Article 1Scope

1

This Decision establishes harmonised animal health rules 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 for immediate human consumption or further processing before human consumption.

2

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

Article 2Definitions

1

For the purpose of this Decision, the definitions in Article 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;

b

‘coastal zone’ means a zone consisting of a part of the coast or sea water or an estuary:

  1. (i)

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

  2. (ii)

    which is situated between the mouths of two watercourses; or

  3. (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 after transport (immersion), conditioning, cleaning, purification, thawing, and operations affecting the anatomical wholeness such as shucking;

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 farm, including any establishment, harvested natural bed 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 considered 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 the third country concerned for exportation to the Community.

Article 3Conditions 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 territory 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 destination, as stated on the animal health certificate.

Article 4F1Conditions related to the importation of live molluscs intended for human consumption

1

Member States shall authorise the importation into their territory of live molluscs intended for further processing before human consumption only if the consignment:

a

complies with the conditions laid down in Article 3(1); or

b

is sent directly to an approved import centre for further processing.

2

Member States shall authorise the importation into their territory of live molluscs intended for immediate 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; and

  • either

    1. (a)

      the consignment consists of molluscs packed in packages of a size suitable for retail sale to restaurants or directly to the consumer; and the packages are clearly labelled with the following text Live molluscs for immediate human consumption. Not to be relayed in Community waters.;

  • or

    1. (b)

      the consignment is sent directly to an approved import centre where the molluscs are further processed. However, viable molluscs can only leave such premises if they are packaged and labelled as required in (a) above.

Article 5Conditions related to importation of non-viable molluscs intended for human consumption

Member States shall authorise the importation into their territory 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.

Article 6F1Control procedures

1

Live bivalve molluscs imported from third countries shall be subject to veterinary checks at the border inspection post in the Member State of arrival according to Article 8 of Directive 97/78/EC.

2

In the case of live molluscs, their eggs and gametes, imported into the Community for the purpose of further growth, fattening or relaying, the common veterinary entry document provided for in Regulation (EC) No 282/2004 shall be completed accordingly.

3

In the case of live molluscs imported into the Community for immediate human consumption or for the purpose of further processing before human consumption, the common veterinary entry document provided for in Regulation (EC) No 136/2004 shall be completed accordingly.

Article 7Preventing contamination of natural waters

1

Member States shall ensure that imported molluscs intended for immediate human consumption or further processing 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 imported consignments does not lead to contamination of natural waters within their territory.

Article 8Approval of import centres

1

The competent authority of 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.

3

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

Article 9Repeal

Decision 95/352/EC is repealed.

Article 10Review

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

Article 11Date of application

This Decision shall apply from 1 May 2004.

Article 12

This Decision is addressed to the Member States.