3.2. and II.2.4. may be deleted, the remaining attestations set out in Part II.2. of FISH-CRUST-HC or MOL-HC apply, as relevant to the commodity.

The specific options which have been mentioned can be understood as follows:

Products for human consumption: this applies to products of animal origin from aquatic animals, other than live aquatic animals, which are intended for human consumption.

Live aquatic animals for human consumption: this applies to live aquatic animals which are intended for direct human consumption i.e. aquatic animals, which are delivered to the final consumer live or consumed live.

Dispatch Centre: this applies to live aquatic animals which are destined for a Dispatch Centre in the Union, before conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.