2003/858/EC: Commission Decision of 21 November 2003 laying down the animal health conditions and certification requirements for imports of live fish, their eggs and gametes intended for farming, and live fish of aquaculture origin and products thereof intended for human consumption (Text with EEA relevance) (notified under document number C(2003) 4219)
Date: 2003-11-21
Institutions: European Commission
Subjects: aquaculture, fish, food consumption, health certificate, health control, import

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COMMISSION

COMMISSION DECISION

of 21 November 2003

laying down the animal health conditions and certification requirements for imports of live fish,
their eggs and gametes intended for farming, and live fish of aquaculture origin and products
thereof intended for human consumption

(notified under document number C(2003) 4219)

(Text with EEA relevance)

(2003/858/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty establishing the European
Community,

Attention should be paid to emerging diseases and
diseases which are exotic to the Community and which
could have serious impact on the fish stocks in the Com-
munity. Furthermore,
the vaccination policy and the
disease situation as regards epizootic haematopoietic
necrosis (EHN) and the fish diseases referred to in Annex
A to Directive 91/67/EEC, at the place or production
and where appropriate at the place of destination should
be taken into account.

Having regard to Council Directive 91/67/EEC of 28 January
1991 concerning the animal health conditions governing the
placing on the market of aquaculture animals and products (1),
as last amended by Council Regulation (EC) No 806/2003 (2),
and in particular Article 19(1), Article 20(1) and Article 21(2)
thereof,

(4)

Whereas:

(1)

(2)

A list of third countries or parts thereof, from which
Member States are authorised to import live fish, their
eggs and gametes for farming in the Community, should
be established.

It is necessary to lay down specific animal health condi-
tions and model certificates for those third countries,
taking into account the animal health situation of the
third country concerned and of the fish, eggs or gametes
to be imported, in order to prevent the introduction of
disease agents that could cause significant impact to the
fish stock in the Community.

(1) OJ L 46, 19.2.1991, p. 1.
(2) OJ L 122, 16.5.2003, p. 1.

It is necessary that countries or parts thereof from which
Member States are authorised to import live fish, their
eggs and gametes for farming, must apply conditions for
disease control, and monitoring at least equivalent to
Community standards as laid down in Directive 91/67/
EEC and in Council Directive 93/53/EC of 24 June 1993
introducing minimum Community measures for
the
control of certain fish diseases (3), as last amended by
Commission Decision 2001/288/EC (4). The sampling
and testing methods used should be at least equivalent
to Commission Decision 2001/183/EC (5) of 22 February
2001 laying down the sampling plans and diagnostic
methods for the detection and confirmation of certain
fish diseases and repealing Decision 92/532/EEC, and
Commission Decision 2003/466/EC (6) of 13 June 2003
establishing criteria for zoning and official surveillance
following suspicion or confirmation of the presence of
Infectious
In cases where
sampling and testing methods are not laid down in the
Community
and testing
the
methods used should be in accordance with those laid
down in the International Office of Epizootics (OIE)
Manual of Diagnostic Tests for Aquatic Animals.

salmon anaemia

legislation,

sampling

(ISA).

(3) OJ L 175, 19.7.1993, p. 23.
(4) OJ L 99, 10.4.2001, p. 11.
(5) OJ L 67, 9.3.2001, p. 65.
(6) OJ L 156, 25.6.2003, p. 61.

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(5)

(6)

(7)

(8)

It is necessary that the responsible competent authorities
of these third countries undertake to notify by fax, tele-
gram or electronic mail,
the Commission and the
Member States within 24 hours, of any occurrence of
epizootic haematopoietic necrosis (EHN), or diseases
referred to in Annex A to Directive 91/67/EEC, as well
as any other disease outbreaks causing a significant
impact to the fish stock within their territory or parts
thereof from which imports covered by this Decision are
the responsible competent
authorised.
authorities of those third countries must take measures
to prevent the disease spreading into the Community.
Furthermore and as applicable, the Commission and the
Member States should be notified of any alteration in
the vaccination policy against such diseases.

In such event,

In addition, when importing live fish of aquaculture
origin and products thereof for human consumption, it
is necessary to prevent the introduction into the Com-
munity of serious diseases affecting aquaculture animals.

Therefore, it is necessary to supplement the certification
requirements relating to the importation of live fish of
aquaculture origin and products thereof under Council
Directive 91/493/EEC of 22 July 1991 laying down the
health conditions for the production and the placing on
the market of fishery products (1), as last amended by
Regulation (EC) No 806/2003, with the animal health
certification requirements.

It would reduce the possibility to control and eradicate
diseases which are exotic to the Community and which
could have serious impact on the fish stocks in the Com-
munity, if fish that could carry the disease are released
into unenclosed waters in the Community. Live fish,
eggs and gametes of aquaculture origin, should therefore
be imported into the Community only if they are intro-
duced into a farm.

(13)

The principles laid down in Council Directive 2002/99/
EC of 16 December 2002 laying down the animal health
rules governing the production, processing, distribution
and introduction of products of animal origin for human
consumption (3), in particular Article 3 of that Directive
should be taken into account.

(14) A transitional period of time should be provided for the
implementation of the new import certification require-
ments.

(15)

(16)

The list of approved countries referred to in Annex I to
this Decision should be reviewed no later than 12
months after the date of application.

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

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision establishes harmonised animal health rules

1.
for the importation of:

(a) live fish, their eggs and gametes, intended for farming in

the Community;

(b) live fish of aquaculture origin intended for restocking of

put-and take fisheries in the Community;

(c) live fish of aquaculture origin and products

thereof,
intended for immediate human consumption or further
processing before human consumption.

(9)

This Decision should not apply to the importation of
tropical ornamental fish kept permanently in aquariums.

This Decision shall not to apply to the importation of

2.
tropical ornamental fish kept permanently in aquariums.

(10)

(11)

(12)

This Decision should apply without prejudice to the
public health conditions established under Directive 91/
493/EEC.

Article 2

Definitions

This Decision should apply without prejudice to Com-
munity or national provision on the conservation of
species.

Council Directive 96/93/EC of 17 December 1996 on
the certification of animals and animal products (2) lays
down standards of certification. The rules and principles
applied by third-country certifying officers
should
provide guarantees, which are equivalent to those laid
down in that Directive.

For the purpose of this Decision, the definitions in Article

1.
2 of Directives 91/67/EEC and 93/53/EEC shall apply.

2.

The following definitions shall also apply:

(a) ‘aquaculture origin’ means fish originating from a farm;

(b) ‘approved import centre’ means any establishment in the
Community where special bio-security measures have been
put in place, approved by the competent authority of the
Member State
further processing of
imported live fish of aquaculture origin and products
thereof;

concerned,

for

(1) OJ L 268, 24.9.1991, p. 15.
(2) OJ L 13, 16.1.1997, p. 28.

(3) OJ L 18, 23.1.2003, p. 11.

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(c) ‘coastal zone’ means a zone consisting of a part of the coast

or sea water or an estuary:

(i) which has a precise geographical delimitation and
consists of a homogeneous hydrological system or a
series of such systems, or

(ii) which is situated between the mouths of two water-

courses, or

(iii) where there are one or more farms and all farms are
surrounded by appropriate buffer zones on both sides
of the farm or farms;

(d) ‘continental zone’ means a zone consisting of either:

(i) a part of the territory comprising an entire catchment
area from the sources of the waterways to the estuary
or more than one catchment area in which fish is
reared, kept or caught, as necessary surrounded by a
buffer zone in which a monitoring program is carried
out without the necessity of obtaining the status of an
approved zone, or

(ii) a part of a catchment area from the sources of the
waterways to a natural or artificial barrier preventing
fish migrating from downstream of
that barrier, as
necessary surrounded by a buffer zone in which a
monitoring program is carried out without the neces-
sity of obtaining the status of an approved zone.

(g) ‘farming’ means: the activity that takes place on any farm
or,
in general, any geographically defined installation in
which fish are reared or kept with a view to their being
placed on the market;

(h) ‘fish products of aquaculture origin’ means any products
intended for human consumption derived from fish of
aquaculture origin,
including whole fish (un-eviscerated),
eviscerated fish, and filets, and any products thereof;

(i) ‘further processing’ means preparation and processing
before human consumption by any kind of measures and
techniques, that produces waste or byproducts which could
including: operations
cause a risk of spreading diseases,
such as bleeding,
affecting the anatomical wholeness
gutting/evisceration, heading, slicing, filleting;

(j) ‘immediate human consumption’ means

the fish
imported for the purpose of human consumption do not
undergo any further processing within the Community
before being placed on the retail market
for human
consumption;

that

(k) ‘put and take fisheries’ means ponds, lakes or unenclosed
fish
waters that are sustained by the introduction of
primarily for recreational fishing rather than for conserva-
tion or improvement of natural population;

(l) ‘territory’ means either a whole country, a coastal zone, a
continental zone or a designated farm, which is authorised
by the central competent authority of the third country
concerned for exportation to the Community.

The size and the geographical situation of the continental
zone must be such that the possibilities for recontamina-
tion e.g. by migrating fish are reduced to a minimum;

Article 3

(e) ‘designated farm’ means either:

(i) a coastal farm in a third country subject to all necessary
measures to prevent the introduction of diseases and to
which the water is supplied by means of a system
which ensures
the
complete
following pathogens: infectious salmon anaemia (ISA),
viral heamorrhagic septicaemia (VHS) and infectious
haemorrhagic necrosis (IHN), or

inactivation of

the

(ii) an inland farm in a third country subject to all neces-
sary measures to prevent the introduction of diseases.
The farm is, if necessary, protected against flooding and
infiltration of water, and there is a natural or artificial
barrier situated down stream, which prevents fish from
entering the farm. The water is supplied directly to the
farm from a borehole, spring, or well, channelled
through a pipe, open channel or a natural conduit,
which does not constitute a source of infection for the
farm and does not allow the introduction of wild fish.
The water channel is under the control of the farm or
of the competent authorities;

(f) ‘establishment’ means: any premises approved according to
Directive 91/493/EEC, where fishery products are prepared,
processed,
stored, but
excluding auction and wholesale markets in which only
display and sale by wholesale takes place;

frozen, packaged or

chilled,

Conditions for importation of live fish, their eggs and
gametes intended for farming, and of live fish of aquacul-
ture origin for restocking of put-and take fisheries, within
the European Community

1. Member States shall authorise the importation into their
territory live fish, their eggs and gametes for farming only if:

(a) the fish originate in a territory listed in Annex I;

(b) the consignment complies with the guarantees,

including
those for packaging and labelling and the appropriate
specific additional requirements, as laid down in the animal
health certificate, drawn up in conformity with the model
in Annex II, taking into account the explanatory notes in
Annex III;

(c) the fish have been transported under conditions not

altering their health status.

2. Member States shall authorise the importation into their
territory live fish of aquaculture origin, their eggs and gametes
intended for direct restocking of put-and take fisheries only if:

(a) the consignment comply with the rules laid down in para-

graph 1;

(b) the put and take fishery do not represent lakes or unen-

closed waters.

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3. Member States shall ensure that imported fish of aquacul-
ture origin, their eggs and gametes intended for farming or
restocking of put-and take fisheries in Community waters, only
are introduced into farms or put-and take fisheries representing
ponds, and not introduced into unenclosed waters.

4. Member States shall ensure that imported live fish or
aquaculture origin,
their eggs and gametes are transported
directly to the farm or pond of destination, as stated on the
animal health certificate.

Article 4

Conditions related to importation of live fish of aquacul-
ture origin for human consumption

Member States shall authorise the importation into their terri-
tory live fish of aquaculture origin intended for immediate
human consumption or for further processing before human
consumption, only if:

(a) the consignment complies with the conditions laid down in
Article 3 paragraph 1 and Article 7 paragraph 1 of this
Decision; or

(b) the fish are sent directly to an approved import centre to

be slaughtered and eviscerated.

Article 5

Conditions related to importation of fish products of aqua-
further processing before human
culture origin for
consumption

1. Member States shall authorise the importation into their
territory fish products of aquaculture origin intended for
further processing before human consumption only if:

(a) the fish originate in third countries and establishments
authorised under Article 11 of Directive 91/493/EEC and
comply with the public health certification requirements
laid down under that Directive; and

(b) the consignment complies with the guarantees,

including
those for packaging and labelling and the appropriate
specific additional requirements, as laid down in the animal
health certificate, drawn up in conformity with the model
in Annex IV, taking into account the explanatory notes in
Annex III.

fish
2. Member States
products of aquaculture origin takes place in approved import
centres unless:

shall ensure that processing of

(a) the fish are eviscerated before dispatch; or

(b) the place of origin has a health status equivalent to the
place where they are to be processed in particular as
regards epizootic haematopoietic necrosis (EHN) and the
diseases referred to in lists I and II, column 1, of Annex A
to Directive 91/67/EEC.

Article 6

Conditions related to importation of fish products of aqua-
culture origin for immediate human consumption

Member States shall authorise the importation into their terri-
tory of
fish products of aquaculture origin intended for
immediate human consumption only if:

(a) the fish originate in third countries and establishments
authorised under Article 11 of Directive 91/493/EEC and
comply with the public health certification requirements
laid down under that Directive;

(b) the consignment complies with the guarantees,

including
those for packaging and labelling as laid down in the
animal health certificate, drawn up in conformity with the
model
in Annex V, taking into account the explanatory
notes in Annex III;

(c) the consignment consists of consumer-ready packages of a
size suitable for retail sale directly to the end consumer,
like

(i) vacuum packed filets,

(ii) hermetically sealed or other heat-treated products,

(iii) frozen blocks of fish meat,

(iv) eviscerated fish frozen or placed on ice.

Article 7

Certification

live fish,

their eggs and gametes,

the
1.
In the case of
competent authority at
in the
Member State of arrival shall complete the document referred
to in Annex of Commission Decision 92/527/EEC (1) with one
of the statements laid down in Annex VI to this Decision as
appropriate.

the border inspection post

In the case of fish products of aquaculture origin, the
2.
competent authority at
in the
Member State of arrival shall complete the document referred
to in Annex B to Commission Decision 93/13/EEC (2) with one
of the statements laid down in Annex VI of this Decision as
appropriate.

the border inspection post

Article 8

Preventing contamination of natural waters

1. Member States shall ensure that imported live fish of
aquaculture origin and products thereof intended for human
consumption are not introduced into, and do not contaminate
any natural waters within their territory.

2. Members States shall ensure that transport water from
imported consignments does not
lead to contamination of
natural waters within their territory.

(1) OJ L 332, 18.11.1992, p. 22.
(2) OJ L 9, 15.1.1993, p. 33.

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Article 9

Approval of import centres

The competent authority of

1.
the Member States shall
approve an establishment as an approved import centre
provided that it satisfies the minimum animal health conditions
of Annex VII to this Decision.

2.
The competent authority of the Member State shall draw
up a list of approved import centres, each of which shall be
given an official number.

3.
The list of approved import centres, and any subsequent
amendments thereto, shall be communicated by the competent
authority of each Member State to the Commission and to the
other Member States.

Article 10

Date of application

This Decision shall apply from 1 May 2004.

This Decision is addressed to the Member States.

Article 11

Done at Brussels, 21 November 2003.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

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ANNEX II

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ANNEX III

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ANNEX IV

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ANNEX V

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ANNEX VI

Statements to be issued by the competent authority at the border inspection post to complete the document
referred to in the Annex to Decision 92/527/EEC or in the Annex B of Decision 93/13/EEC

The competent authority at the border inspection post in the Member State of arrival shall complete the document
referred to in the Annex of Decision 92/527/EEC or of Annex B of Decision 93/13/EEC with one of the following
statements as appropriate:

A. Statements to be added to the document referred to in the Annex of Decision 92/527/EEC as regards live
fish, their eggs and gametes intended for farming, and live fish of aquaculture origin for restocking of put-
and take fisheries, in the European Community

either:

‘(Live fish) (1) (and) (1) (Eggs) (1) (and) (1) (Gametes) (1) certified for farming in European Community zones and farms
except those with a Community approved programme or status, additional guarantees or protective measures with
regard to: viral haemorrhagic septicaemia (VHS), and infectious haematopoietic necrosis (IHN), and spring viraemia
of carp (SVC), and Gyrodactylus salaris.’

or:

‘Live fish of aquaculture origin certified for restocking of put-and take fisheries in European Community zones and
farms except those with a Community approved programme or status, additional guarantees or protective measures
with regard to: viral haemorrhagic septicaemia (VHS), and infectious haematopoietic necrosis (IHN), and spring
viraemia of carp (SVC), and Gyrodactylus salaris.’

or:

‘(Live fish) (1) (and) (1) (Eggs) (1) (and) (1) (Gametes) (1) certified for farming in European Community zones and farms
including those with a Community approved programme or status, additional guarantees or protective measures with
regard to: (viral haemorrhagic septicaemia (VHS)) (1) (and) (1) (infectious haematopoietic necrosis (IHN)) (1) (and) (1)
(spring viraemia of carp (SVC)) (1) (and) (1) (Gyrodactylus salaris) (1).’

or:

‘Live fish of aquaculture origin certified for restocking of put-and take fisheries in European Community zones and
farms including those with a Community approved programme or status, additional guarantees or protective
(infectious haematopoietic necrosis
measures with regard to:
(IHN)) (1) (and) (1) (spring viraemia of carp (SVC)) (1) (and) (1) (Gyrodactylus salaris) (1).’

(viral haemorrhagic septicaemia (VHS)) (1)

(and) (1)

B. Statements to be added to the document referred to in the Annex B of Decision 93/13/EEC as regards fish

products of aquaculture origin intended for human consumption

either:

‘Uneviscerated fish products of aquaculture origin certified for export to the European Community (except to zones
with Community approved status as regards (VHS) (1) (and) (1) (IHN) (1)) (1), for further processing (in approved import
centres) (1) before human consumption.’

or

‘Eviscerated fish products of aquaculture origin certified for export to the European Community, for further proces-
sing before human consumption.’

or

‘Fish products of aquaculture origin certified for export to the European Community for immediate human consump-
tion.’.

(1) Retain as appropriate.

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ANNEX VII

Minimum animal health conditions for the approval of ‘approved import centres’ for processing of fish of aqua-
culture origin

A. General provisions

1. Member States shall only approve establishments as import centres for further processing of imported live fish of
aquaculture origin and products thereof provided that the conditions at the import centre are such that risks of
contamination of fish in Community waters, with pathogens capable of causing significant impact to fish stock,
via discharges or other waste, or by other means, are avoided.

2. Establishments approved as ‘approved import centre’, must not be allowed to move live fish out of the establish-

ment.

3. In addition to the appropriate public health provisions laid down under Directive 91/493/EEC for any establish-
ments, as well as health rules laid down by Community legislation concerning animal by-products not intended
for human consumption, the minimum animal health conditions as laid down below, shall apply.

B. Management provisions

1. Approved import centres must be open to inspection and control by the competent authority at all times.

2. Approved import centres must have an efficient disease control, and monitoring system; in application of Council
Directive 93/53/EEC, cases of suspected disease and mortality shall be investigated by the competent authority;
the necessary analysis and treatment must be carried out in consultation with and under the control of the
competent authority, taking into consideration the requirement in Article 3(1)(a) of Directive 91/67/EEC.

3. Approved import centres must apply a management system, approved by the competent authority, including
hygiene and disposal routines for transports, transport containers, facilities, and equipment. The guidelines laid
down for disinfection of fish farms in the OIE International Aquatic Animal Health Code, Sixth Edition, 2003,
Appendix 5.2.2, should be followed. The disinfectants used must be approved for the purpose by the competent
authority and appropriate equipment must be available for cleaning and disinfection. Discharges of by-products
and other waste materials including dead fish and their products must be carried out in accordance with Regu-
lation (EC) No 1774/2002 of the European Parliament and of the Council (1). The management system at the
approved import centre shall be such that risks of contamination of fish in Community waters with pathogens
capable of causing significant impact to fish stock, in particular as regards pathogens exotic to the Community
and the fish pathogens referred to in list I and II, column 1, of Annex A to Directive 91/67/EEC, are avoided.

4. Approved import centres must keep an updated record of: observed mortality; and of all the live fish, eggs and
gametes entering the centre and products leaving the centre including their source, their suppliers and their desti-
nation. The record should be open to scrutiny by the competent authority at all times.

5. Approved import centres must be cleaned and disinfected regularly in accordance with the programme described

in point 3 above.

6. Only authorised persons may enter approved import centres and must wear protective clothing including appro-

priate footwear.

(1) OJ L 273, 10.10.2002, p. 1.