Corrigendum to Commission Decision 2004/453/EC of 29 April 2004 implementing Council Directive 91/67/EEC as regards measures against certain diseases in aquaculture animals (OJ L 156, 30.4.2004)
Date: 2004-06-07
Institutions: European Commission
Subjects: animal disease, aquaculture, disease prevention, health legislation, intra-EU trade, veterinary legislation

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Corrigendum to Commission Decision 2004/453/EC of 29 April 2004 implementing Council Directive
91/67/EEC as regards measures against certain diseases in aquaculture animals

(Official Journal of the European Union L 156 of 30 April 2004)

Decision 2004/453/EC should read as follows:

COMMISSION DECISION

of 29 April 2004

implementing Council Directive 91/67/EEC as regards measures against certain diseases in aquacul-
ture animals

(notified under document number C(2004) 1679)

(Text with EEA relevance)

(2004/453/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

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),
and in particular Article 12(2), the second subparagraph of
Article 13(1) and Article 13(2) thereof,

Having regard to 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 (2), and in
particular Article 10 thereof,

Whereas:

(1)

(2)

to Article 13 of

A Member State that considers its territory or part of
territory free from one or more of the diseases listed in
Annex A, column I, list III to Directive 91/67/EEC, may
pursuant
the
evidence supporting the claim of freedom of diseases to
the purpose of being granted
the Commission for
disease-free status. Denmark, Finland,
Ireland, Sweden
and the United Kingdom have submitted such claims to
the Commission.

that Directive submit

A Member State that draws up a programme to control
with a view to eradicating one or more of the diseases
listed in Annex A, column I,
to Directive
91/67/EEC, may pursuant to Article 12 of that Directive
submit the programme to the Commission for approval.
Finland, Ireland, Sweden and the United Kingdom have
submitted such programmes to the Commission.

list

III

(1) OJ L 46, 19.2.1991, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003 p. 1).

(2) OJ L 224, 18.8.1990, p. 24. Directive as last amended by Directive
2002/33/EC of the European Parliament and of the Council (OJ L
315, 19.11.2002, p. 14).

(3)

(4)

(5)

(6)

Council Regulation (EEC) No 706/73 of 12 March 1973
concerning the Community arrangements applicable to
the Channel Islands and the Isle of Man for trade in agri-
cultural products (3), lays down that veterinary legislation
is to apply to those islands under the same conditions as
in the United Kingdom for the products imported into
those islands or exported from them to the Community.

is necessary to establish the requirements to be
It
fulfilled for Member States to be declared disease-free
and the criteria the Member States are to apply under
the control and eradication programmes. It is also neces-
sary to define the additional guarantees which are
required for the introduction of certain fish species into
the disease-free zones and the zones concerned by the
control and eradication programmes. For those purposes
the recommendations of
the World Organisation of
Animal Health (OIE) should be taken into account.

Denmark has
freedom from
submitted evidence of
spring viraemia of carp (SVC), and should therefore be
considered free from that disease.

Finland has submitted evidence of freedom from SVC for
its entire territory, and of
freedom from Gyrodactylus
salaris and infectious pancreatic necrosis (IPN) for parts
of its territory. The territories concerned should there-
fore be considered free from those diseases. Finland has
also submitted a programme for the control and eradica-
tion of bacterial kidney disease (BKD) which will apply
to the continental parts of its territory. That programme
should be approved with a view to eradicating the
disease and achieving disease-free status.

(7)

Ireland has submitted evidence of freedom from SVC,
BKD and Gyrodactylus salaris for its entire territory, and
should therefore be considered free from those diseases.

(3) OJ L 68, 15.3.1973, p. 1. Regulation as amended by Regulation

(EEC) No 1274/86 (OJ L 107, 24.4.1986, p. 1).

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(8)

(9)

Sweden has submitted evidence of freedom from SVC
and IPN for its entire territory, and should therefore be
considered free from those diseases. Sweden has also
submitted a programme for the control and eradication
of BKD which will apply to the continental parts of its
territory. That programme should be approved with a
view to eradicating the disease and achieving disease-free
status.

The United Kingdom has submitted evidence of freedom
from Gyrodactylus salaris for its entire territory and of
freedom from IPN, BKD and SVC for parts of its terri-
tory. The territories concerned should therefore be
considered free
from those diseases. The United
Kingdom has also submitted programmes for the control
and eradication of SVC and BKD applicable to other
parts of
its territory. Those programmes should be
approved with a view to eradicating the diseases and
achieving disease-free status.

(10)

The additional guarantees provided for by this Decision
taking into
should be reconsidered after three years,
account the experience gained in relation to control and
eradication of the diseases and the development of alter-
native control measures such as vaccines.

(11) Additional guarantees as regards SVC have been defined
for certain fish species for consignment to Great Britain,
Northern Ireland,
the Isle of Man and Guernsey by
Commission Decision 93/44/EC (1). That Decision
should be repealed and replaced by this Decision.

(12)

(13)

introduction of Gyrodactylus

Commission Decision 2003/513/EC (2)
is a safeguard
decision protecting certain regions of the Community
against
salaris. Those
measures have been in force since 1996, and are by
their very nature additional guarantees and not safeguard
measures. Decision 2003/513/EC should therefore also
be repealed and replaced by this Decision.

The guarantees laid down in Decisions 93/44/EC and
2003/513/EC should be updated to take into account
the present scientific knowledge and current recommen-
dations of the World Organisation of Animal Health
(OIE).

(14)

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

HAS ADOPTED THIS DECISION:

Article 1

Requirements for territory being considered disease-free
disease

The requirements to be fulfilled in order for territory to be
considered free of one or more of the diseases listed in Column

(1) OJ L 16, 25.1.1993, p. 53. Decision amended by Decision

94/865/EC (OJ L 352, 31.12.1994, p. 75).

(2) OJ L 177, 16.7.2003, p. 22.

I, List III of Annex A to Directive 91/67/EEC, are laid down in
Annex I, Chapter I to this Decision.

Article 2

Territories considered disease-free

The territories listed in Annex I, Chapter II to this Decision are
considered to be free from the diseases listed in Column I, List
III of Annex A to Directive 91/67/EEC.

Article 3

Criteria for control and eradication programmes

The criteria a Member States shall apply under a control and
eradication programme for one or more of the diseases referred
to in Column I, List III of Annex A to Directive 91/67/EEC, are
laid down in Annex II, Chapter I to this Decision.

Article 4

Approval of control and eradication programmes

The control and eradication programmes for the territories
listed in Annex II, Chapter II to this Decision are approved.

Article 5

Additional guarantees

Live aquaculture fish, eggs and gametes which are intro-
1.
duced into the territories listed in Annex I, Chapter II or Annex
II, Chapter II, shall comply with the guarantees, including those
for packaging and labelling and the appropriate specific addi-
tional requirements, as laid down in the health certificate,
drawn up in conformity with model health certificate in Annex
III, taking into account the explanatory notes in Annex IV.

2.
The requirements laid down in paragraph 1 shall not
apply when eggs are introduced into the territories listed in
Annex I, Chapter II or Annex II, Chapter II, for the purpose of
human consumption.

The additional guarantees should be maintained when the

3.
requirements laid down in Annex V are fulfilled.

Article 6

Transport

Live aquaculture fish, eggs and gametes introduced into the
territories listed in Annex I Chapter II, or Annex II Chapter II,
shall be transported under conditions not altering their health
status and not jeopardising the health status at the place of
destination.

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Article 7

Repeal

Article 9

Addressees

Decisions 93/44/EC and 2003/513/EC are repealed.

This Decision is addressed to the Member States

Article 8

Review

The Commission shall review the additional guarantees laid
down by this Decision by 30 April 2007 at the latest. The
review shall take account of the experience gained in relation
to control and eradication of the diseases and the development
of alternative control measures such as vaccines.

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

Disease-free status

Chapter I

Requirements for disease-free status

A. Disease-free country

A Member State shall be considered free of a disease if none of the susceptible species are present or if it meets the
conditions in point 1 or 2 below.

If a Member State shares a water catchment area with one or more other Member States, it can only be declared a
disease-free country if all the shared water catchment areas are declared disease-free zones in both Member States.

1. A Member State where there has not been any observed occurrence of the disease for at least the past 25 years

despite conditions that are conducive to its clinical expression may be considered disease-free if

1.1. basic disease security conditions have been in place continuously for at least the previous 10 years. The

basic disease security conditions should as a minimum consist of:

(a) the disease is compulsorily notifiable to the competent authority, including notification of suspicion;

(b) an early detection system ensuring the rapid recognition of signs suspicious of a disease, or an emerging
disease situation, or unexplained mortality, in aquatic animals in an aquaculture establishment or in the
wild, and the rapid communication of the event to the competent authority, with the aim to activate
is in place within the country enabling the competent
diagnostic investigation with minimal delay,
authority to undertake effective disease investigation and reporting,
including access to laboratories
capable of diagnosing and differentiating relevant diseases, and training of veterinarians or fish health
specialists in detecting and reporting unusual disease occurrence. Such an early detection system must at
least include the following:

(i) broad awareness, e.g. among the personnel employed at aquaculture establishments or involved in

processing, of the characteristic signs of the listed diseases;

(ii) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious

disease occurrence;

(iii) ability of the competent authority to undertake rapid and effective disease investigation;

(iv) access by the competent authority to laboratories with the facilities for diagnosing and differen-

tiating listed and emerging diseases

1.2.

infection is not known to be established in wild populations;

1.3. conditions applied to trade and imports to prevent the introduction of the disease into the Member State are

in place.

2. A Member State where the last known clinical occurrence was within the past 25 years or where the infection
status prior to targeted surveillance was unknown, for example because of the absence of conditions conducive to
clinical expression, may be considered free from the disease if:

2.1.

it meets basic disease security conditions as described in point 1.1; and

2.2. targeted surveillance has been in place for at least the past two years in aquaculture establishments holding
any of the susceptible species without detection of the disease agent. If there are areas of the country in
which surveillance in aquaculture establishments only, does not give sufficient epidemiological data (where
the number of aquaculture establishments are limited), but in which there are wild populations of any of the
susceptible species, those wild populations must be included in the targeted surveillance. The sampling
methods and sample sizes should be at least equivalent to those laid down in Decision 2001/183/EC or in
the relevant chapters of the OIE International Aquatic Animal Health Code and OIE Manual of Diagnostic
Tests for Aquatic Animals. The diagnostic methods should be at least equivalent to those laid down in the
relevant chapters of the OIE Manual for diagnostic tests in aquatic animals.

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B. Disease-free zone

A disease-free zone may be established within the territory of one Member State of infected or unknown status for a
disease, if none of the susceptible species are present in the zone, or if the zone meets the conditions referred to in
point 1 or 2 below.

Such disease-free zones must comprise: one or more entire water-catchment area(s) from the sources of the water-
ways to the sea, or part of a catchment area from the source(s) to a natural or artificial barrier that prevents the
upward migration of fish from lower stretches of the waterway. Such zones must be clearly delineated on a map of
the territory of the country concerned by the competent authority.

If a water-catchment area extends over more than one Member State, it can only be declared a disease-free zone if
the conditions outlined below apply to all areas of the zone. Both Member States concerned should apply for
approval of the zone.

1. A zone where there has not been any observed occurrence of the disease for at least the past 25 years despite

conditions that are conducive to its clinical expression may be considered free if:

1.1. basic disease security conditions have been in place continuously for at least the previous 10 years. The

basic disease security conditions should as a minimum consist of:

(a) the disease is compulsorily notifiable to the competent authority, including notification of suspicion;

(b) an early detection system ensuring the rapid recognition of signs suspicious of a disease, or an emerging
disease situation, or unexplained mortality, in aquatic animals in an aquaculture establishment or in the
wild, and the rapid communication of the event to the competent authority, with the aim to activate
diagnostic investigation with minimal delay,
is in place within the country enabling the competent
including access to laboratories
authority to undertake effective disease investigation and reporting,
capable of diagnosing and differentiating relevant diseases, and training of veterinarians or fish health
specialists in detecting and reporting unusual disease occurrence. Such an early detection system must at
least include the following:

(i) broad awareness, e.g. among the personnel employed at aquaculture establishments or involved in

processing, of the characteristic signs of the listed diseases;

(ii) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious

disease occurrence;

(iii) ability of the competent authority to undertake rapid and effective disease investigation;

(iv) access by the competent authority to laboratories with the facilities for diagnosing and differen-

tiating listed and emerging diseases

1.2.

infection is not known to be established in wild populations;

1.3. conditions applied to trade and imports to prevent the introduction of the disease into the zone are in place.

2. A zone where the last known clinical occurrence was within the past 25 years or where the infection status prior
to targeted surveillance was unknown, for example because of the absence of conditions conducive to clinical
expression, may be considered free from the disease if:

2.1.

it meets basic disease security conditions as described in point 1.1;

2.2. targeted surveillance has been in place for at least the past two years in aquaculture establishments holding
any of the susceptible species without detection of the disease agent. If surveillance in aquaculture establish-
ments only, does not give sufficient epidemiological data (where the number of aquaculture establishments
are limited), but in which there are wild populations of any of the susceptible species, those wild populations
must be included in the targeted surveillance. The sampling methods and sample sizes should be at least
equivalent to those laid down in Decision 2001/183/EC or in the relevant chapters of the OIE International
Aquatic Animal Health Code and OIE Manual of Diagnostic Tests for Aquatic Animals. The diagnostic
methods should be at least equivalent to those laid down in the relevant chapters of the OIE Manual for diag-
nostic tests in aquatic animals.

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Territories with approved freedom of certain diseases referred to in Column 1, List III of Annex A to Council
Directive 91/67/EEC

Chapter II

Disease

Member State

Territory or parts of territory

Spring viraemia of carp (SVC)

Denmark

Whole territory

Finland

Ireland

Sweden

Whole territory; the water catchment area of River
Vuoksi should be considered as buffer zone.

Whole territory

Whole territory

United Kingdom

The territories of Northern Ireland, The Isle of Man
Jersey, and Guernsey

Bacterial kidney disease (BKD)

Ireland

Whole territory

United Kingdom

The territories of Northern Ireland, The Isle of
Man, and Jersey

Infectious pancreatic necrosis virus
(IPN)

Finland

The continental parts of the territory; the water
catchment areas of River Vuoksi and River Kemi-
joki should be considered as buffer zones.

Sweden

Whole territory

United Kingdom

The territory of The Isle of Man

Infection with Gyrodactylus salaris

Finland

The water catchment areas of Tenojoki and Näätä-
mönjoki; the water catchment areas of Paatsjoki,
Luttojoki, and Uutuanjoki are considered as buffer
zones.

Ireland

The whole territory

United Kingdom

The territories of Great Britain, Northern Ireland,
The Isle of Man, Jersey and Guernsey.

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ANNEX II

Control and eradication programmes

Chapter I

Minimum criteria to be applied in a programme aimed at control and eradication of certain diseases referred to
in Column 1, List III of Annex A to Directive 91/67/EEC

A. The minimum criteria to be applied by the Member State under an approved control and eradication

programme are

1. The disease must be compulsorily notifiable to the competent authority, including notification of suspicion.

2. An early detection system ensuring the rapid recognition of signs suspicious of the disease in question, in aquatic
animals in an aquaculture establishment or in the wild, and the rapid communication of the event to the compe-
tent authority, with the aim to activate diagnostic investigation with minimal delay must be in place enabling the
competent authority to undertake effective disease investigation and reporting, including access to laboratories
capable of diagnosing and differentiating relevant diseases, and training of veterinarians or fish health specialists
in detecting and reporting unusual disease occurrence. Such an early detection system must at least include the
following:

2.1. broad awareness, e.g. among the personnel employed at aquaculture establishments or involved in proces-

sing, of the characteristic signs of the listed diseases;

2.2. veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease

occurrence;

2.3. ability of the competent authority to undertake rapid and effective disease investigation;

2.4. access by the competent authority to laboratories with the facilities for diagnosing and differentiating the

disease in question.

3. Conditions to trade and imports to prevent the introduction of the disease into the Member State must be in

place.

4. Targeted surveillance must been in place in aquaculture establishments holding any of the susceptible species. If
there are areas of the country in which surveillance in aquaculture establishments only, does not give sufficient
epidemiological data (where the number of aquaculture establishments are limited), but in which there are wild
populations of any of the susceptible species, those wild populations must be included in the targeted surveillance.
to those laid down in Decision
The sampling methods and sample sizes should be at
2001/183/EC or in the relevant chapters of the OIE International Aquatic Animal Health Code and OIE Manual
of Diagnostic Tests for Aquatic Animals. The diagnostic methods should be at least equivalent to those laid down
in the relevant chapters of the OIE Manual for diagnostic tests in aquatic animals.

least equivalent

5. The control and eradication programme should continue until the requirements in Annex I have been fulfilled,

and the Member State or parts thereof could be considered free of the disease.

6. Before 1 May each year submit a report to the Commission giving information on the number of suspicions, the
number of confirmations, the number of farms and sites under restrictions, the number of restrictions lifted and
the result of any active surveillance performed the previous calendar year according to the following table.

Member State and disease

Number of suspicions

Number of confirmations

Number of farms and sites under restrictions

The number of restrictions lifted

How many farms and fish/pools of
sampled

fish have been

How many wild fish/pools of fish have been sampled
from which water catchment areas

Result of sampling

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B. In the case of suspicion of a disease the official service in the Member States shall ensure that:

1. Appropriate samples are taken for examinations with a view of establish the presence of the pathogen in ques-

tion.

2. Pending the result of the examination referred to in point 1, the competent authority shall place the farm under
official surveillance and relevant control measures must be implemented and no fish should leave the affected
farm, unless authorised by the official service.

3. If the examination referred to in point 1 show the presence of a pathogen or clinical signs, an epizootic investiga-
tion must be carried out by the official service in order to determine the possible means of contamination and to
investigate whether fish have left the farm, during the relevant period preceding observation of the suspicion.

4. If the epizootic investigation shows that the disease has been introduced into one or more farms or unenclosed

waters the provisions of point 1 shall apply in these areas and;

4.1. all of the farms situated in the same water catchment area or coastal area be placed under official surveil-

lance,

4.2. no fish, eggs or gametes leave these farms without the authorisation of the official service.

5. In the case of extensive water catchment areas or coastal areas, the official service may decide to limit this
measure to a less extensive area close to the farm suspected of being infected, if it considers that this area affords
maximum guarantees for the prevention of the spread of the disease.

C. In case of confirmation of the disease, the Member States shall ensure that

1. The farm or site containing the infected fish is immediately placed under restrictions and no live fish is moved
into the premises, and no fish is moved out of the farm unless authorised by the official services in the Member
State.

2. The restrictions shall be maintained until eradication has been achieved either through the requirements in 2.1 or

2.2 below:

2.1. Immediate withdrawal of all stock by

(a) slaughter of all live fish under the supervision of the official service or, in the case of fish which have
reached commercial size and show no clinical sign of disease, slaughter under the supervision of the offi-
cial service for marketing or processing for human consumption. In the latter case, the official service
shall ensure that the fish are immediately slaughtered and gutted, that these operations are carried out in
conditions such as to prevent the spread of pathogens. The Member State may on a case by case basis,
taking into consideration the risk of spreading the disease to other farms or to the wild population,
allow fish which have not yet reached commercial size to be kept at the farm until market size is
reached; and

(b) fallowing of the farm or site (and where appropriate disinfection) for an appropriate period following
withdrawal, taking into consideration Section 1.7 of the most current edition of the OIE International
Aquatic Animal Health Code.

2.2. Progressive measures to clear infection by careful management of infected farms or sites by

(a) removal and destruction of dead fish and fish displaying clinical signs of disease, harvesting fish not
displaying clinical signs of disease, until each epidemiological unit affected by disease within the site is
emptied of fish and disinfected; or

(b) removal and destruction of dead fish and fish displaying clinical signs of disease, in the case of sites
where withdrawal and/or disinfection may not be possible because of the nature of the site (e.g. a river
system or extensive lake).

3. To facilitate a swift and rapid eradication of the disease from infected premises, the competent authority of the
Member State may allow fish not displaying clinical signs of disease to be transported — under the supervision of
the competent authority — to other farms or areas within the Member State in question that is not covered by
disease-free status or an approved control and eradication programme.

4. Fish removed and disposed of as a consequence of the action in paragraphs 2.1 and 2.2 must be disposed of in

accordance with Regulation (EC) No 1774/2002.

5. Fish used to re-stock sites must originate from certified disease-free sources.

6. Member States shall take the necessary measures to prevent the spreading of the disease to other farmed fish or

wild stocks.

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Territories with approved control and eradication programmes of certain diseases referred to in Column 1, List
III of Annex A to Directive 91/67/EEC

Chapter II

Disease

Member State

Territory or parts of territory

Spring viraemia of carp

United Kingdom

The territories of Great Britain

Bacterial kidney disease

Finland

Sweden

The continental parts of the territory.

The continental parts of the territory.

United Kingdom

The territories of Great Britain

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ANNEX III

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ANNEX IV

Explanatory notes for the movement document and labelling

(e) If for reasons of identification of the items of the
consignment, additional pages are attached to the
movement document, these pages shall be considered
as forming part of the original and be signed and
stamped by the certifying official inspector on each
page.

(f)

The original of

the movement document must
accompany the consignment until it reaches the place
of destination.

(g) The movement document 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.

(h) The aquatic animals, their eggs and gametes, shall
not be transported together with other aquatic
animals or their eggs and gametes that are of a lower
health status. Furthermore, they must not be trans-
ported under any other conditions that alter their
health status or could jeopardise the health status at
the place of destination.

(a) The movement documents shall be produced by the
competent authorities of the Member State of origin,
based on the model appearing in Annex I to this Deci-
sion taking into account the species of the consign-
ment and the status of the place of destination.

(b)

The original of each movement document shall
consist of a single page, double-sided, or, where more
than one page is required, it shall be in such a form
that all pages form part of an integrated whole and are
indivisible.

It shall, on the right hand side of the top of each page,
be marked as “original” and bear a specific code
number issued by the competent authority. All pages
of the movement document shall be numbered —
(page number) of (total number of pages).

(c) The original of the movement document and the
labels referred to in the model movement document
shall be drawn up in at least one official language of
the Member State of destination. However, Member
States may allow other languages, if necessary, accom-
panied by an official translation.

(d) The original of the movement document must be
completed, on the day of loading of the consignment,
with an official stamp and signed by an official
inspector designated by the competent authority. In
doing so, the competent authority of the Member State
of origin shall ensure that the principles of certification
equivalent
to those laid down in Council Directive
96/93/EC are followed.

The stamp, unless embossed, and the signature shall be
in a colour different to that of the printing.

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ANNEX V

Minimum criteria to be applied to maintain additional guarantees for certain diseases referred to in Column 1,
List III of Annex A to Directive 91/67/EEC, according to Articles 12 and 13 of that Directive

A. In order to maintain additional guarantees granted, the Member States must as a minimum comply with the

following criteria:

1. The disease must be compulsorily notifiable to the competent authority, including notification of suspicion.

2. All farms having species susceptible to the disease, to which the Member State has been granted free status, must

be under the supervision of the competent authority.

3. An early detection system ensuring the rapid recognition of signs suspicious of the disease in question, in aquatic
animals in an aquaculture establishment or in the wild, and the rapid communication of the event to the compe-
tent authority, with the aim to activate diagnostic investigation with minimal delay must be in place enabling the
competent authority to undertake effective disease investigation and reporting, including access to laboratories
capable of diagnosing and differentiating relevant diseases, and training of veterinarians or fish health specialists
in detecting and reporting unusual disease occurrence. Such an early detection system must at least include the
following:

3.1. broad awareness, e.g. among the personnel employed at aquaculture establishments or involved in proces-

sing, of the characteristic signs of the listed diseases;

3.2. veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease

occurrence;

3.3. ability of the competent authority to undertake rapid and effective disease investigation;

3.4. access by the competent authority to laboratories with the facilities for diagnosing and differentiating the

disease in question.

4. Conditions to trade and imports as well as management of wild fish stocks of the susceptible species, to prevent
the introduction of the disease in question into the Member State or parts thereof covered by this Decision must
be in place. Fish originating in coastal zones should not be introduced into continental zones, unless authorised
by the competent authority of the Member State of destination.

5. In Member States where only parts of territory is declared free according to Annex I, Chapter II (not whole terri-
tory is declared free), targeted surveillance must been maintained in accordance with the provisions of Annex II,
Chapter I.4 in the areas declared free.

6. Live aquaculture fish, eggs and gametes introduced into the territories listed in Annex I Chapter II, or Annex II
Chapter II, shall be transported under conditions not altering their health status and not jeopardising the health
status at the place of destination. The transport shall take place in water considered free from the disease in ques-
tion as it is taken from the water source of the farm or site of origin, and that water exchange during transport is
done only at places authorised by the competent authority of the Member State of destination, where appropriate
in collaboration with the competent authority of the Member State of origin.

7. Vaccination against the disease in question shall not take place.

8. Before 1 May each year submit a report to the Commission giving information on the number of suspicions, the
number confirmations, the number of farms and sites under restrictions, the number of restrictions lifted and the
result of any active surveillance performed the previous calendar year according to the following table.

Member State and disease

Number of suspicions

Number of suspicions

Number of farms and sites under restrictions

The number of restrictions lifted

How many farms and fish/pools of
sampled

fish have been

How many wild fish/pools of fish have been sampled
from which water catchment areas

Result of sampling

7.6.2004

EN

Official Journal of the European Union

L 202/19

B. In the case of suspicion of a disease the official service in the Member States shall ensure that:

1. Appropriate samples are taken for examinations with a view of establish the presence of the pathogen in ques-

tion.

2. Pending the result of the examination referred to in point 1, the competent authority shall place the farm under
official surveillance and relevant control measures must be implemented and no fish should leave the affected
farm, unless authorised by the official service.

3. If the examination referred to in point 1 show the presence of a pathogen or clinical signs, an epizootic investiga-
tion must be carried out by the official service in order to determine the possible means of contamination and to
investigate whether fish have left the farm, during the relevant period preceding observation of the suspicion.

4. If the epizootic investigation shows that the disease has been introduced into one or more farms or unenclosed

waters the provisions of point 1 shall apply in these areas and;

4.1. all of the farms situated in the same water catchment area or coastal area be placed under official surveil-

lance,

4.2. no fish, eggs or gametes leave these farms without the authorisation of the official service.

5. In the case of extensive water catchment areas or coastal areas, the official service may decide to limit this
measure to a less extensive area close to the farm suspected of being infected, if it considers that this area affords
maximum guarantees for the prevention of the spread of the disease.

C. In case of confirmation of the disease, the Member States shall ensure that

1. The farm or site containing the infected fish is immediately placed under restrictions and no live fish is moved
into the premises, and no fish is moved out of the farm unless authorised by the official services in the Member
State.

2. The restrictions shall be maintained until eradication has been achieved either through the requirements in 2.1 or

2.2 below:

2.1. Immediate withdrawal of all stock from a farm by

(a) slaughter of all live fish under the supervision of the official service or, in the case of fish which have
reached commercial size and show no clinical sign of disease, slaughter under the supervision of the offi-
cial service for marketing or processing for human consumption. In the latter case, the official service
shall ensure that the fish are immediately slaughtered and gutted, that these operations are carried out in
conditions such as to prevent the spread of pathogens. The Member State may on a case by case basis,
taking into consideration the risk of spreading the disease to other farms or to the wild population,
allow fish which have not yet reached commercial size to be kept at the farm until market size is
reached; and

(b) fallowing, and where appropriate disinfection, of the farm or site for an appropriate period following
withdrawal, taking into consideration Section 1.7 of the most current edition of the OIE International
Aquatic Animal Health Code.

2.2. Progressive measures to clear infection by careful management of infected farms or waters by

(a) removal and destruction of dead fish and fish displaying clinical signs of disease, harvesting fish not
displaying clinical signs of disease, until each epidemiological unit affected by disease within the site is
emptied of fish and disinfected; or

(b) removal and destruction of dead fish and fish displaying clinical signs of disease, in the case of sites
where withdrawal and/or disinfection may not be possible because of the nature of the site (e.g. a river
system or extensive lake).

3. To facilitate a swift and rapid eradication of the disease from infected premises, the competent authority of the
Member State may allow fish not displaying clinical signs of disease to be transported — under the supervision of
the competent authority — to other farms or areas within the Member State in question that is not covered by
disease-free status or an approved control and eradication programme.

4. Fish removed and disposed of as a consequence of the action in paragraphs 2.1 and 2.2 must be disposed of in

accordance with Regulation 1774/2002.

5. Fish used to re-stock sites must originate from certified disease-free sources.

6. Member States shall take the necessary measures to prevent the spreading of the disease to other farmed fish or

wild stocks.

7. When the Member State has eradicated the disease from a continental farm according to Point C 2.1 of this
Annex, and the epizootic investigations required in Point B 3 of this Annex concludes that the disease has not
spread to other farms or into the wild, disease-free status is reinstated immediately. Otherwise, the disease-free
status could only be reinstated after compliance with Annex I.’