Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals
Date: 2006-10-24
Institutions: Council of the European Union
Subjects: animal disease, disease prevention, fish, fishery produce, health certificate, health control, import (EU), marketing standard, shellfish farming

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Official Journal of the European Union

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COUNCIL DIRECTIVE 2006/88/EC

of 24 October 2006

on animal health requirements for aquaculture animals and products thereof, and on the prevention
and control of certain diseases in aquatic animals

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the European Economic and
Social Committee (1),

Whereas:

(1)

(2)

(3)

Aquaculture animals and products fall under the scope of
Annex I to the Treaty as live animals, fish, molluscs
and crustaceans. The breeding, rearing and the placing on
the market of aquaculture animals and products thereof
constitutes an important source of income for persons
working in this sector.

In the context of the internal market, specific animal
health rules were laid down for the placing on the market
and introduction from third countries of the products con-
cerned by Council Directive 91/67/EEC of 28 Janu-
ary 1991 concerning the animal health conditions
governing the placing on the market of aquaculture ani-
mals and products (2).

Outbreaks of diseases in aquaculture animals could cause
severe losses to the industry concerned. Minimum mea-
sures to be applied in case of outbreaks of the most impor-
tant diseases in fish and molluscs were established by
Council Directive 93/53/EEC of 24 June 1993 introduc-
ing minimum Community measures for the control of cer-
tain fish diseases (3) and Council Directive 95/70/EC of
22 December 1995 introducing minimum Community
measures for the control of certain diseases affecting
bivalve molluscs (4).

additional fish species, particularly marine species, are now
farming practices
used in aquaculture. New types of
involving other fish species have also become increasingly
common, particularly following the recent enlargement of
the Community. Furthermore, farming of crustaceans,
mussels, clams and abalones is becoming increasingly
important.

(5)

(6)

(7)

All disease control measures have an economic impact on
aquaculture. Inadequate controls may lead to a spread of
pathogens, which may cause major losses and compro-
mise the animal health status of fish, molluscs and crusta-
ceans used in Community aquaculture. On the other hand,
over-regulation could place unnecessary restrictions on
free trade.

The Communication from the Commission to the Coun-
cil and the European Parliament dated 19 Septem-
ber 2002 sets out a strategy for
the sustainable
development of European aquaculture. That Communica-
tion outlined a series of measures designed to create long-
term employment in the aquaculture sector, including
promoting high animal health and welfare standards, and
environmental actions to ensure a sound industry. Those
measures should be taken into account.

Since the adoption of Directive 91/67/EEC, the Commu-
nity has ratified the World Trade Organisation (WTO)
Agreement on the Application of Sanitary and Phytosani-
tary Measures (SPS Agreement). The SPS Agreement refers
to the standards of the World Organisation for Animal
Health (OIE). The animal health requirements for placing
live aquaculture animals and products thereof on the mar-
ket within the Community set out in Directive 91/67/EEC
are more stringent than those standards. Therefore, this
Directive should take into account the Aquatic Animal
Health Code and the Manual of Diagnostic Tests for
Aquatic Animals of the OIE.

(4)

Existing Community legislation was drafted mainly to take
into account the farming of salmon, trout and oysters.
Since that legislation was adopted, the Community aquac-
ulture industry has developed significantly. A number of

(8)

(1) OJ C 88, 11.4.2006, p. 13.
(2) 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).

(3) OJ L 175, 19.7.1993, p. 23. Directive as last amended by the 2003

Act of Accession.

(4) OJ L 332, 30.12.1995, p. 33. Directive as last amended by the 2003

Act of Accession.

In order to ensure the rational development of the aquac-
ulture sector and to increase productivity, aquatic animal
health rules should be laid down at Community level.
These rules are necessary, inter alia, in order to contribute
to the completion of the internal market and to avoid the
spread of infectious diseases. Legislation should be flex-
ible to take into account the continuing developments in
and diversity of the aquaculture sector, as well as the
health status of aquatic animals within the Community.

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(9)

(10)

(11)

(12)

(13)

This Directive should cover aquaculture animals, and those
environments which may affect the health status of such
animals. In general the provisions of this Directive should
only apply to wild aquatic animals where the environmen-
tal situation may impinge on the health status of aquacul-
ture animals, or where necessary in order to fulfil the
purpose of other Community legislation, such as Council
Directive 92/43/EEC of 21 May 1992 on the conserva-
tion of natural habitats and of wild fauna and flora (1) or
to protect species referred to in the list drawn up by the
Convention on International Trade in Endangered Species
of Wild Fauna and Flora (CITES). This Directive should
not prejudice the adoption of more stringent rules on the
introduction of non-native species.

The competent authorities designated for the purpose of
this Directive should perform their functions and duties
in accordance with the general principles laid down in
Regulation (EC) No 854/2004 of European Parliament and
of the Council of 29 April 2004 laying down specific rules
for the organisation of official controls on products of ani-
mal origin intended for human consumption (2) and Regu-
lation (EC) No 882/2004 of the European Parliament and
of the Council of 29 April 2004 on official controls per-
formed to ensure the verification of compliance with feed
and food law, animal health and animal welfare rules (3).

It is necessary for the development of aquaculture in the
Community to increase the awareness and preparedness
of the competent authorities and aquaculture production
business operators with respect to the prevention, control
and eradication of aquatic animal diseases.

The competent authorities of Member States should have
access to and apply state-of-the-art techniques and knowl-
edge in the fields of risk analysis and epidemiology. This
is of increasing importance because international obliga-
tions now focus on risk analysis in relation to the adop-
tion of sanitary measures.

It is appropriate to introduce at Community level a sys-
tem of authorisation of aquaculture production busi-
nesses. Such authorisation would enable the competent
authorities to establish a complete overview of the aquac-
ulture industry, which would assist in the prevention, con-
trol
animal diseases.
Furthermore, authorisation allows the laying down of spe-
cific requirements that should be fulfilled by the aquacul-
ture production business in order to operate. Such

and eradication of

aquatic

(1) OJ L 206, 22.7.1992, p. 7. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226, 25.6.2004,
p. 83. Regulation as last amended by Commission Regulation (EC)
No 2076/2005 (OJ L 338, 22.12.2005, p. 83).

(3) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.
last amended by Commission Regulation (EC)

Regulation as
No 776/2006 (OJ L 136, 24.5.2006, p. 3).

authorisation should, where possible, be combined with
or included in an authorisation regime which the Mem-
ber States may already have established for other pur-
poses, for example under environmental legislation. Such
authorisation should therefore not be an extra burden to
the aquaculture industry.

(14) Member States should refuse to issue an authorisation if
the activity in question would pose an unacceptable risk
of spreading diseases to other aquaculture animals or to
wild stocks of aquatic animals. Before deciding to refuse
an authorisation, consideration should be given to risk
mitigation measures or alternative siting of the activity in
question.

(15)

The rearing of aquaculture animals for the purpose of
human consumption is defined as primary production in
Regulation (EC) No 852/2004 of the European Parliament
and of the Council of 29 April 2004 on the hygiene of
foodstuffs (4). Obligations imposed on individual aquacul-
ture production businesses under this Directive, such as
record keeping, and internal systems enabling the aquac-
ulture production business to demonstrate to the compe-
tent authority that
this
Directive are being fulfilled, should, where possible, be
combined with the obligations laid down in Regulation
(EC) No 852/2004.

the relevant requirements of

(16) More attention should be paid to preventing disease occur-
rence than to controlling the disease once it has occurred.
It is therefore appropriate to lay down minimum mea-
sures of disease prevention and risk mitigation which
should be applied to the whole production chain in aquac-
ulture, from fertilisation and hatching of eggs to the pro-
cessing of aquaculture animals for human consumption,
including transportation.

(17)

(18)

(19)

In order to improve general animal health and assist in
the prevention and control of animal disease through
improved traceability, the movement of aquaculture ani-
mals should be recorded. Where appropriate, such move-
ments should also be subject to animal health certification.

In order to have an overview of the disease situation, to
facilitate a rapid reaction in the case of a suspicion of dis-
ease and to protect farms or mollusc farming areas hav-
ing a high animal health standard, a risk-based animal
health surveillance should be applied in all such farms and
mollusc farming areas.

It is necessary to ensure that the main aquatic animal dis-
eases at Community level do not spread. Harmonised ani-
mal health provisions for placing on the market should
therefore be laid down with specific provisions applicable
to species susceptible to those diseases. Therefore a list of
such diseases and species susceptible thereto should be
laid down.

(4) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004, p. 3.

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(20)

The prevalence of such aquatic animal diseases is not the
same throughout the Community. Reference should there-
fore be made to the concept of Member States declared
disease free, and when dealing with parts of the territory
concerned, to the concept of zones or compartments.
General criteria and procedures for the granting, mainte-
nance, suspension, restoration and withdrawal of such sta-
tus should be laid down.

(21) Without prejudice 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 (1), in order to maintain and improve
the general aquatic animal health status in the Commu-
nity, Member States, zones or compartments declared free
of one or more of the diseases listed should be protected
against the introduction of such disease.

(22) Where necessary, Member States may take interim protec-
tive measures in accordance with Article 10 of Directive
90/425/EEC and Article 18 of Council Directive
91/496/EEC of 15 July 1991 laying down the principles
governing the organisation of veterinary checks on ani-
mals entering the Community from third countries and
amending
90/425/EEC
and 90/675/EEC (2).

89/662/EEC,

Directives

(23)

(24)

(25)

In order to avoid the creation of unnecessary trade restric-
tions, the exchange of aquaculture animals between Mem-
ber States, zones or compartments where one or more of
such diseases are present should be allowed, provided that
appropriate risk mitigation measures are taken, including
during transport.

The slaughter and processing of aquaculture animals
which are subject to disease control measures may spread
the disease, inter alia as a result of the discharge of efflu-
ents containing pathogens from processing plants. It is
therefore necessary for the Member States to have access
to processing establishments that have been duly autho-
rised to undertake such slaughter and processing without
jeopardising the health status of farmed and wild aquatic
animals, including in respect of the discharge of effluents.

The designation of Community and national reference
laboratories should contribute to the high quality and uni-
formity of diagnostic results. That objective can be
achieved by activities such as the application of validated
diagnostic tests and the organisation of comparative test-
ing and training of staff from laboratories.

(26)

Laboratories involved in the examination of official
samples should work in accordance with internationally
approved procedures or criteria based on performance
standards and should use diagnostic methods that have,

(1) OJ L 224, 18.8.1990, p. 29 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).

(2) OJ L 268, 24.9.1991, p. 56. Directive as last amended by the 2003

Act of Accession.

for

Standardisation (CEN),

as far as possible, been validated. For a number of activi-
ties related to such examination, the European Commit-
tee
International
Organisation for Standardisation (ISO) have developed
European Standards (EN Standards) and International
Standards (ISO Standards) respectively, appropriate for the
purpose of this Directive. Such standards relate in particu-
lar to the operation and assessment of laboratories and to
the operation and accreditation of control bodies.

and

(27)

(28)

(29)

(30)

In order to ensure early detection of any possible outbreak
of an aquatic animal disease, it is necessary to oblige those
in contact with aquatic animals of susceptible species to
notify any suspect case of disease to the competent
authority. Routine inspections should be carried out in the
Member States to ensure that aquaculture production busi-
ness operators are familiar with, and apply, the general
rules on disease control and biosecurity laid down in this
Directive.

It is necessary to prevent the spread of non-exotic but seri-
ous diseases in aquaculture animals as soon as an out-
break occurs by carefully monitoring movements of live
aquaculture animals and products thereof, and the use of
equipment liable to be contaminated. The choice of the
measures to be used by the competent authorities should
depend on the epidemiological situation in the Member
State concerned.

In order to advance the animal health status of the Com-
munity, it is appropriate that epidemiologically based pro-
grammes to control and eradicate certain diseases are
submitted by Member States for recognition at Commu-
nity level.

For diseases not subject to Community measures, but
which are of local importance, the aquaculture industry
should, with the assistance of the competent authorities
of the Member States, take more responsibility for pre-
venting the introduction of or controlling such diseases
through self regulation and the development of ‘codes of
practice’. However, it may be necessary for the Member
States to implement certain national measures. Such
national measures should be justified, necessary and pro-
portionate to the goals to be achieved. Furthermore, they
should not affect the trade between the Member States
unless this is necessary in order to prevent the introduc-
tion of or to control the disease, and should be approved
and regularly reviewed at Community level. Pending the
establishment of such measures under this Directive, the
additional guarantees granted in Commission Decision
2004/453/EC of 29 April 2004 implementing Council
Directive 91/67/EEC as regards measures against certain
diseases in aquaculture animals (3) should remain in force.

(3) OJ L 156, 30.4.2004, p. 5, as corrected by OJ L 202, 7.6.2004, p. 4.
Decision as last amended by Commission Decision 2006/272/EC
(OJ L 99, 7.4.2006, p. 31.).

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(31)

(32)

There is a continuous development in knowledge with
respect to hitherto unknown diseases in aquatic animals.
It may therefore be necessary for a Member State to apply
control measures in the case of such emerging disease.
Such measures should be swift and adapted to each indi-
vidual case, but should not be maintained longer than nec-
essary to achieve their goal. As such emerging diseases
may also affect other Member States, all Member States
and the Commission should be informed of the presence
of an emerging disease and any control measures taken.

It is necessary and appropriate for the achievement of the
basic objective of maintaining and, in the event of an out-
break, returning to a disease-free status in Member States,
to lay down rules on the measures to increase disease pre-
paredness. Outbreaks should be controlled as speedily as
possible, if necessary by emergency vaccination, in order
to limit the adverse effects on the production of, and trade
in, live aquaculture animals and products thereof.

(33) Directive of the European Parliament and of the Council
2001/82/EC of 6 November 2001 on the Community
code relating to veterinary medicinal products (1) and
Regulation (EC) No 726/2004 of the European Parliament
and of the Council of 31 March 2004 laying down Com-
munity procedures for the authorisation and supervision
of medicinal products for human and veterinary use and
establishing a European Medicines Agency (2) require that,
with only minor exceptions, all veterinary medicinal prod-
ucts that are placed on the market within the Community
are to hold a marketing authorisation. In general, all vac-
cines used in the Community should have a marketing
authorisation. However, the Member States may permit
the use of a product without a marketing authorisation in
the event of a serious epidemic subject to certain condi-
tions, in accordance with Regulation (EC) No 726/2004.
Vaccines against exotic and emerging diseases in aquacul-
ture animals may qualify for such derogation.

(34)

This Directive should lay down provisions to ensure the
necessary level of preparedness to effectively tackle the
emergency situations related to one or more outbreaks of
serious exotic or emerging diseases affecting aquaculture,
in particular by drawing up contingency plans to combat
them. Such contingency plans should be reviewed and
updated regularly.

(35) Where the control of a serious aquatic animal disease is
subject to harmonised Community eradication measures,
Member States should be allowed to make use of finan-
cial contribution from the Community under Council

(36)

(37)

(38)

Regulation (EC) No 1198/2006 of 27 July 2006 on the
European Fisheries Fund (3). Any application for Commu-
nity support should be subject to scrutiny as regards com-
pliance with control provisions laid down in this Directive.

Live aquaculture animals and products thereof imported
from third countries should not present an animal health
hazard for aquatic animals in the Community. To that end,
this Directive should set out measures for the prevention
of the introduction of epizootic diseases.

It is necessary in order to safeguard the aquatic animal
health situation in the Community to further ensure that
consignments of
live aquaculture animals transiting
through the Community comply with the relevant animal
health requirements applicable to the species concerned.

The placing on the market of ornamental aquatic animals
involves a wide variety of species, often tropical species,
solely for ornamental purposes. Those ornamental aquatic
animals are normally kept in private aquariums or ponds,
garden centres, or in exhibition aquariums, not in direct
contact with Community waters. Consequently, ornamen-
tal aquatic animals held under such conditions do not pose
the same risk to other sectors of Community aquaculture
or to wild stocks. It is therefore appropriate to lay down
special provisions applicable to the placing on the mar-
ket, transit and import of ornamental aquatic animals, kept
under such conditions.

(39) However, where ornamental aquatic animals are kept out-
side closed systems or aquariums, in direct contact with
the natural waters of the Community, they could pose a
significant risk to Community aquaculture or wild stocks.
That is particularly the case for the populations of carp
(Cyprinidae), as popular ornamental fish such as koi carp
are susceptible to some diseases affecting other carp spe-
cies farmed in the Community or found in the wild. In
such cases, the general provisions of this Directive should
apply.

(40)

The setting up of electronic means of
information
exchange is vital for simplification, for the benefit of the
aquaculture industry and of the competent authorities. In
order to meet that obligation, common criteria need to be
introduced.

(41) Member States should lay down rules on penalties appli-
cable to infringements of the provisions of this Directive
and ensure that they are implemented. Those penalties
must be effective, proportionate and dissuasive.

(1) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(2) OJ L 136, 30.4.2004, p. 1.

(3) OJ L 223, 15.8.2006, p. 1.

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(42)

(43)

(44)

(45)

In accordance with paragraph 34 of the Interinstitutional
agreement on better law-making (1), Member States are
encouraged to draw up, for themselves and in the interest
of the Community, their own tables, which will, as far as
possible, illustrate the correlation between this Directive
and the transposition measures and to make them public.

Since the objectives of this Directive, namely to provide
for the approximation of the concepts, principles and pro-
cedures forming a common basis for aquatic animal health
legislation in the Community, cannot be sufficiently
achieved by the Member States and can therefore, by rea-
son of the scale and effects of this Directive, be better
achieved at Community level, the Community may adopt
measures, in accordance with the principle of subsidiarity
as set out in Article 5 of the Treaty. In accordance with
the principle of proportionality as set out in that Article,
this Directive does not go beyond what is necessary in
order to achieve those objectives.

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (2).

It is appropriate to update Community animal health leg-
islation concerning aquaculture animals and products
thereof. Accordingly, Directives 91/67/EEC, 93/53/EEC
and 95/70/EC should be repealed and replaced by this
Directive,

(c) minimum control measures to be applied in the event of a
suspicion of, or an outbreak of certain diseases in aquatic
animals.

2. Member States shall remain free to take more stringent
measures in the field covered by Article 13 of Chapter II,
and Chapter V, provided that such measures do not affect trade
with other Member States.

Article 2

Scope

1.

This Directive shall not apply to:

(a) ornamental aquatic animals reared in non-commercial

aquaria;

(b) wild aquatic animals harvested or caught for direct entry into

the food chain;

(c) aquatic animals caught for the purpose of production of fish-

meal, fish feed, fish oil and similar products.

2.
Chapter II, Sections 1 to 4 of Chapter III, and Chapter VII
shall not apply where ornamental aquatic animals are kept in pet
shops, garden centres, garden ponds, commercial aquaria, or with
wholesalers:

HAS ADOPTED THIS DIRECTIVE:

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

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

1.

This Directive lays down:

(a)

the animal health requirements to be applied for the placing
on the market, the importation and the transit of aquacul-
ture animals and products thereof;

(b) minimum preventive measures aimed at increasing the
awareness and preparedness of the competent authorities,
aquaculture production business operators and others related
to this industry, for diseases in aquaculture animals;

(1) OJ C 321, 31.12.2003, p. 1. Corrected version in OJ C 4, 8.1.2004,

p. 7.

(2) OJ L 184, 17.7.1999, p. 23. Decision as last amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

Community;

or

(b) which are equipped with an effluent treatment system reduc-
ing the risk of transmitting diseases to the natural waters to
an acceptable level.

3.
This Directive shall apply without prejudice to provisions
on the conservation of species or the introduction of non-native
species.

Article 3

Definitions

For the purposes of this Directive, the following definitions

1.
shall apply:

(a)

‘aquaculture’ means the rearing or cultivation of aquatic
organisms using techniques designed to increase the produc-
tion of those organisms beyond the natural capacity of the
environment and where the organisms remain the property
of one or more natural or legal persons throughout the rear-
ing or culture stages, up to and including harvesting;

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(b)

(c)

(d)

‘aquaculture animal’ means any aquatic animal 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;

(l)

‘placing on the market’ means the sale, including offering for
sale or any other form of transfer, whether free of charge or
not, and any form of movement of aquaculture animals;

‘aquaculture production business’ means any undertaking,
whether for profit or not and whether public or private, car-
rying out any of the activities related to the rearing, keeping
or cultivation of aquaculture animals;

‘aquaculture production business operator’ means any natu-
ral or legal person responsible for ensuring that the require-
ments of this Directive are met within the aquaculture
production business under their control;

(e)

‘aquatic animal’ means:

(m) ‘production area’ means any freshwater, sea, estuarine, con-
tinental or lagoon area containing natural beds of molluscs
or sites used for the cultivation of molluscs, and from which
molluscs are taken;

(n)

(o)

‘put and take fisheries’ means ponds or other installations
where the population is maintained only for recreational
fishing by restocking with aquaculture animals;

‘relaying area’ means any freshwater, sea, estuarine or lagoon
area with boundaries clearly marked and indicated by buoys,
posts or any other fixed means, and used exclusively for the
natural purification of live molluscs;

(i)

fish belonging to the superclass Agnatha and to the
classes Chondrichthyes and Osteichthyes;

(p)

‘wild aquatic animal’ means an aquatic animal which is not
an aquaculture animal.

(ii) mollusc belonging to the Phylum Mollusca;

For the purposes of this Directive, the following definitions

2.
shall also apply:

(iii) crustacean belonging to the Subphylum Crustacea;

(a)

the technical definitions laid down in Annex I;

‘authorised processing establishment’ means any food busi-
ness approved in accordance with Article 4 of Regulation
(EC) No 853/2004 of the European Parliament and of the
Council of 29 April 2004 laying down specific hygiene rules
for food of animal origin (1), for processing aquaculture ani-
mals for food purposes, and authorised in accordance with
Articles 4 and 5 of this Directive;

‘authorised processing establishment operator’ means any
natural or legal person responsible for ensuring that the
requirements of this Directive are met within the authorised
processing establishment under their control;

‘farm’ means any premises, enclosed area, or installation
operated by an aquaculture production business in which
aquaculture animals are reared with a view to their being
placed on the market, with the exception of those where
wild aquatic animals harvested or caught for the purpose of
human consumption are temporarily kept awaiting slaugh-
ter without being fed;

‘farming’ means the rearing of aquaculture animals in a farm
or in a mollusc farming area;

(b) as appropriate, the definitions laid down respectively in:

(i) Articles 2 and 3 of Regulation (EC) No 178/2002 of the
European Parliament and of the Council of 28 Janu-
ary 2002 laying down the general principles and
requirements of food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (2);

(ii) Article 2 of Regulation (EC) No 852/2004;

(iii) Article 2 of Regulation (EC) No 853/2004;

(iv) Article 2 of Regulation (EC) No 882/2004.

CHAPTER II

AQUACULTURE PRODUCTION BUSINESSES AND
AUTHORISED PROCESSING ESTABLISHMENTS

‘mollusc farming area’ means a production area or relaying
area in which all aquaculture production businesses operate
under a common biosecurity system;

Article 4

Authorisation of aquaculture production businesses and
processing establishments

(f)

(g)

(h)

(i)

(j)

(k)

‘ornamental aquatic animal’ means an aquatic animal which
is kept, reared, or placed on the market for ornamental pur-
poses only;

1. Member States shall ensure that each aquaculture produc-
tion business is duly authorised by the competent authority in
accordance with Article 5.

(1) OJ L 139, 30.4.2004, p. 55.

(2) OJ L 31, 1.2.2002, p. 1.

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Where appropriate, such authorisation may cover several aquac-
ulture production businesses for molluscs in a mollusc farming
area.

Authorisation shall not be granted if the activity in ques-
2.
tion were to lead to an unacceptable risk of spreading diseases
to farms, mollusc farming areas or to wild stocks of aquatic ani-
mals in the vicinity of the farm or mollusc farming area.

However, dispatch centres, purification centres or similar busi-
nesses located inside a mollusc farming area shall have an indi-
vidual authorisation.

2. Member States shall ensure that each processing establish-
ment slaughtering aquaculture animals for disease control pur-
poses in accordance with Article 33 of Chapter V is duly
authorised by the competent authority in accordance with
Article 5.

3. Member States shall ensure that each aquaculture produc-
tion business and authorised processing establishment has a
unique authorisation number.

4.
By way of derogation from the authorisation requirement
in paragraph 1, Member States may require only the registration
by the competent authority of the following:

(a)

installations other than aquaculture production businesses,
where aquatic animals are kept without the intention of
being placed on the market;

(b) put and take fisheries;

(c) aquaculture production businesses which place aquaculture
animals on the market solely for human consumption in
accordance with of Article 1(3)(c) of Regulation (EC)
No 853/2004.

In those cases, the provisions of this Directive shall apply mutatis
mutandis, taking into account the nature, characteristics and situ-
ations of the installation, put and take fishery or business con-
cerned and the risk of spreading aquatic animal diseases to other
populations of aquatic animals as a result of its operation.

In the case of non-compliance with the provisions of this
5.
Directive, the competent authority shall act in accordance with
Article 54 of Regulation (EC) No 882/2004.

Article 5

Authorisation conditions

However, before a decision to refuse authorisation is taken, con-
sideration shall be given to risk-mitigation measures, including
possible alternative siting of the activity in question.

3. Member States shall ensure that the aquaculture produc-
tion business operator or authorised processing establishment
operator submits all relevant information in order to allow the
competent authority to assess that the conditions for authorisa-
tion are fulfilled, including the information required in accor-
dance with Annex II.

Article 6

Register

The Member States shall establish, keep up to date and make
publicly available a register of aquaculture production businesses
and authorised processing establishments containing at least the
information set out in Annex II.

Article 7

Official controls

1.
In accordance with Article 3 of Regulation (EC)
No 882/2004, official controls on aquaculture production busi-
nesses and authorised processing establishments shall be carried
out by the competent authority.

2.
The official controls provided for in paragraph 1 shall at
least consist of regular inspections, visits, audits, and where
appropriate, sampling, for each aquaculture production business,
taking account of the risk the aquaculture production business
and authorised processing establishment poses in relation to the
contracting and spreading of diseases. Recommendations for the
frequencies of such controls, depending on the health status of
the concerned zone or compartment, are laid down in Part B of
Annex III.

1. Member States shall ensure that authorisations, as provided
for in Article 4(1) and (2), are only granted by the competent
authority if the aquaculture production business operator or
authorised processing establishment operator:

Detailed rules for the implementation of this Article may
3.
be adopted in accordance with the procedure referred to in
Article 62(2).

(a)

fulfils the relevant requirements of Articles 8, 9 and 10;

(b) has a system in place which enables the operator to demon-
strate to the competent authority that those relevant require-
ments are being fulfilled;

and

Article 8

Recording obligations - Traceability

1. Member States shall ensure that aquaculture production
businesses keep a record of:

(c)

remains under the supervision of the competent authority,
which shall perform the duties laid down in Article 54(1).

(a) all movements of aquaculture animals and products thereof

into and out of the farm or mollusc farming area;

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(b)

the mortality in each epidemiological unit as relevant for the
type of production;

(b)

the diseases listed in Part II of Annex IV, in farms and mol-
lusc farming areas were species susceptible to those diseases
are present.

and

(c)

the results of the risk-based animal health surveillance
scheme provided for in Article 10.

2. Member States shall ensure that authorised processing
establishments keep a record of all movement of aquaculture ani-
mals and products thereof into and out of such establishments.

3. Member States shall ensure that when aquaculture animals
are transported, transporters keep a record of:

(a) mortality during transport, as practicable for the type of

transport and the species transported;

(b)

farms, mollusc farming areas and processing establishments
visited by the means of transport;

and

(c) any water exchange during transport,

in particular the

sources of new water and site of release of water.

4. Without prejudice to specific provisions on traceability,
Member States shall ensure that all movements of animals
recorded by the aquaculture production business operators as
provided for in paragraph 1(a) are registered in such a way that
the tracing of the place of origin and destination can be guaran-
teed. Member States may require such movements to be recorded
on a national register and kept in a computerised form.

Article 9

Good hygiene practice

Member States shall ensure that aquaculture production busi-
nesses and authorised processing establishments implement good
hygiene practice, as relevant for the activity concerned, to pre-
vent the introduction and spreading of diseases.

Article 10

Animal health surveillance scheme

1. Member States shall ensure that a risk-based animal health
surveillance scheme is applied in all farms and mollusc farming
areas, as appropriate for the type of production.

The risk-based animal health surveillance scheme referred

2.
to in paragraph 1 shall aim at the detection of:

(a) any increased mortality in all farms and mollusc farming

areas as appropriate for the type of production;

and

Recommendations for the frequencies of such animal health
3.
surveillance schemes, depending on the health status of the con-
cerned zone or compartment, are laid down in Part B of
Annex III. This surveillance shall apply without prejudice to the
sampling and surveillance carried out in accordance with Chap-
ter V or Article 49(3), Article 50(4) and Article 52.

4.
The risk-based animal health surveillance scheme referred
to in paragraph 1 shall take account of guidelines to be drawn
up by the Commission in accordance with the procedure referred
to in Article 62(2).

5.
In the light of the outcome of official controls carried out
in accordance with Article 7 and of the outcome of Community
controls carried out in accordance with Article 58, and of any
other relevant information, the Commission shall submit to the
Council a report on the overall operation of risk-based animal
health surveillance in Member States. This report may, where
appropriate, be accompanied by an appropriate proposal, in
accordance with the procedure referred to in Article 62(2) lay-
ing down detailed rules for the implementing of this Article.

CHAPTER III

ANIMAL HEALTH REQUIREMENTS FOR PLACING ON THE
MARKET OF AQUACULTURE ANIMALS AND PRODUCTS
THEREOF

SECTION 1

General Provisions

Article 11

Scope

Unless otherwise provided, this Chapter shall apply only to
1.
the diseases and the species susceptible thereto listed in Part II of
Annex IV.

2. Member States may allow the placing on the market for
scientific purposes of aquaculture animals and products thereof,
which do not comply with this Chapter under the strict supervi-
sion of the competent authority.

The competent authority shall ensure that such placing on the
market does not jeopardise the health status with regard to the
diseases listed in Part II of Annex IV of aquatic animals at the
place of destination or at places of transit.

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Any such movements between Member States shall not take place
without prior notification of the competent authorities of the
Member States concerned.

Article 14

Animal health certification

Article 12

General requirements for the placing of aquaculture
animals on the market

1. Member States shall ensure that the placing on the market
of aquaculture animals and products thereof does not jeopardise
the health status of aquatic animals at the place of destination
with regard to the diseases listed in Part II of Annex IV.

2.
Detailed rules on the movement of aquaculture animals are
laid down in this Chapter, in particular relating to movements
between Member States, zones and compartments with different
health statuses, as referred to in Part A of Annex III.

1. Member States shall ensure that the placing on the market
of aquaculture animals is subject to animal health certification
when the animals are introduced into a Member State, zone
or compartment declared disease-free in accordance with
Articles 49 and 50 or subject to surveillance, or eradication pro-
gramme in accordance with Article 44(1) or (2) for:

(a)

farming and restocking purposes;

or

(b)

further processing before human consumption, unless:

Article 13

(i)

as regards fish, they are slaughtered and eviscerated
before dispatch;

Disease prevention requirements in relation to transport

1. Member States shall ensure that:

(ii) as regards molluscs and crustaceans, they are dispatched

as unprocessed or processed products.

(a)

the necessary disease prevention measures are applied dur-
ing the transport of aquaculture animals in order not to alter
the health status of those animals during transport, and to
reduce the risk of spreading diseases;

2. Member States shall also ensure that the placing on the
market of aquaculture animals is subject to animal health certifi-
cation when the animals are allowed to leave an area subject to
the control provisions provided for in Sections 3, 4, 5 and 6 of
Chapter V.

and

(b) aquaculture animals are transported under conditions which
neither alter their health status nor jeopardise the health sta-
tus of the place of destination, and where appropriate, of
places of transit.

This paragraph shall also apply to diseases and the species sus-
ceptible thereto not listed in Part II of Annex IV.

2. Member States shall ensure that any water exchanges dur-
ing transport are carried out at places and under conditions
which do not jeopardise the health status of:

(a)

the aquaculture animals being transported;

(b) any aquatic animals at the place of water exchange;

and

(c) aquatic animals at the place of destination.

This paragraph shall also apply to diseases and the species sus-
ceptible thereto not listed in Part II of Annex IV.

3.
The following movements shall be subject to notification
under the computerised system provided for in Article 20(1) of
Directive 90/425/EEC:

(a) movements of aquaculture animals between Member States
where animal health certification is required in accordance
with paragraphs 1 or 2 of this Article;

and

(b) all other movements of live aquaculture animals for farm-
ing or restocking purposes between Member States where
no animal health certification is required under this Directive.

4. Member States may decide to use the computerised system
provided for in paragraph 3 to trace movements taking place
entirely within their territory.

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SECTION 2

Article 16

Aquaculture animals intended for farming and restocking

Introduction of aquaculture animals of species susceptible
to a specific disease into areas free of that disease

Article 15

General requirements for the placing of aquaculture
animals on the market for farming and restocking

1. Without prejudice to the provisions laid down in Chapter
V, Member States shall ensure that aquaculture animals placed
on the market for farming are:

(a)

clinically healthy;

and

(b) do not come from a farm or mollusc farming area where

there is any unresolved increased mortality.

1.
In order to be introduced for farming or restocking into a
Member State, zone or compartment declared free of a specific
disease in accordance with Articles 49 or 50, aquaculture ani-
mals of species susceptible thereto shall originate from another
Member State, zone or compartment also declared free of that
disease.

2. Where it can be scientifically justified that species suscep-
tible to the specific disease at certain life stages do not transmit
that disease, paragraph 1 shall not apply to those life stages.

A list of species and life stages to which the first subparagraph
may apply shall be adopted and when necessary amended to take
account of scientific and technological developments in accor-
dance with the procedure referred to in Article 62(2).

This paragraph shall also apply in relation to diseases and the
species susceptible thereto not listed in Part II of Annex IV.

Article 17

2.
By way of derogation from paragraph 1(b), Member States
may allow such placing on the market, based on an assessment
of risk, provided that the animals originate from a part of the
farm or mollusc farming area independent of the epidemiologi-
cal unit where the increased mortality has occurred.

3. Member States shall ensure that aquaculture animals
intended for destruction or slaughter in accordance with the dis-
ease control measures provided for in Chapter V are not placed
on the market for farming and restocking purposes.

Aquaculture animals may only be released into the wild for

4.
restocking purposes or into put and take fisheries if they:

Introduction of live aquaculture animals of vector species
into disease-free areas

1. Where scientific data or practical experience substantiates
that species other than those referred to in Part II of Annex IV
may be responsible for the transmission of a specific disease by
acting as vector species, Member States shall ensure that where
introduced for farming or restocking purposes into a Member
State, zone or compartment declared free of that specific disease
in accordance with Articles 49 or 50, such vector species shall:

(a) originate from another Member State, zone or compartment

declared free of that specific disease;

(a)

comply with the requirements in paragraph 1;

or

and

(b) come from a farm or mollusc farming area with a health sta-
tus as referred to in Part A of Annex III, at least equivalent
to the health status of the waters in which they are to be
released.

(b) be held in quarantine facilities in water free of the pathogen
in question, for an appropriate period of time, where, in the
light of the scientific data or practical experience provided,
this proves to be sufficient to reduce the risk of transmis-
sion of the specific disease to a level acceptable for prevent-
ing the transmission of the disease concerned.

However, Member States may decide that the aquaculture ani-
mals shall come from a zone or compartment declared disease-
free in accordance with Articles 49 or 50. Member States may
also decide to apply this paragraph to programmes drawn up
and applied in accordance with Article 43.

2.
A list of vector species and life stages of such species to
which this Article applies and, where appropriate, the conditions
under which those species can transmit a disease shall be
adopted, and when necessary amended taking into account sci-
entific and technological developments in accordance with the
procedure referred to in Article 62(2).

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Pending the possible inclusion of a species on the list
3.
referred to in paragraph 2, the Commission may decide in accor-
dance with the procedure referred to in Article 62(3), to allow
Member States
in
paragraph 1.

to apply the provisions provided for

Article 19

Aquaculture animals and products thereof placed on the
market for human consumption without further
processing

SECTION 3

Aquaculture animals and products thereof intended for
human consumption

Article 18

Aquaculture animals and products thereof placed on the
market for further processing before human consumption

1. Member States shall ensure that aquaculture animals of spe-
cies susceptible to one or more of the non-exotic diseases listed
in Part II of Annex IV, and products thereof, may only be placed
on the market for further processing in a Member State, zone
or compartment declared free of those diseases in accordance
with Articles 49 or 50, if they comply with one of the following
conditions:

(a)

they originate from another Member State, zone or com-
partment declared free of the disease in question;

(b)

they are processed in an authorised processing establishment
under conditions which prevent the spreading of diseases;

(c) as regards fish, they are slaughtered and eviscerated before

dispatch;

or

(d) as regards molluscs and crustaceans, they are dispatched as

unprocessed or processed products.

2. Member States shall ensure that live aquaculture animals of
species susceptible to one or more of the non-exotic diseases listed
in Part II of Annex IV which are placed on the market for further
processing in a Member State, zone or compartment declared free
of those diseases in accordance with Articles 49 or 50, may only
be temporarily stored at the place of processing if:

(a)

they originate from another Member State, zone, or com-
partment declared free of the disease in question;

or

(b)

they are temporarily kept in dispatch centres, purification
centres or similar businesses which are equipped with an
effluent treatment system inactivating the pathogens in ques-
tion, or where the effluent is subject to other types of treat-
ment reducing the risk of transmitting diseases to the natural
waters to an acceptable level.

1.
This section shall not apply where aquaculture animals of
species susceptible to one or more of the diseases listed in Part II
of Annex IV, or products thereof, are 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 packaging and labelling provided for in Regula-
tion (EC) No 853/2004.

2. Where live molluscs and crustaceans of species susceptible
to one or more of the diseases listed in Part II of Annex IV are
temporarily relayed in Community waters, or introduced into
dispatch centres, purification centres or similar businesses, they
shall comply with Article 18(2).

SECTION 4

Wild aquatic animals

Article 20

Release of wild aquatic animals in Member States, zones
or compartments declared disease-free

1. Wild aquatic animals of species susceptible to one or more
of the diseases listed in Part II of Annex IV caught in a Member
State or zone or compartment not declared disease-free in accor-
dance with Articles 49 or 50 shall be placed in quarantine under
the supervision of the competent authority in suitable facilities,
for a period of time sufficient to reduce to an acceptable level
the risk of transmission of the disease, before they may be
released into a farm or mollusc farming area situated in a Mem-
ber State, zone, or compartment declared free from that disease
in accordance with Articles 49 or 50.

2.
The Member States may allow traditional extensive lagoon
aquaculture practice, without the quarantine provided for in para-
graph 1, provided a risk assessment is undertaken and that the
risk is considered not higher than what is expected from the
application of paragraph 1.

SECTION 5

Ornamental aquatic animals

Article 21

Placing on the market of ornamental aquatic animals

1. Member States shall ensure that the placing on the market
of ornamental aquatic animals does not jeopardise the health sta-
tus of aquatic animals with regard to the diseases listed in Part II
of Annex IV.

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This Article shall apply also in relation to diseases not listed

2.
in Part II of Annex IV.

(e) any experience of marketing live aquaculture animals from
the third country and the results of any import controls car-
ried out;

CHAPTER IV

INTRODUCTION OF AQUACULTURE ANIMALS AND
PRODUCTS THEREOF INTO THE COMMUNITY FROM THIRD
COUNTRIES

Article 22

General requirements for introduction of aquaculture
animals and products thereof from third countries

Member States shall ensure that aquaculture animals and prod-
ucts thereof are introduced into the Community only from third
countries or parts of third countries that appear on a list drawn
up and updated in accordance with the procedure referred to
Article 62(2).

(f)

(g)

(h)

the results of the Community assessment, in particular the
results of the assessment carried out by the competent
authorities of the third country concerned or, where the
Commission so requests, the report submitted by the com-
petent authorities of the third country on any inspections
carried out;

the health status of farmed and wild aquatic animals in the
third country, with particular regard to exotic animal dis-
eases and any aspects of the general aquatic animal health
situation in the country which might pose a risk to aquatic
animal health in the Community;

the regularity, speed and accuracy with which the third coun-
try supplies information on the existence of infectious
or contagious aquatic animal diseases in its territory, particu-
larly the notifiable diseases, listed by the World Organisa-
tion for Animal Health (OIE);

Article 23

and

Lists of third countries and parts of third countries from
which introduction of aquaculture animals and products
thereof is permitted

1.
A third country, or a part of a third country, shall appear
on the list provided for in Article 22 only if a Community assess-
ment of that country, or that part of a third country, has dem-
onstrated that the competent authority provides appropriate
guarantees as regards compliance with the relevant animal health
requirements of Community legislation.

2.
The Commission may decide if an inspection as referred
to in Article 58(2) is necessary to complete the assessment of
the third country, or part of the third country, provided for in
paragraph 1.

3. When drawing up or updating the lists provided for in
Article 22, particular account shall be taken of:

(a)

the legislation of the third country;

(b)

(c)

the organisation of the competent authority and its inspec-
tion services in the third country, the powers of these ser-
vices, the supervision to which they are subject, and the
means at their disposal, including staff capacity, to apply
their legislation effectively;

the aquatic animal health requirements in force that apply
to the production, manufacture, handling, storage and dis-
the
patch of
Community;

live aquaculture animals

intended for

(i)

the rules on the prevention and control of aquatic animal
diseases in force in the third country and their implementa-
tion, including rules on imports from other countries.

The Commission shall arrange for all lists to be drawn up
4.
or updated in accordance with Article 22 and made available to
the public.

Lists drawn up in accordance with Article 22 may be com-
5.
bined with other lists drawn up for animal and public health
purposes.

Article 24

Documents

All consignments of aquaculture animals and products
1.
thereof shall be accompanied by a document containing an ani-
mal health certificate upon their entry into the Community.

The animal health certificate shall certify that the consign-

2.
ment satisfies:

(a)

the requirements laid down for such commodities under this
Directive;

and

(b) any special import conditions established in accordance with

Article 25(a).

(d)

the assurances which the competent authority of the third
country may give regarding compliance or equivalence with
the relevant aquatic animal health conditions;

The document may include details required under other

3.
provisions of Community public and animal health legislation.

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Article 25

Detailed rules

(d) official veterinarians, senior staff of veterinary or other offi-

cial or private laboratories;

Where necessary, detailed rules for the application of this Chap-
ter may be established in accordance with the procedure referred
to in Article 62(2). These rules may concern in particular:

(a)

import conditions for each third country, parts

special
thereof or group of third countries;

(b)

the criteria for classifying third countries and parts thereof
with regard to aquatic animal diseases;

(c)

the use of electronic documents;

(d) model animal health certificates and other documents;

and

and

(e) any other person with an occupational relationship to
aquatic animals of susceptible species or to products of such
animals.

Article 27

Notification of the other Member States, the Commission
and EFTA Member States

Member States shall notify the other Member States, the Com-
mission and EFTA Member States within 24 hours in case of con-
firmation of:

(e) procedures and certification for transit.

(a) an exotic disease listed in Part II of Annex IV;

CHAPTER V

NOTIFICATION AND MINIMUM MEASURES FOR CONTROL
OF DISEASES OF AQUATIC ANIMALS

SECTION 1

Disease notification

Article 26

National notification

1. Member States shall ensure that:

(a) when there are any reasons to suspect the presence of a dis-
ease listed in Part II of Annex IV, or the presence of such
disease is confirmed in aquatic animals, the suspicion and/or
the confirmation is immediately notified to the competent
authority;

and

(b) when increased mortality occurs in aquaculture animals, the
mortality is immediately notified to the competent author-
ity or a private veterinarian for further investigations.

2. Member States shall ensure that the obligations to notify
the matters referred to in paragraph 1 are imposed on:

(b) a non-exotic disease listed in Part II of Annex IV where the
Member State concerned, zone, or compartment has been
declared free of that disease.

SECTION 2

Suspicion of a listed disease – Epizootic investigation

Article 28

Initial control measures

Member States shall ensure that, in the case of a suspicion of an
exotic disease listed in Part II of Annex IV or, in the case of sus-
picion of a non-exotic disease listed in Part II of Annex IV in
Member States, zones or compartments with a health status of
either category I or III as referred to in Part A of Annex III, for
that disease:

(a) appropriate samples are taken and examined in a laboratory

designated in accordance with Article 57;

(b) pending the result of the examination provided for in

point (a):

(i)

the farm, or mollusc farming area, in which the disease
is suspected, is placed under official surveillance and rel-
evant control measures are implemented to prevent the
spreading of the disease to other aquatic animals;

(a)

the owner and any person attending aquatic animals;

(b) any person accompanying aquaculture animals during

transport;

(ii) no aquaculture animals are allowed to leave or enter the
affected farm or mollusc farming area in which the dis-
ease is suspected, unless authorised by the competent
authority;

(c) veterinary practitioners and other professionals involved in

(iii) the epizootic investigation provided for in Article 29 is

aquatic animal health services;

initiated.

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Article 29

Epizootic investigation

Article 30

Lifting restrictions

1. Member States shall ensure that the epizootic investigation
initiated in accordance with Article 28(b)(iii) is carried out where
the examination provided for in Article 28(a) shows the pres-
ence of:

(a) an exotic disease listed in Part II of Annex IV in any Mem-

ber State;

or

The competent authority shall lift the restrictions provided for
in Article 28(b) where the examination provided for in point (a)
of that Article fails to demonstrate the presence of the disease.

SECTION 3

Minimum control measures in the case of confirmation of
exotic diseases in aquaculture animals

Article 31

Introductory provision

(b) a non-exotic disease listed in Part II of Annex IV in Member
States, zones or compartments with a health status of either
category I or III, as referred to in Part A of Annex III, for the
disease in question.

This Section shall apply in the case of confirmation of an exotic
disease listed in Part II of Annex IV in aquaculture animals.

The epizootic investigation provided for in paragraph 1

2.
shall be aimed at:

Article 32

General measures

(a) determining the possible origin and means of contamination;

Member States shall ensure that:

(b)

investigating whether aquaculture animals have left the farm
or mollusc farming area during the relevant period preced-
ing the notification of
the suspicion provided for in
Article 26(1);

(c)

investigating whether other farms have been infected.

3. Where the epizootic investigation provided for in para-
graph 1 shows that the disease may have been introduced into
one or more farms, mollusc farming areas or unenclosed waters,
the Member State concerned shall ensure that the measures pro-
vided for in Article 28 are applied in such farms, mollusc farm-
ing areas or unenclosed waters.

In the case of extensive water catchment areas or coastal areas,
the competent authority may decide to limit the application of
Article 28 to a less extensive area in the vicinity of the farm or
the mollusc farming area suspected of being infected, where it
considers that such less extensive area is sufficiently large to guar-
antee that the disease does not spread.

4. Where necessary, the competent authority of neighbour-
ing Member States or third countries shall be informed of the
suspected case of disease.

In that event, the competent authorities of the Member States
involved shall take appropriate action to apply the measures pro-
vided for in this Article within their territory.

(a)

the farm or mollusc farming area is officially declared
infected;

(b) a containment area appropriate to the disease in question is
established, including a protection zone and surveillance
zone, around the farm or mollusc farming area declared
infected;

(c) no restocking takes place and no aquaculture animals are
moved into, within, and out of the containment area unless
authorised by the competent authority;

and

(d) any additional measures necessary to prevent the further

spread of the disease are implemented.

Article 33

Harvesting and further processing

Aquaculture animals which have reached commercial size
1.
and show no clinical sign of disease may be harvested under the
supervision of the competent authority for human consumption,
or for further processing.

2.
Harvesting, introduction into dispatch centres or purifica-
tion centres, further processing and any other related operations
involved in the preparation of the aquaculture animals for entry
into the food chain shall be carried out under conditions which
prevent the spread of the pathogen responsible for causing the
disease.

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Dispatch centres, purification centres or similar businesses
3.
shall be equipped with an effluent treatment system inactivating
the pathogen responsible for causing the disease, or the effluent
shall be subject to other types of treatment reducing the risk of
transmitting diseases to the natural waters to an acceptable level.

Article 37

Lifting measures

The measures provided for in this Section shall be maintained
until:

Further processing shall be performed in authorised pro-

4.
cessing establishments.

(a)

the eradication measures provided for in this Section have
been carried out;

Article 34

Removal and disposal

(b)

sampling and surveillance as appropriate for the disease in
question and the types of aquaculture production businesses
affected has been carried out in the containment area with
negative results.

1. Member States shall ensure that dead fish and crustaceans,
as well as live fish and crustaceans showing clinical signs of dis-
ease, are removed and disposed of under the supervision of the
competent authority in accordance with Regulation (EC)
No 1774/2002 of the European Parliament and of the Council
of 3 October 2002 laying down health rules concerning animal
by-products not intended for human consumption (1), as soon
as possible in accordance with the contingency plan provided for
in Article 47 of this Directive.

SECTION 4

Minimum control measures in the case of confirmation of
non-exotic diseases in aquaculture animals

Article 38

General provisions

2.
Aquaculture animals which have not reached commercial
size and do not show clinical signs of disease shall, in an appro-
priate timeframe taking into account the type of production and
the risk such animals pose for further spread of the disease, be
removed and disposed of under the supervision of the compe-
tent authority in accordance with Regulation (EC) No 1774/2002,
and the contingency plan provided for in Article 47 of this
Directive.

1.
In the case of confirmation of a non-exotic disease listed
in Part II of Annex IV in a Member State, zone or compartment
declared free of that disease, the Member State concerned shall
either:

(a) apply the measures provided for in Section 3 in order to

regain such disease-free status,

Article 35

Fallowing

Where possible, infected farms or mollusc farming areas shall
undergo an appropriate period of fallowing after being emptied
and, where appropriate, cleansed and disinfected.

For farms or mollusc farming areas rearing aquaculture animals
not susceptible to the disease in question, decisions on fallowing
shall be based on a risk assessment.

Article 36

Protection of aquatic animals

or

(b) draw up an eradication programme in accordance with

Article 44(2).

2.
By way of derogation from Article 34(2), where a Member
State decides to apply the measures provided for in Section 3, it
may allow clinically healthy animals to be raised to market size
before slaughter for human consumption or to be moved to
another infected zone or compartment. In such cases, measures
shall be taken to reduce and as far as possible, prevent the fur-
ther spreading of the disease.

3. Where the Member State concerned does not wish to regain
disease-free status, Article 39 shall apply.

Article 39

Containment measures

Member States shall take the necessary measures to prevent the
spreading of diseases to other aquatic animals.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commis-
sion Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25).

In the case of confirmation of a non-exotic disease listed in Part
II of Annex IV in a Member State, zone or compartment not
declared free of that disease, the Member State concerned shall
take measures to contain the disease.

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Those measures shall at least consist of:

(a) declaring the farm or mollusc farming area to be infected;

(b) establishing a containment area appropriate to the disease
in question, including a protection zone and surveillance
zone around the farm or mollusc farming area declared
infected;

(c)

restricting the movement of aquaculture animals from the
containment area to the effect that such animals may only be:

(i)

introduced into farms or mollusc farming areas in accor-
dance with Article 12(2);

or

(ii) harvested and slaughtered for human consumption in

accordance with Article 33(1);

(d)

the removal and disposal of dead fish and crustaceans, under
the supervision of the competent authority in accordance
with Regulation (EC) No 1774/2002, in an appropriate time-
frame taking into account the type of production and the
risk such dead animals pose for further spread of the disease.

SECTION 5

Minimum control measures in the case of confirmation of
diseases listed in Part II of Annex IV in wild aquatic animals

Article 40

Control of diseases listed in Part II of Annex IV in wild
aquatic animals

3. Member States shall inform the Commission and the other
Member States within the Committee referred to in Article 62(1)
of the measures they have taken in accordance with paragraphs 1
and 2.

SECTION 6

Control measures in case of emerging diseases

Article 41

Emerging diseases

1. Member States shall take appropriate measures to control
an emerging disease situation and prevent that disease from
spreading, where the emerging disease in question has the poten-
tial to jeopardise the health situation of aquatic animals.

2.
In the case of an emerging disease situation, the Member
State concerned shall inform the Member States, the Commis-
sion and EFTA Member States without delay thereof, where the
findings are of epidemiological significance to another Member
State.

3. Within four weeks of informing the other Member States,
the Commission and EFTA Member States as required in para-
graph 2, the matter shall be brought to the attention of the Com-
mittee referred to in Article 62(1). The measures taken by the
Member State concerned pursuant to paragraph 1 of this Article
may be extended, amended or repealed in accordance with the
procedure referred to in Article 62(2).

4. Where appropriate, the list set out in Part II of Annex IV
shall be amended in accordance with the procedure referred to in
Article 62(2) to include the emerging disease in question or a
new susceptible host species to a disease already listed in that
Annex.

SECTION 7

Alternative measures and national provisions

Article 42

Procedure for adoption of ad hoc epidemiological
measures for diseases listed in Part II of Annex IV

1. Where wild aquatic animals are infected or suspected of
being infected with exotic diseases listed in Part II of Annex IV,
the Member State concerned shall monitor the situation, and take
measures to reduce and, as far as possible, to prevent the further
spreading of the disease.

A decision may be adopted in accordance with the procedure
referred to in Article 62(2) to authorise the implementation of
ad hoc measures for a limited period of time, under conditions
appropriate to the epidemiological situation where:

2. Where wild aquatic animals are infected or suspected of
being infected with non-exotic diseases listed in Part II of
Annex IV in a Member State, zone or compartment declared free
of that disease, the Member State shall also monitor the situa-
tion and take measures to reduce, and as far as possible, to pre-
vent the further spreading of the disease.

(a)

the measures provided for in this chapter are found not to
be suited to the epidemiological situation;

or

(b)

the disease appears to be spreading despite the measures
taken in accordance with this chapter.

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Article 43

Provisions for limiting the impact of diseases not listed in
Part II of Annex IV

1. Where a disease not listed in Part II of Annex IV consti-
tutes a significant risk for the animal health situation of aquacul-
ture or wild aquatic animals in a Member State, the Member State
concerned may take measures to prevent the introduction of or
to control that disease.

2. Where a Member State known to be infected (category V
as referred to in Part A of Annex III) by one or more of the non-
exotic diseases listed in Part II of Annex IV, draws up an eradica-
tion programme for one or more of those diseases, it shall submit
that programme for approval in accordance with the procedure
referred to in Article 62(2).

Such programmes may also be amended or terminated in accor-
dance with that procedure.

Member States shall ensure that these measures do not exceed
the limits of what is appropriate and necessary to prevent the
introduction of or to control the disease.

3.
An overview of the programmes approved in accordance
with paragraphs 1 and 2 of this Article shall be made available
at Community level in accordance with the procedures provided
for in Article 51.

2. Member States shall notify to the Commission any mea-
sures referred to in paragraph 1 that may affect trade between
Member States. Those measures shall be subject to approval in
accordance with the procedure referred to in Article 62(2).

3.
Approval referred to in paragraph 2 shall only be granted
where the establishment of intra-Community trade restrictions is
necessary to prevent the introduction of or to control the dis-
ease, and shall take into account the provisions laid down in
Chapters II, III, IV and V.

4.
From the date of approval of the programmes referred to in
this Article, the requirements and measures provided for in
Article 14, Sections 2, 3, 4 and 5 of Chapter III, Section 2 of
Chapter V, and Article 38(1) in relation to areas declared disease-
free shall apply to the areas which are covered by the
programmes.

Article 45

Content of programmes

CHAPTER VI

Programmes shall not be approved unless they contain at least
the following:

CONTROL PROGRAMMES AND VACCINATION

SECTION 1

Surveillance and eradication programmes

Article 44

Drawing up and approval of surveillance and eradication
programmes

1. Where a Member State not known to be infected but not
declared free (category III as referred to in Part A of Annex III) of
one or more of the non-exotic diseases listed in Part II of
Annex IV draws up a surveillance programme for achieving
disease-free status for one or more of those diseases, it shall sub-
mit that programme for approval in accordance with the proce-
dure referred to in Article 62(2).

(a) a description of the epidemiological situation of the disease
before the date of commencement of the programme;

(b) an analysis of the estimated costs and the anticipated ben-

efits of the programme;

(c)

the likely duration of the programme and the objective to
be attained by the completion date of the programme;

and

(d) a description and demarcation of the geographical and
administrative area in which the programme is to be applied.

Article 46

Period of application of programmes

Such programmes may also be amended or terminated in accor-
dance with that procedure.

1.

Programmes shall continue to be applied until:

The specific requirements for surveillance, sampling and diagnos-
tic shall be those provided for in Article 49(3).

However, where a programme provided for in this paragraph is
to cover individual compartments or zones, which comprise less
than 75 % of the territory of the Member State, and the zone
or compartment consists of a water catchment area not shared
with another Member State or third country, the procedure
referred to in Article 50(2) shall apply for any approval, or
amendment or termination of such programme.

(a)

the requirements laid down in Annex V have been fulfilled,
and the Member State, zone or compartment is declared free
of the disease;

or

(b)

the programme is withdrawn, namely if it no longer fulfils
its purpose, by the competent authority of the Member State
concerned, or by the Commission.

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If the programme is withdrawn as provided for in para-
2.
graph 1(b), the Member State concerned shall apply the contain-
ment measures in Article 39 from the date of withdrawal of the
programme.

2. Member States shall ensure that vaccination against the
non-exotic diseases listed in Part II of Annex IV is prohibited in
any parts of their territory declared free of the diseases in ques-
tion in accordance with Article 49 or 50, or covered by a sur-
veillance programme, approved in accordance with Article 44(1).

SECTION 2

Contingency plan for emerging and exotic diseases

Article 47

Contingency plan for emerging and exotic diseases

1.
Each Member State shall draw up a contingency plan speci-
fying the national measures required to maintain a high level of
disease awareness and preparedness and to ensure environmen-
tal protection.

2.

The contingency plan shall:

Member States may allow such vaccination in parts of their ter-
ritory not declared free from the diseases in question, or where
vaccination is a part of an eradication programme approved in
accordance with Article 44(2).

3. Member States shall ensure that the vaccines used are
authorised in accordance with Directive 2001/82/EC and Regu-
lation (EC) No 726/2004.

4.
Paragraphs 1 and 2 shall not apply to scientific studies for
the purpose of developing and testing vaccines under controlled
conditions.

(a) provide the competent authority with the authority and
means to access all facilities, equipment, personnel and other
appropriate materials necessary for the rapid and efficient
eradication of an outbreak;

During such studies, Member States shall ensure that the appro-
priate measures are taken to protect other aquatic animals from
any adverse effect of the vaccination carried out within the frame-
work of the studies.

(b) ensure coordination and compatibility with neighbouring
Member States and encourage cooperation with neighbour-
ing third countries;

and

(c) where relevant, give a precise indication of the vaccine
requirements and vaccination conditions considered neces-
sary in the event of emergency vaccination.

3. Member States shall comply with the criteria and require-
ments laid down in Annex VII when drawing up contingency
plans.

4. Member States shall submit the contingency plans for
in accordance with the procedure referred to in
approval
Article 62(2).

Every five years, each Member State shall update its contingency
plan and submit the updated plan for approval in accordance
with that procedure.

5.
The contingency plan shall be implemented in the event of
an outbreak of emerging diseases and of exotic diseases listed in
Part II of Annex IV.

SECTION 3

Vaccination

Article 48

Vaccination

1. Member States shall ensure that vaccination against the
exotic diseases listed in Part II of Annex IV is prohibited unless
such vaccination is approved in accordance with Articles 41,
42 or 47.

CHAPTER VII

DISEASE-FREE STATUS

Article 49

Disease-free Member State

1.
A Member State shall be declared free of one or more of
the non-exotic diseases listed in Part II of Annex IV in accor-
dance with the procedure referred to in Article 62(2), if para-
graph 2 of this Article is complied with and:

(a) none of the species susceptible to the disease(s) in question

is present in its territory;

or

(b)

the pathogen is known not to be able to survive in the Mem-
ber State, and in its water source;

or

(c)

the Member State meets the conditions laid down in Part I
of Annex V.

2. Where neighbouring Member States, or water catchment
areas shared with neighbouring Member States, are not declared
disease-free, the Member State shall establish appropriate buffer
zones in its territory. The demarcation of buffer zones shall be
such that they protect the disease-free Member State from pas-
sive introduction of the disease.

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The specific requirements for surveillance, buffer zones,
3.
sampling and diagnostic methods that shall be used by Member
States to grant disease-free status in accordance with this Article
shall be adopted in accordance with the procedure referred to in
Article 62(2).

(e)

if the arbitration referred to in point (d) fails, the Commis-
sion may decide to make an on-the-spot inspection in accor-
dance with Article 58 to verify the compliance of the
declaration submitted with the criteria set out in para-
graph 1, unless the declaring Member State withdraws its
declaration;

Article 50

Disease-free zone or compartment

1.
A Member State may declare a zone or a compartment
within its territory free of one or more of the non-exotic dis-
eases listed in Part II of Annex IV, where:

(a) none of the species susceptible to the disease(s) in question
is present in the zone or compartment, and where relevant
in its water source;

or

(b)

the pathogen is known not to be able to survive in the zone
or compartment, and where relevant in its water source;

or

(c)

the zone or compartment complies with the conditions laid
down in Part II of Annex V.

2.
A Member State shall submit the declaration referred to in
paragraph 1 to the Standing Committee on Food Chain and Ani-
mal Health in accordance with the following procedure:

(f) where necessary in the light of the results achieved, a deci-
sion in accordance with the procedure referred to in
Article 62(2) shall be taken, to suspend the self-declaration
of the disease-free status of the zone or compartment
concerned.

3. Where the zone(s) or compartment(s) referred to in para-
graph 1 comprise more than 75 % of the territory of the Mem-
ber State, or if the zone or compartment consists of a water
catchment area shared by another Member State or third coun-
try, the procedure referred to in paragraph 2 shall be replaced
by the procedure referred to in Article 62(2).

4.
The specific requirements of the surveillance, sampling and
diagnostic methods used by Member States to obtain disease-
free status in accordance with this Article shall be laid down in
accordance with the procedure referred to in Article 62(2).

Article 51

Lists of disease-free Member States, zones
or compartments

(a)

the declaration shall be supported by evidence in a form to
be determined in accordance with the procedure referred
to in Article 62(2) and be accessible by electronic means to
the Commission and Member States, in accordance with the
requirements of Article 59;

1.
Each Member State shall establish and maintain an updated
list of zones and compartments declared disease-free in accor-
dance with Article 50(2). Such lists shall be made publicly
available.

(b)

the Commission shall add the notification of the declaration
to the agenda of the next meeting of the Committee referred
to in Article 62(1) as an information point. The declaration
shall take effect 60 days after the date of the meeting;

2.
The Commission shall draw up and update a list of Mem-
ber States, zones or compartments declared disease-free in accor-
dance with Articles 49 or 50(3), and shall make the list publicly
available.

(c) within this period, the Commission or Member States may
seek clarification or additional information on the support-
ing evidence from the Member State making the declaration;

(d) where written comments are made by at least one Member
State, or the Commission, within the period referred to in
point (b) indicating significant objective concerns related to
the supporting evidence, the Commission and the Member
States concerned shall together examine the submitted evi-
dence in order to resolve the concerns. In that case, the
period referred to in point (b) may be prolonged for 30 days.
Such comments shall be submitted to the declaring Member
State and to the Commission;

Article 52

Maintenance of disease-free status

A Member State that is declared free from one or more non-
exotic diseases listed in Part II of Annex IV in accordance with
Article 49 may discontinue targeted surveillance and maintain its
disease-free status provided that
the conditions conducive
to clinical expression of the disease in question exist, and the rel-
evant provisions of this Directive are implemented.

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However, for disease-free zones or compartments in Member
States not declared disease-free, and in all cases where condi-
tions are not conducive to clinical expression of the disease in
question, targeted surveillance shall be continued in accordance
with the methods provided for in Articles 49(3) or 50(4) as
appropriate, but at a level commensurate with the degree of risk.

Article 53

Suspension and restoration of disease-free status

1. Where a Member State has reason to believe that any of
the conditions for maintaining its status as a disease-free Mem-
ber State, zone or compartment have been breached, that Mem-
ber State shall immediately suspend trade in susceptible species
and vector species to other Member States, zones or compart-
ments with a higher health status for the disease in question as
laid down in Part A of Annex III and apply the provisions of Sec-
tions 2 and 4 of Chapter V.

the

epizootic

in
2. Where
Article 29(1) confirms that the suspected breach has not taken
place, the disease-free status of the Member State, zone or com-
partment shall be restored.

investigation provided for

3. Where the epizootic investigation confirms a significant
likelihood that infection has occurred, the disease-free status of
the Member State, zone or compartment shall be withdrawn, in
accordance with the procedure under which that status was
declared. The requirements laid down in Annex V shall be com-
plied with before the disease-free status is restored.

Information shall also, to the extent necessary, be exchanged
between the competent authorities of the different Member
States.

Each Member State shall ensure that the competent authori-
3.
ties have access to adequate laboratory services and state-of-the-
art know-how in risk analysis and epidemiology, and that there
is a free exchange of any information relevant to the implemen-
tation of this Directive between the competent authorities and
laboratories.

Article 55

Community reference laboratories

Community reference laboratories for the aquatic animal
1.
diseases relevant to this Directive shall be designated in accor-
dance with the procedure referred to in Article 62(2) for a period
to be defined in accordance with that procedure.

2.
Community reference laboratories for aquatic animal dis-
eases shall comply with the functions and duties laid down in
Part I of Annex VI.

3.
The Commission shall review the designation of the Com-
munity reference laboratories by the end of the period referred
to in paragraph 1 at the latest, in the light of their compliance
with the functions and duties referred to in paragraph 2.

Article 56

National reference laboratories

CHAPTER VIII

COMPETENT AUTHORITIES AND LABORATORIES

1. Member States shall arrange for the designation of a
national reference laboratory for each of the Community refer-
ence laboratories referred to in Article 55.

Article 54

General obligations

Member States may designate a laboratory situated in another
Member State or EFTA Member State, and a single laboratory
may be the national reference laboratory for more than one
Member State.

1.
Each Member State shall designate its competent authori-
ties for the purposes of this Directive and notify the Commis-
sion thereof.

The competent authorities shall operate and perform their duties
in accordance with Regulation (EC) No 882/2004.

Each Member State shall ensure that effective and continu-
2.
ous cooperation based on the free exchange of information rel-
evant to the implementation of this Directive is established
between the competent authorities it designates for the purposes
of this Directive and any of its other authorities involved in regu-
lating aquaculture, aquatic animals, and food and feed of aquac-
ulture origin.

2. Member States shall communicate the name and address
of each designated national reference laboratory to the Commis-
sion, the relevant Community reference laboratory and other
Member States, including any updates hereto.

3.
The national reference laboratory shall liaise with the rel-
evant Community reference laboratory provided for in Article 55.

4.
In order to ensure an efficient diagnostic service through-
out the territory of a Member State in accordance with the
requirements of this Directive, the national reference laboratory
shall collaborate with any laboratory designated in accordance
with Article 57 situated in the territory of the same Member State.

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5. Member States shall ensure that any national reference labo-
ratory on their territory is adequately equipped and staffed with
the appropriate numbers of trained personnel to carry out the
laboratory investigations required in accordance with this Direc-
tive and to comply with the functions and duties laid down in
Part II of Annex VI.

Article 57

Diagnostic services and methods

Member States shall ensure that:

(a)

(b)

laboratory examinations for the purposes of this Directive
are carried out in laboratories designated for such purpose
by the competent authority;

laboratory examinations in the case of suspicion and to con-
firm the presence of the diseases listed in Part II of Annex IV
are carried out by diagnostic methods to be established in
accordance with the procedure referred to in Article 62(2);

and

(c)

laboratories designated for diagnostic services in accordance
with this Article shall comply with the functions and duties
laid down in Part III of Annex VI.

CHAPTER IX

INSPECTIONS, ELECTRONIC MANAGEMENT AND PENALTIES

Article 58

Community inspections and audits

1.
Experts from the Commission may carry out on-the-spot
inspections, including audits, in cooperation with the competent
authorities of the Member States, insofar as they are necessary
for the uniform application of this Directive.

The Member States in the territory of which such inspections and
audits are made shall provide the experts with all the assistance
necessary for carrying out their duties.

The Commission shall inform the competent authority of the
results of any such inspections and audits.

2.
Experts from the Commission may also carry out on-the-
spot inspections, including audits, in third countries, in coopera-
tion with the competent authorities of
the third country
concerned, in order to verify conformity with or equivalence
to Community aquatic animal health rules.

3. Where a serious animal health risk is identified during a
Commission inspection, the Member State concerned shall imme-
diately take all measures necessary to safeguard animal health.

Where such measures are not taken, or where they are consid-
ered to be insufficient, the measures necessary to safeguard ani-
mal health shall be adopted in accordance with the procedure
referred to in Article 62(3) and the Member State concerned shall
be informed thereof.

Article 59

Electronic management

1. Member States shall, by 1 August 2008 at the latest, ensure
that all procedures and formalities relating to making the infor-
mation provided for in Article 6, Article 50(2) Article 51(1) and
Article 56(2) available by electronic means are in place.

2.
The Commission shall, in accordance with the procedure
referred to in Article 62(2), adopt detailed rules for the imple-
mentation of paragraph 1 in order to facilitate the interoperabil-
ity of information systems and use of procedures by electronic
means between Member States.

Article 60

Penalties

The Member States shall lay down the rules on penalties appli-
cable to infringements of the national provisions adopted pursu-
ant to this Directive and shall take all measures necessary to
ensure that they are implemented. The penalties provided for
must be effective, proportionate and dissuasive. The Member
States shall notify those provisions to the Commission by the
date specified in Article 65(1) at the latest and shall notify it with-
out delay of any subsequent amendment affecting them.

CHAPTER X

AMENDMENTS, DETAILED RULES AND COMMITTEE
PROCEDURE

Article 61

Amendments and detailed rules

Article 50(2) may be amended in accordance with the pro-

1.
cedure referred to in Article 62(2).

The Annexes to this Directive may be amended in accor-

2.
dance with the procedure referred to in Article 62(2).

The measures necessary for the implementation of this
3.
Directive shall be adopted in accordance with the procedure
referred to in Article 62(2).

Article 62

Committee procedure

1.
The Commission shall be assisted by the Standing Commit-
tee on the Food Chain and Animal Health (hereinafter referred
to as the Committee).

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2. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply.

Article 65

Transposition

1. Member States shall adopt and publish, not later than
1 May 2008, the laws, regulations and administrative provisions
necessary to comply with this Directive before 14 Decem-
ber 2008 They shall forthwith inform the Commission thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at 15 days.

They shall apply those provisions from 1 August 2008.

4.

The Committee shall adopt its Rules of Procedure.

CHAPTER XI

TRANSITIONAL AND FINAL PROVISIONS

Article 63

Repeal

Directives 91/67/EEC, 93/53/EEC and 95/70/EC shall be

1.
repealed as from 1 August 2008.

2.
References to the repealed Directives shall be construed as
references to this Directive and shall be read in accordance with
the correlation table laid down in Annex VIII.

3.
However, Commission Decision 2004/453/EC shall con-
tinue to apply for the purpose of this Directive pending the adop-
tion of the necessary provisions in accordance with Article 43
of this Directive, which shall be adopted not later than 3 years
after the entry into force of this Directive.

Article 64

Transitional provisions

Transitional provisions may be adopted in accordance with the
procedure referred to in Article 62(2) for a period of four years
from 14 December 2006.

When they are adopted by Member States, these measures shall
contain a reference to this Directive or shall be accompanied by
such reference on the occasion of their official publication. The
methods of making such reference shall be laid down by Mem-
ber States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 66

Entry into force

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 67

Addressees

This Directive is addressed to the Member States.

Done at Luxembourg, 24 October 2006.

For the Council
The President

J. KORKEAOJA

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ANNEX I

DEFINITIONS

In addition to the definitions in Article 3, the following technical definitions shall apply:

(a)

‘compartment’ means one or more farms under a common biosecurity system containing an aquatic animal popula-
tion with a distinct health status with respect to a specific disease;

(b)

‘common biosecurity system’ means that the same aquatic animal health surveillance, disease prevention, and disease
control measures are applied;

(c)

‘containment area’ means an area around an infected farm or mollusc farming area where disease control measures
are applied with the purpose of preventing the spread of the disease;

(d)

‘disease’ means a clinical or non-clinical infection with one or more aetiological agents in aquatic animals;

(e)

‘disease-free zones or compartments’ means zones or compartments declared disease-free in accordance with
Articles 49 or 50;

(f)

(g)

‘emerging disease’ means a newly identified serious disease, the cause of which may or may not yet be established,
that has the potential to be spread within and between populations, such as by way of trade in aquatic animals and/or
aquatic animal products. It also means a listed disease identified in a new host species not yet included in Part II of
Annex IV as a susceptible species;

‘epidemiological unit’ means a group of aquatic animals that share approximately the same risk of exposure to a
disease agent within a defined location. This risk may be because they share a common aquatic environment, or
because management practices make it likely that a disease agent in one group of animals would quickly spread to
another group of animals;

(h)

‘fallowing’ means, for disease management purposes, an operation where a farm is emptied of aquaculture animals
susceptible to the disease of concern or known to be capable of transferring the disease agent, and, where feasible, of
the carrying water;

(i)

(j)

‘further processing’ means processing of aquaculture animals before human consumption by any type of measures
and techniques affecting anatomical wholeness, such as bleeding, gutting/evisceration, heading, slicing and filleting,
which produces waste or by-products and could cause a risk of spreading diseases;

‘increased mortality’ means unexplained mortalities significantly above the level of what is considered to be normal
for the farm or mollusc farming area in question under the prevailing conditions. What is considered to be increased
mortality shall be decided in cooperation between the farmer and the competent authority;

(k)

‘infection’ means the presence of a multiplying, or otherwise developing, or latent disease agent in, or on, a host;

(l)

‘infected zone or compartment’ means zones or compartments where the infection is known to occur;

(m)

‘quarantine’ means maintaining a group of aquatic animals in isolation with no direct or indirect contact with other
aquatic animals, in order to undergo observation for a specified length of time and, where appropriate, testing and
treatment, including proper treatment of the effluent waters;

(n)

‘susceptible species’ means any species in which infection by a disease agent has been demonstrated by natural cases
or by experimental infection that mimics the natural pathways;

24.11.2006

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Official Journal of the European Union

L 328/37

(o)

(p)

‘vector’ means a species that is not susceptible to a disease but which is capable of spreading infection by conveying
pathogens from one host to another;

‘zone’ means a precise geographical area with a homogeneous hydrological system comprising part of a water catch-
ment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals
from lower stretches of the water catchment area, an entire water catchment area from its source(s) to its estuary, or
more than one water catchment area, including their estuaries, due to the epidemiological link between the catch-
ment areas through the estuary.

L 328/38

EN

Official Journal of the European Union

24.11.2006

Information required in the official register of aquaculture production businesses and authorised processing
establishments

ANNEX II

PART I

Authorised aquaculture production business

1.

The following minimum information on each aquaculture production business shall be kept by the competent author-
ity in a register, as provided for in Article 6:

(a)

the name and addresses of the aquaculture production business, and contact details (telephone, facsimile, e-mail);

(b)

(c)

(d)

the registration number and particulars of the authorisation delivered, (i.e. dates for specific authorisations, iden-
tification codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s));

the geographical position of the farm defined by a suitable system of coordinates of all farm-sites (if possible,
GIS coordinates);

the purpose, type (i.e. type of culture system, or facilities such as land-based facilities, sea cages, earth ponds)
and maximum volume of production where this is regulated;

(e)

for continental farms, dispatch centres and purification centres, details on the farm’s water supply and discharges;

(f)

the species of aquaculture animals reared at the farm (for multi-species farms or ornamental farms, it shall as a
minimum be registered whether any of the species are known to be susceptible to diseases listed in Part II of
Annex IV, or known vectors of such diseases);

(g) updated information on the health status (i.e. if the farm is disease-free (located in a Member State, zone or com-
partment), where the farm is under a programme with a view of achieving such status, or where the farm is
declared infected by a disease referred to in Annex IV).

2. Where an authorisation is granted to a mollusc farming area in accordance with the second subparagraph of
Article 4(1), the data required pursuant to point 1(a) of this part shall be recorded for all aquaculture production
businesses which operate within the mollusc farming area. The data required pursuant to points 1(b) to 1(g) of this
part shall be recorded at mollusc farming area level.

PART II

Authorised processing establishments

The following minimum information on each authorised processing establishment shall be kept by the competent author-
ity in a register, as provided for in Article 6:

(a)

the name and addresses of the authorised processing establishment, and contact details (telephone, facsimile, e-mail);

(b)

(c)

the registration number and particulars of the authorisation delivered (i.e. dates for specific authorisations, identifica-
tion codes or numbers, specified conditions for production, any other matter relevant to the authorisation(s));

the geographical position of the processing establishment defined by a suitable system of coordinates (if possible GIS
coordinates);

(d) details on the authorised processing establishment’s water effluent treatment systems;

(e)

the species of aquaculture animals handled in the authorised processing establishment.

ANNEX III

PART A

Health status of aquaculture zones or compartments to be considered for the application of Article 12

Aquaculture animals for farming and restocking

Category

Health status

May introduce animals from

Health certification

Introduction

Dispatching

May dispatch animals to

I

II

III

IV

V

Disease-free
(Articles 49 or 50)

Only category I

Surveillance Programme
(Article 44(1))

Undetermined
(not known to be infected but not subject
to a programme for achieving disease-
free status)

Only category I

Categories I, II, or III

Eradication Programme
(Article 44(2))

Infected
(Article 39)

Only category I

All categories

YES

YES

NO

YES

NO

All categories

NO when dispatched
to category III or V

YES when dispatched
to categories I, II or IV

NO

NO

YES

YES

Categories III and V

Categories III and V

Only category V

Only category V

.

2
4
1
1
2
0
0
6

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

L

3
2
8
/
3
9

PART B

Recommended surveillance and inspections on farms and mollusc-farming areas

Species present

Health status as referred to in Part
A

Risk level

Surveillance

Recommended inspection
frequency by the
competent authority
(Article 7)

Recommended inspection
frequency by qualified
aquatic animal health
services (Article 10)

Specific requirements for
inspections, sampling and
surveillance necessary to maintain
the health status

Comments

No species
susceptible to
the diseases
listed in
Annex IV

Species suscep-
tible to one or
more of the
diseases listed in
Annex IV

Category I
Declared disease-free in accor-
dance with Article 49(1)(a)
or (b) or Article 50(1)(a) or (b).

Category I
Declared disease-free in accor-
dance with of Article 49(1)(c)
or of Article 50(1)(c).

Category II
Not declared disease-free but
subject to a surveillance pro-
gramme approved in accor-
dance with Article 44(1).

Category III
Not known to be infected but
not subject to surveillance pro-
gramme for achieving disease-
free status.

Category IV
Known to be infected but sub-
ject to an eradication pro-
gramme approved in
accordance with Article 44(2).

Category V
Known to be infected. Subject
to minimum control measures
as provided for in Chapter V.

Low

Passive

1 every 4 years

1 every 4 years

Specific requirements for the
maintenance of the disease-free
status in accordance with
Article 52.

The recommended inspection
frequencies shall apply without
prejudice to the specific require-
ments mentioned for each health
status.

However, where possible, such
inspections and sampling should
be combined with the inspec-
tions required pursuant to
Articles 7 and 10.

The aim of inspections by the
competent authority is to check
compliance with this Directive in
accordance with Article 7.

The aim of inspections by quali-
fied aquatic animal health ser-
vices is to check the health status
of the animals, to advise the
aquaculture production business
operator on aquatic animal
health issues, and where neces-
sary, undertake the necessary
veterinary measures.

High

Medium

Low

High

Medium

Low

High

Active, targeted
or passive

1 every year

1 every year

1 every 2 years

1 every 2 years

1 every 4 years

1 every 2 years

Targeted

1 every year

1 every year

Specific requirements in accor-
dance with Article 44(1).

1 every 2 years

1 every 2 years

1 every 4 years

1 every 2 years

Active

1 every year

3 every year

Medium

1 every year

2 every year

Low

High

Medium

Low

High

Medium

Low

1 every 2 years

1 every year

Targeted

1 every year

1 every year

Specific requirements in accor-
dance with Article 44(2).

1 every 2 years

1 every 2 years

1 every 4 years

1 every 2 years

Passive

1 every 4 years

1 every year

Specific requirements in accor-
dance with Chapter V.

1 every 4 years

1 every 2 years

1 every 4 years

1 every 4 years

L

3
2
8
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
4
1
1
2
0
0
6

.

24.11.2006

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Official Journal of the European Union

L 328/41

Risk levels

A high-risk farm or mollusc farming area is a farm or mollusc farming area which:

(a)

has a high risk of spreading diseases to or contracting diseases from other farms or wild stocks;

(b) operates under farming conditions which could increase the risk of disease outbreaks (high biomass, low water qual-

ity), taking into account the species present;

(c)

sells live aquatic animals for further farming or restocking.

A medium-risk farm or mollusc farming area is a farm or mollusc farming area which:

(a)

has medium risk of spreading diseases to or contracting diseases from other farms or wild stocks;

(b) operates under farming conditions which would not necessarily increase the risk of disease outbreaks (medium bio-

mass and water quality), taking into account the species present;

(c)

sells live aquatic animals mainly for human consumption.

A low-risk farm of mollusc farming area is a farm or mollusc farming area which:

(a)

has a low risk of spreading diseases to or contracting diseases from other farms or wild stocks;

(b) operates under farming conditions which would not increase the risk of disease outbreaks (low biomass, good water

quality), taking into account the species present;

(c)

sells live aquatic animals for human consumption only.

Types of health surveillance

Passive surveillance shall include mandatory immediate notification of the occurrence or suspicion of specified diseases or
of any increased mortalities. In such cases investigation in accordance with Section 2 of Chapter V shall be required.

Active surveillance shall include:

(a)

routine inspection by the competent authority or by other qualified health services on behalf of the competent
authorities;

(b)

examination of the aquaculture animal population on the farm or in the mollusc farming area for clinical disease;

(c)

diagnostic samples to be collected on suspicion of a listed disease or observed increased mortality during inspection;

(d) mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.

Targeted surveillance shall include:

(a)

routine inspection by the competent authority or by other qualified health services on behalf of the competent
authorities;

(b) prescribed samples of aquaculture animals to be taken and tested for specific pathogen(s) by specified methods;

(c) mandatory immediate notification of occurrence or suspicion of specified diseases or of any increased mortalities.

L 328/42

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Official Journal of the European Union

24.11.2006

ANNEX IV

Disease listing

PART I

Criteria for listing diseases

A.

Exotic diseases shall meet the following criteria laid down in point 1 and either point 2 or 3.

1.

2.

3.

The disease is exotic to the Community, i.e. the disease is not established in Community aquaculture, and the
pathogen is not known to be present in Community waters.

It has potential for significant economic impact if introduced into the Community, either by production losses
in Community aquaculture or by restricting the potential for trade in aquaculture animals and products thereof.

It has potential for detrimental environmental impact if introduced into the Community, to wild aquatic animal
populations of species, which are an asset worth protecting by Community law or international provisions.

B. Non-exotic diseases shall meet the following criteria laid down in points 1, 4, 5, 6, 7, and 2 or 3.

1.

Several Member States, or regions in several Member States, are free of the specific disease.

2.

3.

4.

5.

It has potential for significant economic impact if introduced into a Member State free of the disease, either by
production losses, and annual costs associated with the disease and its control exceeding 5 % of the value of the
production of the susceptible aquaculture animal species production in the region, or by restricting the possi-
bilities for international trade in aquaculture animals and products thereof.

The disease has shown, where it occurs, to have a detrimental environmental impact if introduced into a Mem-
ber State free of the disease, to wild aquatic animal populations of species that is an asset worth protecting
under Community law or international provisions.

The disease is difficult to control and contain at farm or mollusc farming area level without stringent control
measures and trade restrictions.

The disease may be controlled at Member State level, experience having shown that zones or compartments free
of the disease may be established and maintained, and that this maintenance is cost-beneficial.

6. During placing on the market of aquaculture animals, there is a risk that the disease will establish itself in a

previously uninfected area.

7.

Reliable and simple tests for infected aquatic animals are available. The tests must be specific and sensitive and
the testing method harmonised at Community level.

24.11.2006

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Official Journal of the European Union

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PART II

Listed diseases

EXOTIC DISEASES

DISEASE

SUSCEPTIBLE SPECIES

FISH

Epizootic haematopoietic necrosis

Rainbow trout (Oncorhynchus mykiss) and redfin perch (Perca
fluviatilis)

Epizootic ulcerative syndrome

Genera: Catla, Channa, Labeo, Mastacembelus, Mugil, Puntius and
Trichogaster.

MOLLUSCS

Infection with Bonamia exitiosa

Australian mud oyster (Ostrea angasi) and Chilean flat oyster
(O. chilensis)

Infection with Perkinsus marinus

Pacific oyster (Crassostrea gigas) and Eastern oyster (C. virginica)

Infection with Microcytos mackini

CRUSTACEANS

Taura syndrome

Yellowhead disease

Pacific oyster (Crassostrea gigas), Eastern oyster (C. virginica),
Olympia flat oyster (Ostrea conchaphila) and European flat oyster
(O. edulis)

Gulf white shrimp (Penaeus
(P. stylirostris), and Pacific white shrimp (P. vannamei)

setiferus), Pacific blue shrimp

Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (P.
duorarum), Kuruma prawn (P. japonicus), black tiger shrimp (P.
monodon), Gulf white shrimp (P. setiferus), Pacific blue shrimp (P.
stylirostris), and Pacific white shrimp (P. vannamei)

NON-EXOTIC DISEASES

DISEASE

SUSCEPTIBLE SPECIES

FISH

Spring viraemia of carp (SVC)

Viral haemorrhagic
(VHS)

septicaemia

Infectious haematopoietic necrosis
(IHN)

Bighead carp (Aristichthys nobilis), goldfish (Carassius auratus),
crucian carp (C. carassius), grass carp (Ctenopharyngodon idellus),
common carp and koi carp (Cyprinus
silver carp
(Hypophthalmichthys molitrix), sheatfish (Silurus glanis) and tench
(Tinca tinca)

carpio),

Herring (Clupea spp.), whitefish (Coregonussp.), pike (Esox lucius),
haddock (Gadusaeglefinus), Pacific cod (G. macrocephalus), Atlantic
cod (G. morhua), Pacific salmon (Oncorhynchus spp.) rainbow trout
(O. mykiss), rockling (Onos mustelus), brown trout (Salmo trutta),
turbot (Scophthalmus maximus), sprat (Sprattussprattus) and grayling
(Thymallus thymallus)

Chum salmon (Oncorhynchus keta), coho salmon (O. kisutch),
Masou salmon (O. masou), rainbow or steelhead trout (O. mykiss),
sockeye salmon (O. nerka), pink salmon (O. rhodurus) chinook
salmon (O.tshawytscha), and Atlantic salmon (Salmo salar)

Koi herpes virus (KHV) disease

Common carp and koi carp (Cyprinus carpio).

Infectious salmon anaemia (ISA)

Rainbow trout
(Salmo salar), and brown and sea trout (S. trutta).

(Oncorhynchus mykiss), Atlantic

salmon

MOLLUSCS

Infection with Marteilia refringens

Infection with Bonamia ostreae

Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chil-
ensis), European flat oyster (O. edulis), Argentinian oyster (O. puel-
chana), blue mussel (Mytilus edulis) and Mediterranean mussel
(M. galloprovincialis)

Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chil-
ensis), Olympia flat oyster (O. conchaphila), Asiatic oyster (O. dense-
lammellosa), European flat oyster (O. edulis), and Argentinian
oyster (O. puelchana).

CRUSTACEANS White spot disease

All decapod crustaceans (order Decapoda).

L 328/44

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Official Journal of the European Union

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ANNEX V

Requirements for declaring a Member State, zone or compartment disease-free

PART I

Disease-free Member State

1. On historical grounds

1.1. A Member State where susceptible species are present, but where there has not been any observed occurrence of
the disease for at least for a period of 10 years before the date of application for the disease-free status despite
conditions that are conducive to its clinical expression may be considered disease-free where:

(a)

basic biosecurity measure conditions have been in place continuously for at least a period of 10 years before
the date of application for the disease-free status;

(b)

infection is not known to be established in wild populations;

(c)

the implementation of trade and imports conditions to prevent the introduction of the disease into the
Member State is effective.

A Member State wishing to benefit from a disease-free status, shall submit an application in accordance with
Article 49 before1 November 2008. After this date, disease-free status may only be granted in accordance with
Part I.2.

1.2. The basic biosecurity measures referred to in point 1.1(a) shall consist, as a minimum, of the following:

(a)

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

(b)

an early detection system is in place throughout the Member State, enabling the competent authority to
undertake effective disease investigation and reporting, and ensuring in particular:

(i)

the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease,
or unexplained mortality in farms or molluscs farming areas, and in the wild;

(ii)

the rapid communication of the event to the competent authority with the aim to activating diagnos-
tic investigation with minimum delay.

1.3. The early detection system referred to in point 1.2(b) shall include at least the following:

(a)

broad awareness, among the personnel employed in aquaculture businesses or involved in the processing
of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians
or aquatic animal health specialists in detecting and reporting unusual disease occurrence;

(b)

veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease
occurrence;

(c)

access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed
and emerging diseases.

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2.

Based on targeted surveillance

A Member State where the last known clinical occurrence was within 10 years before the date of application for the
disease-free status 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 of the specific disease where:

(a)

the Member State meets the basic disease control conditions laid down in point 1.2;

and

(b)

targeted surveillance in accordance with methods adopted pursuant to Article 49(3), has been in place for at
least a period of two years without detection of the disease agent on farm, or in mollusc farming areas that rears
any of the susceptible species.

Where there are parts of the Member State in which the number of farms, or molluscs farming areas is limited,
and consequently targeted surveillance in these parts do not provide sufficient epidemiological data, but in which
there are wild populations of any of the susceptible species, those wild populations shall be included in the targeted
surveillance.

PART II

Disease-free zone or compartment

1.

Zones

1.1. A zone may comprise:

(a)

an entire water catchment area from its source to its estuary;

or

(b) part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward

migration of aquatic animals from lower stretches of the water catchment area;

or

(c) more than one water catchment area, including their estuaries, due to the epidemiological link between the

catchment areas through the estuary.

The geographical demarcation of the zone shall be clearly identified on a map.

1.2. Where a zone extends over more than one Member State, it may not be declared a disease-free zone unless the
conditions outlined in points 1.3, 1.4 and 1.5 apply to all areas of that zone. In that case both Member States
concerned shall apply for approval for the part of the zone situated in their territory.

1.3. A zone where susceptible species are present, but where there has not been any observed occurrence of the
disease for at least a period of 10 years before the date of application for the disease-free status, despite condi-
tions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis mutandis
with the requirements laid down in Part I.1.

A Member State wishing to benefit from a disease-free status shall notify its intention in accordance with
Article 50(2) before 1 November 2008. After this date, disease-free status may only be granted in accordance
with Part I.2.

1.4. A zone where the last known clinical occurrence was within a period of 10 years before the date of application
for the disease-free status 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 disease-free where it
complies mutatis mutandis with the requirements laid down in Part I.2.

1.5. A buffer zone in which a monitoring programme is carried out shall be established, as appropriate. The demar-
cation of the buffer zones shall be such that it protects the disease-free zone from passive introduction of the
disease.

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Official Journal of the European Union

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2.

Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific
disease is dependent on the health status regarding that disease of surrounding natural waters

2.1. A compartment may comprise one or more farms, a group or cluster of farms or a mollusc farming area that
may be considered as one epidemiological unit due to its geographical localisation and distance from other
groups or clusters of farms or mollusc farming areas, provided that all farms comprising the compartment fall
within a common biosecurity system. The geographical demarcation of a compartment shall be clearly identi-
fied on a map.

2.2. A compartment where susceptible species are present, but where there has not been any observed occurrence of
the disease for at least a period of 10 years before the date of application for the disease-free status despite
conditions that are conducive to its clinical expression, may be considered disease-free if it complies mutatis
mutandis with the requirements in Part I.1 of this Annex.

Member States wishing to benefit from this provision shall notify their intention in accordance with Article 50(2)
before 1 November 2008. After this date, disease-free status may only be granted in accordance with Part I.2.

2.3. A compartment where the last known clinical occurrence was within 10 years before the date of application for
the disease-free status, or where the infection status in the compartment or in the waters surrounding the com-
partment prior to targeted surveillance was unknown, for example because of the absence of conditions condu-
cive to clinical expression, may be considered disease-free if it complies mutatis mutandis with the requirements
laid down in Part I.2.

2.4. Each farm or mollusc farming area in a compartment shall be subject to additional measures imposed by the
competent authority, when considered necessary to prevent the introduction of diseases. Such measures may
include the establishment of a buffer zone around the compartment in which a monitoring programme is car-
ried out, and the establishment of additional protection against the intrusion of possible pathogen carriers
or vectors.

3.

Compartments comprising one or more individual farms where the health status regarding a specific disease is inde-
pendent of the health status regarding that disease of the surrounding natural waters.

3.1. A compartment may comprise:

(a)

an individual farm which may be considered a single epidemiological unit, as it is not influenced by the
animal health status in the surrounding waters;

or

(b) more than one farm where each farm in the compartment complies with the criteria laid down in
point 3.1(a) and points 3.2 to 3.6, but, due to extensive movement of animals between farms, shall be
considered as a single epidemiological unit, provided that all farms are under a common biosecurity system.

3.2. A compartment shall be supplied with water:

(a)

through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the intro-
duction of the disease to an acceptable level;

or

(b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of

the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.

3.3. There shall be natural or artificial barriers that prevent aquatic animals from entering each farm in a compart-

ment from the surrounding watercourses.

3.4. The compartment shall, where appropriate, be protected against flooding and infiltration of water from the sur-

rounding watercourses.

3.5. The compartment shall comply, mutatis mutandis, with the requirements laid down in Part I.2.

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3.6. A compartment shall be subject to additional measures imposed by the competent authority, when considered
necessary to prevent the introduction of diseases. Such measures may include the establishment of additional
protection against the intrusion of possible pathogen carriers or vectors.

3.7. Implementing measures concerning point 3.2(a) shall be laid down in accordance with the procedure referred

to in Article 62(2).

4.

Special provisions for individual farms which commence or recommence their activities

4.1. A new farm, which meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, but which commences its
activities with aquaculture animals from a compartment declared disease-free may be considered disease-free
without undergoing the sampling required for approval.

4.2. A farm which recommences its activities after a break with aquaculture animals from a compartment declared
disease-free, and meets the requirements referred to in points 3.1(a) and 3.2 to 3.6, may be considered disease-
free without undergoing the sampling required for approval, provided that:

(a)

(b)

(c)

the health history of the farm over the last four years of its operation is known to the competent authority;
however, if the farm concerned has been in operation for less than four years, the actual period in which it
has been in operation will be taken into account;

the farm has not been subject to animal-health measures in respect of the diseases listed in Part II of
Annex IV and there have been no antecedents of those diseases on the farm;

prior to the introduction of the aquaculture animals, eggs or gametes, the farm is cleaned and disinfected,
followed, as necessary, by a period of fallowing.

L 328/48

EN

Official Journal of the European Union

24.11.2006

ANNEX VI

Functions and duties of laboratories

PART I

Community reference laboratories

1.

In order to be designated as a Community reference laboratory in accordance with Article 55, laboratories shall fulfil
the following requirements. They must:

(a)

have suitably qualified staff with adequate training in diagnostic and analytical techniques applied in their area
of competence, including trained personnel available for emergency situations occurring within the Community;

(b) possess the equipment and products needed to carry out the tasks assigned to them;

(c)

have an appropriate administrative infrastructure;

(d)

ensure that their staff respect the confidential nature of certain subjects, results or communications;

(e)

have sufficient knowledge of international standards and practices;

(f)

have available, as appropriate, an updated list of available reference substances and reagents and an updated list
of manufacturers and suppliers of such substances and reagents;

(g)

take account of research activities at national and Community level.

2. However, the Commission may designate only laboratories that operate and are assessed and accredited in accor-
dance with the following European Standards, account being taken of the criteria for different testing methods laid
down in this Directive:

(a)

EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;

(b)

EN 45002 on ‘General criteria for the assessment of testing laboratories’;

3.

4.

(c)

EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for operation
and recognition’.

The accreditation and assessment of testing laboratories referred to in paragraph 2 may relate to individual tests or
groups of tests.

For one or more of the diseases under their responsibility, the Community reference laboratories may take advantage
of the skills and capacity of laboratories in other Member States or EFTA Member States, provided that the laborato-
ries concerned comply with the requirements laid down in points 1, 2 and 3 of this Annex. Any intention to take
advantage of such cooperation shall be part of the information provided as a basis for the designation in accordance
with Article 55(1). However, the Community reference laboratory shall remain the contact point for the National
reference laboratories in the Member States, and for the Commission.

5.

The Community reference laboratories shall:

(a)

coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing
the disease concerned, specifically by:

(i)

typing, storing and, where appropriate, supplying strains of the pathogen of the relevant disease to facili-
tate the diagnostic service in the Community,

(ii)

supplying standard sera and other reference reagents to the national reference laboratories in order to stan-
dardise the tests and reagents used in each Member State, where serological tests are required,

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(iii) organising periodic comparative tests (ring tests) of diagnostic procedures at Community level with the
national reference laboratories designated by the Member States, in order to provide information on the
methods of diagnosis used and the results of tests carried out in the Community;

(iv)

retaining expertise on the relevant disease pathogen and other pertinent pathogens to enable rapid differ-
ential diagnosis;

assist actively in the diagnosis of outbreaks of the relevant disease in Member States by receiving pathogen iso-
lates for confirmatory diagnosis, characterisation and epizootic studies;

facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic tech-
niques throughout the Community;

collaborate, as regards methods of diagnosing animal diseases falling within their areas of competence, with the
competent laboratories in third countries where those diseases are prevalent;

collaborate with the relevant OIE reference laboratories with regard to exotic diseases listed in Part II of Annex IV
under their responsibility;

collate and forward information on exotic and endemic diseases, that are potentially emerging in Community
aquaculture.

(b)

(c)

(d)

(e)

(f)

PART II

National reference laboratories

1.

The national reference laboratories designated pursuant to Article 56 shall be responsible for coordinating the diag-
nostic standards and methods within their field of responsibility in the Member State concerned. These national ref-
erence laboratories shall:

(a)

(b)

(c)

(d)

(e)

(f)

undertake to notify, without delay, the competent authority whenever the laboratory is aware of a suspicion of
any of the diseases referred to in Annex IV;

coordinate, in consultation with the relevant Community reference laboratory, the methods employed in Mem-
ber States for diagnosing the diseases concerned under their responsibility;

assist actively in the diagnosis of outbreaks of the relevant disease by receiving pathogen isolates for confirma-
tory diagnosis, characterisation and epizootic studies;

facilitate the training or retraining of experts in laboratory diagnosis with a view to harmonising diagnostic tech-
niques throughout the Member State;

ensure confirmation of positive results of all outbreaks of exotic diseases listed in Part II of Annex IV, and of
primary outbreaks of non-exotic diseases listed in that Annex;

organise periodic comparative tests (ring tests) of diagnostic procedures at national level with the laboratories
designated by the Member States in accordance with Article 57, in order to provide information on the meth-
ods of diagnosis used and the results of tests carried out in the Member State;

(g)

cooperate with the Community reference laboratory referred to in Article 55 and participate in the comparative
tests organised by the Community reference laboratories;

(h)

ensure a regular and open dialogue with their national competent authorities;

(i)

operate and be assessed and accredited in accordance with the following European Standards account being
taken of the criteria for different testing methods laid down in this Directive:

(i)

EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;

(ii)

EN 45002 on ‘General criteria for the assessment of testing laboratories’;

(iii) EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for opera-

tion and recognition’.

L 328/50

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Official Journal of the European Union

24.11.2006

2.

3.

The accreditation and assessment of testing laboratories referred to in point 1(i) may relate to individual tests or
groups of tests.

The Member States may designate national reference laboratories which do not comply with the requirements referred
to in point 1(i)(i) of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided the labora-
tory operates under quality assurance in line with the guidelines in ISO 9001.

4. Member States may authorise a national reference laboratory situated on their territory to take advantage of the skills
and capacity of other laboratories designated pursuant to Article 57, for one or more of the diseases under their
responsibility, provided that these laboratories comply with the relevant requirements of this Part. However, the
national reference laboratory shall remain the contact point for the central competent authority of the Member State,
and for the Community reference laboratory.

PART III

Designated laboratories in Member States

1.

The competent authority of a Member State shall designate only laboratories for diagnostic services pursuant to
Article 57 that fulfil the following requirements. They must:

(a)

undertake to notify, without delay, the competent authority whenever a laboratory is aware of a suspicion of
any of the diseases referred to in Annex IV;

(b) undertake to participate in comparative tests (ring-tests) of diagnostic procedures arranged by the national ref-

erence laboratory;

(c)

operate and be assessed and accredited in accordance with the following European Standards account being
taken of the criteria for different testing methods laid down in this Directive:

(i)

EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;

(ii)

EN 45002 on ‘General criteria for the assessment of testing laboratories’;

(iii) EN 45003 on ‘Calibration and testing laboratory accreditation system — General requirements for opera-

tion and recognition’.

2.

3.

4.

The accreditation and assessment of testing laboratories referred to in paragraph 1(c) may relate to individual tests or
groups of tests.

The Member States may designate laboratories which do not comply with the requirements referred to in point 1(c)(i)
of this Part, where operation under EN ISO/IEC 17025 is practically difficult, provided that the laboratory operates
under quality assurance in line with the guidelines in ISO 9001.

The competent authority shall cancel the designation where the conditions referred to in this Annex are no longer
fulfilled.

24.11.2006

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Official Journal of the European Union

L 328/51

ANNEX VII

CRITERIA AND REQUIREMENTS FOR CONTINGENCY PLANS

Member States shall ensure that contingency plans meet at least the following requirements:

1.

2.

Provision must be made to ensure the legal powers needed to implement contingency plans and put into effect a
rapid and successful eradication campaign;

Provision must be made to ensure access to emergency funds, budgetary means and financial resources in order
to cover all aspects of the fight against exotic diseases listed in Part II of Annex IV;

3. A chain of command must be established to guarantee a rapid and effective decision-making process for dealing with
exotic diseases listed in Annex IV or emerging diseases. A central decision-making unit must be in charge of the
overall direction of control strategies;

4. Detailed plans must be available for Member States to be prepared for the immediate establishment of local disease
control centres in the event of an outbreak of exotic diseases listed in Part II of Annex IV or emerging diseases and
to implement disease control and environment protection measures at a local level;

5. Member States must ensure cooperation between the competent authorities and competent environmental authori-
ties and bodies in order to ensure that actions on veterinary and environmental safety issues are properly coordinated;

6.

Provision must be made for adequate resources to ensure a rapid and effective campaign, including personnel, equip-
ment and laboratory capacity;

7. An up-to-date operations manual must be available, with a detailed, comprehensive and practical description of all
the actions, procedures, instructions and control measures to be employed in handling exotic diseases listed in Part II
of Annex IV or emerging diseases;

8. Detailed plans must be available for emergency vaccination, where appropriate;

9.

Staff must be regularly involved in training in clinical signs, epidemiological enquiry and control of epizootic dis-
eases, in real-time alert exercises, and in training in communication skills to provide ongoing disease awareness cam-
paigns for authorities, farmers and veterinarians;

10. Contingency plans must be prepared that take into account the resources needed to control a large number of out-

breaks occurring within a short period of time;

11. Without prejudice to the veterinary requirements laid down in Regulation (EC) No 1774/2002, contingency plans
must be prepared to ensure that, in the event of an outbreak of diseases, any mass disposal of aquatic animal carcases
and aquatic animal waste is done without endangering animal and human health, using processes or methods which
prevent damage to the environment and in particular:

(i) with minimum risk to soil, air, surface and groundwater, and to plants and animals;

(ii) with minimum nuisance caused by noise or odours;

(iii) with minimum adverse effects on the nature or places of special interest;

12. Such plans must include the identification of appropriate sites and undertakings for the treatment or disposal of
animal carcasses and animal waste in the event of an outbreak in accordance with Regulation (EC) No 1774/2002.

L 328/52

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Official Journal of the European Union

24.11.2006

ANNEX VIII

CORRELATION TABLE

This Directive

Repealed Directives

91/67/EEC

93/53/EEC

95/70/EC

Article 1(1)(a)

Article 1(1)(b)

Article 1(1)(c)

Article 1(2)

Article 2(1)

Article 2(2)

Article 2(3)

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8(1)

Article 8(2)

Article 8(3)

Article 8(4)

Article 9

Article 10

Article 11

Article 12

Article 13(1)

Article 13(2)

Article 14(1)(a)

Article 14(1)(b)

Article 14(2)

Article 14(3)

Article 14(4)

Article 15(1)

Article 15(2)

Article 15(3)

Article 15(4)

Article 1,
first subparagraph

—

—

—

—

—

Article 1,
second subparagraph

—

—

—

—

Article 1

Article 1

Article 20(2)

Article 12(2)

—

—

—

—

—

—

Article 2

Article 2

Article 2

—

—

—

—

—

—

—

—

Article 3(2)

Article 3(2)

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 4, first paragraph —

Article 4, second para-
graph

Article 7(1),

Article 8(1)

—

Article 16(1)

Article 16(1),

—

Article 3(1)(a) and (2)

—

Article 3(1)(b) and (2)

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 4

—

—

—

—

—

—

—

—

—

—

—

—

—

24.11.2006

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Official Journal of the European Union

L 328/53

This Directive

Repealed Directives

91/67/EEC

93/53/EEC

95/70/EC

Article 16(1)

Article 7(1)(a), first sen-
tence

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 7(1)(b)

Article 8(1)(a)

Article 8(1)(b)

—

—

Article 9

—

—

Article 9(2)

Article 14(3)

—

Article 19(1)

—

Article 22

Article 19(2)

Article 19(3)

—

Article 21

Article 20

—

—

Article 21(2)

—

—

—

—

—

—

Article 16(2)

Article 17

Article 18(1)

Article 18(2)

Article 19(1)

Article 19(2)

Article 20

Article 21

Article 22

Article 23(1)

Article 23(2)

Article 23(3)

Article 23(4)

Article 23(5)

Article 24

Article 25(a)

Article 25(b)

Article 25(c)

Article 25(d)

Article 25(e)

Article 26

Article 27

Article 28(a)

Article 28(b)

Article 29(1)

Article 4

—

Article 5(1)

Article 5(5)

Article 5(1)

Article 5(2)(a)

Article 10(1)(a)

Article 5(2)(b)

Article 5(2)(b)

Article 10(1)(c)

Article 5 (2)(h)

Article 6(a), seventh
indent

Article 8(1)

Article 9(1), first sen-
tence

Article 10(1)b

Article 4(1), third sub-
paragraph, third indent

Article 5(4), first and
fourth subparagraph

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Official Journal of the European Union

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This Directive

Repealed Directives

Article 29(2)

Article 29(3)

Article 29(4)

Article 30

Article 31

Article 32

—

—

—

—

—

—

91/67/EEC

93/53/EEC

95/70/EC

Article 5(2)(i)

Article 5(4), second and
fourth subparagraph

—

Article 6(b)

Article 6(d)

Article 8(2)

Article 8(3)

Article 9(2)

Article 5(2)(i), second
indent

—

Article 5(4)

Article 5(3)

—

—

Article 5(2), Article 6

Article 4(1), third sub-
paragraph, second indent,
Article 5(2)(b),
Article 5(4), third and
fourth subparagraph

Article 33(1)

Article 3(3)

Article 33(2)

Article 33(3)

Article 33(4)

Article 34(1)

Article 34(2)

Article 35

Article 36

Article 37(a)

Article 37(b)

Article 38(1)

Article 38(2)

Article 38(3)

Article 39(a)

Article 39(b)

Article 39(c)

Article 39(d)

Article 40

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 6(a) fourth
indent

Article 6(a), fourth
indent

—

—

Article 5(2)(c)

Article 6(a), first and
third indent

Article 6(a), fourth
indent

Article 6(a), second, fifth
and sixth indent

—

—

—

Article 9(1), second sen-
tence

Article 9(3)

—

Article 10(1)(c)

—

Article 10(1)(c)

—

Article 7

—

—

—

—

—

—

—

—

—

Article 5(3)

—

—

—

Article 4(1), third para-
graph, first indent

—

—

—

—

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Official Journal of the European Union

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This Directive

Repealed Directives

91/67/EEC

93/53/EEC

95/70/EC

Article 41

Article 42

Article 43

Article 44(1)

Article 44(2)

Article 45

Article 46

Article 47

Article 48(1)

Article 48(2)

Article 48(3)

Article 48(4)

Article 49(1)

Article 49(2)

Article 49(3)

Article 50(1)

Article 50(2)

Article 50(3)

Article 50(4)

Article 51(1)

Article 51(2)

Article 52

Article 53(1)

Article 53(2)

Article 53(3)

Article 54(1)

Article 54(2)

Article 54(3)

Article 55(1)

Article 55(2)

Article 55(3)

Article 56(1)

Article 56(2)

Article 56(3)

Article 56(4)

Article 56(5)

—

—

—

Article 10

Article 10

Article 10(1)

—

—

—

—

—

—

Article 5(1)

—

Article 15

Article 5(1)

Article 6(1)

—

Article 5(1)

Article 15

—

Article 5(2)

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 10(2)

Article 10(2)

—

—

Article 6(a), first indent

Article 15

Article 14(1)

Article 14(1)

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 9(1), second sen-
tence

—

Article 6(d)

Article 8(3)

—

Article 13(1)

Article 13(2)

—

Article 12(1)

Article 12(4)

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Article 7(1)

Article 7(2)

—

Article 6(2)

Article 6(3)

—

Article 12(6)

Article 6(5)

—

Article 12(1)

Article 12(3)

—

Article 6(2)

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This Directive

Repealed Directives

91/67/EEC

93/53/EEC

95/70/EC

Article 57(a)

Article 57(b)

Article 57(c)

Article 58(1)

Article 58(2)

Article 58(3)

Article 59

Article 60

Article 61(1)

Article 61(2)

Article 61(3)

Article 62

Article 63

Article 64

Article 65

Article 66

Article 67

—

—

—

Article 17

Article 22

Article 17

—

—

—

Article 25

Article 9(3)

Article 17(2)

Article 26

Article 27

—

—

Article 29

—

Article 30

Article 11(2)

Article 11(1)

—

Article 16

—

—

—

—

—

—

Article 6(1)

—

Article 8

—

—

—

—

—

Article 18

Article 18a

Article 9

Article 4(2)

Article 5(4), fourth sub-
paragraph

Article 19

—

—

Article 20

—

Article 21

Article 8(4)

Article 10

—

—

Article 12

Article 13

Article 14