Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture
Date: 2007-06-11
Institutions: Council of the European Union
Subjects: aquaculture, biodiversity, conservation of resources, ecological balance, marine life, protection of animal life

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I

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)

REGULATIONS

COUNCIL REGULATION (EC) No 708/2007

of 11 June 2007

concerning use of alien and locally absent species in aquaculture

THE COUNCIL OF THE EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 37 and Article 299(2) 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:

Invasive alien species have been identified as one of the key
causes of loss of native species and harm to bio-diversity.
Under Article 8(h) of
the Convention on Biological
Diversity (CBD), to which the Community is a Party, each
Contracting Party is required, as far as possible and as
appropriate, to prevent the introduction of, control or
eradicate those alien species which threaten ecosystems,
habitats or species. In particular, the Conference of the
Parties to the CBD has adopted Decision VI/23 on alien
species that threaten ecosystems, habitats or species, the
annex to which sets out Guiding Principles
the
prevention, introduction and mitigation of impacts of such
alien species.

for

(1)

In accordance with Article 6 of the Treaty, environmental
protection requirements must be integrated into the
definition and implementation of the Community policies
and activities,
in particular with a view to promoting
sustainable development.

(5)

The translocation of species within their natural range to
for specific bio-
areas where they are locally absent
geographical reasons may also present risks for ecosystems
in these areas and should also be covered by this
Regulation.

(2) Aquaculture is a fast-growing sector where innovation and
new outlets are being explored.
In order to adapt the
production to the conditions of the market, it is important
for the aquaculture industry to diversify the species reared.

(6)

(3) Aquaculture has benefited economically from the introduc-
tion of alien species and translocation of locally absent
species in the past (for example rainbow trout, Pacific oyster
and salmon) and the policy objective for the future is to
optimise benefits
and
translocations while at the same time avoiding alterations
to ecosystems, preventing negative biological interaction,
including genetic change, with indigenous populations and
restricting the spread of non-target species and detrimental
impacts on natural habitats.

associated with introductions

(1) OJ C 324, 30.12.2006, p. 15.

The Community should therefore develop its own frame-
work to ensure adequate protection of aquatic habitats from
the risks associated with the use of non-native species in
aquaculture. This framework should include procedures for
the analysis of the potential risks, the taking of measures
based on the prevention and precautionary principles and
the adoption of contingency plans where necessary. These
procedures should build on experience gained through the
existing voluntary frameworks, and notably the Inter-
national Council for the Exploration of the Sea (ICES) Code
of Practice on the Introductions and Transfers of Marine
Organisms and the European Inland Fisheries Advisory
Commission (EIFAC) Code of Practice and Manual of
Procedures for consideration of introduction and transfer of
marine and freshwater organisms.

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(7)

(8)

The measures provided for in this Regulation should be
without prejudice to Council Directive 85/337/EEC of
impact assessment (1),
27 June 1985 on environmental
Council Directive 92/43/EEC of 21 May 1992 on the
conservation of natural habitats and of wild fauna and
flora (2), Directive 2000/60/EC of the European Parliament
and the Council of 23 October 2000 establishing a
framework for Community action in the field of water
policy (3) and 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 (4).

local aquatic environments

The potential risks, which may in some cases be far
reaching, are initially more evident locally. The character-
istics of
the
Community are very diverse and Member States have the
appropriate knowledge and expertise to evaluate and
manage the risks to the aquatic environments falling within
their sovereignty or jurisdiction. It is therefore appropriate
that the implementation of the measures provided for in
this Regulation falls primarily under the responsibility of
Member States.

throughout

is free of non target species. Member States who wish to
restrict the use of such long-used species in their territory
should be permitted to do so.

(12) Nothing in this Regulation shall prevent Member States
from regulating the keeping of alien or locally absent
species in private aquaria and garden ponds through
national regulations.

(13) The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
implementing powers
the exercise of
procedures
conferred on the Commission (7).

for

(14) For the sake of efficiency, the procedure for the amend-
ments to Annexes I,
this Regulation,
necessary to adapt them to technical and scientific progress,
should be the management procedure referred to in
Article 30(2) of Regulation (EC) No 2371/2002,

III and IV of

II,

(9)

It should be taken into account that movements of alien or
locally absent species to be held in closed aquaculture
facilities which are secure and which present a very low risk
of escape should not be subject to prior environmental risk
assessment.

(10) However, in cases where risks are not negligible and may
affect other Member States there should be a Community
system for consultation of interested parties and validation
of permits prior to their granting by Member States. The
Scientific, Technical and Economic Committee for Fisheries
(STECF)
established under Council Regulation (EC)
No 2371/2002 of 20 December 2002 on the conservation
and sustainable exploitation of fisheries resources under the
Common Fisheries Policy (5) should provide the scientific
advice in this consultation and the Advisory Committee for
Fisheries and Aquaculture set up by Commission Decision
1999/478/EC (6) should give the advice of stakeholders in
the field of aquaculture and environmental protection.

HAS ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation establishes a framework governing aquaculture
practices in relation to alien and locally absent species to assess
and minimise the possible impact of these and any associated
non-target species on aquatic habitats and in this manner
contribute to the sustainable development of the sector.

(11) Some

alien species have

commonly been used in
aquaculture for a long time in certain parts of
the
Community. The activities connected therewith should
therefore benefit from a differential treatment facilitating
their development without any additional administrative
burden on condition that the source can provide stock that

(1) OJ L 175, 5.7.1985, p. 40. Directive as last amended by Directive
2003/35/EC of the European Parliament and of the Council (OJ
L 156, 25.6.2003, p. 17).

(2) OJ L 206, 22.7.1992, p. 7. Directive as last amended by Directive

2006/105/EC (OJ L 363, 20.12.2006, p. 368).

(3) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision
No 2455/2001/EC of the European Parliament and of the Council
(OJ L 331, 15.12.2001, p. 1).
(4) OJ L 328, 24.11.2006, p. 14.
(5) OJ L 358, 31.12.2002, p. 59.
(6) OJ L 187, 20.7.1999, p. 70. Decision as amended by Decision 2004/

Article 2

Scope

1. This Regulation shall apply to the introduction of alien
species and translocation of locally absent species for their use in
aquaculture in the Community taking place after the date this
Regulation becomes applicable by virtue of Article 25(1).

2. This Regulation shall not apply to translocations of locally
absent species within Member States, except for cases where, on
the basis of scientific advice, there are grounds for foreseeing
environmental threats due to the translocation. In the case that
an advisory committee has been appointed under Article 5 it will
be responsible for assessing the risks.

(7) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/

864/EC (OJ L 370, 17.12.2004, p. 91).

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

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3. This Regulation shall cover all aquaculture activities located
within the jurisdiction of Member States irrespective of their size
or characteristics. It shall cover all alien and locally absent aquatic
organisms farmed. It shall cover aquaculture using any form of
aquatic medium.

4. This Regulation shall not apply to the keeping of ornamental
aquatic animals or plants in pet-shops, garden centres, contained
garden ponds or aquaria which comply with Article 6 of
Commission Decision 2006/656/EC of 20 September 2006
laying down the animal health conditions and certification
requirements for imports of fish for ornamental purpose (1) or in
facilities which are equipped with effluent treatment systems
which fulfil the aims set out in Article 1.

5. This Regulation, except for Articles 3 and 4, shall not apply
to the species listed in Annex IV. The risk assessment in Article 9
shall not apply to species listed in Annex IV except in cases where
Member States wish to take measures to restrict the use of the
species concerned in their territory.

6. Movements of alien or locally absent species to be held in
closed aquaculture facilities
to prior
environmental risk assessment except in cases where Member
States wish to take appropriate measures.

shall not be subject

7.
Introductions and translocations for use in ‘closed aqua-
culture facilities’ may at a future date be exempted from the
permit requirement of Chapter III, based on new scientific
information and advice. Advances in the scientific understanding
of bio security of modern closed systems are expected inter alia
from Community-funded research on alien species. The relative
decision will be taken not later than 31 March 2009 following
the procedure described under Article 24.

Article 3

Definitions

4.

5.

‘aquatic organisms’ means any species living in water
belonging to the animalia, plantae and protista kingdoms,
including any part, gametes, seeds, eggs or propagules of
their
individuals that might survive and subsequently
reproduce;

‘Polyploid organisms’ means artificially induced tetraploid
organisms (4N). These are aquatic organisms in which the
number of chromosomes in the cells has been doubled
through cell manipulation techniques;

6.

‘alien species’ means:

(a)

(b)

a species or subspecies of an aquatic organism
occurring outside its known natural range and the
area of its natural dispersal potential;

polyploid organisms, and fertile artificially hybridised
species irrespective of their natural range or dispersal
potential;

7.

8.

‘locally absent species’ means a species or subspecies of an
aquatic organism which is locally absent from a zone
within its natural range of distribution for biogeographical
reasons;

‘non-target species’ means any species or subspecies of an
aquatic organism likely to be detrimental to the aquatic
environment that is moved accidentally together with an
aquatic organism that is being introduced or translocated
not including disease-causing organisms which are covered
by Directive 2006/88/EC;

9.

‘movement’ means introduction and/or translocation;

For the purpose of this Regulation the following definitions shall
apply:

10.

‘introduction’ means the process by which an alien species
is intentionally moved to an environment outside its natural
range for use in aquaculture;

1.

2.

3.

‘aquaculture’ means the activity defined in Article 3,
paragraph (d) of Council Regulation (EC) No 1198/2006
of 27 July 2006 on the European Fisheries Fund (2);

‘open aquaculture facility’ means a facility where aqua-
culture is conducted in an aquatic medium not separated
from the wild aquatic medium by barriers preventing the
escape of reared specimens or biological material
that
might survive and subsequently reproduce;

‘closed aquaculture facility’ means a facility where aqua-
culture is conducted in an aquatic medium, which involves
recirculation of water and which is separated from the wild
aquatic medium by barriers preventing the escape of reared
specimens or biological material that might survive and
subsequently reproduce;

(1) OJ L 271, 30.9.2006, p. 71.
(2) OJ L 223, 15.8.2006, p. 1.

11.

12.

‘translocation’ means the process by which a locally absent
species is intentionally moved within its natural range for
its use in aquaculture to an area where it previously did not
exist because of bio-geographical reasons;

‘pilot release’ means the introduction of alien species or
translocation of locally absent species on a limited scale to
assess ecological interaction with native species and habitats
in order to test the risk assessment assumptions;

13.

‘applicant’ means the natural or legal person or entity
proposing to conduct the introduction or translocation of
an aquatic organism;

14.

‘quarantine’ means a process by which aquatic organisms
and any of their associated organisms can be maintained in
complete isolation from the surrounding environment;

15.

16.

17.

18.

19.

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‘quarantine facility’ means a facility in which aquatic
organisms and any of their associated organisms can be
maintained in complete isolation from the surrounding
environment;

species not covered by Article 2(5) shall apply for a permit from
the competent authority of
the receiving Member State.
Applications may be submitted for multiple movements to take
place over a period of not longer than seven years.

the movement of aquatic
‘routine movement’ means
organisms
from a source which has a low risk of
transferring non-target species and which, on account of
the characteristics of the aquatic organisms and/or the
method of aquaculture to be used, for example closed
systems as defined in 3, does not give rise to adverse
ecological effects;

2. The applicant shall submit with the application a dossier
following the indicative guidelines listed in Annex I. The advisory
committee shall give an opinion on whether the application
contains all the information required to assess whether the
proposed movement is routine or non-routine, and is therefore
admissible, and shall
its
opinion.

inform the competent authority of

‘non-routine movement’ shall mean any movement of
aquatic organisms which does not fulfil the criteria for
routine movement;

‘receiving Member State’ shall mean the Member State into
the territory of which the alien species is introduced or the
locally absent species is translocated;

‘sending Member State’ means the Member State from the
territory of which the alien species is introduced or the
locally absent species is translocated.

CHAPTER II

GENERAL OBLIGATIONS OF THE MEMBER STATES

Article 4

Measures for avoiding adverse effects

Member States shall ensure that all appropriate measures are
taken to avoid adverse effects to biodiversity, and especially to
species, habitats and ecosystem functions which may be expected
to arise from the introduction or
translocation of aquatic
organisms and non-target species in aquaculture and from the
spreading of these species into the wild.

Article 5

Decision making and advisory bodies

Member States shall designate the competent authority or
authorities
responsible for ensuring compliance with the
requirements of this Regulation (the competent authority(ies)).
Each competent authority may appoint an advisory committee to
assist it, which shall include appropriate scientific expertise (the
advisory committee). If a Member State does not appoint an
advisory committee then the competent authority or competent
authorities shall assume the tasks assigned to the advisory
committee in this Regulation.

CHAPTER III

PERMITS

Article 6

Application for a permit

1. Aquaculture operators intending to undertake the introduc-
tion of an alien species or the translocation of a locally absent

3. By the end of the permit period an application for another
permit may be submitted by referring to the former permit. If
there have been no documented adverse effects on the
environment, the proposed movement shall be considered a
routine movement.

Article 7

Type of proposed movement

The advisory committee shall give its opinion on whether the
proposed movement is a routine or a non-routine movement
and whether release must be preceded by quarantine or pilot
release and shall inform the competent authority of its opinion.

Article 8

Routine movement

In the case of routine movements, the competent authority may
grant a permit, indicating, where applicable, the requirement for
quarantine or pilot release as set out in Chapters IV and V.

Article 9

Non-routine movement

1.
In the case of non-routine movements, an environmental
risk assessment shall be carried out as outlined in Annex II. The
competent authority shall decide whether the applicant or an
independent body is responsible for conducting the environ-
mental risk assessment and who shall bear the cost.

2. On the basis of the environmental risk assessment, the
advisory committee shall give its opinion on the risk to the
competent authority, using the summary report form set out in
Annex II, Part 3. If the advisory committee finds that the risk is
low, the competent authority may grant the permit without
further formalities.

3.
If the advisory committee finds that the risk associated with
the proposed movement of aquatic organisms is high or medium
in the sense of Annex II, part 1, it shall examine the application
in consultation with the applicant to see if there are mitigation
procedures or technologies available to reduce the level of risk to
low. The advisory committee shall forward the results of its
examination to the competent authority, detailing the level of
risk and specifying the reasons for any reduction in risk, in the
form specified in Annex II, Part 3.

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4. The competent authority may only issue permits for non-
routine movements in cases where the risk assessment, including
any mitigation measures, show a low risk to the environment.
Any refusal of a permit must be duly motivated on scientific
grounds and, where scientific information is as yet insufficient,
on the grounds of the precautionary principle.

negative effects on the environment or on native populations
occur. Any withdrawal of a permit must be justified on scientific
grounds and, where scientific information is as yet insufficient,
on the grounds of the precautionary principle and having due
regard to national administrative rules.

Article 10

Decision period

1. The applicant
shall be informed in writing within a
reasonable time of the decision to issue or refuse a permit, and
than six months from the date of
in any case not
application,
excluding time when an applicant provides
additional information if the advisory committee so requests.

later

2. Member States which are signatories to ICES may request to
have applications and risk assessments
regarding marine
organisms reviewed by ICES prior to the issuing of an opinion
by the advisory committee. In such cases an additional period of
six months shall be allowed.

Article 11

Movements affecting neighbouring Member States

1. Where the potential or known environmental effects of a
proposed movement of an organism are liable to affect
the competent authority shall
neighbouring Member States,
notify the Member State or States concerned and the Commis-
sion of its intention to grant a permit by sending a draft decision,
accompanied by an explanatory memorandum and a summary
of the environmental risk assessment as specified in Annex II,
Part 3.

2. Within two months of the date of notification, the other
Member States concerned may submit written comments to the
Commission.

the date of notification,

3. Within six months of
the
Commission shall, after consulting the Scientific, Technical and
Economic Committee for Fisheries (STECF), established under
Article 33 of Regulation (EC) No 2371/2002 and the Advisory
Committee
established by
Decision 1999/478/EC, confirm, reject or amend the proposed
decision to grant a permit.

for Fisheries and Aquaculture,

CHAPTER IV

CONDITIONS FOR INTRODUCTION AFTER ISSUE OF A PERMIT

Article 13

Compliance with other Community provisions

A permit may only be issued for an introduction under this
Regulation, where it is apparent that requirements under other
legislation can be met, and in particular:

(a)

(b)

the animal health conditions set out in Directive 2006/88/
EC on animal health requirements for aquaculture animals
and products thereof, and on the prevention and control of
certain diseases in aquatic animals;

the conditions set out in Council Directive 2000/29/EC of
8 May 2000 on protective measures against the introduc-
tion into the Community of organisms harmful to plants or
plant products and against
spread within the
Community (1).

their

Article 14

Release into aquaculture facilities in case of routine
introductions

In the case of routine introductions,
the release of aquatic
organisms into open or closed aquaculture facilities shall be
allowed without quarantine or pilot release, unless, in excep-
tional cases, the competent authority decides otherwise on the
basis of specific advice given by the advisory committee.
Movements from a closed aquaculture facility to an open
aquaculture facility shall not be regarded as routine.

Article 15

Release into open aquaculture facilities in case of non-
routine introductions

4. Within 30 days of the date of the Commission's decision,
the Member States concerned may refer that decision to the
Council. Within a further 30 day period, the Council, acting by
qualified majority, may take a different decision.

1.
In the case of non-routine introductions, the release of
aquatic organisms into open aquaculture facilities shall be
subject, if necessary, to the conditions set out in paragraphs 2, 3
and 4.

Article 12

Withdrawal of permit

2. The aquatic organisms shall be placed in a designated
quarantine facility within the territory of the Community in
accordance with the conditions set out in Annex III, for the
purpose of constituting a brood-stock.

At any point in time, the Competent Authority can withdraw the
permit, temporarily or permanently, if unforeseen events with

(1) OJ L 169, 10.7.2000, p. 1.

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3. The quarantine facility may be located in a Member State
other than the receiving Member State, provided that all Member
States concerned agree and that this option has been included in
the environmental risk assessment under Article 9.

If appropriate, only progeny of

4.
the introduced aquatic
organisms may be used in aquaculture facilities of the receiving
Member State, provided that no potentially harmful non-target
species are found during quarantine. Adult stock may be released
in those cases where the organisms do not reproduce in captivity
or are fully reproductively sterile, providing the absence of
potentially harmful non target species is confirmed.

Article 16

which shall include a summary of the results in the national
register established under Article 23.

CHAPTER V

CONDITIONS FOR TRANSLOCATIONS AFTER ISSUE OF A
PERMIT

Article 19

Compliance with other Community provisions

A permit may only be issued for a translocation under this
Regulation where it is apparent that requirements under other
legislation can be met and in particular:

Pilot release into open aquaculture facilities

(a)

the animal health conditions set out in Directive 2006/88/
EC;

The competent authority may require that the release of the
aquatic organisms into open aquaculture systems be preceded by
an initial pilot release subject to specific containment and to
preventive measures based on the advice and recommendations
of the advisory committee.

Article 17

Contingency plans

For all non-routine introductions and pilot releases, the applicant
the
shall draw up a contingency plan for the approval of
competent authority, which shall include, inter alia, the removal
of the introduced species from the environment, or a reduction
in density, for unforeseen events with negative effects on the
environment or on native populations. If such an event occurs,
the contingency plans shall be implemented immediately and the
permit can be withdrawn, temporarily or permanently as per
Article 12.

Article 18

Monitoring

1. Alien species shall be monitored after their release into open
aquaculture facilities for a period of two years or a full generation
cycle, whichever is longer, to assess whether the impacts were
accurately predicted or
there are additional or different
impacts. The level of spread or containment of the species shall
be studied in particular. The competent authority shall decide
whether the applicant has the adequate expertise or whether
another body is to carry out the monitoring.

if

Subject

to the opinion of

2.
the
competent authority may require longer monitoring periods to
assess any possible long-term ecosystem effects not easily
detectable in the period laid down in paragraph 1.

the advisory committee,

(b)

the conditions set out in Directive 2000/29/EC.

Article 20

Non-routine translocation into open aquaculture facilities

In the case of non-routine translocations into open aquaculture
facilities, the competent authority may require that release of
aquatic organisms be preceded by an initial pilot release with
specific containment and preventive measures based on the
advice and recommendations of the advisory committee.

Article 21

Quarantine

The receiving Member State may, in exceptional cases and subject
to approval by the Commission,
in
accordance with Article 15(2),
(3) and (4) before release of
species from non-routine translocations into open aquaculture
facilities. The request for approval by the Commission shall
indicate the reasons why quarantine is required. The Commission
shall reply to such requests within 30 days.

require quarantine

Article 22

Monitoring following translocation

Following a non-routine translocation,
monitored in accordance with Article 18.

the species shall be

CHAPTER VI

REGISTER

Article 23

Register

3. The advisory committee shall evaluate the results of the
monitoring programme and note in particular any event not
correctly anticipated in the environmental risk assessment. The
results of that evaluation shall be sent to the competent authority

Member States shall keep a register of
introductions and
translocations containing a historical record of all applications
made and the associated documentation gathered before the
issue of a permit and during the monitoring period.

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The register shall be made freely available to the Member States
and public in accordance with Directive 2003/4/EC of
the
European Parliament and of the Council of 28 January 2003 on
public access to environmental information (1).

To allow Member States to share the information contained in
their registers, a specific information system may be developed in
accordance with the procedure referred to in Article 30(2) of
Regulation (EC) No 2371/2002.

4. After the adoption by the Commission of the implementing
rules mentioned in paragraph 3, Member States may request the
Commission to add species to Annex IV making use of the
procedure mentioned in paragraph 1. Member States may
provide scientific data to prove coherence with relevant criteria
for adding species to Annex IV. The Commission shall decide
within five months following receipt of the requests on their
suitability excluding time when the Member State provides
additional information if the Commission so requests.

CHAPTER VII

FINAL PROVISIONS

Article 24

Detailed rules and adaptation to technical progress

I,

to Annexes

1. Amendments
III and IV and their
corresponding provisions necessary in order to adapt them to
technical and scientific progress shall be adopted in accordance
with the procedure referred to in Article 30(2) of Regulation (EC)
No 2371/2002.

II,

5. However, Member States’ requests to add species to Annex IV
received before the date of entry into force of the Regulation,
shall be decided before 1 January 2009.

6. Member States concerned may propose in respect of their
outermost regions, as referred to in Article 299(2) of the Treaty
establishing the European Community, the addition of species to
be included in a separate part of Annex IV.

Article 25

Entry into force

In order for species to be added to Annex IV, the aquatic
2.
organism must have been used in aquaculture for a long time
(with reference to its life cycle) in certain parts of the Community
with no adverse effects, and introductions and translocations
must be able to take place without the coincident movement of
potentially harmful non target species.

3. The Commission shall adopt,
in accordance with the
procedure referred to in Article 30(2) of Regulation (EC)
No 2371/2002, the rules implementing the conditions necessary
for adding species to Annex IV, as referred in paragraph 2.

1. This Regulation shall enter into force 20 days following its
publication in the Official Journal of the European Union.

It shall apply six months after a Commission's Regulation on
implementing rules referred to in Article 24(3) enters into force,
but not later than 1 January 2009.

the provisions contained in Chapter

2. However,
I and
Chapter II as well as Article 24, shall be applicable as from the
date of entry into force of the Regulation.

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

Done at Luxembourg, 11 June 2007.

For the Council

The President

H. SEEHOFFER

(1) OJ L 41, 14.2.2003, p. 26.

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ANNEX I

APPLICATION

(Indicative guidelines for the dossier to be completed by applicant as foreseen under Article 6)

Wherever possible, information is to be supported with references from the scientific literature, and notations to personal
communications with scientific authorities and fisheries experts. Applicants are advised to distinguish between movements
to ‘open’ or ‘closed’ aquaculture facilities.

For the purpose of this Annex when an application refers to a proposed translocation, rather than an introduction, the
terms introduction/introduced are to be replaced by translocation/translocated.

A.

Executive summary

Provide a brief summary of the document including a description of the proposal, the potential impacts on native
species and their habitats and mitigation steps to minimise the potential impacts on native species.

B.

Introduction

(1) Name (common and scientific) of the organism proposed for introduction or translocation, indicating the

genus, species, subspecies or lower taxonomic classification where applicable.

(2) Describe the characteristics,
drawing or photograph.

including distinguishing characteristics, of the organism. Include a scientific

(3) Describe the history in aquaculture, enhancement or other introductions (if appropriate).

(4) Describe the objectives and rationale for the proposed introduction, including an explanation as to why such an

objective cannot be met through the utilisation of an indigenous species.

(5) What alternate strategies have been considered in order to meet the objectives of the proposal?

(6) What is the geographic area of the proposed introduction? Describe the habitats, ecosystem and protection

status of the receiving environment. Include a map.

(7) Describe the numbers of organisms it is proposed to introduce (initially, ultimately). Can the project be broken
down into different sub-components? If so, how many organisms are involved in each sub-component?

(8) Describe the source(s) of the stock (facility) and genetic stock (if known).

C.

Life history information of the species to be introduced — for each life history stage

(1) Describe the native range and range changes due to introductions.

(2) Does the stock from which the introduction/translocation will be made have a link with any known non-target

species?

(3) What is the distribution of such non-target species within the area of origin of the stock to be introduced/

translocated?

(4)

Record where the species was introduced previously and describe the ecological effects on the environment of
the receiving area (predator, prey, competitor, and/or structural/functional elements of the habitat).

(5) What factors limit the species in its native range.

(6) Describe the physiological tolerances (water quality, temperature, oxygen, and salinity) at each life history stage

(early life-history stages, adult and reproductive stages).

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(7) Describe the habitat preferences and tolerances for each life-history stage.

(8) Describe the reproductive biology.

(9) Describe the migratory behaviour.

(10) Describe the food preferences for each life-history stage.

(11) Describe the growth rate and lifespan (also in the area of the proposed introduction, if known).

(12) What is the age or age-range of the species concerned?

(13) Describe the behavioural traits (social, territorial, aggressive).

D.

Interaction with native species

(1) What is the potential for survival and establishment of the introduced organism if it escapes? (This question

applies to movements into open and closed aquaculture facilities.)

(2) What habitat(s) will the introduced species be likely to occupy in the proposed area of introduction and will this
overlap with any vulnerable, threatened or endangered species? (Indicate if the proposed area of introduction
also includes contiguous waters.).

(3) With which native species will there be a niche overlap? Are there any unused ecological resources of which the

species would take advantage?

(4) What will the introduced organism eat in the receiving environment?

(5) Will this predation cause any adverse impacts on the receiving ecosystem?

(6) Will the introduced organisms survive and successfully reproduce in the proposed area of introduction or will

annual stocking be required? (This question applies to species not intended for closed aquaculture facilities.)

(7) Will the introduced organisms hybridise with native species? Is local extinction of any native species or stocks
possible as a result of the proposed introduction? Are there any possible effects of the introduced organisms on
the spawning behaviour and spawning grounds of local species?

(8) Are there any potential impacts on habitat or water quality as a result of the proposed introduction?

E.

Receiving environment and contiguous waters

(1)

Provide physical information on the receiving environment and contiguous waterbodies such as seasonal water
temperatures, salinity, and turbidity, dissolved oxygen, pH, nutrients and metals. Do those parameters match the
tolerances/preferences of the species to be introduced, including conditions needed for reproduction?

(2)

List species composition (major aquatic vertebrates, invertebrates and plants) of the receiving waters.

(3)

Provide information on habitat in the area of introduction, including contiguous waters, and identify critical
habitat. Which of those parameters match the tolerances/preferences of the organisms to be introduced? Can the
introduced organisms disturb any of the habitats described?

(4) Describe the natural or man-made barriers that should prevent the movement of the introduced organisms to

adjacent waters.

F.

Monitoring

Describe the plans for follow-up assessments of the proposed introduced species’ success and how any negative
impacts on native species and their habitats will be assessed.

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G. Management plan

(1) Describe the management plan for the proposed introduction. This should include, but not be restricted to, the

following information:

(a) measures taken to ensure that no other species (non-target species) accompany the shipment;

(b) who will be permitted to use the proposed organisms and under what terms and conditions;

(c)

will there be a pre-commercial phase for the proposed introduction?

(d)

description of the contingency plan for the removal of species;

(e)

description of the quality assurance plan for the proposal, and,

(f)

other legislative requirements that need to be met.

(2) Describe the chemical, biophysical and management measures being taken to prevent accidental escape of the
organism and non-target species, to and their establishment in, non-target recipient ecosystems. Give details of
the water source, effluent destination, any effluent treatment, proximity to storm sewers, predator control, site
security and measures to prevent escapes, if necessary.

(3) Describe contingency plans in the event of an unintentional, accidental or unauthorised liberation of the
organisms from rearing and hatchery facilities or an accidental or unexpected expansion of the range of
colonisation after release.

(4)

If this proposal is intended to create a fishery, give details of the fishery objective. Who would benefit from such
a fishery? Give details of the management plan and, if appropriate, include changes in the management plans for
species which will be impacted.

H.

Business data

(1)

Provide the name of the owner and/or company, the aquaculture licence number and the business licence (if
applicable) or the name of the government agency or department with a contact name, telephone, fax and
e-mail information.

(2)

Provide an indication as to the economic viability of the proposed project.

I.

References

(1)

Provide a detailed bibliography of all references cited in the course of preparing the application.

(2)

Provide a list of names, including addresses, of scientific authorities and fisheries experts consulted.

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Procedures and minimum elements to be addressed in an environmental risk assessment as foreseen under
Article 9

ANNEX II

To evaluate risks associated with the introduction or translocation of aquatic organisms it is necessary to assess the
probability that the organisms will become established and the consequences of that establishment.

The process addresses the major environmental components. It provides a standardised approach for evaluating the risk of
genetic and ecological impacts as well as the potential for introducing a non-target species that might impact the native
species of the proposed receiving waters.

During the review process, emphasis is not on the ratings but on the detailed biological and other relevant information
statements that motivate them. In case of scientific uncertainty, the precautionary principle should be applied.

For the purpose of this Annex, where an application refers to a proposed translocation the terms ‘introduction/introduced’
are to be replaced by ‘translocation/translocated’.

PART 1

ECOLOGICAL AND GENETIC RISK ASSESSMENT PROCESS

Step 1

Likelihood of establishment and spreading beyond the intended area of introduction

Event

Likelihood
(H, M, L) (1)

Certainty
(VC, RC, RU, VU) (2)

Comments in support of
assessment (3)

The introduced or translocated species, escaped
or dispersed, successfully colonises and main-
tains a population in the intended area of
introduction beyond the control of the aqua-
culture facility.

The introduced species or translocated, escaped
or dispersed, spreads beyond the intended area
of introduction.

Final rating (4)

(1) H = High, M = Medium, L = Low
(2) VC = Very certain, RC = Reasonably certain, RU = Reasonably uncertain, VU = Very uncertain
(3) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(4) The final rating for the likelihood of establishment and spreading is assigned the value of the element with the lowest rating (for example,
high and low ratings for the above elements would result in a final low rating). Again, both events — probability of the organism
successfully colonising and maintaining a population in the intended area of introduction (be it a confined environment such as a facility,
or a natural habitat) and the probability of spreading beyond the intended area of introduction (estimated as explained above) — need to
occur in order to have establishment beyond the intended area of introduction.
The final rating for the level of Certainty is assigned the value of the element with the lowest level of certainty (e.g. very certain and
reasonably certain ratings would result in a final reasonably certain rating). The harmfulness of a establishment and spreading should be
taken into account, together with risk/benefit ration, in arriving at the final rating.

Step 2

Consequences of establishment and spreading

Event

Likelihood
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

Genetic mixing with local populations leads to
a loss of genetic diversity.

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Event

Likelihood
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

Competition (food, space) with or predation on
native populations leads to their extirpation.

Other undesirable events of ecological nature

Some of the abovementioned events persist
even after removal of the introduced species.

Final rating (2)

(1) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(2) The final rating for the consequences of establishment and spreading is assigned the value of the element (individual probability) with the
highest rating and the final rating for the level of certainty is assigned the value of the element with the lowest level of certainty.

Step 3

Risk potential associated to the alien and locally absent species

A single value is given based on the assessments done in Steps 1 and 2:

Component

Risk potential
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

Establishment and spreading (step 1)

Ecological consequences (step 2)

Final rating of overall risk potential (2)

(1) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(2) The final categorisation of risk potential takes the value of the highest of the two probabilities when there is no probability increment
between the two estimates (i.e. if the Risk of establishment and spreading is high and the risk of ecological consequences is medium, the
final rating takes the value of the highest of the two probabilities which is high. When there is a probability increment between the two
estimates (i.e. a mixture of high and low) the final value is medium.

The result of this assessment will be expressed in terms of the following risk levels:

A high-risk movement:

(a)

has a high risk of damaging biodiversity from spreading and other ecological consequences;

(b)

operates under farming conditions which would increase the risk of such damage;

(c)

involves an aquaculture facility which sells live aquatic animals for further farming or restocking;

(d)

as a consequence, the movement is of major concern (major mitigation measures are required). It is advised that the
proposal be rejected unless mitigation procedures can be developed to reduce the risk to low.

A medium-risk movement:

(a)

has a medium risk of damaging biodiversity from spreading and other ecological consequences;

(b)

operates under farming conditions which would not necessarily increase the risk of such damage, taking account of
the species and the containment conditions;

(c)

involves an aquaculture facility which sells its products mainly for human consumption;

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(d)

as a consequence the movement is of moderate concern. It is advised that the proposal be rejected unless mitigation
procedures can be developed to reduce the risk to low.

A low-risk movement:

(a)

has a low risk of damaging biodiversity from spreading and other ecological consequences.

(b)

operates under farming conditions which would not increase the risk of such damage;

(c)

involves an aquaculture facility which sells its products for human consumption only;

(d)

as a consequence the movement is of negligible concern. It is advised that the proposal be approved. Mitigation is not
needed.

The proposal can only be approved as presented (no mitigating measures required) if the overall estimated risk potential is
low and if the overall certainty for which the overall risk has been estimated is very certain or reasonably certain.

If, as a result of a first analysis, a high or medium category is attributed to the overall risk, then containment or mitigation
proposals are to be incorporated in the application, which will be subject to subsequent risk analysis until the final rating for
the overall risk becomes low with a very certain or reasonably certain assessment. Descriptions of these additional steps,
together with detailed specifications of the containment or mitigation measures, will become an integral part of the risk
assessment.

PART 2

NON-TARGET SPECIES ASSESSMENT PROCESS

Step 1

Likelihood of establishment and spreading of non-target species beyond the intended area of introduction

Event

Likelihood
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

A non-target species is introduced as a
consequence of the introduction or transloca-
tion of the aquatic organisms.

The introduced non-target species encounters
susceptible habitats or host organisms.

Final rating (2)

(1) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(2) The final rating under likelihood is assigned the value of the element with the lowest risk rating and the final rating for the level of

certainty is also assigned the value of the element with the lowest level of certainty.

Step 2

Consequences of non-target species establishment and spreading

Event

Likelihood
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

The non-target species compete with or predate
on native populations, leading to their extir-
pation.

Genetic mixing of the non-target species with
local populations leads to a loss of genetic
diversity.

Other undesirable events of ecological or
pathological nature

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Event

Likelihood
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

Some of the abovementioned events persist
even after removal of the non-target species.

Final rating (2)

(1) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(2) The final rating for the consequences is assigned the value of the highest risk rating and final rating for the level of certainty is also

assigned the value of the element with the lowest level of certainty.

Step 3

Risk potential associated with non-target species

A single value is given based on the assessments performed in Steps 1 and 2:

Component

Risk potential
(H, M, L)

Certainty
(VC, RC, RU, VU)

Comments in support of
assessment (1)

Establishment and spreading (step 1)

Ecological consequences (step 2)

Final rating (2)

(1) The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice.
(2) The final rating under risk potential is assigned the value of the element with the lowest risk rating and the final rating for the level of

certainty is also assigned the value of the element with the lowest level of certainty.

The conditions applicable to the assessment of risk potential associated to the alien species (part 1) are to also apply, mutatis
mutandis, to this risk potential associated with non-target species (part 2), including the obligation to introduce containment
and mitigation measures.

OVERALL ENVIRONMENTAL RISK ASSESSMENT — SUMMARY REPORT

PART 3

— History, background and rationale for the request:

— risk assessment summary information

— summary of the ecological and genetic risk assessment

— summary of the non-target species risk assessment

— Comments:

— Mitigation measures:

— Concluding statement on total organism potential risk:

— Advice to competent authority:

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ANNEX III

Quarantine

Quarantine is the means by which live animals or plants and any of their associated organisms are maintained in complete
isolation from the surrounding environment so as to prevent impact on wild and farmed species and undesirable changes to
natural ecosystems.

It is necessary to keep alien or locally absent species in quarantine long enough to detect all non-target species and to
confirm the absence of pathogens or diseases. The unit is to be constructed in accordance with the specifications of the
competent authority in the Member State of its location which is to be responsible for approving it. The duration of
quarantine must be indicated in the permit. If the facility is not located of the receiving Member State, the advisory
committee responsible for the facility and the advisory committee in the receiving Member State must agree on the duration.

Operators are to run quarantine facilities in accordance with the following conditions. In addition the operator must have a
quality assurance programme and an operating manual.

For the purpose of this Annex where an application refers to a proposed translocation, the terms introduction/introduced
are to be replaced by translocation/translocated.

Effluent and waste disposal

All effluents and wastes generated within the facility must be treated in a manner that effectively destroys all possible target
species and associated organisms. To ensure continuous operation and complete containment, quarantine effluent treatment
systems must be equipped with fail-safe backup mechanisms.

Treated effluent and waste may contain substances which are harmful to the environment (e.g. antifouling agents) and must
be disposed of in a manner which minimises environmental impact.

Details of effluent and solid waste treatment must be prepared, listing the personnel responsible for treatments and timing.
The system must be monitored to ensure effective operation and early detection of possible failures.

Physical separation

The organisms which have been transferred must be kept separate from other organisms to ensure containment. This
excludes sentinel species which are specifically included to test the effects of the introduced species. The entry of birds, other
animals, disease agents and contaminants must be prevented.

Personnel

Access must be restricted to trained, authorised personnel. Footwear, hands and any material used within the facility should
be disinfected (see below) before exiting the facility.

Equipment

Upon receipt, all life-stages, tanks, water, shipping containers and equipment in contact with the introduced species,
including the transport vehicles, must be handled is such a way as to ensure that there is no escape of the species or
associated non-target species from the facility. All shipping and packing material must be disinfected, or burned if burning
of the material is authorised.

Mortalities and disposal

Daily records or mortalities must be maintained and must be available for inspection by the competent authority. All
mortalities must be kept on site. No mortalities, tissue or shells are to be discarded without approved treatment to ensure
complete disinfection. Heat treatment such as autoclaving or chemical sterilisation may be employed.

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Mortalities must be reported to the competent authority and Member States must investigate the cause of mortalities in a
timely manner. Mortalities must be stored, transported and disposed of, 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).

Inspection and testing

Regular inspections must be carried out for non-target species. If such a species or a previously undetected disease or
parasite is identified in an organism, actions necessary to control the situation must be taken. These actions may include
destruction of the organisms and disinfection of the facility.

Duration

The required duration of quarantine will vary according to the organism in question, seasonality of non-target species of
concern and the rearing conditions.

Record keeping

Quarantine facilities must maintain accurate records of the following:

— entry/exit times of personnel,

— number of mortalities and method of storage or disposal,

— treatment of incoming water and of effluent,

— samples submitted to experts to test for non-target species,

— any abnormal conditions affecting quarantine operation (power cuts, building damage, serious weather conditions,

etc.).

Disinfection

Disinfection involves the application of disinfectants in sufficient concentrations and for sufficient time to kill harmful
organisms. The disinfectants and concentrations for quarantine disinfection must be based on complete seawater and
freshwater disinfection. Similar concentrations must be used for routine facility disinfection. It is recommended that all
disinfectants be neutralised before release into the surrounding environment and facilities using seawater must deal with
residual oxidants produced during chemical disinfection. In case of an emergency, such as the finding of an imported
parasite or disease agent, sufficient disinfectant must be available to enable treatment of the entire facility.

(1) OJ L 273, 10.10.2002, p. 1. Regulation last amended by Commission Regulation (EC) No 2007/2006 (OJ L 379, 28.12.2006, p. 98).

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ANNEX IV

List of species foreseen by Article 2(5)

Rainbow trout, Oncorhynchus mykiss

Brook trout, Salvelinus fontinalis

Common carp, Cyprinus carpio

Grass carp, Ctenopharyntgodon idella

Silver carp, Hypophthalmichthys molitrix

Big head carp, Aristichtys nobilis

Pacific cupped oyster, Crassostrea gigas

Japanese or Manila clam, Ruditapes philippinarum

Large-mouth bass, Micropterus salmoides

Arctic char, Salvelinus alpinus