Commission Regulation (EC) No 535/2008 of 13 June 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 708/2007 concerning use of alien and locally absent species in aquaculture
Date: 2008-06-13
Institutions: European Commission
Subjects: animal resources, aquaculture, biodiversity, ecological balance, exchange of information, information system, zootechnics

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 535/2008

of 13 June 2008

laying down detailed rules for the implementation of Council Regulation (EC) No 708/2007
concerning use of alien and locally absent species in aquaculture

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS REGULATION:

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EC) No 708/2007 of
11 June 2007 concerning use of alien and locally absent
species in aquaculture (1), and in particular the third paragraph
of Article 23 and Article 24(3) thereof,

Whereas:

Article 1

This Regulation lays down detailed rules implementing the
conditions necessary for adding species to Annex IV to Regu-
lation (EC) No 708/2007 and regarding the development of a
specific information system concerning the permits for the
introductions and translocations of alien and locally absent
species in aquaculture.

Article 2

the purposes of Article 24(2) of Regulation (EC) No

For
708/2007:

(1)

(2)

(3)

(4)

Regulation (EC) No 708/2007 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. It provides, inter alia, that detailed rules
implementing the conditions necessary for adding species
to Annex IV to that Regulation are to be adopted.

It
is therefore appropriate to establish a transparent
procedure in order to assess the requests made by the
Member States for the addition of species to Annex IV to
Regulation (EC) No 708/2007.
is
necessary to further clarify and define the conditions
provided for in Article 24(2) of Regulation (EC) No
708/2007 and to identify the information Member
States should provide to support their requests for the
addition of species.

In particular,

it

In addition, Regulation (EC) No 708/2007 provides that
a specific information system may be developed to allow
Member States to share the information contained in the
registers concerning alien and locally absent species in
aquaculture.

It is therefore necessary to develop common informatics
standards and communication language to be used by the
Member States in order to share a set of minimum data
contained in their national registers of introductions and
translocations. Provisions should be laid down to assist
the harmonisation of the information systems to be im-
plemented by the Member States.

(a)

(with reference

‘long time
cycle)’ shall mean a
to its
minimum period of 10 years following the completion of
two production cycles;

life

(b) ‘adverse effect’ shall mean a case where scientific evidence
shows that an aquatic species, after its introduction in a
certain Member State, cause inter alia, significant:

(i) habitat degradation;

(ii) competition with native species for spawning habitat;

(iii) hybridisation with native species threatening species

integrity;

(iv) predation on native species' population resulting in

their decline;

(v) depletion of native food resources;

(vi) spread of disease and novel pathogens in wild aquatic

organisms and ecosystems.

Article 3

1. Member States shall submit requests to the Commission
for the addition of species to the list of species set out in Annex
IV to Regulation (EC) No 708/2007.

2.
Those requests shall be forwarded to the Commission
together with a fact-sheet indicating the following information:

(5)

The measures provided for in this Regulation are in
accordance with the opinion of
the Committee for
Fisheries and Aquaculture,

(a)

the scientific name of the species;

(1) OJ L 168, 28.6.2007, p. 1.

(b) the geographic distribution;

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(c)

the habitat and the biology;

(d) the aquaculture production;

(e)

the impact of introductions;

(f)

the factors likely to influence spread and distribution;

(g) coherence with the criteria provided for in Article 24(2) of

Regulation (EC) No 708/2007.

Article 4

1. Member States shall establish and keep up to date an
requests
information system containing details of all
for
to translocate a
permits to introduce an alien species or
in for each
fill
locally absent species. Member States shall
request for a permit an information sheet setting out the data

indicated in the Annex to this Regulation and in accordance
with the format set out therein.

2. Member States shall set up by 31 December 2009 at the
latest a website accessible via Internet and containing the infor-
mation listed in the Annex to this Regulation. The Web site
shall follow the guidelines of the ‘Web Accessibility Initiative’.

3. Member States shall communicate the Internet address of
the website to the Commission.

Article 5

This Regulation shall enter into force on the 20th day following
that of
the European
Union.

its publication in the Official

Journal of

However, Article 4 shall apply six months after 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 Brussels, 13 June 2008.

For the Commission

Joe BORG
Member of the Commission

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ANNEX

The information sheet referred to in Article 4(1)

The information sheet is to be filled in for a single/multiple (1) movement (introduction/translocation) of an alien/locally
absent species

1.

1.1.

1.2.

1.3.

1.4.

General information

Number or reference of the application for a permit:

First application: YES/NO, if NO: reference of the previous applications for a permit

Date of the application for a permit:

dd/mm/yyyy

Data on the species:

1.4.1.

FAO code:

1.4.2.

Common name:

1.4.3.

Scientific name:

1.4.4.

Sub-species (if relevant):

1.4.5.

Additional information:

1.4.5.1.

Tetraploid:

1.4.5.2.

Fertile artificially hybrid:

YES/NO

YES/NO

1.4.5.3.

If YES, FAO code and name of the parent species:

1.5.

Source:

1.5.1.

Country:

1.5.2.

Location (name and address of the source):

1.5.3.

Type of source (hatchery/on-growing farm/wild):

1.6.

Receiving aquaculture facility:

1.6.1.

Location (name and address):

1.6.2.

Method of farming: Closed/Open (2) system

1.7.

1.8.

1.9.

Number of organisms and life stage (eggs, larvae, juveniles, adults):

Purpose (human consumption, farming for further restocking, research, etc.):

Number of movements foreseen:

2.

Screening and risk assessment

2.1.

Type of movement:

2.1.1.

Routine introduction or translocation:

YES/NO

2.1.1.1.

Permit approval:

YES/NO

2.1.1.2. Date of the delivery of the permit:

dd/mm/yyyy

(1) Applications may be submitted for multiple movements to take place over a period of not longer than seven years (Article 6(1) of

Regulation (EC) No 708/2007).

(2) As defined in Article 3(2) and (3) of Regulation (EC) No 708/2007.

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2.1.1.3. Authority issuing the permit (complete address):

2.1.1.4. Duration of the permit:

X years XX months

2.1.1.5.

If subject to conditions:

2.1.1.5.1. Quarantine:

2.1.1.5.2. Pilot releases:

YES/NO

YES/NO

2.1.2.

Non-routine introduction or translocation:

YES/NO

2.1.2.1.

Type of risk:

2.1.2.1.1. Low

2.1.2.1.2. Medium

2.1.2.1.3. High

2.1.2.2.

Summary report of the overall environment risk assessment (some lines and a PDF document) also in a second
Community language (some lines)

2.1.2.3.

Permit approval:

YES/NO

2.1.2.4. Date of the delivery of the permit:

dd/mm/yyyy

2.1.2.5. Authority issuing the permit:

2.1.2.6. Duration of the permit:

X years XX months

2.1.2.7.

If subject to conditions:

2.1.2.7.1. Quarantine:

2.1.2.7.2. Pilot releases:

YES/NO

YES/NO

3.

3.1.

3.2.

Monitoring

Duration of monitoring programme:

XX months

Summary of the results of the evaluation of the monitoring programme (some lines and a PDF document) also
in a second Community language (some lines)

3.3.

Contingency plans applied:

YES/NO

3.4.

Withdrawal of the permit (if applicable):

YES/NO

3.4.1.

If YES: Temporarily/permanently

3.4.2.

Date:

dd/mm/yyyy

3.4.3.

Reasons for the withdrawal (some lines) also in a second Community language (some lines):