# L_2011097EN.01000901.xml

| 12.4.2011 | EN | Official Journal of the European Union | L 97/9 |
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12.4.2011

EN

Official Journal of the European Union

L 97/9

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COMMISSION REGULATION (EU) No 350/2011

of 11 April 2011

amending Regulation (EC) No 1251/2008 as regards the placing on the market requirements for consignments of Pacific oysters intended for Member States or parts thereof with national measures regarding ostreid herpes virus 1 μνar (OsHV-1 μνar) approved by Decision 2010/221/EU

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (1), and in particular Article 61(3) thereof,

Whereas:

| (1) | 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 (2) lays down placing on the market requirements, including animal health certification requirements, for movements of aquaculture animals into areas covered by national measures approved by Commission Decision 2010/221/EU of 15 April 2010 approving national measures for limiting the impact of certain diseases in aquaculture animals and wild aquatic animals in accordance with Article 43 of Council Directive 2006/88/EC (3). |
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(1)

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 (2) lays down placing on the market requirements, including animal health certification requirements, for movements of aquaculture animals into areas covered by national measures approved by Commission Decision 2010/221/EU of 15 April 2010 approving national measures for limiting the impact of certain diseases in aquaculture animals and wild aquatic animals in accordance with Article 43 of Council Directive 2006/88/EC (3).

| (2) | Since 2008, increased mortality in Pacific oysters (Crassostrea gigas) has occurred in several areas in Ireland, France and the United Kingdom. The epidemiological investigations undertaken in 2009 suggested that a newly described strain of ostreid herpesvirus-1 (OsHV-1), namely OsHV-1 μνar, played a major role in the increased mortality. |
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(2)

Since 2008, increased mortality in Pacific oysters (Crassostrea gigas) has occurred in several areas in Ireland, France and the United Kingdom. The epidemiological investigations undertaken in 2009 suggested that a newly described strain of ostreid herpesvirus-1 (OsHV-1), namely OsHV-1 μνar, played a major role in the increased mortality.

| (3) | Commission Regulation (EU) No 175/2010 of 2 March 2010 implementing Council Directive 2006/88/EC as regards measures to control increased mortality in oysters of the species Crassostrea gigas in connection with the detection of Ostreid herpesvirus 1 μνar (OsHV-1 μνar) (4) was adopted with the aim of preventing the further spread of OsHV-1 μνar. It introduced measures to control the spread of that disease and it applies until 30 April 2011. |
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(3)

Commission Regulation (EU) No 175/2010 of 2 March 2010 implementing Council Directive 2006/88/EC as regards measures to control increased mortality in oysters of the species Crassostrea gigas in connection with the detection of Ostreid herpesvirus 1 μνar (OsHV-1 μνar) (4) was adopted with the aim of preventing the further spread of OsHV-1 μνar. It introduced measures to control the spread of that disease and it applies until 30 April 2011.

| (4) | Decision 2010/221/EU, as recently amended by Commission Decision 2011/187/EU (5), allows the Member States listed in Annex III thereto to impose placing on the market requirements on the movement of Pacific oysters into areas covered by approved surveillance programmes, in order to prevent the introduction of OsHV-1 μνar into those areas. In the interests of clarity and simplification of Union legislation, the respective placing on the market requirements should be laid down in Regulation (EC) No 1251/2008. |
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(4)

Decision 2010/221/EU, as recently amended by Commission Decision 2011/187/EU (5), allows the Member States listed in Annex III thereto to impose placing on the market requirements on the movement of Pacific oysters into areas covered by approved surveillance programmes, in order to prevent the introduction of OsHV-1 μνar into those areas. In the interests of clarity and simplification of Union legislation, the respective placing on the market requirements should be laid down in Regulation (EC) No 1251/2008.

| (5) | In order to prevent the introduction of OsHV-1 μνar into Member States or parts thereof listed in Annex III to Decision 2010/221/EU, consignments of Pacific oysters intended for farming or relaying areas, and for dispatch centres, purification centres or similar businesses before human consumption, introduced into such Member States or parts thereof, should originate from an area with an equivalent health status. |
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(5)

In order to prevent the introduction of OsHV-1 μνar into Member States or parts thereof listed in Annex III to Decision 2010/221/EU, consignments of Pacific oysters intended for farming or relaying areas, and for dispatch centres, purification centres or similar businesses before human consumption, introduced into such Member States or parts thereof, should originate from an area with an equivalent health status.

| (6) | To ensure that those requirements are complied with, such consignments should be accompanied by an animal health certificate providing the necessary attestations. |
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(6)

To ensure that those requirements are complied with, such consignments should be accompanied by an animal health certificate providing the necessary attestations.

| (7) | Regulation (EC) No 1251/2008 should therefore be amended accordingly. |
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(7)

Regulation (EC) No 1251/2008 should therefore be amended accordingly.

| (8) | It is appropriate to provide for transitional measures to allow Member States and the industry to take the necessary measures to comply with the requirements laid down in this Regulation. |
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(8)

It is appropriate to provide for transitional measures to allow Member States and the industry to take the necessary measures to comply with the requirements laid down in this Regulation.

| (9) | To avoid the further spread of OsHV-1 μνar, this Regulation should apply immediately following the date of expiry of Regulation (EU) No 175/2010. |
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(9)

To avoid the further spread of OsHV-1 μνar, this Regulation should apply immediately following the date of expiry of Regulation (EU) No 175/2010.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1251/2008 is amended as follows:

| (1) | in Article 1, point (b)(ii) is replaced by the following:






  ‘(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); |
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(1)

in Article 1, point (b)(ii) is replaced by the following:

‘(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);

(*1)  
  OJ L 98, 20.4.2010, p. 7.’;"

| (2) | in Article 8a(1)(a), the following point (iii) is added:






  ‘(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;’; |
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(2)

in Article 8a(1)(a), the following point (iii) is added:

‘(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;’;

| (3) | the following Article 8b is inserted:

  ‘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; |
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(3)

the following Article 8b is inserted:

‘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). |
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(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 |
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(a)

inactivates enveloped viruses; or

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

reduces the risk of transmitting diseases to the natural waters to an acceptable level.’;

| (4) | Annex II is replaced by the text in the Annex to this Regulation. |
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(4)

Annex II is replaced by the text in the Annex to this Regulation.

Article 2

1.   For a transitional period until 15 May 2011, consignments of Pacific oysters accompanied by animal health certificates issued in accordance with Part A or B of Annex II to Regulation (EC) No 1251/2008 before the amendments introduced by the present Regulation, and an animal health certificate issued in accordance with Annex II to Regulation (EU) No 175/2010 may be placed on the market provided that they reach their place of final destination before that date.

2.   For a transitional period until 1 July 2012, consignments of aquaculture animals accompanied by animal health certificates issued in accordance with Part A or B of Annex II to Regulation (EC) No 1251/2008 before the amendments introduced by the present Regulation, may continue to be placed on the market provided that the animal health attestations as regards OsHV-1 μνar set out in Part II of those certificates are not applicable and they reach their place of final destination before that date.

Article 3

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

It shall apply from 1 May 2011.

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

Done at Brussels, 11 April 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 328, 24.11.2006, p. 14.

1

(2)  
  OJ L 337, 16.12.2008, p. 41.

2

(3)  
  OJ L 98, 20.4.2010, p. 7.

3

(4)  
  OJ L 52, 3.3.2010, p. 1.

4

(5)  
  OJ L 80, 26.3.2011, p. 15.

5

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ANNEX

‘ANNEX II

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

Image 1

Part I: Details of consignment presented

EUROPEAN UNION

Intra trade certificate

I.1. Consignor

Name

Address

Postal code

I.2. Certificate reference No

I.2.a. Local reference No

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

I.6.

I.7.

I.8. Country of origin

ISO code

I.9.

I.10. Country of destination

ISO code

I.11.

I.12. Place of origin

Approved aquaculture holding

Other

Name

Approval number

Address

Postal code

I.13. Place of destination

Approved aquaculture holding

Other

Name

Approval number

Address

Postal code

I.14. Place of loading

Postal code

I.15. Date and time of departure

I.16. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

I.17. Transporter

Name

Approval number

Address

Postal code

Member State

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

I.25. Commodities certified for:

Breeding

Game restocking

Relaying

Pets

Quarantine

Other

I.26. Transit through third country

Third country

ISO code

Exit point

Code

Entry point

BIP No

I.27. Transit through Member States

Member State

ISO code

Member State

ISO code

Member State

ISO code

I.28. Export

Third country

ISO code

Exit point

Code

I.29.

I.30.

I.31. Identification of the commodities

Species (Scientific name)

Quantity

Image 2

Part II: Сertification

EUROPEAN UNION

Placing on the market of aquaculture animals for farming, relaying, put and take fisheries, open ornamental facilities and restocking

II. Health information

II.a. Certificate reference No

II.b.

II.1 General requirements

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to in Part I of this certificate:

II.1.1 either (1)[have been inspected within (1)
  (2)[72] (1)[24] hours of loading, and showed no clinical signs of disease]

or (1)[in the case of eggs and molluscs, come from a farm or mollusc farming area where, according to the records of the farm or mollusc farming area, there is no indication of disease problems]

or (1)
  (3)[in the case of wild aquatic animals, according to the best of my knowledge and belief are clinically healthy];

II.1.2 are not subject to any prohibitions due to unresolved increased mortality;

II.1.3 are not intended for destruction or slaughter for the eradication of diseases;

II.1.4 comply with the requirements for placing on the market laid down in Directive 2006/88/EC;

II.1.5 (1)[in the case of molluscs, were subject to an individual visual check of each part of the consignment, and no molluscs species other than those specified in Part I of the certificate were detected.]

II.2 (1)
  (4)
  (5)[Requirements for species susceptible to Viral haemorrhagic septicaemia (VHS), Infectious haematopoietic necrosis (IHN), Infectious salmon anaemia (ISA), Koi herpes virus (KHV), Marteilia refringens, Bonamia ostreae, and/or White spot disease

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to above:

either (1)
  (6)[originate from a Member State, zone or compartment declared free from (1)[VHS] (1)[IHN] (1)[ISA] (1)[KHV] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[White spot disease] in accordance with Chapter VII of Directive 2006/88/EC.]

or (1)(5)(6)[in the case of wild aquatic animals, have been subject to quarantine in accordance with Decision 2008/946/EC.]]

II.3 (1)
  (7)[Requirements for vector species to Viral haemorrhagic septicaemia (VHS), Infectious haematopoietic necrosis (IHN), Infectious salmon anaemia (ISA), Koi herpes virus (KHV), Marteilia refringens, Bonamia ostreae, and/or White spot disease

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to above which are to be regarded as possible vectors to (1)[VHS] (1)[IHN] (1)[ISA] (1)[KHV] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[White spot disease] as they are of species listed in Column 2 and fulfil the conditions set out in Column 3 of the table in Annex I to Regulation (EC) No 1251/2008:

either (1)
  (6)[originate from a Member State, zone or compartment declared free from (1)[VHS] (1)[IHN] (1)[ISA] (1)[KHV] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[White spot disease] in accordance with Chapter VII of Directive 2006/88/EC.]

or (1)
  (6)
  (7)[have been subject to quarantine in accordance with Decision 2008/946/EC.]]

II.4 Transport and labelling requirements

I, the undersigned official inspector, hereby certify that:

II.4.1 the aquaculture animals referred to above,

(i) are placed under conditions, including with a water quality, that do not alter their health status,

(ii) as appropriate, comply with the general conditions for the transport of animals laid down in Article 3 of Regulation (EC) No 1/2005;

Image 3

EUROPEAN UNION

Placing on the market of aquaculture animals for farming, relaying, put and take fisheries, open ornamental facilities and restocking

II. Health information

II.a. Certificate reference No

II.b.

II.4.2 the transport container or well boat prior to loading is clean and disinfected or previously unused; and

II.4.3 the consignment is identified by a legible label on the exterior of the container, or when transported by well boat, in the ship's manifest, with the relevant information referred to in boxes I.8 to I.13 of Part I of this certificate, and the following statement:

either (1)[“(1)[Wild] (1)[Fish] (1)[Molluscs] (1)[Crustaceans] intended for farming in the European Union”],

or (1)[“(1)[Wild] (1)[Molluscs] intended for relaying in the European Union”],

or (1)[“(1)[Wild] (1)[Fish] (1)[Molluscs] (1)[Crustaceans] intended for put and take fisheries in the European Union”],

or (1)[“(1)[Wild] (1)[Ornamental fish] (1)[Ornamental molluscs] (1)[Ornamental crustaceans] intended for open ornamental facilities in the European Union”],

or (1)[“(1)[Fish] (1)[Molluscs] (1)[Crustaceans] intended for restocking in the European Union”],

or (1)[“(1)[Wild] (1)[Fish] (1)[Molluscs] (1)[Crustaceans] intended for quarantine in the European Union”],

II.5 (1)
  (8)[Attestation for consignments originating from an area subject to disease control measures as provided for in Section 3 to 6 of Chapter V of Directive 2006/88/EC

I, the undersigned official inspector, hereby certify that:

II.5.1 the animals referred to above originate from an area subject to disease control measures regarding (1)[Epizootic ulcerative syndrome (EUS)] (1)[Epizootic haematopoietic necrosis (EHN)] (1)[Viral haemorrhagic septicaemia (VHS)] (1)[Infectious haematopoietic necrosis (IHN)] (1)[Infectious salmon anaemia (ISA)] (1)[Koi herpes virus (KHV)] (1)[Bonamia exitiosa] (1)[Perkinsus marinus] (1)[Mikrocytos mackini] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[Taura syndrome] (1)[Yellowhead disease] (1)[White spot disease] (1)
  (9)[the following emerging disease: ...];

II.5.2 the animals referred to above are allowed to be placed on the market according to the control measures laid down; and

II.5.3 the consignment is identified by a legible label on the exterior of the container, or when transported by well boat, in the ship's manifest, with the relevant information referred to in boxes I.8 to I.13 of Part I of this certificate, and the following statement:

“(1)[Wild] (1)[Fish] (1)[Molluscs] (1)[Crustaceans] originating from an area subject to disease control measures”.]

II.6 (1)
  (10)[Requirements for species susceptible to Spring vireamia of carp (SVC), Bacterial kidney disease (BKD), Infectious pancreatic necrosis virus (IPN) and Infection with Gyrodactylus salaris (GS)

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to above,

either (1)[originate from a Member State or part thereof:

(a) where (1)[SVC] (1)[GS] (1)[BKD] (1)[IPN] are notifiable to the competent authority and reports of suspicion of infection of the relevant disease must be immediately investigated by the competent authority,

(b) where all aquaculture animals of species susceptible to the relevant disease(s) introduced into that Member State or part thereof comply with the requirements set out in II.6 of this certificate,

(c) where species susceptible to the relevant diseases are not vaccinated against the relevant diseases, and

Image 4

EUROPEAN UNION

Placing on the market of aquaculture animals for farming, relaying, put and take fisheries, open ornamental facilities and restocking

II. Health information

II.a. Certificate reference No

II.b.

(d) either (1)[which, in the case of (1)[IPN](1)[BKD], complies with requirements for disease freedom equivalent to those laid down in Chapter VII of Directive 2006/88/EC.]

and/or (1)[which, in the case of (1)[SVC] (1)[GS], comply with requirements for disease freedom laid down in the relevant OIE Standard.]

and/or (1)[which, in the case of (1)[SVC] (1)[IPN] (1)[BKD], comprises one individual farm which under the supervision of the competent authority:

(i) has been emptied, cleansed and disinfected, and fallowed in at least 6 weeks,

(ii) has been restocked with animals from areas certified free from the relevant disease by the competent authority.]]

and/or (1)[in the case of wild aquatic animals susceptible to (1)[SVC] (1)[IPN] (1)[BKD], have been subject to quarantine under conditions at least equivalent to those laid down in Decision 2008/946/EC.]

and/or (1)[in the case of consignments for which GS requirements apply, have been held, immediately prior to the placing on the market, in water with a salinity of at least 25 parts per thousand for a continuous period of at least 14 days and no other live aquatic animals of the species susceptible to GS have been introduced during that period.]

and/or (1)[in the case of eyed fish eggs for which GS requirements apply, have been disinfected by a method demonstrated to be effective against GS.]]

II.7 (1)
  (11)[Requirements for species susceptible to OsHV-1 μνar

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to above,

either (1)[originate from a Member State or compartment:

(a) where OsHV-1 μνar is notifiable to the competent authority and reports of suspicion of infection of the relevant disease must be immediately investigated by the competent authority,

(b) where all aquaculture animals of species susceptible to OsHV-1 μνar introduced into that Member State or compartment comply with the requirements set out in II.7 of this certificate,

(c) either (1)[which comply with requirements for disease freedom equivalent to those laid down in Chapter VII of Directive 2006/88/EC,]

and/or (1)[in the case of consignments intended for a Member State or compartment covered by a programme approved by Decision 2010/221/EU, which itself is also covered by a surveillance programme approved by Decision 2010/221/EU,]

and/or (1)[have been subject to quarantine under conditions at least equivalent to those laid down in Decision 2008/946/EC.]

Notes

Part I:

Box I.12: If appropriate, use the authorisation number for the farm or mollusc farming area in question. Use “other” if wild aquatic animals,

Box I.13: If appropriate, use the authorisation number for the farm or mollusc farming area in question. Use “other” if intended for restocking,

Box I.19: Use the appropriate HS codes: 0301, 0306, 0307, 030110 or 030270,

Box I.20 and I. 31: As regards quantity, give the total number,

Box I.25: Use the option “Breeding” if intended for farming, “Relaying” if intended for relaying, “Pets” if intended for open ornamental facilities, “Game restocking” if intended for restocking, “Quarantine” if the aquaculture animals are intended for a quarantine facility, and “Other” if intended for put and take fisheries.

Part II:

(1) Keep as appropriate.

(2) The 24-hour option applies only to consignments of aquaculture animals which according to Article 8 of Regulation (EC) No 1251/2008 must be accompanied by a certificate and which in compliance with the placing on the market requirements of Directive 2006/88/EC are allowed by the competent authority to leave an area subject to control provisions provided for in Sections 3 to 6 of Chapter V of Directive 2006/88/EC or a Member State, zone or compartment with an eradication programme approved in accordance with Article 44(2) of that Directive. In all other cases the 72-hour option applies.

Image 5

EUROPEAN UNION

Placing on the market of aquaculture animals for farming, relaying, put and take fisheries, open ornamental facilities and restocking

II. Health information

II.a. Certificate reference No

II.b.

(3) Only applicable to consignments of aquaculture animals caught in the wild and immediately transported to a farm or mollusc farming area without any temporary storage.

(4) Part II.2 of this certificate applies to species susceptible to one or more of the diseases referred to in the title. Susceptible species are listed in Part II of Annex IV to Directive 2006/88/EC.

(5) Consignments of wild aquatic animals may be placed on the market regardless of the requirements in Part II.2 of this certificate if they are intended for a quarantine facility complying with the requirements laid down in Decision 2008/946/EC.

(6) To be authorised into a Member State, zone or compartment declared free from VHS, IHN, ISA, KHV, Marteilia refringens, Bonamia ostreae, or Whitespot disease or with a surveillance or eradication programme established in accordance with Article 44(1) or (2) of Directive 2006/88/EC, one of these statements must be kept if the consignment contain susceptible or vector species to the disease(s) for which disease freedom or programme(s) apply(ies). Data on the disease status of each farm and mollusc farming area in the Union are accessible at http://ec.europa.eu/food/animal/liveanimals/aquaculture/index_en.htm

(7) Part II.3 of this certificate applies to vector species to one or more of the diseases referred to in the title. Possible vector species and the conditions, under which consignments of such species are to be considered vector species, are listed in Annex I to Regulation (EC) No 1251/2008. Consignments of possible vector species may be placed on the market regardless of the requirements in Part II.3 if the conditions set out in Column 4 of the table in Annex I to Regulation (EC) No 1251/2008 are not fulfilled or they are intended for a quarantine facility complying with the requirements laid down in Decision 2008/946/EC.

(8) Part II.5 of this certificate applies to consignments of aquaculture animals which according to Article 8 of Regulation (EC) No 1251/2008 must be accompanied by a certificate and which in compliance with the placing on the market requirements of Directive 2006/88/EC are allowed by the competent authority to leave an area subject to control provisions provided for in Sections 3 to 6 of Chapter V of Directive 2006/88/EC or a Member State, zone or compartment with an eradication programme approved in accordance with Article 44(2) of that Directive.

(9) Applicable when measures are taken in accordance with Article 41 of Directive 2006/88/EC.

(10) Part II.6 of this certificate only applies to consignments intended for a Member State or part thereof which is regarded as disease-free, or for which an programme is approved in accordance with Decision 2010/221/EU as regards SVC, BKD, IPN or GS, and the consignment comprises species listed in Part C of Annex II as susceptible to the disease(s) for which the disease-free status or programme(s) apply(ies).

Part II.6 shall also 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 GS, 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 GS.

Consignments of wild aquatic animals for which SVC, IPN and/or BKD related requirements are applicable, may be placed on the market regardless of the requirements in Part II.6 of this certificate if they are intended for a quarantine facility complying with the requirements laid down in Decision 2008/946/EC.

(11) Part II.7 of this certificate only applies to consignments intended for a Member State or compartment which is regarded as disease-free, or for which a programme is approved by Decision 2010/221/EU as regards OsHV-1 μνar, and the consignment comprises species listed in Part C of Annex II to Regulation (EC) No 1251/2008 as susceptible to OsHV-1 μνar.

The requirements set out in part II.7 shall not apply to consignments intended for a quarantine facility complying with the requirements at least equivalent to those laid down in Decision 2008/946/EC.

Official veterinarian or official inspector

Name (in capital letters):

Qualification and title:

Local veterinary unit:

LVU No:

Date:

Signature:

Stamp:

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

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

Image 6

Part I: Details of consignment presented

EUROPEAN UNION

Intra trade certificate

I.1. Consignor

Name

Address

Postal code

I.2. Certificate reference No

I.2.a. Local reference No

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

I.6.

I.7.

I.8. Country of origin

ISO code

I.9.

I.10. Country of destination

ISO code

I.11.

I.12. Place of origin

Approved aquaculture holding

Other

Name

Approval number

Address

Postal code

I.13. Place of destination

Approved aquaculture holding

Other

Name

Approval number

Address

Postal code

I.14. Place of loading

Postal code

I.15. Date and time of departure

I.16. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

I.17. Transporter

Name

Approval number

Address

Postal code

Member State

I.18. Description of commodity

I.19. Commodity code (HS code)

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Seal/Container No

I.24. Type of packaging

I.25. Commodities certified for:

Human consumption

I.26. Transit through third country

Third country

ISO code

Exit point

Code

Entry point

BIP No

I.27. Transit through Member States

Member State

ISO code

Member State

ISO code

Member State

ISO code

I.28. Export

Third country

ISO code

Exit point

Code

I.29.

I.30.

I.31. Identification of the commodities

Species (Scientific name)

Quantity

Image 7

Part II: Certification

EUROPEAN UNION

Placing on the market of aquaculture animals or products thereof for human consumption

II. Health information

II.a. Certificate reference No

II.b.

II.1 General requirements

I, the undersigned official inspector, hereby certify that the aquaculture animals or products thereof referred to in Part I of this certificate:

II.1.1 comply with the requirements for placing on the market laid down in Council Directive 2006/88/EC.

II.2 (1)(2)[Requirements for species susceptible to Viral haemorrhagic septicaemia (VHS), Infectious haematopoietic necrosis (IHN), Infectious salmon anaemia (ISA), Koi herpes virus (KHV), Marteilia refringens, Bonamia ostreae, and/or White spot disease

I, the undersigned official inspector, hereby certify that the aquaculture animals or products thereof referred to above:

II.2.1 (1)originate from a Member State, zone or compartment declared free from (1)[VHS] (1)[IHN] (1)[ISA] (1)[KHV] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[White spot disease] in accordance with Chapter VII of Directive 2006/88/EC.]

II.3 Transport and labelling requirements

I, the undersigned official inspector, hereby certify that:

II.3.1 the aquaculture animals or products thereof referred to above,

(i) are placed under conditions, including with a water quality, that do not alter their health status;

(ii) as appropriate, comply with the general conditions for the transport of animals laid down in Article 3 of Council Regulation (EC) No 1/2005;

II.3.2 the transport container or well boat prior to loading is clean and disinfected or previously unused; and

II.3.3 the consignment is identified by a legible label on the exterior of the container, or when transported by well boat, in the ship’s manifest, with the relevant information referred to in boxes I.8 to I.13 of Part I of this certificate, and the following statement:

“(1)[Fish] (1)[Molluscs] (1)[Crustaceans] intended for (1)[further processing] (1)[dispatch centres or similar businesses] (1)[purification centres or similar businesses] before human consumption in the European Union”.

II.4 (1)(3)[Attestation for consignments originating from an area subject to disease control measures

I, the undersigned official inspector, hereby certify that:

II.4.1 either (1)[the animals referred to above have been inspected within 24 hours of loading, and showed no clinical signs of disease],

or (1)[in the case of eggs and molluscs, come from a farm or mollusc farming area where, according to the records of the farm or mollusc farming area, there is no indication of disease problems];

II.4.2 the animals referred to above originate from an area subject to disease control measures regarding (1)[Epizootic ulcerative syndrome (EUS)] (1)[Epizootic haematopoietic necrosis (EHN)] (1)[Viral haemorrhagic septicaemia (VHS)] (1)[Infectious haematopoietic necrosis (IHN)] (1)[Infectious salmon anaemia (ISA)] (1)[Koi herpes virus (KHV)] (1)[Bonamia exitiosa] (1)[Perkinsus marinus] (1)[Mikrocytos mackini] (1)[Marteilia refringens] (1)[Bonamia ostreae] (1)[Taura syndrome] (1)[Yellowhead disease] (1)[White spot disease] (1)(4)[the following emerging disease: ...];

II.4.3 the animals referred to above are allowed to be placed on the market according to the control measures laid down; and

II.4.4 the consignment is identified by a legible label on the exterior of the container, or when transported by well boat, in the ship manifest, with the relevant information referred to in boxes I.8 to I.13 of Part I of this certificate, and the following statement:

“(1)[Fish] (1)[Molluscs] (1)[Crustaceans] originating from an area subject to disease control measures”]

II.5 (1)
  (5)[Requirements for species susceptible to OsHV-1 μνar

I, the undersigned official inspector, hereby certify that the aquaculture animals referred to above,

either (1)[originate from a Member State or compartment:

(a) where OsHV-1 μνar is notifiable to the competent authority and reports of suspicion of infection of that disease must be immediately investigated by the competent authority,

Image 8

EUROPEAN UNION

Placing on the market of aquaculture animals or products thereof for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(b) where all aquaculture animals of species susceptible to OsHV-1 μνar introduced into that Member State or compartment comply with the requirements set out in II.5 of this certificate,

(c) either (1)[which comply with requirements for disease freedom equivalent to those laid down in Chapter VII of Directive 2006/88/EC,]

and/or (1)[in the case of consignments intended for a Member State or compartment covered by a programme is approved by Decision 2010/221/EU, which itself is also covered by a surveillance programme approved by Decision 2010/221/EU,]

or (1)[have been subject to quarantine under conditions at least equivalent to those laid down in Decision 2008/946/EC.]

Notes

Part I

Box I.12 and I.13: If appropriate, use the authorisation number for the farm, mollusc farming area or establishment in question,

Box I.19: Use the appropriate HS codes: 0301, 0302, 030270, 0303, 0306 or 0307,

Box I.20 and I.31: As regards quantity, give the total number,

Part II

(1) Keep as appropriate.

(2) Part II.2 of this certificate applies to species susceptible to one or more of the diseases referred to in the title. Susceptible species are listed in Part II of Annex IV to Directive 2006/88/EC.

To be authorised into a Member State, zone or compartment declared free from VHS, IHN, ISA, KHV, Marteilia refringens, Bonamia ostreae, or Whitespot disease or with a surveillance or eradication programme established in accordance with Article 44(1) or (2) of Directive 2006/88/EC, this statement must be kept if the consignment contains species susceptible to the disease(s) for which disease freedom or programme(s) apply(ies), unless the consignment is intended for processing establishments authorised in accordance with Article 4(2) of Directive 2006/88/EC, or for dispatch centres, purification centres or similar businesses which are equipped with an effluent treatment system inactivating the pathogens in question, or where the effluent is subject to other types of treatment reducing the risk of transmitting diseases to the natural waters to an acceptable level.

Data on the disease status of each farm and mollusc farming area in the European Union are accessible at http://ec.europa.eu/food/animal/liveanimals/aquaculture/index_en.htm

(3) Part II.4 of this certificate applies to consignments of aquaculture animals and products thereof which according to Article 8 of Regulation (EC) No 1251/2008 must be accompanied by a certificate and which in compliance with the placing on the market requirements of Directive 2006/88/EC are allowed by the competent authority to leave an area subject to control provisions provided for in Sections 3 to 6 of Chapter V of Directive 2006/88/EC or a Member State, zone or compartment with an eradication programme approved in accordance with Article 44(2) of that Directive.

(4) Applicable when measures are taken in accordance with Article 41 of Directive 2006/88/EC.

(5) Part II.5 of this certificate only applies to consignments intended for dispatch centres, purification centres or similar businesses in Member States or compartments which are regarded as disease-free, or for which a programme is approved by Decision 2010/221/EU as regards OsHV-1 μνar, and the consignment comprises species listed in Part C of Annex II to Regulation (EC) No 1251/2008 as susceptible to OsHV-1 μνar.

The requirements set out in part II.5 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 inactivates enveloped viruses or reduces the risk of transmitting diseases to the natural waters to an acceptable level.

Official veterinarian or official inspector

Name (in capital letters):

Qualification and title:

Local veterinary unit:

LVU No:

Date:

Signature:

Stamp:

PART C

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

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 torut (Salvelinus fontinalis), brown trout (Salmo trutta), Atlantic salmon (Salmo salar) and (Oncorhynchus spp.), whitefish (Coregonus lavaretus) |
| Infection with Gyrodactilys 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)’ |

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)

Aristichthys nobilis

Carassius auratus

Carassius carassius

Ctenopharyngodon idellus

Cyprinus carpio

Hypophthalmichthys molitrix

Silurus glanis

Tinca tinca

Leuciscus idus

Bacterial kidney disease (BKD)

Family: Salmonidae

Salmonidae

Infectious pancreatic necrosis virus (IPN)

Rainbow trout (Oncorhynchus mykiss), brook torut (Salvelinus fontinalis), brown trout (Salmo trutta), Atlantic salmon (Salmo salar) and (Oncorhynchus spp.), whitefish (Coregonus lavaretus)

Oncorhynchus mykiss

Salvelinus fontinalis

Salmo trutta

Salmo salar

Oncorhynchus spp

Coregonus lavaretus

Infection with Gyrodactilys 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)

Salmo salar

Oncorhynchus mykiss

Salvelinus alpinus

Salvelinus fontinalis

Thymallus thymallus

Salvelinus namaycush

Salmo trutta

Ostreid herpesvirus 1 μνar (OsHV-1 μνar)

Pacific oyster (Crassostrea gigas)’

Crassostrea gigas

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