2003/804/EC: Commission Decision of 14 November 2003 laying down the animal health conditions and certification requirements for imports of molluscs, their eggs and gametes for further growth, fattening, relaying or human consumption (Text with EEA relevance) (notified under document number C(2003) 4153)
Date: 2003-11-14
Institutions: European Commission
Subjects: food consumption, health certificate, import, livestock farming, mollusc, veterinary inspection, veterinary legislation

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 14 November 2003

laying down the animal health conditions and certification requirements for imports of molluscs,
their eggs and gametes for further growth, fattening, relaying or human consumption

(notified under document number C(2003) 4153)

(Text with EEA relevance)

(2003/804/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/67/EEC of 28 January
1991 concerning the animal health conditions governing the
placing on the market of aquaculture animals and products (1),
as last amended by Regulation (EC) No 806/2003 (2), and in
particular Article 19(1), Article 20(1) and Article 21(2) thereof,

Whereas:

(1)

(2)

(3)

A list of third countries or parts thereof, from which
Member States are authorised to import live molluscs,
their eggs and gametes for further growth,
fattening,
relaying or human consumption in the Community,
should be established.

It is necessary to lay down specific animal health condi-
tions and model certificates for those third countries,
taking into account the animal health situation of the
third country concerned and of the molluscs, eggs or
gametes to be imported, in order to prevent the intro-
duction of disease agents that could cause significant
impact to the mollusc stock in the Community.

Attention should be paid to emerging diseases and
diseases which are exotic to the Community and which
could have a serious impact on the mollusc stock in the
Community.
situation as
regards the mollusc diseases referred to in Annex D to
Council Directive 95/70/EC of 22 December 1995 intro-

Furthermore,

the disease

ducing minimum Community measures for the control
of certain diseases affecting bivalve molluscs (3), as last
amended by Regulation (EC) No 806/2003, and in list II,
column 1, of Annex A to Directive 91/67/EEC, at the
place of production and where appropriate at the place
of destination should be taken into account.

It is necessary that the countries or parts thereof from
which Member States are authorised to import molluscs,
their eggs and gametes for further growth or fattening,
relaying or human consumption, apply conditions for
disease control and monitoring at least equivalent to
Community standards as laid down in Directives 91/67/
EEC and 95/70/EC. The sampling and testing methods
used should be at least equivalent to Commission Deci-
sion 2002/878/EC (4).
In cases where sampling and
testing methods are not laid down in the Community
legislation,
the sampling and testing methods used
should be in accordance with those laid down in the
International Office of Epizootics (OIE) Manual of diag-
nostic tests for aquatic animals.

It is necessary that the responsible competent authorities
of these third countries undertake to notify, by fax, tele-
gram or electronic mail,
the Commission and the
Member States within 24 hours of any occurrence of
diseases referred to in Annex D to Directive 95/70/EC,
and list II, column 1 of Annex A to Directive 91/67/
EEC, as well as any other disease outbreaks causing a
significant abnormal mortality in molluscs within their

(4)

(5)

(1) OJ L 46, 19.2.1991, p. 1.
(2) OJ L 122, 16.5.2003, p. 1.

(3) OJ L 332, 30.12.1995, p. 33.
(4) OJ L 305, 7.11.2002, p. 57.

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territory or parts thereof from which imports covered by
this Decision are authorised. In such event, the respon-
sible competent authorities of those third countries must
take measures to prevent the disease spreading into the
Community.

(12)

(6)

(7)

(8)

(9)

(10)

(11)

Taking into account the international practical and scien-
tific experiences gained, the animal health provisions laid
down by Commission Decision 95/352/EC of 25 July
1995 laying down the animal health conditions and the
certification requirements for the importation from third
countries of Crassostrea gigas for relaying in Community
waters (1) needs to be updated and amended as appro-
priate. For the sake of clarity, those provisions should be
included in this Decision and Decision 95/352/EC
should be repealed.

Therefore, it is necessary to supplement the public health
certification requirements relating to the importation of
live molluscs and unprocessed products
in
Council Directive 91/492/EEC of 15 July 1991 laying
down the health conditions for the production and
placing of the market of live bivalve molluscs (2), as last
amended by Regulation (EC) No 806/2003, with the
animal health certification requirements for import of
live molluscs.

thereof,

This Decision should apply without prejudice to the
public health conditions established under Directive 91/
492/EEC and Council Directive 91/493/EEC of 22 July
1991 laying down the health conditions for the produc-
tion and the placing on the market of
fishery
products (3), as last amended by Decision 806/2003/EC.

The risk of introducing diseases that can cause signifi-
cant
impact on molluscs within the community by
imports of non-viable molluscs is considered low. The
requirements laid down in Directive 91/493/EEC,
in
particular Articles 11 of that Directive, gives the appro-
priate level of protection as regards non-viable molluscs,
and therefore additional animal health certification for
non-viable molluscs is not necessary.

Council Directive 96/93/EC of 17 December 1996 on
the certification of animals and animal products (4) lays
down standards of certification. The rules and principles
applied by third country certifying officers in accordance
with this Decision should provide guarantees which are
equivalent to those laid down in that Directive.

The principles laid down in Council Directive 2002/99/
EC of 16 December 2002 laying down the animal health
rules governing the production, processing, distribution
and introduction of products of animal origin for human
consumption (5), in particular Article 3 of that Directive
should be taken into account.

(1) OJ L 204, 30.8.1995, p. 13.
(2) OJ L 268, 24.9.1991, p. 1.
(3) OJ L 268, 24.9.1991, p. 15.
(4) OJ L 13, 16.1.1997, p. 28.
(5) OJ L 18, 23.1.2003, p. 11.

It would reduce the possibility to control and eradicate
diseases which are exotic to the Community and which
could have serious impact on the mollusc stocks in the
Community, if molluscs that could carry the disease are
released into free waters
in the Community. Live
should therefore be
eggs
molluscs,
imported into the Community only if they are intro-
duced into a farm registered by the competent authority
in the Member State in accordance with Article 3(1) of
Directive 95/70/EC.

and gametes,

(13)

This Decision should not apply to the importation of
ornamental molluscs kept permanently in aquariums.

(14) A transitional period of time should be provided for the
certification

these new import

implementation of
requirements.

(15) Annex I to this Decision should be reviewed before the

date of application.

(16)

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision establishes harmonised animal health rules

1.
for the importation of:

(a) live molluscs, their eggs and gametes, for further growth,

fattening or relaying; and

(b) live molluscs and non-viable molluscs

immediate
human consumption or further processing before human
consumption.

for

This Decision shall not apply to the importation of orna-

2.
mental molluscs kept permanently in aquariums.

Article 2

Definitions

For the purpose of this Decision, the definitions in Article

1.
2 of Directives 91/67/EEC and 95/70/EC shall apply.

2.

The following definitions shall also apply:

(a) ‘approved import centre’ means any establishment, dispatch
centre or purification centre in the Community, approved
according to Directives 91/492/EEC or 91/493/EEC where
special biosecurity measures have been put
in place,
approved by the competent authority of the Member State
concerned for further processing of imported live molluscs;

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(b) ‘coastal zone’ means a zone consisting of a part of the coast

Article 3

or sea water or an estuary:

(i) which has a precise geographical delimitation and
consists of a homogeneous hydrological system or a
series of such systems; or

(ii) which is situated between the mouths of two water-

courses; or

(iii) where there are one or more farms and all farms are
surrounded by appropriate buffer zones on both sides
of the farm or farms;

(c) ‘designated farm’ means a coastal farm or an inland farm to
which the water is supplied by means of an artificial water
system which ensures the complete inactivation of
the
pathogens referred to in Annex D to Directive 95/70/EC;

(d) ‘further processing’ means preparation and processing
before human consumption, by any kind of measures and
techniques that produce waste or by-products which could
cause a risk of spreading of diseases, including: putting live
molluscs into water in order to allow them to recover
during or
conditioning,
cleaning, purification, thawing, and operations affecting the
anatomical wholeness such as shucking;

(immersion),

transport

after

(e) ‘immediate human consumption’ means

that molluscs
imported for the purpose of human consumption do not
undergo any further processing within the Community
before being placed on the retail market
for human
consumption;

(f) ‘molluscs’ means aquatic organisms belonging to the Phylum
Mollusca, classes Bivalvia and Gastropoda; originating from a
including any establishment, harvested natural bed
farm,
or,
in general, any geographical defined installation in
which molluscs are reared or kept with a view to their
being placed on the market;

(g) ‘non-viable molluscs’ means molluscs no longer able to
survive as living animals if returned to the environment
from which they were obtained, and includes mollusc
products intended for immediate human consumption or
further processing before human consumption;

(h) ‘relaying’ means an operation whereby live molluscs are
transferred to approved sea or lagoon areas or approved
estuarine areas under the supervision of the competent
authority for the time necessary to remove contamination
as defined in Directive 91/492/EEC, but excluding the
specific operation of transferring molluscs to areas more
suitable for further growth or fattening, as this is consid-
ered as farming;

(i) ‘territory’ means either a whole country, a coastal zone, a
designated farm, a farming area, or a harvested natural bed
which is authorised by the central competent authority of
exportation to the
the
Community.

third country concerned for

Conditions for importation of live molluscs, their eggs and
gametes intended for further growth, fattening or relaying
in European Community waters

1. Member States shall authorise the importation into their
territory of live molluscs, their eggs and gametes for further
growth or fattening or relaying only if:

(a) the molluscs originate and have been harvested in a terri-

tory listed in Annex I;

(b) the consignment complies with the guarantees,

including
those for packaging and labelling and the appropriate
specific additional requirements, as laid down in the animal
health certificate, drawn up in conformity with the model
in Annex II, taking into account the explanatory notes in
Annex III; and

(c) the molluscs have been transported under conditions not

altering their health status.

2. Member States shall ensure that imported molluscs, their
eggs and gametes intended for further growth, fattening or
relaying in Community waters, only are introduced into farms
registered by the competent authority in accordance with
Article 3(1) of Directive 95/70/EC.

3. Member States shall ensure that imported live molluscs,
eggs and gametes are transported directly to the farm of desti-
nation, as stated on the animal health certificate.

Article 4

Conditions

related to importation of
intended for human consumption

live molluscs

Member States shall authorise the importation into their terri-
tory of live molluscs intended for immediate human consump-
tion or for further processing before human consumption only
if the consignment:

(a) complies with the conditions laid down in Article 3(1) and

Article 6 of this Decision; or

(b) is sent directly to an approved import centre for further

processing.

Article 5

Conditions related to importation of non-viable molluscs
intended for human consumption

Member States shall authorise the importation into their terri-
tory of non-viable molluscs for immediate human consumption
or for further processing before human consumption only if
the molluscs originate in third countries and establishments
authorised under Article 9 of Directive 91/492/EEC and Article
11 of Directive 91/493/EEC and comply with the public health
certification requirements laid down under those Directives.

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Article 6

Certification

In the case of live molluscs, their eggs and gametes, the compe-
tent authority at the border inspection post in the Member
State of arrival shall complete the document referred to in the
Annex to Decision 92/527/EEC with one of the statements laid
down in Annex IV in this Decision as appropriate.

Article 7

Preventing contamination of natural waters

1. Member States
imported molluscs
shall ensure that
intended for immediate human consumption or further proces-
sing before human consumption are not introduced into, and
do not contaminate any natural waters within their territory.

2. Members States shall ensure that transport water from
lead to contamination of
imported consignments does not
natural waters within their territory.

The list of approved import centres, and any subsequent
3.
amendments thereto, shall be communicated by the competent
authority of each Member State, to the Commission and to the
other Member States.

Article 9

Repeal

Decision 95/352/EC is repealed.

Article 10

Review

Annex I to this Decision should be reviewed before 1 May
2004.

Article 11

Date of application

This Decision shall apply from 1 May 2004.

Article 8

Article 12

Approval of import centres

This Decision is addressed to the Member States.

The competent authority of

1.
the Member States shall
approve an establishment as an approved import centre
provided that it satisfies the minimum animal health conditions
of Annex V to this Decision.

2.
The competent authority of the Member States shall draw
up a list of approved import centres, each of which shall be
given an official number.

Done at Brussels, 14 November 2003.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

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ANNEX II

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ANNEX III

Explanatory notes for certification and labelling

(a) The certificates shall be produced by the competent authorities of the exporting country, based on the appropriate
model appearing in Annex II to this Decision taking into account the use to which the molluscs are to be put after
the arrival to the EC.

(b) Considering the status of the place of destination as regards Bonamia ostreae and Marteilia refringens in the EC Member

State, the appropriate specific additional requirements shall be incorporated and completed in the certificate.

(c) The original of each certificate shall consist of a single page, double-sided, or, where more than one page is required,

it shall be in such a form that all pages form part of an integrated whole and are indivisible.

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

(d) The original of the certificate and the labels referred to in the model certificate shall be drawn up in at least one offi-
cial language of the EC Member State in which the inspection at the border post shall be carried out and of the EC
Member State of destination. However, these Member States may allow other languages, if necessary, accompanied
by an official translation.

(e) The original of the certificate must be completed on the day of loading the consignment for exportation to the
European Community with an official stamp and signed by an official
inspector designated by the competent
authority. In doing so, the competent authority of the exporting country shall ensure that the principles of certifica-
tion equivalent to those laid down in Council Directive 96/93/EC are followed.

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

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

(g) The original of the certificate must accompany the consignment until it reaches the EC border inspection post.

(h) The certificate shall be valid for 10 days from the date of issue. In the case of transport by ship, the time of validity

is prolonged by the time of the journey at sea.

(i) The molluscs, their eggs and gametes, shall not be transported together with other molluscs, eggs or gametes that,
either are not destined to the European Community, or are of a lower health status. Furthermore, they must not be
transported under any other conditions that alter their health status.

(j) The possible presence of pathogens in the water is a relevant factor when considering the health status of molluscs.

The certifying officer should therefore consider the following:
the ‘place of origin’ should be the localisation of the farm or harvested natural bed where the molluscs were reared
reaching their commercial size relevant for the consignment covered by this certificate.
The ‘place of harvest’ should be the last place the molluscs were in contact with natural waters in the exporting
country, like purification centres or intermediate storage places where molluscs are kept before exported to the
Community.

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ANNEX IV

Statements as regard live molluscs, their eggs and gametes intended for further growth, fattening, relaying or
human consumption in the European Community to be issued by the competent authority at the border
inspection post to complete the document referred to in the Annex to Decision 92/527/EEC

The competent authority at the border inspection post in the Member State of arrival shall complete the document
referred to in the Annex to Decision 92/527/EEC with one of the following statements as appropriate:

Statements:
either:

‘[Live molluscs] (1) [and] (1) [Eggs] (1) [and] (1) [Gametes] (1) certified for further growth, fattening or relaying into
European Community coastal zones and farms except those with a Community approved program or status, with regard
to Bonamia ostreae and Marteilia refringens’;
or:

‘[Live molluscs] (1) [and] (1) [Eggs] (1) [and] (1) [Gametes] (1) certified for further growth, fattening or relaying into
European Community coastal zones and farms including those with a Community approved program or status, with
regard to [Bonamia ostreae] (1) [and] (1) [Marteilia refringens] (1)’;
or:

‘Live molluscs certified for export to the European Community (1) [including to zones having Community approved
status or program as regards [Bonamia ostreae] (1) [and] (1) [Marteilia refringens] (1) [for immediate human consumption] (1)
[for further processing in approved import centres before human consumption] (1)’.

(1) Retain as appropriate.

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ANNEX V

MINIMUM ANIMAL HEALTH CONDITIONS FOR THE APPROVAL OF ‘APPROVED IMPORT CENTRES’

A. General Provisions

1. Member States shall only approve centres and establishments as import centres for further processing of
imported molluscs provided that the conditions at the import centre are such that risks of contamination of
molluscs in Community waters via discharges or other waste, or by other means, with pathogens capable of
causing significant abnormal mortality in molluscs are avoided.

2. Establishments approved as ‘approved import centres’, must not be allowed to move live molluscs out of the

establishment.

3. The minimum animal health conditions as laid down in part B of this Annex shall apply, in addition to the
public health provisions laid down under Directive 91/492/EEC for any centres and establishments, including
dispatch centres and purification centres, as well as to the health rules laid down by Community legislation
concerning animal by-products not intended for human consumption.

B. Management Provisions

1. Approved import centres must be under the control and responsibility of the competent authority.

2. Approved import centres must have an efficient disease control, and monitoring system; in application of Direc-
tive 95/70/EC, cases of suspected disease and mortality shall be investigated by the competent authority; the
necessary analysis and treatment must be carried out in consultation with and under the control of the compe-
tent authority, taking into consideration the requirement in Article 3(1)(a) of Directive 91/67/EEC.

3. Approved import centres must apply a management system, approved by the competent authority, including
hygiene and disposal routines for transport, transport containers, facilities, and equipment. The guidelines laid
down for disinfection of mollusc farms in the OIE International aquatic animal health code, sixth edition, 2003,
Appendix 5.2.2, should be followed. The disinfectants used must be approved for the purpose by the competent
authority and appropriate equipment must be available for cleaning and disinfection. Discharges of by-products
and other waste materials including dead molluscs and their products must be carried out in accordance with
Regulation (EC) No 1774/2002. The management system at the approved import centre shall be such that risks
of contamination of molluscs in Community waters with pathogens capable of causing significant impact to
mollusc stocks, in particular diseases referred to in Annex D to Directive 95/70/EC, are avoided.

4. Approved import centres must keep an updated record of observed abnormal mortality, and of all the live
molluscs, eggs and gametes entering the centre and products leaving the centre including their source, their
suppliers and their destination.

5. Approved import centres must be cleaned and disinfected regularly in accordance with the programme described

in point 3 above.

6. Only authorised persons may enter approved import centres and must wear protective clothing including appro-

priate footwear.