2008/946/EC: Commission Decision of 12 December 2008 implementing Council Directive 2006/88/EC as regards requirements for quarantine of aquaculture animals (notified under document number C(2008) 7905) (Text with EEA relevance)
Date: 2008-12-12
Institutions: European Commission
Subjects: animal disease, aquaculture, food hygiene, food safety, foodstuffs legislation, health certificate, originating product, third country

L 337/94

EN

Official Journal of the European Union

16.12.2008

COMMISSION

COMMISSION DECISION

of 12 December 2008

implementing Council Directive 2006/88/EC as regards requirements for quarantine of aquaculture
animals

(notified under document number C(2008) 7905)

(Text with EEA relevance)

(2008/946/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/496/EEC of 15 July 1991
laying down the principles governing the organisation of
veterinary checks on animals entering the Community from
third
89/662/EEC,
90/425/EEC and 90/675/EEC (1), and in particular the second
subparagraph of Article 10(3) and the first subparagraph of
Article 10(4) thereof,

amending Directives

countries

and

Having regard to 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
and in particular
Articles 25 and 61(3) thereof,

animals (2),

Whereas:

(1)

Pursuant to Article 16(1) of Directive 2006/88/EC aqua­
culture animals of species susceptible to diseases listed in
Part II of Annex IV to that Directive which are to be
introduced for farming or restocking into a Member
State, zone or compartment declared free of a specific
disease must originate from a Member State, zone or
compartment
disease.
Pursuant to Article 44(4) of that Directive, the same is
to apply to areas subject to a surveillance or eradication
programme with regard to a specific disease.

also declared

free of

that

(2)

Pursuant to Article 17(1) of Directive 2006/88/EC vector
species to diseases listed in Part II of Annex IV to that

(3)

(4)

Directive which are to be introduced for farming or
restocking purposes
into a Member State, zone or
compartment declared free of a specific disease must
either originate from another Member State, zone or
compartment declared free of that disease or be held in
quarantine 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 transmission
of the specific disease to a level acceptable for preventing
the transmission of the disease concerned. Pursuant to
Article 44(4) of Directive 2006/88/EC, the same is to
apply to areas subject to a surveillance or eradication
programme with regard to a specific disease.

is set out

A list of possible vector species to the diseases listed in
Part II of Annex IV to Directive 2006/88/EC, including
the conditions under which those species are to be
regarded as vectors for the purpose of Article 17 of
that Directive,
to Commission
Regulation (EC) No 1251/2008 of 12 December 2008
regards
implementing
the
for
conditions
into the
placing on the market
Community of
and products
thereof and laying down a list of vector species (3).

as
requirements
import

2006/88/EC

in Annex I

certification

aquaculture

and the

Directive

animals

and

Article 20(1) of Directive 2006/88/EC provides, by way
of derogation from Article 16 of that Directive, that the
release of wild aquatic animals of species susceptible to
diseases listed in Part II of Annex IV to that Directive,
caught in a Member State, zone or compartment not
declared free of a specific disease,
in a Member State,
zone or compartment declared free of that disease is
subject to the placing of the wild aquatic animals in
the competent
quarantine under
authority in suitable facilities,
time
sufficient to reduce to an acceptable level the risk of
transmission of the disease. Pursuant to Article 44(4) of
Directive 2006/88/EC,
the same is to apply to areas
subject to a surveillance or eradication programme with
regard to a specific disease.

the supervision of

for a period of

(1) OJ L 268, 24.9.1991, p. 56.
(2) OJ L 328, 24.11.2006, p. 14.

(3) See page 41 of this Official Journal.

16.12.2008

EN

Official Journal of the European Union

L 337/95

(5)

(6)

(7)

Pursuant to Articles 10 and 11 of Regulation (EC) No
1251/2008 animals of vector species and wild aquatic
animals intended for farming, relaying areas, put and take
fisheries and open ornamental facilities, and ornamental
aquatic animals of susceptible species intended for closed
ornamental facilities may be imported into a Member
State, zone or compartment declared free of a specific
disease or into areas subject to a surveillance or eradi­
cation programme with regard to a specific disease
without having to originate from disease free areas if
they have been subject to quarantine, as provided for
in Directive 2006/88/EC, for an appropriate period of
time. According
indent of
to Article 10(1)
Directive 91/496/EEC,
the quarantine may be carried
out in a third country.

first

To ensure that the quarantine is carried out in a manner
that reduces the risk of transmission of diseases listed in
Part
II of Annex IV to Directive 2006/88/EC to an
acceptable level, detailed rules on quarantine should be
laid down.

Quarantine facilities in the Community are covered by
the definition of ‘aquaculture production businesses’
in
Article 3(1)(c) of Directive 2006/88/EC. In the interest
of the animal health situation within the Community,
quarantine facilities in third countries should comply
with equivalent requirements as those laid down for
Directive
aquaculture
2006/88/EC.

production

businesses

in

(8) When quarantine is carried out in the Community it is of
vital importance that the transport of the consignments
of aquaculture animals
to the quarantine facility is
monitored to ensure that the animals to be quarantined
are transported directly to the quarantine facility in a safe
manner.

(9)

Quarantine facilities should be constructed and managed
in a manner that prevents the spread of diseases between
quarantine units and between the quarantine facilities and
other aquaculture production businesses.

(10)

to

relating

activities

quarantine
fall within the definition of

in
the
Certain
‘official
Community
controls’
in Article 2(1) of Regulation (EC) No
the
the European Parliament and of
882/2004 of
Council of 29 April 2004 on official
controls
performed to ensure the verification of compliance
with feed and food law, animal health and animal
welfare rules (1). Costs relating to quarantine in the

(1) OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004,

p. 1.

Community should therefore be covered by Article 27
of that Regulation, which provides that Member States
may collect fees or charges to cover the cost occasioned
by official controls.

(11)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Decision lays down the requirements for the quarantine,
which is provided for in:

(a) Articles 17 and 20 of Directive 2006/88/EC; and

(b) Chapter IV of Regulation (EC) No 1251/2008 and the
model certificates set out in Annex IV to that Regulation.

Article 2

Definitions

For the purposes of this Decision, the following definitions shall
apply:

1.

‘quarantine facility’ means a facility:

(a)

in which quarantine of aquaculture animals is carried
out;

(b) which contains one or more quarantine units; and

(c) which is authorised and registered by a competent
authority, within the meaning of Article 2(4) of Regu­
lation (EC) No 882/2004, as a quarantine facility in
accordance with Articles 4 and 6 of Directive
2006/88/EC, and which complies with the minimum
conditions for quarantine facilities set out in Annex I
to this Decision;

2.

‘quarantine unit’ means an operationally and physically
separated unit of a quarantine facility, which only contains
aquaculture animals of the same consignment, with the same
health status, and, when appropriate, sentinel aquaculture
animals;

L 337/96

EN

Official Journal of the European Union

16.12.2008

3.

‘sentinel aquaculture animals’ means aquaculture animals
which are to be used as a diagnostic aid during quarantine;

The aquaculture animals must only be released from quar­

4.
antine on written authorisation by the competent authority.

4.

‘listed diseases’ means the diseases listed in Part II of Annex
IV to Directive 2006/88/EC;

5.

‘approved qualified aquatic animal health professional’ means
a qualified aquatic animal health professional designated by
the competent authority to carry out specific official controls
on quarantine facilities on its behalf.

Article 5

Authorisation of quarantine facilities in third countries

In order to be authorised by the competent authority,

1.
quarantine facilities must comply with:

(a) provisions which are at least equivalent to the authorisation
conditions laid down in Article 5 of Directive 2006/88/EC;

CHAPTER II

QUARANTINE OF AQUACULTURE ANIMALS IN THIRD
COUNTRIES

(b) the minimum conditions for quarantine facilities set out in

Annex I to this Decision.

Article 3

Conditions for imports

a

is

condition for

consignments of

into the
Where quarantine
in
Community of
accordance with Chapter
(EC) No
1251/2008, such consignments shall only be imported into
the Community if the conditions laid down in this Chapter
are complied with.

IV of Regulation

aquaculture

imports

animals

Article 4

Quarantine conditions in third countries

The quarantine must have been carried out in a quarantine

1.
facility as referred to in Article 2(1)(c).

Each authorised quarantine facility must be assigned a

2.
registration number.

A list of authorised quarantine facilities must be drawn up

3.
and communicated to the Commission.

Article 6

Suspension and withdrawal of authorisation of quarantine
facilities in third countries

1. Where the competent authority has received notification
that the presence of listed disease(s) is suspected in a quarantine
facility, it must:

The quarantine facility must be under the control of the

2.
competent authority and that authority must:

(a)

immediately suspend the authorisation of that facility;

(a) visit the premises of the quarantine facility at least once a

year;

(b) ensure that the measures necessary to confirm or rule out
the suspicion are taken in accordance with point 3 of
Annex II.

(b) ensure that the quarantine facility meets the conditions set

out in this Decision;

A suspension pursuant

2.
removed until:

to paragraph 1 must not be

(c) audit the activity of the approved qualified aquatic animal

health professional; and

(a)

the suspicion of the relevant listed disease(s) has been offi­
cially ruled out; or

(d) verify that the conditions under which the authorisation was

granted remain fulfilled.

The aquaculture animals must have been subject to the

3.
quarantine provisions laid down in the following Articles:

(a)

in the case of susceptible species, Articles 13, 14 and 15;

(b) the eradication of the relevant listed disease(s) in the quar­
antine facility is successfully completed and the relevant
quarantine units are cleansed and disinfected.

The authorisation of a quarantine facility must be immedi­
3.
ately withdrawn by the competent authority where the facility
no longer complies with the conditions set out in Article 5(1).

(b) in the case of vector species, Articles 16 and 17.

The Commission must be immediately informed thereof.

16.12.2008

EN

Official Journal of the European Union

L 337/97

Article 7

Article 10

Lists of quarantine facilities

Monitoring of transport of aquaculture animals

The Commission shall provide the Member States with any new
it receives in
and updated lists of quarantine facilities that
accordance with Article 5(3) and shall make them available to
the public.

1. Where consignments of aquaculture animals imported
into the Community are intended for quarantine in the
Community:

CHAPTER III

QUARANTINE OF AQUACULTURE ANIMALS IN THE
COMMUNITY

Article 8

Attestation

1. Where consignments of aquaculture animals imported
into the Community are intended for quarantine in the
Community, the importer or his agent shall provide a written
attestation signed by the person responsible for the quarantine
facility confirming that the aquaculture animals will be accepted
for quarantine.

2.

The attestation provided for in paragraph 1 shall:

(a) be drawn up in at least one official language of the Member
State of the border inspection post where the veterinary
checks are carried out; however, that Member State may
instead permit another official language of the Community
to be used, accompanied, if necessary, by an official trans­
lation into one of its official languages;

(b) include the registration number of the quarantine facility.

(a)

the official veterinarian of the border inspection post shall
notify the competent authority of the quarantine facility
within one working day of
the
consignment at the border inspection post, of the place of
origin and the place of destination of the consignment via
the computerised system provided for in Article 20(1) of
Council Directive 90/425/EEC (1) (‘the Traces system’);

the date of arrival of

(b) the person responsible for

the quarantine facility shall
notify, within one working day of the date of arrival of
the consignment at the quarantine facility, the competent
authority of that facility of the arrival of the consignment;

(c)

the quarantine facility shall
the competent authority of
notify via the Traces system, within three working days of
the date of arrival of the consignment at that facility, the
official veterinarian of the border inspection post which
notified it of the shipment of the consignment as referred
to in point (a), of the arrival of the consignment.

inspection post,

If confirmation is provided to the competent authority of
2.
the aquaculture animals
that
the border
declared as being intended for a quarantine facility in the
Community have not arrived at their destination within three
working days of the estimated date of arrival, the competent
authority shall take appropriate measures.

3.

The attestation provided for in paragraph 1 shall:

Article 11

Quarantine conditions in the Community

(a) reach the border inspection post before the arrival of the

consignment; or

(b) be presented to the border inspection post by the importer
or his agent before the aquaculture animals are released
from that post.

Article 9

Direct

transport of aquaculture animals to quarantine

facilities

Where consignments of aquaculture animals imported into the
Community are intended for quarantine in the Community,
they shall be transported directly from the border inspection
post to the quarantine facility.

consignments of

Where quarantine in the Community is a condition for the
placing on the market of
aquaculture
animals in accordance with Article 17 or 20 of Directive
2006/88/EC or for imports of such consignments into the
Community in accordance with Chapter IV of Regulation (EC)
No 1251/2008,
shall comply with the
following conditions:

the consignments

(a)

the quarantine period must be carried out
quarantine facility in the Community;

in the same

(b) the aquaculture animals must be subject to the quarantine

provisions laid down in the following Articles:

(i) in the case of susceptible species, Articles 13, 14

and 15;

When vehicles are used for that transport they shall be sealed
by the official veterinarian of the border inspection post with a
tamper proof seal.

(ii) in the case of vector species, Articles 16 and 17;

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

L 337/98

EN

Official Journal of the European Union

16.12.2008

(c)

the aquaculture animals must only be released from quar­
antine on written authorisation by the competent authority.

2.

Crustaceans shall be quarantined for at least 40 days.

Article 12

Measures in case of suspicion or confirmation of listed
disease(s)

If during quarantine, the presence of disease(s) is suspected

1.
in the quarantine facility, the competent authority shall:

(a)

take and analyse appropriate samples in accordance with
point 3 of Annex II;

(b) ensure that, pending the laboratorial results, no aquaculture
animals are moved into or out of the quarantine facility.

If during quarantine, the presence of the relevant listed
is confirmed, the competent authority shall ensure

2.
disease(s)
that:

3. Molluscs shall be quarantined for at least 90 days.

Article 14

Examination, sampling, testing and diagnosis

To demonstrate

listed
relevant
1.
disease(s),
testing and diagnosis
referred to in Annex II shall be carried out with negative results.

the
the examination, sampling,

absence of

the

2.
Sentinel aquaculture animals may be used for the exam­
ination, sampling, testing and diagnosis, except where species
susceptible to infection with Marteilia refringens are quarantined.

3.
The competent authority shall determine the number of
sentinel aquaculture animals to be used, taking into account the
number of aquaculture animals kept, the size of the quarantine
unit, and the characteristics of the relevant listed disease(s) and
species.

(a) all aquaculture animals in the quarantine units concerned
are removed and disposed of, taking into account the risk of
spreading the relevant listed disease(s);

4.

Sentinel aquaculture animals shall be:

(b) the quarantine units concerned are cleansed and disinfected;

(c) no aquaculture animals are moved into the quarantine units
concerned during a period of 15 days following the final
cleansing and disinfection;

(d) water in the quarantine units concerned is treated in a
the infectious agent

manner
that effectively inactivates
responsible for the relevant listed disease(s).

3.
By way of derogation from paragraph 2(a), the competent
authority may authorise the placing on the market of the aqua­
culture animals kept in the quarantine facility and products
thereof provided that the health status of the aquatic animals
at the place of destination with regard to the relevant listed
disease(s) is not jeopardised.

4. Member States shall
measures taken pursuant to this Article.

inform the Commission of any

CHAPTER IV

QUARANTINE PROVISIONS

SECTION 1

Susceptible species

Article 13

(a) of species susceptible to the relevant listed disease(s) and,
living

where possible
their
conditions, being at the most susceptible life stages;

and taking into account

(b) sourced from a Member State, zone or compartment, or
from a third country or part thereof declared free of the
relevant listed disease(s);

(c) unvaccinated against the relevant listed disease(s);

(d) placed in the quarantine unit immediately before or upon
arrival of the aquaculture animals to be quarantined and
kept in contact with those animals and under the same
zootechnical and environmental conditions.

Article 15

Inspection

The competent authority shall
inspect the conditions of the
quarantine at least at the beginning and the end of the quar­
antine period of each consignment of aquaculture animals.

When the competent authority carries out such inspections, it
shall:

Duration of quarantine for susceptible species

1.

Fish shall be quarantined for at least 60 days.

(a) ensure that the environmental conditions conducive to the
laboratorial detection of the relevant listed disease(s) are
present;

16.12.2008

EN

Official Journal of the European Union

L 337/99

(b) examine the mortality records during the quarantine;

(c) where relevant, check the aquaculture animals in the quar­

antine units.

CHAPTER V

FINAL PROVISIONS

Article 18

Transitional provision

SECTION 2

Vector species

Article 16

Quarantine provisions applicable to vector species

1.

Vector species shall be quarantined for at least 30 days.

The water of the quarantine unit shall be exchanged at

2.
least once a day.

Article 17

Inspection

The competent authority shall
inspect the conditions of the
quarantine at least at the beginning and the end of the quar­
antine period of each consignment of aquaculture animals.

When the competent authority carries out such inspections, it
shall:

(a) examine the mortality records during the quarantine;

(b) where relevant, check the aquaculture animals in the quar­

antine units.

in

testing of samples

accordance with Article

Pending the adoption of the diagnostic methods to be laid
down
of Directive
2006/88/EC,
taken to demonstrate the
absence of the relevant listed disease(s) during quarantine shall
be carried out in accordance with the diagnostic methods laid
down in the corresponding chapter to each listed disease(s) of
the last version of the Manual of diagnostic tests for aquatic
animals of the World Organisation for Animal Health (OIE).

49(3)

Article 19

Date of application

This Decision shall apply from 1 January 2009.

Article 20

Adressees

This Decision is addressed to the Member States.

Done at Brussels, 12 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 337/100

EN

Official Journal of the European Union

16.12.2008

ANNEX I

Minimum conditions for quarantine facilities

PART A

Construction and equipment conditions

1. The quarantine facility must be a premise which is separated from other quarantine facilities, other farms or other
mollusc farming areas, by a distance specified by the competent authority on the basis of a risk assessment which
takes into account the epidemiology of the relevant listed disease(s). However, a quarantine facility may be located
within a farm or mollusc farming area.

2. The quarantine units must be constructed in such a way that water exchanges amongst them are not possible. In
addition, the water outlet system of each quarantine unit must be designed to prevent any possible cross-contam­
ination amongst quarantine units or other units of the same farm or mollusc farming area.

3. The water supply of the quarantine units must be free of the relevant listed disease(s).

4. When the draining system of the quarantine units is located in a Member State, zone, compartment or third country
or part thereof declared free of a listed disease(s) or subject to a surveillance or eradication programme with regard to
a listed disease(s), it must have an effluent treatment system approved by the competent authority. The effluent
treatment system must:

(a)

treat all effluents and wastes generated within the quarantine unit in a manner that effectively inactivates the
infectious agent responsible for the relevant listed disease(s);

(b) be equipped with fail-safe backup mechanisms to ensure continous operation and complete containment.

5. The quarantine units must be constructed in such a way that the contact with other animals likely to spread the

relevant listed disease(s) is prevented.

6. All equipment must be constructed in such a way that it can be cleansed and disinfected and appropriate equipment

must be available for cleansing and disinfection.

7. Hygiene barriers have to be installed at all entrances/exits to the quarantine facility and to its different units.

8. Each quarantine unit of the quarantine facility must have its own equipment in order to avoid cross contamination

amongst the different quarantine units.

PART B

Management conditions

1. The aquaculture production business operator of the quarantine facility must secure, by contract or legal instrument,

the services of an approved qualified aquatic animal health professional.

2. For each consignment of aquaculture animals quarantined:

(a)

the quarantine unit must be cleansed and disinfected and then kept free from aquaculture animals for at least
seven days before the introduction of a new consignment;

(b) the quarantine period shall only start when the last aquaculture animals of the consignment are introduced.

3. Appropriate measures shall be taken to prevent cross-contamination between incoming and outgoing consignments.

4. No unauthorised persons may enter the quarantine facility.

5. Persons entering the quarantine facility must wear protective clothing including footwear.

16.12.2008

EN

Official Journal of the European Union

L 337/101

6. No contacts between personnel or equipment, which may cause contamination between quarantine facilities or

quarantine units or between quarantine facilities and farms or mollusc farming areas, shall take place.

7. Upon receipt, transport vehicles and equipment, including tanks, containers and water must be treated in a manner

that effectively inactivates the infectious agent responsible for the relevant listed disease(s).

8. Dead aquaculture animals and aquaculture animals showing clinical signs of disease must be clinically inspected by an
approved qualified aquatic animal health professional and a representative selection of dead aquaculture animals and
aquaculture animals showing clinical signs of disease must be examined in a laboratory designated by the competent
authority.

9. The necessary examination, sampling and diagnostic methods must be carried out in consultation with and under the

control of the competent authority.

10. In addition to the recording obligations provided for in Article 8 of Directive 2006/88/EC, the quarantine facility

must keep a record of:

(a) entry/exit time of personnel;

(b) treatment of incoming water and of effluent water as appropriate;

(c) any abnormal conditions affecting quarantine operation (power cuts, building damage or serious weather

conditions);

(d) dates and results of samples submitted for testing.

ANNEX II

Examination, sampling, testing and diagnosis of aquaculture animals

1. The examination, sampling, testing and diagnosis of aquaculture animals shall be carried out ensuring that the
enviromental conditions conducive to the laboratorial detection of the relevant listed disease(s) are present in the
quarantine facility during the whole quarantine period.

2. During quarantine, the following aquaculture animals shall be sampled within 15 days before date of the expiry of the

quarantine period:

(a) when sentinel aquaculture animals are used, samples from all of them must be taken;

(b) when sentinel aquaculture animals are not used, samples must be taken from a relevant number of aquaculture
animals ensuring the detection of the relevant listed disease(s) with a 95 % confidence if the design prevalence is
10 % (never less than 10 animals).

3. Subject to Article 18, testing of samples taken during quarantine must be carried out in laboratories designated by the
competent authority using the diagnostic methods to be laid down in accordance with Article 49(3) of Directive
2006/88/EC.