# EUR-Lex - 32003D0804 - EN

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# 32003D0804

**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) **

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Official Journal L 302 , 20/11/2003 P. 0022 - 0033 *

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) 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.

(2) It is necessary to lay down specific animal health conditions 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 introduction of disease agents that could cause significant impact to the mollusc stock in the Community.

(3) 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. Furthermore, the disease situation as regards the mollusc diseases referred to in Annex D to Council Directive 95/70/EC of 22 December 1995 introducing 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.

(4) 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 Decision 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 diagnostic tests for aquatic animals.

(5) It is necessary that the responsible competent authorities of these third countries undertake to notify, by fax, telegram 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 territory or parts thereof from which imports covered by this Decision are authorised. In such event, the responsible competent authorities of those third countries must take measures to prevent the disease spreading into the Community.

(6) Taking into account the international practical and scientific 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(5) needs to be updated and amended as appropriate. For the sake of clarity, those provisions should be included in this Decision and Decision 95/352/EC should be repealed.

(7) Therefore, it is necessary to supplement the public health certification requirements relating to the importation of live molluscs and unprocessed products thereof, 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(6), as last amended by Regulation (EC) No 806/2003, with the animal health certification requirements for import of live molluscs.

(8) 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 production and the placing on the market of fishery products(7), as last amended by Decision 806/2003/EC.

(9) The risk of introducing diseases that can cause significant 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 appropriate level of protection as regards non-viable molluscs, and therefore additional animal health certification for non-viable molluscs is not necessary.

(10) Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products(8) 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.

(11) 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(9), in particular Article 3 of that Directive should be taken into account.

(12) 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 molluscs, eggs and gametes, should therefore be imported into the Community only if they are introduced into a farm registered by the competent authority in the Member State in accordance with Article 3(1) of Directive 95/70/EC.

(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 implementation of these new import certification 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 accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Scope

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 2

Definitions

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:

(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 watercourses; 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 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 3

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 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 4

Conditions related to importation of live molluscs intended for human consumption

Member States shall authorise the importation into their territory of live molluscs intended for immediate human consumption 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 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 6

Certification

In the case of live molluscs, their eggs and gametes, 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 statements laid down in Annex IV in this Decision as appropriate.

Article 7

Preventing 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 8

Approval 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 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 12

This Decision is addressed to the Member States.

Done at Brussels, 14 November 2003.

For the Commission

David Byrne

Member of the Commission

(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.

(5) OJ L 204, 30.8.1995, p. 13.

(6) OJ L 268, 24.9.1991, p. 1.

(7) OJ L 268, 24.9.1991, p. 15.

(8) OJ L 13, 16.1.1997, p. 28.

(9) OJ L 18, 23.1.2003, p. 11.

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 official 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 certification 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.

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](2) [Eggs](3) [and](4) [Gametes](5) 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](6) [and](7) [Eggs](8) [and](9) [Gametes](10) 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](11) [and](12) [Marteilia refringens](13)";

or:

"Live molluscs certified for export to the European Community(14) [including to zones having Community approved status or program as regards [Bonamia ostreae](15) [and](16) [Marteilia refringens](17) [for immediate human consumption](18) [for further processing in approved import centres before human consumption](19)".

(1) Retain as appropriate.

(2) Retain as appropriate.

(3) Retain as appropriate.

(4) Retain as appropriate.

(5) Retain as appropriate.

(6) Retain as appropriate.

(7) Retain as appropriate.

(8) Retain as appropriate.

(9) Retain as appropriate.

(10) Retain as appropriate.

(11) Retain as appropriate.

(12) Retain as appropriate.

(13) Retain as appropriate.

(14) Retain as appropriate.

(15) Retain as appropriate.

(16) Retain as appropriate.

(17) Retain as appropriate.

(18) Retain as appropriate.

(19) Retain as appropriate.

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 Directive 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 competent 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 appropriate footwear.