Proposal for a COUNCIL DIRECTIVE introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs (Codified version)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. In the context of a people's Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make it clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the specific rights it gives him.

This aim cannot be achieved so long as numerous provisions that have been amended several times, often quite substantially, remain scattered, so that they must be sought partly in the original instrument and partly in later amending ones. Considerable research work, comparing many different instruments, is thus needed to identify the current rules.

For this reason a codification of rules that have frequently been amended is also essential if Community law is to be clear and transparent.

2. On 1 April 1987 the Commission therefore decided [1] to instruct its staff that all legislative acts should be codified after no more than ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

[1] COM(87) 868 PV.

3. The Conclusions of the Presidency of the Edinburgh European Council (December 1992) confirmed this [2], stressing the importance of codification as it offers certainty as to the law applicable to a given matter at a given time.

[2] See Annex 3 to Part A of the Conclusions.

Codification must be undertaken in full compliance with the normal Community legislative procedure.

Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council and the Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-track adoption of codification instruments.

4. The purpose of this proposal is to undertake a codification of Council Directive 95/70/EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs [3]. The new Directive will supersede the various acts incorporated in it [4]; this proposal fully preserves the content of the acts being codified and hence does no more than bringing them together with only such formal amendments as are required by the codification exercise itself.

[3] Carried out pursuant to the Communication from the Commission to the European Parliament and the Council - Codification of the Acquis communautaire, COM(2001) 645 final.

[4] Annex V, Part A of this proposal.

5. The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Directive 95/70/EC and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table contained in Annex VI to the codified Directive.

95/70/EC (adapted)

2004/0100(CNS)

Proposal for a COUNCIL DIRECTIVE introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament [5],

[5] OJ C [...], [...], [...].

Having regard to the opinion of the European Economic and Social Committee [6],

[6] OJ C [...], [...], [...].

Whereas:

(1) Council Directive 95/70/EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs [7] has been substantially amended several times [8]. In the interests of clarity and rationality the said Directive should be codified.

[7] OJ L 332, 30.12.1995, p. 33. Directive as last amended by the 2003 Act of Accession.

[8] See Annex V, part A.

95/70/EC Recital (1) (adapted)

(2) Molluscs are listed in Annex I to the Treaty. The marketing of molluscs constitutes an important source of revenue for the aquaculture sector.

95/70/EC Recital (2) (adapted)

(3) The mollusc diseases referred to in Annex A, list II, 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 [9], have a very serious effect on the shellfish industry. Other diseases having a similar effect occur in third countries. A list of such diseases should be drawn up and the Commission should be given the ability to adjust that list in the light of developments in the animal-health field.

[9] OJ L 46, 19.2.1991, p. 1. Directive as last amended by Ö Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1)Õ .

95/70/EC Recital (3)

(4) An outbreak of such diseases can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable considerably to reduce the profitability of shellfish farming.

95/70/EC Recital (4)

(5) It is therefore necessary to establish at Community level the measures to be taken in the event of outbreaks of disease, in order to ensure rational development of shellfish farming and to contribute to the protection of animal health in the Community.

95/70/EC Recital (5)

(6) Member States should report to the Commission and the other Member States all cases of abnormal mortality observed in bivalve molluscs.

95/70/EC Recital (6)

(7) In such an event, measures must be taken aimed at preventing the spread of the disease, in particular with regard to the removal of live bivalve molluscs from the farms or zones concerned.

95/70/EC Recital (7)

(8) A thorough epidemiological investigation is essential to determine the origin of the disease and to prevent further spread.

95/70/EC Recital (8)

(9) In order to ensure an effective system of control, diagnosis of the diseases must be harmonised and carried out under the auspices of responsible laboratories, the coordination of which may be ensured by a reference laboratory designated by the Community.

95/70/EC Recital (9)

(10) In order to ensure uniform implementation of this Directive, a Community inspection procedure should be established.

95/70/EC Recital (10)

(11) Common measures for the control of diseases form a minimum basis for maintaining a uniform standard of animal health.

95/70/EC Recital (11) (adapted)

(12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [10].

[10] OJ L 184, 17.7.1999, p. 23.

(13) This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law of the Directive set out in Annex V, Part B,

95/70/EC

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive establishes minimum Community measures for the control of the diseases affecting bivalve molluscs referred to in this Directive.

Article 2

95/70/EC (adapted)

For the purposes of this Directive, the definitions laid down in Article 2 of Directive 91/67/EEC and Article 2 of Council Directive 91/492/EEC [11] shall apply as necessary.

[11] OJ L 268, 24.9.1991, p. 1.

In addition, "observed abnormal mortality" shall mean sudden mortality affecting approximately 15% of stocks and occurring over a short period between two inspections (confirmed within 15 days). In hatchery a mortality shall be considered abnormal when the farmer cannot obtain larvae during a period which included successive spawns from different broodstocks. In nursery a mortality shall be considered abnormal when a sudden sizeable mortality occurs in a short time on a number of tubes.

95/70/EC

Article 3

Member States shall ensure that all farms rearing bivalve molluscs:

95/70/EC (adapted)

(a) are registered by the official service; this registration must be kept constantly up to date;

(b) keep a record of:

(i) live bivalve molluscs entering the farm, containing all information relating to their delivery, their number or weight, their size and their origin;

(ii) bivalve molluscs leaving the farm for re-immersion, containing all information relating to their dispatch, their number or weight, their size and destination;

(ii) observed abnormal mortality.

95/70/EC

This record, which shall be open to scrutiny by the official service at all times, on demand, shall be updated regularly and kept for four years.

Article 4

1. Member States shall ensure that a monitoring and sampling programme is applied in bivalve mollusc farms, farming areas and harvested natural beds in order to observe whether there is an abnormal mortality and keep track of the health situation of stocks.

In addition, the official service may apply the above programme to purification centres and storage tanks which discharge water into the sea.

95/70/EC (adapted)

2. If, during application of the programme referred to in paragraph 1 , any abnormal mortality is observed, or if the official service has information giving it reason to suspect the presence of diseases, the following measures shall be taken:

(a) a list shall be drawn up of the sites where the diseases referred to in Annex A, list II to Directive 91/67/EEC are present, provided that such diseases are not the subject of a programme approved pursuant to the aforementioned Directive;

(b) a list shall be drawn up of the sites at which abnormal mortality has been observed as a result of the presence of the diseases referred to in Annex IV of this Directive , or on which the official service has information giving it reason to suspect the presence of diseases;

(c) monitoring of the evolution and geographical spread of the diseases referred to in points (a) and (b) .

3. The detailed rules for implementing this Article, and inter alia the rules to be applied for establishing the programme referred to in paragraph 1, particularly as regards the frequency and timetable of monitoring, procedures for taking samples (statistically representative volume) and methods of diagnosis, shall be adopted in accordance with the procedure referred to in Article 10 (2) .

95/70/EC

Article 5

1. Member States shall ensure that the suspected presence of any diseases referred to in Article 4 and any abnormal mortality rate observed in bivalve molluscs in farms, in farming areas or in harvested natural beds or in purification centres or storage tanks which discharge water into the sea is notified as soon as possible to the official service by the shellfish farmers or any other person who has made such observations.

2. In the case referred to in paragraph 1, the official service in the Member States shall ensure that:

(a) samples are taken for examination in an approved laboratory;

(b) pending the result of the examination referred to in (a), no molluscs leave the affected farm, farming area or harvested natural beds or purification centres or storage tanks which discharge water into the sea for relaying or re-immersion in another farm or in the aquatic environment, unless authorised by the official service.

3. If the examination referred to in paragraph 2(a) fails to demonstrate the presence of a pathogen, the restrictions referred to in paragraph 2(b) shall be lifted.

95/70/EC (adapted)

4. If the examination referred to in paragraph 2 (a) shows the presence of a pathogen causing the observed abnormal mortality capable of being the cause of that mortality, or of a pathogen of one of the diseases referred to in Article 4, an epizootic investigation must be carried out by the official service in order to determine the possible means of contamination and to investigate whether molluscs have left the farm, the farming area or the harvested natural beds for relaying or re-immersion elsewhere during the period preceding observation of the abnormal mortality.

95/70/EC

If the epizootic investigation shows that the disease has been introduced into one or more farms, farming areas or harvested natural beds as a result inter alia of molluscs being moved, the provisions of paragraph 2 shall apply.

However, by way of derogation from Article 3(1)(c) of Directive 91/67/EEC, the official service may, within its territory, authorise the movement of live bivalve molluscs to other farms, farming areas or harvested natural beds which are infected with the same disease.

95/70/EC (adapted)

If necessary, further appropriate measures may be decided on in accordance with the procedure referred to in Article 10 (2) .

95/70/EC

5. The official service shall ensure that the Commission and the other Member States are immediately informed, in accordance with the current Community procedures, of any cases of abnormal mortality rates observed involving a pathogen, of any measures taken to analyse and control the situation and of the cause of the mortality.

95/70/EC (adapted)

Article 6

1. Sampling and laboratory testing for the determination of the cause of abnormal mortality of bivalve molluscs shall be carried out using the methods established in accordance with the procedure referred to in Article 10 (2) .

95/70/EC

2. Member States shall ensure that in each Member State a national reference laboratory is designated, with facilities and expert personnel enabling it to carry out the testing referred to in paragraph 1.

3. By way of derogation from paragraph 2, Member States which do not have a national laboratory competent in the matter may use the services of a national laboratory with competence in the matter in another Member State.

95/70/EC (adapted)

4. The list of national reference laboratories for diseases of bivalve molluscs is set out in Annex III .

95/70/EC

5. National reference laboratories shall cooperate with the Community reference laboratory referred to in Article 7.

Article 7

95/70/EC (adapted)

1. The Community reference laboratory for diseases of bivalve molluscs is indicated in Annex I .

2. Without prejudice to Council Decision 90/424/EEC [12] and in particular Article 28 thereof, the functions and duties of the laboratory referred to in paragraph 1 shall be those laid down in Annex II to this Directive .

[12] OJ L 224, 18.8.1990, p. 19.

95/70/EC

Article 8

1. Commission experts may, to the extent necessary to ensure uniform application of this Directive, carry out on-the-spot checks. In so doing, they may carry out random, non-discriminatory checks to ensure that the competent authority is monitoring compliance with the requirements of this Directive.

The Commission shall inform the Member States of the results of these checks.

2. The checks referred to in paragraph 1 shall be carried out in collaboration with the competent authority.

95/70/EC (adapted)

3. The Member State in whose territory the inspections referred to in paragraph 1 are carried out shall provide the experts with any assistance they require to accomplish their task.

4. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 10 (2) .

Article 9

Annex I shall be amended as necessary by the Council, acting by a qualified majority on a proposal from the Commission.

Annexes II , III and IV may be amended as necessary in accordance with the procedure referred to in Article 10 (2) .

806/2003 Art. 3 and Annex III, pt. 45 (adapted)

Article 10

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [13].

[13] OJ L 31, 1.2.2002, p. 1.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its Rules of Procedure.

95/70/EC Art. 12 (adapted)

Article 11

1. Member States may, subject to the general rules of the Treaty, maintain or apply for their production stricter provisions than those laid down by this Directive. They shall notify the Commission of any such measure.

2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field governed by this Directive.

Article 12

Directive 95/70/EC, as amended by the acts listed in Annex V, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limit for transposition into national law of the Directive set out in Annex V, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VI.

95/70/EC

Article 13

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 14

This Directive is addressed to the Member States.

Done at Brussels,

For the Council

The President

95/70/EC Annex A (adapted)

ANNEX I

COMMMUNITY REFERENCE LABORATORY FOR DISEASES OF BIVALVE MOLLUSCS

IFREMER

Boîte Postale 133

Ronce-les-bains

F -17390 La Tremblade

_____________

95/70/EC Annex B

ANNEX II

FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORATORY FOR DISEASES OF BIVALVE MOLLUSCS

The function and duties of the Community reference laboratory shall be:

1. to coordinate, in consultation with the Commission, the methods employed in Member States for diagnosing diseases of bivalve molluscs, specifically by:

(a) building up and retaining a collection of histological slides, strains or isolates of the relevant pathogens and making these available to approved laboratories in the Member States;

(b) organising periodic comparative tests of diagnostic procedures at Community level;

(c) collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;

(d) characterising isolates of pathogens by the most up-to-date and appropriate methods to allow greater understanding of the epizootiology of the disease;

(e) keeping abreast of developments in the surveillance, epizootiology and prevention of the relevant diseases throughout the world;

(f) retaining expertise on relevant disease pathogens to enable rapid differential diagnosis;

2. to assist actively in the diagnosis of disease outbreaks in Member States by receiving pathogen isolates for confirmatory diagnosis, characterisation and epizootic studies;

3. to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community;

4. to collaborate as regards methods of diagnosing exotic diseases, with the competent laboratories in third countries where those diseases are prevalent.

_____________

2001/293/EC, Art. 1

ANNEX III

NATIONAL REFERENCE LABORATORIES FOR DISEASES OF BIVALVE MOLLUSCS

2003 Act of Accession, Art. 20 and Annex II p. 381 (adapted)

Czech Republic // Laboratoire de Génétique et Pathologie Ifremer

Boîte postale 133

Ronce-les-bains

F- 17390 La Tremblade

2001/293/CE Art. 1

Denmark // Danish Institute for Fisheries Research

Department of Marine Ecology and Aquaculture

Fish Disease Laboratory

Stigbøjlen 4

DK-1870 Frederiksberg C

2001/293/CE Art. 1 (adapted)

Germany // Bundesforschungsanstalt für Viruskrankheiten der Tiere

Boddenblick 5a,

D -17498 Insel Riems

2003 Act of Accession, Art. 20 and Annex II, p. 381 (adapted)

Estonia // Veterinaar- ja Toidulaboratoorium,

Kreutzwaldi 30

EE- 51006 Tartu

2001/293/CE Art. 1 (adapted)

Greece // Centre of Thessaloniki Veterinary Institutions

Departament of Pathology of Aquatic Organisms

80, 26th Octovriou Street

GR-54627, Thessaloniki

Spain // Instituto de Investigaciones Marinas

CSIC

Eduardo Cabello, 6

E -36208 Vigo

France // Laboratoire de Génétique et Pathologie Ifremer

Boîte postale 133

Ronce-les-bains

F -17390 La Tremblade

Ireland // Fish Health Unit

Marine Institute

Abbotstown, Castleknock

Dublin 15

Ireland

Italy // Area Ittiopatologia Laboratorio Patologia Molluschi

Istituto Zooprofilattico Sperimentale delle Venezie

Via della Roggia, 94

I -33030 Basaldella di Campoformido (UD)

2003 Act of Accession, Art. 20 and Annex II, p. 381 (adapted)

Cyprus // Éíóôéôïýôï Ëïéµùäþí êáé Ðáñáóéôéêþí ÍïóçµÜôùí,

ÊÝíôñï Êôçíéáôñéêþí ÉäñõµÜôùí

80, Ïäüò, 26çò Ïêôùâñßïõ

GR -54627, Èåóóáëïíßêç

// Institute of Infectious and Parasitological Diseases

Center of Veterinary Institutes,

80, 26th Octovriou Street

GR -54627, Thessaloniki

2003 Act of Accession, Art. 20 and Annex II, p. 381

Latvia // Valsts veterinrmedic;nas diagnostikas centrs

Lejupes iela 3

LV-1076 R;ga

Lithuania // Nacionalin' veterinarijos laboratorija

J. Kairi{ksio g. 10

LT-2021 Vilnius

Hungary // Országos Állategészségügyi Intézet (OÁI) Pf. 2.

Tábornok u. 2.

H-1581 Budapest

2003 Act of Accession, Art. 20 and Annex II, p. 381 (adapted)

Malta // Area Ittiopatologia Laboratorio Patologia Molluschi

Istituto Zooprofilattico Sperimentale delle Venezie

Via della Roggia, 94

I-33030 Basaldella di Campoformido (UD)

2001/293/CE Art. 1 (adapted)

Netherlands // Fish Diseases Laboratory

ID-Lelystad, Institute for Animal Science and Health

Edelhertweg 15

PO Box 65

8200 AB Lelystad

Nederland

2003 Act of Accession, Art. 20 and Annex II, p. 381

Poland // Laboratorium ZakRadu Higieny jrodków ywienia Zwierzt

PaTstwowego Instytutu Weterynaryjnego

Al. Partyzantów 57

PL-24-100 PuRawy

Slovenia // Nacionalni veterinarski institut

Gerbieva 60

SLO-1000 Ljubljana

2003 Act of Accession, Art. 20 and Annex II, p. 381 (adapted)

Slovakia // Laboratoire de Génétique et Pathologie Ifremer

Boîte postale 133

Ronce-les-bains

F-17390 La Tremblade

2001/293/CE Art. 1 (adapted)

United Kingdom, England // CEFAS Weymouth laboratory

Barrack road

The Nothe

Weymouth

Dorset, DT4 8UB

United Kingdom

United Kingdom, Scotland // Fisheries Research Services Marine Laboratory

PO Box 101 Victoria Road

Aberdeen, AB11 9DB

United Kingdom

__________

2003/83/EC Art. 1

ANNEX IV

>TABLE POSITION>

_____________

ANNEX V

Part A

Repealed Directive and its successive amendments (referred to in Article 12)

Council Directive 95/70/EC [14] (OJ L 332, 30.12.1995, p. 33) //

[14] Directive 95/70/EC has also been amended by the following non-repealed act:

Commission Decision 2001/293/EC (OJ L 100, 11.4.2001, p. 30) //

Commission Decision 2003/83/EC (OJ L 32, 7.2.2003, p. 13) //

Council Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1) // only Annex III, pt. 45

Part B

Time-limits for transposition into national law (referred to in Article 12)

Directive // Deadline for transposition

95/70/EC // 1 June 1997

_____________

ANNEX VI

Correlation Table

Directive 95/70/EC // This Directive

Article 1 // Article 1

Article 2(1) // Article 2, first subparagraph

Article 2(2) // Article 2, second subparagraph

Article 3, introductory wording // Article 3, introductory wording

Article 3, point (1) // Article 3, point (a)

Article 3, point (2), introductory wording // Article 3, point (b), introductory wording

Article 3, point (2)(a) // Article 3, point (b)(i)

Article 3, point (2)(b) // Article 3, point (b)(ii)

Article 3, point (2)(c) // Article 3, point (b)(iii)

Article 4(1), first subparagraph // Article 4(1), first subparagraph

Article 4(1), second subparagraph // Article 4(1), second subparagraph

Article 4(1), third subparagraph, introductory wording // Article 4(2), introductory wording

Article 4(1), third subparagraph, first indent // Article 4(2)(a)

Article 4(1), third subparagraph, second indent // Article 4(2)(b)

Article 4(1), third subparagraph, third indent // Article 4(2)(c)

Article 4(2) // Article 4(3)

Article 5 // Article 5

Article 6 // Article 6

Article 7 // Article 7

Article 8 // Article 8

Article 9 // Article 9

Article 10 // Article 10

Article 11 // _____

Article 12(1) // _____

Article 12(2) // Article 11(1)

Article 12(3) // Article 11(2)

_____ // Article 12

Article 13 // Article 13

Article 14 // Article 14

Annex A // Annex I

Annex B // Annex II

Annex C // Annex III

Annex D // Annex IV

_____ // Annex V

_____ // Annex VI

___________________