02008R1251 — EN — 14.12.2019 — 009.001

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►B COMMISSION REGULATION (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (Text with EEA relevance) (OJ L 337 16.12.2008, p. 41)

Amended by:









▼B

COMMISSION REGULATION (EC) No 1251/2008

of 12 December 2008

implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species

(Text with EEA relevance)







CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation lays down:

(a) a list of vector species;

▼M2

(b) animal health conditions for the placing on the market of: (i) ornamental aquatic animals either originating from or intended for closed ornamental facilities; and ▼M4 (ii) aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities and restocking, and for dispatch centres, purification centres and similar businesses before human consumption in Member States and parts thereof with national measures approved by Commission Decision 2010/221/EU ( 1 );

▼B

(c) animal health certification requirements for the placing on the market of: (i) aquaculture animals intended for farming, including relaying areas, put and take fisheries and open ornamental facilities, and restocking; and (ii) aquaculture animals and products thereof intended for human consumption;

(d) animal health conditions and certification requirements for imports into the Community, and transit therein, including storage during transit, of: (i) aquaculture animals intended for farming, including relaying areas, put and take fisheries and open ornamental facilities; (ii) aquaculture animals and products thereof intended for human consumption; (iii) ornamental aquatic animals intended for closed ornamental facilities.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a) ‘closed ornamental facilities’ means pet shops, garden centres, garden ponds, commercial aquaria or wholesalers keeping ornamental aquatic animals: (i) without any direct contact with natural waters in the Community; or (ii) which are equipped with an effluent treatment system reducing the risk of transmitting diseases to the natural waters to an acceptable level;

(b) ‘open ornamental facility’ means ornamental facilities other than closed ornamental facilities;

(c) ‘restocking’ means the release of aquaculture animals into the wild.







CHAPTER II

VECTOR SPECIES

Article 3

List of vector species

Aquaculture animals of species listed in Column 2 of the table in Annex I to this Regulation shall only be regarded as vectors for the purposes of Article 17 of Directive 2006/88/EC where those animals fulfil the conditions set out in Columns 3 and 4 of that table.







CHAPTER III

PLACING ON THE MARKET OF AQUACULTURE ANIMALS

Article 4

Ornamental aquatic animals originating from or intended for ornamental facilities

1. Movements of ornamental aquatic animals shall be subject to notification under the computerised system provided for in Article 20(1) of Directive 90/425/EEC (Traces) where the animals:

(a) originate from ornamental facilities in one Member State;

(b) are intended for closed ornamental facilities in another Member State, where the entire territory, or certain zones or compartments thereof: (i) are declared free of one or more of the non-exotic diseases listed in Part II of Annex IV to Directive 2006/88/EC in accordance with Articles 49 or 50 thereof; or (ii) are subject to a surveillance or eradication programme in accordance with Article 44(1) or (2) of that Directive; and

(c) are of species susceptible to one or more of the diseases for which the Member State or zone or compartment concerned is declared disease-free, or for which a surveillance or eradication programme applies, as referred to in point (b).

2. Ornamental aquatic animals kept in closed ornamental facilities shall not be released into open ornamental facilities, farms, relaying areas and put- and take fisheries, mollusc farming areas or into the wild, unless authorised by the competent authority.

The competent authority shall only grant such authorisation where the release does not jeopardise the health status of the aquatic animals at the place of release and it shall ensure that appropriate risk mitigating measures are taken.

Article 5

Aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities and restocking

Consignments of aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities, or restocking shall be accompanied by an animal health certificate completed in accordance with the model set out in Part A of Annex II and the explanatory notes in Annex V, where the animals:

(a) are introduced into Member States, zones or compartments: (i) declared free of one or more of the non-exotic diseases listed in Part II of Annex IV to Directive 2006/88/EC in accordance with Articles 49 or 50 thereof; or (ii) subject to a surveillance or eradication programme in accordance with Article 44(1) or (2) of that Directive;

(b) are of species susceptible to one or more of the diseases, or vector species for one or more of the diseases, for which the Member State, zone or compartment concerned is declared disease-free, or for which a surveillance or eradication programme applies, as referred to in point (a).

Article 6

Aquaculture animals and products thereof intended for further processing before human consumption

1. Consignments of aquaculture animals and products thereof intended for further processing before human consumption, shall be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex II and the explanatory notes in Annex V, where they:

(a) are introduced into Member States, zones or compartments: (i) declared free of one or more of the non-exotic diseases in Part II of Annex IV to Directive 2006/88/EC in accordance with Articles 49 or 50 of that Directive; or (ii) subject to a surveillance or eradication programme in accordance with Article 44(1) or (2) of that Directive;

(b) are of species susceptible to one or more of the diseases for which the Member State, zone or compartment concerned is declared disease-free, or for which a surveillance or eradication programme applies, as referred to in point (a).

2. Paragraph 1 shall not apply to:

(a) fish which have been slaughtered and eviscerated before dispatch;

(b) molluscs or crustaceans which are intended for human consumption and packed and labelled for that purpose in accordance with Regulation (EC) No 853/2004, and which are: (i) non-viable, which means no longer able to survive as living animals if returned to the environment from which they were obtained; or (ii) intended for further processing without temporary storage at the place of processing;

(c) aquaculture animals or products thereof placed on the market for human consumption without further processing, provided that they are packed in retail-sale packages which comply with the provisions for such packages in Regulation (EC) No 853/2004.

Article 7

Live molluscs and crustaceans intended for purification centres, dispatch centres and similar businesses before human consumption

Consignments of live molluscs and crustaceans intended for purification centres, dispatch centres and similar businesses before human consumption, shall be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex II and the explanatory notes in Annex V, where they:

(a) are introduced into Member States, zones or compartments: (i) declared free of one or more of the non-exotic diseases listed in Part II of Annex IV to Directive 2006/88/EC in accordance with Articles 49 or 50; or (ii) subject to a surveillance or eradication programme in accordance with Article 44(1) or (2) of that Directive;

(b) are of species susceptible to one or more of the diseases for which the Member State, zone or compartment concerned is declared disease-free, or for which a surveillance or eradication programme applies, as referred to in point (a).

Article 8

Aquaculture animals and products thereof leaving Member States, zones and compartments subject to disease control measures, including eradication programmes

1. Consignments of aquaculture animals and products thereof leaving Member States, zones or compartments subject to the disease control measures provided for in Sections 3 to 6 of Chapter V of Directive 2006/88/EC, but for which an exemption from those disease control measures has been granted by the competent authority, shall be accompanied by an animal health certificate completed in accordance with the model set out in:

(a) Part A of Annex II and the explanatory notes in Annex V where the consignments consist of aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities or restocking; and

(b) Part B of Annex II and the explanatory notes in Annex V where the consignments consist of aquaculture animals and products thereof intended for further processing, purification centres, dispatch centres or similar businesses before human consumption.

2. Consignments of aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities or restocking shall be accompanied by an animal health certificate completed in accordance with the model set out in Part A of Annex II and the explanatory notes in Annex V, where they:

(a) are leaving a Member State, zone or compartment with an eradication programme approved in accordance with Article 44(2) of Directive 2006/88/EC;

(b) are of species susceptible to one or more of the diseases, or vector species for one or more of the diseases, for which the eradication programme applies, as referred to in point (a).

3. Consignments of aquaculture animals and products thereof intended for further processing, purification centres, dispatch centres or similar businesses before human consumption shall be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex II and the explanatory notes in Annex V, where they:

(a) are leaving a Member State, zone or compartment with an eradication programme approved in accordance with Article 44(2) of Directive 2006/88/EC;

(b) are of species susceptible to one or more of the diseases for which the eradication programme applies, as referred to in point (a).

4. This Article shall not apply to:

(a) fish which have been slaughtered and eviscerated before dispatch;

(b) molluscs or crustaceans which are intended for human consumption and packed and labelled for that purpose in accordance with Regulation (EC) No 853/2004, and which are: (i) non-viable, which means no longer able to survive as living animals if returned to the environment from which they were obtained; or (ii) intended for further processing without temporary storage at the place of processing;

(c) aquaculture animals or products thereof placed on the market for human consumption without further processing, provided that they are packed in retail-sale packages which comply with the provisions for such packages in Regulation (EC) No 853/2004.

▼M2

Article 8a

Aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities and restocking in Member States and parts thereof with national measures approved by Decision 2010/221/EU

1. Consignments of aquaculture animals intended for farming, relaying areas, put and take fisheries, open ornamental facilities, or restocking shall be accompanied by an animal health certificate completed in accordance with the model set out in Part A of Annex II and the explanatory notes set out in Annex V, where the animals:

(a) are introduced into Member States or parts thereof listed in the second and fourth column of the table set out in: (i) Annex I to Decision 2010/221/EU as free of one or more of the diseases listed in the first column of that table; or (ii) Annex II to Decision 2010/221/EU as subject to an eradication programme for one or more of the diseases listed in the first column of that table; ▼M4 (iii) Annex III to Decision 2010/221/EU as subject to a surveillance programme for one or more of the diseases listed in the first column of that table; ▼M2

(b) are of species which are listed in Part C of Annex II as species susceptible to the diseases, for which the Member State concerned or part thereof is regarded as disease-free, or for which an eradication programme applies in accordance with Decision 2010/221/EU, as referred to in point (a).

2. Consignments of animals referred to in paragraph 1 shall comply with the animal health requirements set out in the model animal health certificate and explanatory notes as referred to in paragraph 1.

3. Paragraph 1 and 2 shall apply to consignments of fish of any species originating from waters where species listed in Part C of Annex II as species susceptible to infection with Gyrodactylus salaris, are present, where those consignments are intended for a Member State or part thereof listed in Annex I to Decision 2010/221/EU as free of Gyrodactylus salaris (GS).

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Article 8b

Live molluscs intended for dispatch centres, purification centres or similar businesses before human consumption in Member States and parts thereof with national measures approved by Decision 2010/221/EU

1. Consignments of live molluscs intended for dispatch centres, purification centres or similar businesses before human consumption shall be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex II and the explanatory notes set out in Annex V, where the animals:

(a) are introduced into Member States or parts thereof listed in the second and fourth column of the table set out in Annex III to Decision 2010/221/EU as subject to a surveillance programme for one or more of the diseases listed in the first column of that table;

(b) are of species which are listed in Part C of Annex II as species susceptible to the disease(s), for which a surveillance programme applies in accordance with Decision 2010/221/EU, as referred to in point (a).

2. Consignments of live molluscs referred to in paragraph 1 shall comply with the animal health requirements set out in the model animal health certificate and explanatory notes as referred to in that paragraph.

3. This Article shall not apply to consignments intended for dispatch centres, purification centres or similar businesses which are equipped with an effluent treatment system validated by the competent authority that:

(a) inactivates enveloped viruses; or

(b) reduces the risk of transmitting diseases to the natural waters to an acceptable level.

▼B

Article 9

Introduction of aquaculture animals after inspection

Where this Chapter provides that an inspection is required prior to the issue of an animal health certificate, live aquaculture animals of species susceptible to one or more of the diseases, or vector species for one or more of the diseases, referred to in that certificate, shall not be introduced into the farm or mollusc farming area during the period between such inspection and the loading of the consignment.







CHAPTER IV

CONDITIONS FOR IMPORTS

Article 10

Aquaculture animals intended for farming, relaying areas, put and take fisheries and open ornamental facilities

1. Aquaculture animals intended for farming, relaying areas, put and take fisheries and open ornamental facilities shall only be imported into the Community from third countries, territories, zones or compartments listed in Annex III.

2. Consignments of the aquaculture animals referred to in paragraph 1 shall:

(a) be accompanied by an animal health certificate completed in accordance with the model set out in Part A of Annex IV and the explanatory notes in Annex V;

(b) comply with the animal health requirements set out in the model certificate and explanatory notes, as referred to in point (a).

Article 11

Ornamental aquatic animals intended for closed ornamental facilities

1. Ornamental fish of species susceptible to one or more of the diseases listed in Part II of Annex IV to Directive 2006/88/EC and intended for closed ornamental facilities shall only be imported into the Community from third countries, territories, zones or compartments listed in Annex III to this Regulation.

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2. Ornamental fish which are not of susceptible species to any of the diseases listed in Part II of Annex IV to Directive 2006/88/EC, and ornamental molluscs and ornamental crustaceans, intended for closed ornamental facilities, shall only be imported into the Community from third countries or territories that:

(a) are members of the World Organisation for Animal Health (OIE); or

(b) are listed in Annex III and have a formal agreement with the OIE to regularly submit information concerning their animal health status to the members of that organisation.

▼B

3. Consignments of the animals referred to in paragraphs 1 and 2 shall:

(a) be accompanied by an animal health certificate completed in accordance with the model set out in Part B of Annex IV and the explanatory notes in Annex V; and

(b) comply with the animal health requirements set out in the model certificate and explanatory notes, as referred to in point (a).

Article 12

Aquaculture animals and products thereof intended for human consumption

1. Aquaculture animals and products thereof intended for human consumption shall only be imported into the Community from third countries, territories, zones or compartments which are included on a list drawn up in accordance with Article 11(1) of Regulation (EC) No 854/2004.

2. Consignments of the animals and products referred to in paragraph 1 shall:

(a) be accompanied by a joint public and animal health certificate completed in accordance with the relevant models set out in Appendixes IV and V of Annex VI to Regulation (EC) No 2074/2005; and

(b) comply with the animal health requirements and notes set out in the model certificates and attestations, as referred to in point (a).

3. This Article shall not apply where the aquaculture animals are intended for relaying areas or re-immersion into Community waters, in which case Article 10 shall apply.

Article 13

Electronic certification

Electronic certification and other agreed systems harmonised at Community level may be used for the certificates and attestations provided for in this Chapter.

Article 14

Transport of aquaculture animals

1. Aquaculture animals for import into the Community shall not be transported under conditions that may alter their health status. In particular they shall not be transported in the same water or micro-container as aquatic animals which are of a lower health status or which are not intended for import into the Community.

2. During transportation to the Community, the aquaculture animals shall not be unloaded from their micro-container and the water in which they are transported shall not be changed in the territory of a third country which is not approved for import of such animals into the Community or which has a lower health status than the place of destination.

3. Where consignments of aquaculture animals are transported by sea to the Community border, an addendum for transport of live aquaculture animals by sea, completed in accordance with the model set out in Part D of Annex IV, shall be attached to the relevant animal health certificate.

Article 15

Requirements for the release of aquaculture animals and products thereof and for transport water

1. Aquaculture animals and products thereof imported into the Community and intended for human consumption shall be handled appropriately to avoid contamination of natural waters in the Community.

2. Aquaculture animals imported into the Community shall not be released into the wild within the Community, unless authorised by the competent authority of the place of destination.

The competent authority may only grant authorisations where the release does not jeopardise the health status of the aquatic animals at the place of release and it shall ensure that appropriate risk-mitigating measures are taken.

3. Transport water from imported consignments of aquaculture animals and products thereof shall be handled appropriately to avoid contamination of natural waters in the Community.







CHAPTER V

CONDITIONS FOR TRANSIT

Article 16

Transit and storage

Consignments of live aquaculture animals, fish eggs and un-eviscerated fish which are introduced into the Community, but intended for a third country, either by transit immediately through the Community, or after storage in the Community, shall comply with the requirements laid down in Chapter IV. The certificate, which accompanies the consignments, shall bear the words ‘for transit through the EC’. The consignments shall also be accompanied by a certificate required by the third country of destination.

However, where those consignments are intended for human consumption, they shall be accompanied by an animal health certificate completed in accordance with the model set out in Part C of Annex IV and the explanatory notes in Annex V.

Article 17

Derogation for transit through Latvia, Lithuania and Poland

1. By way of derogation from Article 16, transit by road or by rail shall be authorised between the border inspection posts in Latvia, Lithuania and Poland listed in the Annex to Commission Decision 2001/881/EC, of consignments coming from and bound for Russia, directly or via another third country, where the following conditions are met:

(a) the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry.

▼M9 —————

▼B







CHAPTER VI

GENERAL, TRANSITIONAL AND FINAL PROVISIONS

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▼B

Article 19

Repeal

Decisions 1999/567/EC, 2003/390/EC, 2003/804/EC, 2003/858/EC and 2006/656/EC are repealed with effect from 1 January 2009.

References to the repealed Decisions shall be construed as references to this Regulation.

▼M3

Article 20

For a transitional period until 31 December 2012, Member States may authorise the import of ornamental aquatic animals of species susceptible to epizootic ulcerative syndrome (EUS) intended solely for closed ornamental facilities from third countries or territories that are Members of the World Organisation for Animal Health (OIE).

During that transitional period, the requirements concerning EUS set out in Part II.2 of the model animal health certificate set out in Part B of Annex IV, shall not apply to ornamental aquatic animals intended solely for closed ornamental facilities.

▼B

Article 21

Entry into force

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 1 January 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I







List of possible vector species and the conditions under which those species shall be regarded as vectors Diseases Vectors Species which shall be regarded as vectors for the purposes of Article 17(1) and (2) where the additional conditions set out in Columns 3 and 4 of this table are fulfilled Additional conditions related to the place of origin of the aquatic animals of the species listed in Column 2 Additional conditions related to the place of destination of the aquatic animals of the species listed in Column 2 Column 1 Column 2 Column 3 Column 4 Epizootic haematopoietic necrosis Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (C. carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophtalmichthys molitrix), Chub (Leuciscus spp), Roach (Rutilus rutilus), Rudd (Scardinius erythrophthalmus), tench (Tinca tinca) No additional conditions No additional conditions ▼M5 ————— ▼B Infection with Bonamia exitiosa Portuguese oyster (Crassostrea angulata), Pacific cupped oyster (Crassostrea gigas), American cupped oyster (Crassostrea virginica) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm or mollusc farming area where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm or mollusc farming area keeping species susceptible to that disease. Infection with Perkinsus marinus European lobster (Homarus gammarus), Marine crabs (Brachyura spp.), Yabi crayfish (Cherax destructor), Giant river prawn (Macrobrachium rosenbergii), Spiny lobsters (Palinurus spp.), Swimming crab (Portunus puber), Indopacific swamp crab (Scylla serrata), Indian white prawn (Penaeus indicus), Kuruma prawn (Penaeus japonicus), Caramote prawn (Penaeus kerathurus), Blue shrimp (Penaeus stylirostris), Whiteleg shrimp (Penaeus vannamei) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm or mollusc farming area where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm or mollusc farming area keeping species susceptible to that disease. Infection with Microcytos mackini None Not applicable Not applicable Taura syndrome Penshells (Atrina spp.), Common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), Common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), American cupped oyster (Crassostrea virginica), Wedge shell (Donax trunculus), Ezo abalone (Haliotis discus hannai), Tuberculate abalone (Haliotis tuberculata), Periwinkles (Littorina littorea), Northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), Sand gaper (Mya arenaria), Blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), Octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), Grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), Common cuttlefish (Sepia officinalis), Stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), Pullet carpet shell (Venerupis pullastra), Warty venus (Venus verrucosa) European lobster (Homarus gammarus), Marine crabs (Brachyura spp.), Yabi crayfish (Cherax destructor), Giant river prawn (Macrobrachium rosenbergii), Spiny lobsters (Palinurus spp), Swimming crab (Portunus puber), Indopacific swamp crab (Scylla serrata), Indian white prawn (Penaeus indicus), Kuruma prawn (Penaeus japonicus), Caramote prawn (Penaeus kerathurus). Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease. Yellowhead disease Penshells (Atrina spp.), Common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), Common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), American cupped oyster (Crassostrea virginica), Wedge shell (Donax trunculus), Ezo abalone (Haliotis discus hannai), Tuberculate abalone (Haliotis tuberculata), Periwinkles (Littorina littorea), Northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), Sand gaper (Mya arenaria), Blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), Octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), Grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), Common cuttlefish (Sepia officinalis), Stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), Pullet carpet shell (Venerupis pullastra), Warty venus (Venus verrucosa) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm where species susceptible to that disease are present. No additional conditions apply related to the place of destination. Viral haemorrhagic septicaemia (VHS) Beluga (Huso huso), Danube sturgeon (Acipenser gueldenstaedtii), Sterlet sturgeon (Acipenser ruthenus), Starry sturgeon (Acipenser stellatus), Sturgeon (Acipenser sturio), Siberian Sturgeon (Acipenser Baerii) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm or river catchment area where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease. Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), Crucian carp (C. carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophtalmichthys molitrix), Chub (Leuciscus spp), Roach (Rutilus rutilus), Rudd (Scardinius erythrophthalmus), tench (Tinca tinca) North African catfish (Clarias gariepinus), Northern pike (Esox lucius) Catfish (Ictalurus spp.), Black bullhead (Ameiurus melas), Channel catfish (Ictalurus punctatus), Pangas catfish (Pangasius pangasius), Pike perch (Sander lucioperca), Wels catfish (Silurus glanis) European seabass (Dicentrarchus labrax), Striped bass (Morone chrysops x M. saxatilis), Flathead grey mullet (Mugil cephalus), Red drum (Sciaenops ocellatus), Meagre (Argyrosomus regius), Shi drum (Umbrina cirrosa), True tunas (Thunnus spp.), Atlantic bluefin tuna (Thunnus thynnus), White Grouper (Epinephelus aeneus), Dusky grouper (Epinephelus marginatus), Senegalese solea (Solea senegalensis), Common sole (Solea solea), Common pandora (Pagellus erythrinus), Common dentex (Dentex dentex), Gilthead seabream (Sparus aurata), White seabream (Diplodus sargus), Black spot seabream (Pagellus bogaraveo), Red Sea Bream (Pagrus major), Diplodus vulgaris, Sharop snout seabream (Diplodus puntazzo), Common two banded seabream (Diplodus vulgaris), Red porgy (Pagrus pagrus) Tilapia spp (Oreochromis) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease. Infectious haematopoietic necrosis (IHN) Beluga (Huso huso), Danube sturgeon (Acipenser gueldenstaedtii), Sterlet sturgeon (Acipenser ruthenus), Starry sturgeon (Acipenser stellatus), Sturgeon (Acipenser sturio), Siberian Sturgeon (Acipenser Baerii) Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (C. carassius), common carp and koi carp (Cyprinus carpio), silver carp (Hypophtalmichthys molitrix), Chub (Leuciscus spp), Roach (Rutilus rutilus), Rudd (Scardinius erythrophthalmus) tench (Tinca tinca) North African catfish (Clarias gariepinus), Catfish (Ictalurus spp.), Black bullhead (Ameiurus melas), Channel catfish (Ictalurus punctatus), Pangas catfish (Pangasius pangasius), Pike perch (Sander lucioperca), Wels catfish (Silurus glanis) Atlantic halibut (Hippoglossus hippoglossus), Flounder (Platichthys flesus), Atlantic cod (Gadus morhua), Haddock (Melanogrammus aeglefinus) Noble crayfish (Astacus astacus), Signal crayfish (Pacifastacus leniusculus), Redswamp crayfish (Procambarus clarkii) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease. Koi herpes virus (KHV) disease None Not applicable Not applicable Infectious salmon anaemia (ISA) None Not applicable Not applicable Infection with Marteilia refringens Common edible cockle (Cerastoderma edule), Wedge shell (Donax trunculus), Sand gaper (Mya arenaria), Northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), Grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), European aurora venus clam (Venerupis aurea), Pullet carpet shell (Venerupis pullastra), Warty venus (Venus verrucosa) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm or mollusc farming area where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease. Infection with Bonamia ostreae Common edible cockle (Cerastoderma edule), Wedge shell (Donax trunculus), Sand gaper (Mya arenaria), Northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), Grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), European aurora venus clam (Venerupis aurea), Pullet carpet shell (Venerupis pullastra), Warty venus (Venus verrucosa) Great Atlantic scallop (Pecten maximus) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm or mollusc farming area where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm or mollusc farming area keeping species susceptible to that disease. White spot disease Penshells (Atrina spp.), Common whelk (Buccinum undatum), Portuguese oyster (Crassostrea angulata), Common edible cockle (Cerastoderma edule), Pacific cupped oyster (Crassostrea gigas), American cupped oyster (Crassostrea virginica), Wedge shell (Donax trunculus, Ezo abalone (Haliotis discus hannai), Tuberculate abalone (Haliotis tuberculata), Periwinkles (Littorina littorea), Northern quahog (Mercenaria mercenaria), Japanese hard clam (Meretrix lusoria), Sand gaper (Mya arenaria), Blue mussel (Mytilus edulis), Mediterranean mussel (Mytilus galloprovincialis), Octopus (Octopus vulgaris), European flat oyster (Ostrea edulis), Great Atlantic scallop (Pecten maximus), Grooved carpet shell (Ruditapes decussatus), Japanese carpet shell (Ruditapes philippinarum), Common cuttlefish (Sepia officinalis), Stromboid conchs (Strombus spp.), European aurora venus clam (Venerupis aurea), Pullet carpet shell (Venerupis pullastra), Warty venus (Venus verrucosa) Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they originate from a farm where species susceptible to that disease are present. Aquatic animals of the species listed in Column 2 shall only be regarded as vectors for the disease listed in Column 1 where they are intended for a farm keeping species susceptible to that disease.

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ANNEX II

▼M8

PART A

Model animal health certificate for the placing on the market of aquaculture animals for farming, relaying, put and take fisheries, open ornamental facilities and restocking

▼M4

PART B

Model animal health certificate for the placing on the market of aquaculture animals or products thereof intended for further processing, dispatch centres and purification centres and similar businesses before human consumption

▼M8

PART C

List of species susceptible to diseases for which national measures are approved under Decision 2010/221/EU







Disease Susceptible species Spring Viraemia of Carp (SVC) Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus), crucian carp (Carassius carassius), grass carp (Ctenopharyngodon idellus), common carp and koi carp (Cyprinus carpio), silver carp (Hypophthalmichthys molitrix), sheatfish (Silurus glanis), and tench (Tinca tinca), Orfe (Leuciscus idus) Bacterial kidney disease (BKD) Family: Salmonidae Infectious pancreatic necrosis virus (IPN) Rainbow trout (Oncorhynchus mykiss), brook trout (Salvelinus fontinalis), brown trout (Salmo trutta), Atlantic salmon (Salmo salar) and (Oncorhynchus spp.), whitefish (Coregonus lavaretus) Infection with salmonid alphavirus (SAV) Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) Infection with Gyrodactylus salaris Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), Arctic char (Salvelinus alpinus), North American brook trout (Salvelinus fontinalis), grayling (Thymallus thymallus), North American lake trout (Salvelinus namaycush) and brown trout (Salmo trutta). Ostreid herpesvirus 1 μνar (OsHV-1 μνar) Pacific oyster (Crassostrea gigas)

▼M5









ANNEX III

List of third countries, territories, zones or compartments ( 2 )

(referred to in Article 10(1) and Article 11)







Country/territory Aquaculture Species Zone/Compartment ISO-code Name Fish Molluscs Crustaceans Code Description AU Australia X () BR Brazil X () ▼M7 CA Canada X CA 0 (C) Whole territory CA 1 (D) British Columbia CA 2 (D) Alberta CA 3 (D) Saskatchewan CA 4 (D) Manitoba CA 5 (D) New Brunswick CA 6 (D) Nova Scotia CA 7 (D) Prince Edward Island CA 8 (D) Newfoundland and Labrador CA 9 (D) Yukon CA 10 (D) Northwest Territories CA 11 (D) Nunavut CA 12 (D) Quebec ▼M5 CL Chile X () Whole country CN China X () Whole country CO Colombia X () Whole country CG Congo X () Whole country CK Cook Islands X () X () X () Whole country ▼M6 ————— ▼M5 HK Hong Kong X () Whole country ID Indonesia X () Whole country IL Israel X () Whole country JM Jamaica X () Whole country JP Japan X () Whole country KI Kiribati X () X () X () Whole country LK Sri Lanka X () Whole country MH Marshall Islands X () X () X () Whole country MK () the former Yugoslav Republic of Macedonia X () Whole country MY Malaysia X () Peninsular, Western Malaysia NR Nauru X () X () X () Whole country NU Niue X () X () X () Whole country NZ New Zealand X () Whole country PF French Polynesia X () X () X () Whole country PG Papua New Guinea X () X () X () Whole country PN Pitcairn Islands X () X () X () Whole country PW Palau X () X () X () Whole country RU Russia X () Whole country SB Solomon Islands X () X () X () Whole country SG Singapore X () Whole country ZA South Africa X () Whole country TW Taiwan X () Whole country TH Thailand X () Whole country TR Turkey X () Whole country TK Tokelau X () X () X () Whole country TO Tonga X () X () X () Whole country TV Tuvalu X () X () X () Whole country US United States () X X US 0 () Whole country X US 1 () Whole country, except the following states: New York, Ohio, Illinois, Michigan, Indiana, Wisconsin, Minnesota and Pennsylvania X US 2 Humboldt Bay (California) US 3 Netarts Bay (Oregon) US 4 Wilapa Bay, Totten Inlet, Oakland Bay, Quilcence Bay and Dabob Bay (Washington) US 5 NELHA (Hawaii) WF Wallis and Futuna X () X () X () Whole country WS Samoa X () X () X () Whole country (1) Apply to all fish species. (2) Apply only to Cyprinidae. (3) Apply not to fish species susceptible to or vector species for viral haemorrhagic septicaemia according to Part II of Annex IV to Directive 2006/88/EC. (4) Apply only to fish species susceptible to or vector species for viral haemorrhagic septicaemia according to Part II of Annex IV to Directive 2006/88/EC. (5) Provisional code that does not prejudice in any way the definitive denomination for this country, which will be agreed following the conclusion of the negotiations currently taking place on this subject at the United Nations. (6) Apply only to imports of ornamental fish which are not of susceptible species to any of the diseases listed in Part II of Annex IV to Directive 2006/88/EC, and ornamental molluscs and ornamental crustaceans, intended for closed ornamental facilities. (7) For the purposes of this Regulation United States includes Puerto Rico, U.S. Virgin Islands, American Samoa, Guam and Northern Mariana Islands.

▼B









ANNEX IV

▼M5

PART A

Model animal health certificate for the import into the European Union of aquaculture animals for farming, relaying, put and take fisheries and open ornamental facilities

PART B

Model animal health certificate for the import into the European Union of ornamental aquatic animals intended for closed ornamental facilities

▼B

PART C

Model animal health certificate for transit/storage of live aquaculture animals, fish eggs and uneviscerated fish intended for human consumption

PART D

Addendum for transport of live aquaculture animals by sea

(To be completed and attached to the animal health certificate where transport to the European Community border includes transport by ship, even for part of the journey.)

▼M2









ANNEX V

Explanatory notes

(a) Certificates shall be issued by the competent authorities of the country of origin, based on the appropriate model set out in Annex II and IV to this Regulation taking into account the place of destination and use of the consignment after the arrival at the destination.

(b) Considering the status of the place of destination as regards non-exotic diseases referred to in Part II of Annex IV to Directive 2006/88/EC in the EU Member State or diseases for which the place of destination has measures approved by to Decision 2010/221/EU approving national measures in accordance with Article 43 of Council Directive 2006/88/EC, the appropriate specific requirements shall be incorporated and completed in the certificate.

(c) The ‘Place of origin’ shall be the localisation of the farm or mollusc farming area where the aquaculture animals were reared reaching their commercial size relevant for the consignment covered by this certificate. For wild aquatic animals ‘place of origin’ shall be the place of harvest.

(d) Where the model certificate states that certain statements shall be kept as appropriate, statements which are not relevant, may be crossed out and initialled and stamped by the certifying officer, or completely deleted from the certificate.

(e) The original of each certificate shall consist of a single sheet of paper, or, where more text is required it must be in such a form that all sheets of paper required are part of an integrated whole and indivisible.

(f) For import into the Union from third countries, the original of the certificate and the labels referred to in the model certificate shall be drawn up in at least one of the official languages of the Member State of the border inspection post of introduction of the consignment into the Union and of the Member State of destination. However, those Member States may authorise the certificate to be drawn up in the official language of another Member State, and accompanied, if necessary, by an official translation.

(g) Where additional sheets are attached to the certificate for the purpose of identifying the items making up the consignment, such additional sheets shall also be considered to form part of the original of the certificate, provided the signature and stamp of the certifying official inspector appear on each page.

(h) When the certificate, including any additional sheets as referred to in (g), comprises more than one page, each page shall be numbered ‘–x(page number) of y(total number of pages)–’ on the bottom and shall bear the certificate reference number allocated by the competent authority on the top.

(i) The original of the certificate must be completed and signed by an official inspector not more than 72 hours prior to loading of the consignment, or not more than 24 hours in those cases were the aquaculture animals must be inspected within 24 hours of loading. The competent authorities of the country of origin shall ensure that principles of certification equivalent to those laid down in Directive 96/93/EC are followed.

(j) The colour of the signature shall be different from that of the printing. The same requirement shall apply to stamps other than embossed stamps or watermarks.

(k) For import into the Union from third countries, the original of the certificate must accompany the consignment until it reaches the EU border inspection post. For consignments placed on the market within the Union, the original of the certificate must accompany the consignment until it reaches its final destination.

(l) A certificate issued for live aquaculture animals shall be valid for 10 days from the date of issue. In the case of transport by ship, the time of validity is prolonged by the time of journey at sea. To that end, the original of a declaration by the ship's master, drawn up in accordance with the addendum drawn up in conformity with the model laid down in Part D of Annex IV, shall be attached to the animal health certificate.

(m) Please note that the general conditions on the transport of animals laid down in Council Regulation (EC) No 1/2005 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 may, where applicable, require measures to be taken after entry into the Union if the requirements of that Regulation are not fulfilled.