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)
Date: 2008-12-12
Institutions: European Commission
Subjects: aquaculture, crustacean, fish disease, food safety, health certificate, human nutrition, import (EU), marketing standard, mollusc, sea fish, veterinary inspection

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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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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
and in particular
Article 17(2), Articles 22 and 25 and Article 61(3) thereof,

animals (1),

in aquatic

human

live fish,

consumption (5), Commission Decision
or
2003/858/EC of 21 November 2003 laying down the
animal health conditions and certification requirements
for introduction of
their eggs and gametes
intended for farming, and live fish of aquaculture origin
human
and
products
consumption (6)
Decision
2006/656/EC of 20 September 2006 laying down the
animal health conditions and certification requirements
for imports of fish for ornamental purpose (7) lay down
conditions for imports of aquaculture animals into the
Community. Those Decisions
implement Directive
91/67/EEC.

intended
Commission

thereof
and

for

Whereas:

(1)

(2)

(3)

to be applied for

Directive 2006/88/EC lays down the animal health
the placing on the
requirements
through the
market and the import and the transit
and products
Community of
thereof. Directive 2006/88/EC repeals
and replaces
Council Directive 91/67/EEC concerning the animal
health conditions governing the placing on the market
of aquaculture animals and products (2) from 1 August
2008.

aquaculture

animals

According to Directive 2006/88/EC aquaculture animal
means any aquatic animal, including ornamental aquatic
animals, at all its life stages, including eggs and sperm/
gametes, reared in a farm or mollusc farming area,
including any aquatic animal
from the wild intended
for a farm or mollusc farming area. Aquatic animals
mean fish, molluscs and crustaceans.

Commission Decision 1999/567/EC of 27 July 1999
laying down the model of the certificate referred to in
Article 16(1) of Directive 91/67/EEC (3) and Commission
Decision 2003/390/EC of 23 May 2003 establishing
special conditions for placing on the market of aqua­
culture animals species considered not susceptible to
certain diseases and the products thereof (4)
lay down
certain rules for the placing on the market of aquaculture
animals,
requirements.
Commission Decision 2003/804/EC of 14 November
2003 laying down the animal health conditions and
certification requirements for imports of molluscs, their
eggs and gametes for further growth, fattening, relaying

certification

including

(4)

(5)

Directive 2006/88/EC provides that the placing on the
market of aquaculture animals is to be subject to animal
health certification when the animals are introduced into
a Member State, zone or compartment declared disease-
free in accordance with that Directive or subject to a
surveillance or eradication programme. Accordingly,
it
is appropriate to lay down certification requirements
and harmonised model animal health certificates in this
Regulation to replace the certification requirements laid
down under Directive 91/67/EEC and the Decisions im­
plementing that Directive.

the

Regulation (EC) No 853/2004 of
European
Parliament and of the Council of 29 April 2004 laying
down specific hygiene rules for food of animal origin (8)
lays down specific rules on the hygiene of food of animal
origin for food business operators, including packaging
and labelling requirements. The animal health certifi­
cation requirements provided for in the present Regu­
lation for the placing on the market and import of aqua­
culture animals and products thereof intended for further
processing before human consumption should not apply
to those animals and products packed and labelled in
accordance with Regulation (EC) No 853/2004, subject
to certain conditions.

(6)

Directive 2006/88/EC provides that Member States are to
ensure that the placing on the market of ornamental
aquatic animals does not jeopardise the health status of
aquatic animals with regard to non-exotic diseases listed
in Part II of Annex IV thereto.

(1) OJ L 328, 24.11.2006, p. 14.
(2) OJ L 46, 19.2.1991, p. 1.
(3) OJ L 216, 14.8.1999, p. 13.
(4) OJ L 135, 3.6.2003, p. 19.

(5) OJ L 302, 20.11.2003, p. 22.
(6) OJ L 324, 11.12.2003, p. 37.
(7) OJ L 271, 30.9.2006, p. 71.
(8) OJ L 139, 30.4.2004, p. 55.

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(7)

(8)

Ornamental aquatic animals placed on the market in the
Community and intended for facilities without any direct
contact with natural waters, namely closed ornamental
facilities, do not pose the same risks to other sectors of
Community aquaculture or to wild stocks. Accordingly,
animal health certification should not be required under
this Regulation for such animals.

In order to provide Member States, where the entire
territory, or certain zones or compartments thereof, are
declared free of one of more of the non-exotic diseases
for which ornamental aquatic animals are susceptible,
with information on the movements into their territory
of ornamental aquatic animals intended for closed orna­
mental facilities, it is appropriate that such movements
are notified through the Traces system as provided for in
Council Directive 90/425/EEC of 26 June 1990
concerning veterinary and zootechnical checks applicable
in intra-Community trade in certain live animals and
products with a view to the completion of the internal
market (1) and introduced by Commission Decision
2004/292/EC of 30 March 2004 on the introduction
of the Traces system (2).

(9)

facilities to open ornamental

Movements within the Community from closed orna­
facilities or into
mental
the wild, may represent a high risk to other sectors of
Community aquaculture, and should not be allowed
without the authorisation of the competent authorities
of the Member States.

(10) Directive 2006/88/EC provides that Member States are to
take certain minimum control measures in the event of
confirmation of an exotic or non-exotic disease listed in
Part II of Annex IV thereto in aquaculture animals or
in the case of emerging
wild aquatic animals or
diseases.
that
Member States are to ensure that the placing on the
to animal
market of aquaculture animals
health certification when the animals are allowed to
leave an area subject to those control measures.

that Directive provides

In addition,

subject

is

(11) Accordingly,

this Regulation should lay down animal
for
health conditions and certification requirements
consignments of
and products
aquaculture
thereof leaving Member States, zones or compartments
subject to disease control measures.

animals

(12) Directive 2006/88/EC provides that Member States are to
ensure that aquaculture animals and products thereof are
from third
introduced into the Community only
countries or parts thereof that appear on a list drawn
up in accordance with that Directive.

(13)

Imports into the Community of aquaculture animals
should only be permitted from third countries that

animal health legislation and control

system
have
equivalent
to those in the Community. Accordingly,
this Regulation should establish a list of third countries,
territories, zones or compartments, from which Member
States are permitted to introduce into the Community
aquaculture animals for farming, relaying areas, put and
take fisheries and open ornamental facilities. However,
the import into the Community of certain ornamental
fish, molluscs and crustaceans intended for closed orna­
mental facilities should be permitted from third countries
that are members of the World Organisation for Animal
Health (OIE).

to the Community aquaculture animals

Third countries and territories which are allowed to
export
for
human consumption based on public health consid­
to the
should also be allowed to export
erations
Community under the animal health provisions of this
Regulation. Aquaculture animals and products thereof
intended for human consumption should therefore 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 of
European
Parliament and of the Council of 29 April 2004 laying
the organisation of official
down specific rules
controls on products of animal origin intended for
human consumption (3).

the

for

for

fishery

and
a

products

gastropods
and,

Such lists are set out in Annexes I and II to Commission
Decision 2006/766/EC of 6 November 2006 establishing
the lists of third countries and territories from which
tunicates,
imports of bivalve molluscs, echinoderms,
marine
are
permitted (4)
transitional period until
31 December 2009, by Commission Regulation (EC)
No 2076/2005 of 5 December 2005 laying down tran­
sitional arrangements for the implementation of Regu­
lations (EC) No 853/2004, (EC) No 854/2004 and (EC)
No 882/2004 of the European Parliament and of the
Council and amending Regulations (EC) No 853/2004
and (EC) No 854/2004 (5). In the interest of consistency
of Community legislation, those lists should be taken
into account in this Regulation.

(14)

(15)

(16) Directive 2006/88/EC provides that

import of aqua­
culture animals and products thereof are to be accom­
panied by a document containing an animal health cer­
tificate upon their entry into the Community.
is
necessary to lay down in this Regulation in detail the
imports of aquaculture
animal health conditions for
animals into the Community,
including model animal
health certificates, which should replace the import
conditions laid down under Directive 91/67/EEC.

It

(1) OJ L 224, 18.8.1990, p. 29.
(2) OJ L 94, 31.3.2004, p. 63.

(3) OJ L 139, 30.4.2004, p. 206.
(4) OJ L 320, 18.11.2006, p. 53.
(5) OJ L 338, 22.12.2005, p. 83.

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(17)

(EC) No

2074/2005

of
Commission Regulation
5 December 2005 laying down implementing measures
for certain products under Regulation (EC) No 853/2004
of the European Parliament and of the Council and for
the organisation of official controls under Regulation
(EC) No 854/2004 of the European Parliament and of
the Council and Regulation (EC) No 882/2004 of the
the Council, derogating
European Parliament and of
from Regulation (EC) No 852/2004 of
the European
Parliament and of the Council and amending Regulations
(EC) No 853/2004 and (EC) No 854/2004 (1) lays down
model health certificates for import of fishery products
intended for human
and of
consumption.
of
Community legislation, this Regulation should provide
that those model health certificates accompany import
of products covered by this Regulation.

live bivalve molluscs

coherency

interests

the

of

In

(18) Ornamental aquatic animals, including fish, molluscs and
crustaceans, are to a large extent introduced into the
Community from third countries and territories. To
protect the animal health status of ornamental facilities
within the Community,
is necessary to lay down
certain animal health requirements for the import of
such animals.

it

(19)

It is important to ensure that the animal health status of
aquaculture animals imported into the Community is not
jeopardised during transport to the Community.

(20)

The release of imported aquaculture animals into the wild
in the Community poses a particularly high risk to the
animal health status of the Community, since the control
and eradication of diseases in natural waters are difficult.
Accordingly, such release should require a specific au­
thorisation from the competent authority and only be
authorised
appropriate
measures are taken to secure the animal health status
at the place of release.

condition

under

that

the

(21) Aquaculture animals intended for transiting through the
Community should comply with the same requirements
into the
as aquaculture animals intended for import
Community.

(22)

Specific conditions for transit via the Community of
consignments to and from Russia should be provided
for owing to the geographical situation of Kaliningrad
which affects only Latvia, Lithuania and Poland. In the
legislation,
consistency of Community
interests of
Commission Decision 2001/881/EC of 7 December
2001 drawing up a list of border
inspection posts
agreed for veterinary checks on animals and animal

(1) OJ L 338, 22.12.2005, p. 27.

products from third countries and updating the detailed
rules concerning the checks to be carried out by the
the Commission (2) and Council Directive
experts of
97/78/EC of 18 December 1997 laying down the prin­
ciples governing the organisation of veterinary checks on
products
from third
countries (3) should be taken into account in this Regu­
lation.

Community

entering

the

(23)

Council Directive 96/93/EC of 17 December 1996 on
the certification of animals and animal products (4)
which lays down the rules to be observed in issuing
veterinary certificates, should apply to animal health
certificates issued under this Regulation.

(24) Article 17 of Directive 2006/88/EC provides that where
scientific data or practical experience substantiates that
species other than the susceptible species referred to in
Part II of Annex IV to that Directive may be responsible
for the transmission of a specific disease by acting as
vector species, Member States are to ensure that where
those species are introduced for farming or restocking
purposes into a Member State, zone or compartment
declared free of that specific disease, certain requirements
provided for in the Directive are to be complied with.
Article 17 of Directive 2006/88/EC also provides for the
drawing up of a list of vector species. A list of vector
species should therefore be adopted.

(25)

The European Food Safety Authority (EFSA) has delivered
three opinions on that issue: Scientific Opinion of the
Panel on Animal Health and Welfare on a request from
the European Commission on possible vector species and
live stages of susceptible species not transmitting disease
as regards certain fish diseases (5), Scientific Opinion of
the Panel on Animal Health and Welfare on a request
from the European Commission on possible vector
species and live stages of susceptible species not trans­
mitting disease as regards certain mollusc diseases (6), and
Scientific Opinion of the Panel on Animal Health and
Welfare on a request from the European Commission
on possible vector species and live stages of susceptible
species not transmitting disease as regards certain crus­
tacean diseases (7).

(26) According to those scientific opinions, the likelihood of
the transfer and establishment of the diseases listed in
Directive 2006/88/EC by the potential vector species or
groups of vector species assessed ranked from negligible/
extremely low to moderate, under certain conditions.
That assessment covered aquatic species which are used
in aquaculture and traded for the purpose of farming.

(2) OJ L 326, 11.12.2001, p. 44.
(3) OJ L 24, 30.1.1998, p. 9.
(4) OJ L 13, 16.1.1997, p. 28.
(5) The EFSA Journal (2007) 584, 1-163.
(6) The EFSA Journal (2007) 597, 1-116.
(7) The EFSA Journal (2007) 598, 1-91.

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(27)

the EFSA
In drawing up the list of vector species,
opinions should be taken into account.
In deciding
which species should be included in that list, an appro­
priate level of protection of the animal health status of
in the Community should be
aquaculture
ensured, while at
the same time avoiding the intro­
duction of unnecessary trade restrictions. Consequently,
species which pose a moderate risk of disease trans­
mission,
should be
according
included in the list.

to those opinions,

animals

(28) Many of the species identified as possible vectors for
certain diseases in the EFSA opinions, should only be
regarded as such when they originate from an area
where species susceptible to the disease in question are
present and are intended for an area where those same
susceptible species are also present. Accordingly, aqua­
culture animals of possible vector species should only
the purposes of
species
be regarded as vector
Article 17 of Directive 2006/88/EC under
such
conditions.

for

(29)

(30)

(31)

(32)

In the interest of clarity and coherence of Community
legislation, Decisions
2003/390/EC,
2003/804/EC, 2003/858/EC and 2006/656/EC should
be repealed and replaced by this Regulation.

1999/567/EC,

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

species

susceptible

Bearing in mind the large trade flow of ornamental
aquatic animals of
to epizootic
ulcerative syndrome (EUS) and the need to carry out
further studies on the risk of that disease to the orna­
mental aquatic animal industry, including a re-assessment
of the list of susceptible species, an immediate inter­
ruption of import of ornamental fish species susceptible
facilities
to EUS intended only for closed ornamental
to
avoided.
should be
It
the
introduce
a
requirements
those
consignments. A transitional period is also necessary in
order to give third countries sufficient time to document
freedom from that disease.

appropriate
regards
for

therefore
period
that

transitional
to
related

as
disease

is

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

(a) a list of vector species;

(b) animal health conditions for the placing on the market of
ornamental aquatic animals either originating from or
intended for closed ornamental facilities;

(c) animal health certification requirements for the placing on

the market of:

(i) aquaculture animals intended for

including
relaying areas, put and take fisheries and open orna­
mental facilities, and restocking; and

farming,

(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 orna­
mental facilities;

(ii) aquaculture animals and products thereof intended for

human consumption;

(iii) ornamental aquatic animals intended for closed orna­

mental facilities.

Article 2

Definitions

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

(a)

‘closed ornamental
shops, garden
centres, garden ponds, commercial aquaria or wholesalers
keeping ornamental aquatic animals:

facilities’ means pet

(i) without any direct contact with natural waters in the

Community; or

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

(ii) which are equipped with an effluent treatment system
reducing the risk of transmitting diseases to the natural
waters to an acceptable level;

Article 1

Subject matter and scope

This Regulation lays down:

(b) ‘open ornamental facility’ means ornamental facilities other

than closed ornamental facilities;

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(c)

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

farming areas or
competent authority.

into the wild, unless authorised by the

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:

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,
facilities and
put and take fisheries, open ornamental

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 certifi­
cate 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

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

(ii) subject to a surveillance or eradication programme in
accordance with Article 44(1) or (2) of that Directive;

(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

(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

Consignments of
for
intended

and products
1.
thereof
human
before
consumption, shall be accompanied by an animal health certifi­
cate completed in accordance with the model set out in Part B
of Annex II and the explanatory notes in Annex V, where they:

aquaculture
further

processing

animals

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

zone or

(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

2.
Ornamental aquatic animals kept in closed ornamental
facilities shall not be released into open ornamental facilities,
relaying areas and put- and take fisheries, mollusc
farms,

(ii) subject to a surveillance or eradication programme in
accordance with Article 44(1) or (2) of that Directive;

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(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 eradi­
cation 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

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
from

living animals if returned to the environment
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

live molluscs and crustaceans intended for
Consignments of
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;

animals

Consignments of

1.
and products
aquaculture
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
intended for further processing, purifi­
products thereof
cation centres, dispatch centres or
similar businesses
before human consumption.

animals

Consignments of

intended for
aquaculture
2.
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
approved in accordance with

eradication programme
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).

animals

aquaculture

Consignments of

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

businesses

centres

similar

before

or

(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 eradi­
cation programme applies, as referred to in point (a).

(a) are leaving a Member State, zone or compartment with an
approved in accordance with

eradication programme
Article 44(2) of Directive 2006/88/EC;

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

Consignments of the aquaculture animals referred to in

2.
paragraph 1 shall:

4.

This Article shall not apply to:

(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;

(a)

fish which have been slaughtered and eviscerated before
dispatch;

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

(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
from

living animals if returned to the environment
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 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, terri­
tories, zones or compartments listed in Annex III.

Article 11

Ornamental aquatic animals intended for closed
ornamental facilities

listed in Part

Ornamental fish of species susceptible to one or more of
1.
the diseases
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.

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 crus­
taceans, intended for closed ornamental facilities, shall only be
imported into the Community from third countries or terri­
tories
the World Organisation for
Animal Health (OIE).

that are members of

Consignments of the animals referred to in paragraphs 1

3.
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

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

territories,

countries,

L 337/48

EN

Official Journal of the European Union

16.12.2008

Consignments of the animals and products referred to in

2.
paragraph 1 shall:

handled appropriately to avoid contamination of natural waters
in the Community.

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

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 desti­
nation.

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

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 appro­
priate risk-mitigating measures are taken.

This Article shall not apply where the aquaculture animals
re-immersion into
intended

3.
are
Community waters, in which case Article 10 shall apply.

areas or

relaying

for

Article 13

Electronic certification

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

Transport water from imported consignments of aqua­
3.
culture animals and products thereof shall be handled appro­
priately to avoid contamination of natural waters
in the
Community.

CHAPTER V

CONDITIONS FOR TRANSIT

Article 16

Transit and storage

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.

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.

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.

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.

3. Where consignments of aquaculture animals are trans­
ported 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

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;

16.12.2008

EN

Official Journal of the European Union

L 337/49

(b) the documents accompanying the consignment, as provided
for in Article 7 of Directive 97/78/EC, are stamped with the
words ‘Only for transit to Russia via the EC’ on each page
by the official
inspector at the border inspection post of
entry;

(c)

the procedural requirements provided for in Article 11 of
Directive 97/78/EC are complied with; and

(d) the consignment is certified as acceptable for transit on the
common veterinary entry document issued by the official
inspector at the border inspection post of entry.

2.
The consignments referred to in paragraph 1 may not be
unloaded or put into storage, as referred to in Article 12(4) or
in Article 13 of Directive 97/78/EC, within the Community.

3.
Regular audits shall be conducted by the competent
the number of consignments, as
authority to ensure that
referred to in paragraph 1, and the corresponding quantities
of products leaving the Community match the number and
quantities entering the Community.

CHAPTER VI

GENERAL, TRANSITIONAL AND FINAL PROVISIONS

Article 18

Certification requirements laid down in other Community
legislation

The animal health certificates required in accordance with
Chapters III, IV and V of this Regulation shall, where appro­
priate,
incorporate any animal health certificate requirements
pursuant to:

(a) measures to prevent

the introduction of or control of
diseases not
II of Annex IV to Directive
2006/88/EC, approved in accordance with Article 43(2)
thereof; or

listed in Part

(b) Article 5 of Commission Decision 2004/453/EC (1).

Article 19

Repeal

1999/567/EC,

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

2003/390/EC,

Article 20

Transitional provisions

1.
For a transitional period until 30 June 2009, ornamental
aquatic animals referred to in Article 4(1) may be placed on the
market without notification under the computerised system
provided for in Article 20(1) of Directive 90/425/EEC (Traces)
provided that they reach their place of final destination before
that date.

a

30

For

until

transitional

2.
2009,
period
consignments of aquaculture animals and products thereof
accompanied by a movement document or animal health cer­
tificate in accordance with Annex E to Directive 91/67/EEC or
Decisions 1999/567/EC and 2003/390/EC may be placed on
the market provided that they reach their place of final desti­
nation before that date.

June

3.
For a transitional period until 30 June 2009, the following
consignments of aquaculture animals and products thereof may
be imported into or transited through the Community:

(a) consignments accompanied by an animal health certificate
in accordance with Decisions 2003/804/EC, 2003/858/EC
and 2006/656/EC;

(b) consignments covered by Chapter IV of this Regulation, but
covered by Decisions 2003/804/EC,

which are not
2003/858/EC and 2006/656/EC.

Article 14(3) shall not apply to the consignments referred to in
points (a) and (b) during that period.

4.
For a transitional period until 31 December 2009,
Member States may authorise the import of aquaculture
animals and products thereof intended for human consumption
from third countries, territories, zones or compartments which
are listed in Annexes I and II to Regulation (EC) No 2076/2005.

5.
For a transitional period until 31 December 2010,
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).

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

(1) OJ L 156, 30.4.2004, p. 5.

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

L 337/50

EN

Official Journal of the European Union

16.12.2008

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.

Done at Brussels, 12 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

16.12.2008

EN

Official Journal of the European Union

L 337/51

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EN

Official Journal of the European Union

16.12.2008

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EN

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L 337/53

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L 337/54

EN

Official Journal of the European Union

16.12.2008

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16.12.2008

EN

Official Journal of the European Union

L 337/55

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

L 337/56

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/57

L 337/58

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/59

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

PART B

L 337/60

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/61

L 337/62

EN

Official Journal of the European Union

16.12.2008

ANNEX III

Third countries, territories, zones or compartments from which import are permitted of aquaculture animals
intended for farming, put and take fisheries and open ornamental facilities, and ornamental fish 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 (1)

Country/territory

Aquaculture Species

Zone/Compartment

ISO-code

Name

Fish

Molluscs

Crustaceans

Code

Description

AU

BR

CA

Australia

Brazil

Canada

X (A)

X (B)

X

CL

CN

CO

CG

HR

HK

IN

ID

IL

JM

JP

LK

Chile

China

Colombia

Congo

Croatia

Hong Kong

India

Indonesia

Israel

Jamaica

Japan

Sri Lanka

MK (F)

Former Yugoslav
Republic of Macedonia

MY

NZ

RU

Malaysia

New Zealand

Russia

X (A)

X (B)

X (B)

X (B)

X (A)

X (B)

X (C)

X (A)

X (A)

X (B)

X (B)

X (B)

X (B)

X (B)

X (A)

X (A)

CA 0 (D) Whole territory

CA 1 (E)

British Columbia

CA 2 (E)

Alberta

CA 3 (E)

Saskatchewan

CA 4 (E)

Manitoba

CA 5 (E)

New Brunswick

CA 6 (E)

Nova Scotia

CA 7 (E)

Prince Edward Island

CA 8 (E)

Newfoundland and Labrador

CA 9 (E)

Yukon

CA 10 (E) Northwest Territories

CA 11 (E) Nunavut

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Whole country

Peninsular, Western Malaysia

Whole country

Whole country

(1) According to Article 11 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,
facilities, may be
imported into the Community from third countries or territories that are members of the World Organisation for Animal Health (OIE).

intended for closed ornamental

16.12.2008

EN

Official Journal of the European Union

L 337/63

Country/territory

Aquaculture Species

Zone/Compartment

ISO-code

Name

Fish

Molluscs

Crustaceans

Code

Description

SG

ZA

TW

TH

TR

US

Singapore

South Africa

Taiwan

Thailand

Turkey

United States

X (B)

X (A)

X (B)

X (B)

X (A)

X

X

X

Whole country

Whole country

Whole country

Whole country

Whole country

US 0 (D) Whole country

US 1 (E)

Whole country, except the following
Illinois,
states: New York, Ohio,
Michigan,
Indiana, Wisconsin,
Minnesota and Pennsylvania

US 2

US 3

US 4

Humboldt Bay (California)

Netarts Bay (Oregon)

Wilapa Bay, Totten Inlet, Oakland
Bay, Quilcence Bay and Dabob Bay
(Washington)

US 5

NELHA (Hawaii)

VN

Vietnam

X (C)

(A) Apply to all fish species.
(B) Apply only to fish species susceptible to Epizootic ulcerative syndrome according to Part II of Annex IV to Directive 2006/88/EC

intended for closed ornamental facilities and Cyprinidae.

(C) Apply only to fish species susceptible to Epizootic ulcerative syndrome according to Part II of Annex IV to Directive 2006/88/EC

intended for closed ornamental facilities.

(D) 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.

(E) 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.

(F) 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.

L 337/64

EN

Official Journal of the European Union

16.12.2008

ANNEX IV

PART A

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

16.12.2008

EN

Official Journal of the European Union

L 337/65

L 337/66

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/67

L 337/68

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/69

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

PART B

L 337/70

EN

Official Journal of the European Union

16.12.2008

16.12.2008

EN

Official Journal of the European Union

L 337/71

L 337/72

EN

Official Journal of the European Union

16.12.2008

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

PART C

16.12.2008

EN

Official Journal of the European Union

L 337/73

L 337/74

EN

Official Journal of the European Union

16.12.2008

Addendum for transport of live aquaculture animals by sea

PART D

(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.)

16.12.2008

EN

Official Journal of the European Union

L 337/75

ANNEX V

Explanatory notes

(a) The certificates shall be produced by the competent authorities of the country of origin, based on the appropriate
model appearing in Annexes II or 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 additional guarantees
according to Decision 2004/453/EC or measures approved in accordance with Article 43 of 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) The original of the certificate shall consist of a single page printed on both sides or, where more text is required, such

that all the pages form a whole and cannot be separated.

(e) For import into the Community 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 official language of the EU Member State where border inspection
takes place and of the EU Member State of destination. However, those Member States may allow another Community
language instead of their own, accompanied, if necessary, by an official translation.

(f) Where additional pages are attached to the certificate for the purpose of identifying the items making up the
the certificate,

consignment, such additional pages shall also be considered to form part of
provided the signature and stamp of the certifying official inspector appear on each page.

the original of

(g) Where the certificate, including any additional pages as provided for in (f), 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 code number of the
certificate allocated by the competent authority on the top.

(h) 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.

(i) The colour of the signature shall be different from that of the printing. The same rule shall apply to stamps other than

embossed stamps or watermarks.

(j) For import into the Community 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 Community, the
original of the certificate must accompany the consignment until it reaches its final destination.

(k) 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.

(l) 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 Community if the requirements of that Regulation are not fulfilled.