1995L0070 — EN — 05.06.2003 — 003.001 — 1
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►B COUNCILDIRECTIVE95/70/EC
of22December 1995
introducing minimum Community measures for the control of certain diseases affecting bivalve
molluscs
(OJ L 332, 30.12.1995, p. 33)
Amended by:
Official Journal
No page date
►M1Commission Decision 2001/293/EC of 30 March 2001 L 100 30 11.4.2001
►M2Commission Decision 2003/83/EC of 5 February 2003 L 32 13 7.2.2003
►M3Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
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COUNCILDIRECTIVE95/70/EC
of22December 1995
introducing minimum Community measures for the control of
certaindiseasesaffectingbivalvemolluscs
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, andin particular Article 43 thereof,
Having regard to the proposal from the Commission (
1),
Having regard to the opinion of the European Parliament (2),
Whereas molluscs are listed in Annex II to the Treaty; whereas the
marketing of molluscs constitutes an important source of revenue forthe aquaculture sector;
Whereas the mollusc diseases referred to in Annex A, list II, to Council
Directive 91/67/EEC of 28 January 1991 concerning the animal healthconditionsgoverning the placing on the market of aquaculture animals
and products(
3), have a very serious effect on the shellfish industry;
whereas other diseases having a similar effect occur in third countries,whereas a list of such diseases should be drawn up and the Commis-sion should be given the ability to adjust that list in the light ofdevelopmentsin the animal-health field;
Whereas an outbreak of such diseases can quickly take on epizootic
proportions, causing mortality and disturbances on a scale liableconsiderably to reduce the profitability of shellfish-farming;
Whereas 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 tothe protection of animal health in the Community;
Whereas Member States should report to the Commission and the other
Member States all cases of abnormal mortality observed in bivalvemolluscs;
Whereas, in such an event, measures must be taken aimed at
preventing the spread of the disease, in particular with regard to theremoval of live bivalve molluscs from the farms or zones concerned;
Whereas a thorough epidemiological investigation is essential to deter-
mine the origin of the disease and to prevent further spread;
Whereas, in order to ensure an effective system of control, diagnosis of
the diseases must be harmonized and carried out under the auspices of
responsible laboratories, the coordination of which may be ensured by
a reference laboratory designated by the Community;
Whereas, in order to ensure uniform implementation of this Directive, a
Community inspection procedure should be established;
Whereas common measures for the control of diseases form a
minimum basis for maintaining a uniform standard of animal health;
Whereas the Commission should be entrusted with the task of adopting
the necessary implementing measures,1995L0070 — EN — 05.06.2003 — 003.001 — 2
(1) OJ No C 285, 13. 10. 1994, p. 9.
(2) OJ No C 109, 1. 5. 1995, p. 2.
(3) OJ No L 46, 19. 2. 1991, p. 1. Directive aslas t amended by Directive 95/22/
EC (OJ No L 243, 11. 10. 1995, p. 1).
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HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive establishes minimum Community measures for the
control of the diseases affecting bivalve molluscs referred to in thisDirective.
Article 2
1. For the purposes of this Directive, the definitions laid down in
Article 2 of Directive 91/67/EEC and Article 2 of Directive 91/492/
EEC (
1) shall apply as necessary.
2. In addition, ‘observed abnormal mortality’ shall mean sudden
mortality affecting approximately 15 % of stocks and occurring over ashort period between two inspections (confirmed within 15 days). Inhatchery a mortality shall be considered abnormal when the farmercannot obtain larvae during a period which included successive spawnsfrom 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.
Article 3
Member States shall ensure that all farms rearing bivalve molluscs:1. are registered by the official service; this registration must be kept
constantly up to date;
2. keep a record of:
(a) live bivalve molluscs entering the farm, containing all informa-
tion relating to their delivery, their number or weight, their size
and their origin;
(b) bivalve molluscs leaving the farm for reimmersion, containing
all information relating to their dispatch, their number or weight,their size and destination;
(c) observed abnormal mortality.
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 thesea.
If, during application of thisprogramme, any abnormal mortality is
observed, or if the official service has information giving it reason tosuspect the presence of diseases, the following measures shall be taken:
— 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,
— 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 D, or on which the official service has information givingit reason to suspect the presence of diseases,1995L0070 — EN — 05.06.2003 — 003.001 — 3
(1) Council Directive 91/492/EEC of 15 July 1991 laying down the health
conditionsfor the production and the placing on the market of live bivalve
molluscs (OJ No L 268, 24. 9. 1991, p. 1). Directive as amended by the
1994 Act of Accession.
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— monitoring of the evolution and geographical spread of the diseases
referred to in the first and second indents.
2. The detailed rulesfor implementing thisArticle, and inter alia the
rules to be applied for establishing the programme referred to in para-graph 1, particularly asregardsthe frequency and timetable ofmonitoring, procedures for taking samples (statistically representative
volume) and methods of diagnosis, shall be adopted in accordance
with the procedure provided for in Article 10.
Article 5
1. Member States shall ensure that the suspected presence of any
diseases referred to in Article 4 and any abnormal mortality rateobserved in bivalve molluscs in farms, in farming areas or in harvestednatural 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 obser-vations.
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 orpurification centres or storage tanks which discharge water into thesea for relaying or reimmersion in another farm or in the aquaticenvironment, unless authorized by the official service.
3. If the examination referred to in paragraph 2 (a) failsto demon-
strate the presence of a pathogen, the restrictions referred to inparagraph 2 (b) shall be lifted.
4. If the examination referred to in paragraph 2 shows the presence
of a pathogen causing the observed abnormal mortality capable ofbeing the cause of that mortality, or of a pathogen of one of thediseases 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 leftthe farm, the farming area or the harvested natural beds for relaying orreimmersion elsewhere during the period preceding observation of theabnormal mortality.
If the epizootic investigation shows that the disease has been intro-
duced into one or more farms, farming areas or harvested natural bedsasa res ult inter alia of molluscs being moved, the provisions of para-
graph 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, authorize themovement of live bivalve molluscs to other farms, farming areas or
harvested natural beds which are infected with the same disease.
If necessary, further appropriate measures may be decided on in accor-
dance with the procedure in Article 10.
5. The official service shall ensure that the Commission and the
other Member Statesare immediately informed, in accordance withthe 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.
Article 6
1. Sampling and laboratory testing for the determination of the cause
of abnormal mortality of bivalve molluscs shall be carried out using themethods established in accordance with the procedure laid down inArticle 10.
2. Member States shall ensure that in each Member State a national
reference laboratory is designated, with facilities and expert personnelenabling it to carry out the testing referred to in paragraph 1.1995L0070 — EN — 05.06.2003 — 003.001 — 4
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3. By way of derogation from paragraph 2, Member Stateswhich do
not have a national laboratory competent in the matter may use theservices of a national laboratory with competence in the matter in
another Member State.
4. The list of national reference laboratories for diseases of bivalve
molluscs is set out in Annex C.
5. National reference laboratoriess hall cooperate with the Commu-
nity reference laboratory referred to in Article 7.
Article 7
1. The Community reference laboratory for diseases of bivalve
molluscs is indicated in Annex A.
2. Without prejudice to Decision 90/424/EEC of 26 June 1990 (
1)o n
expenditure in the veterinary field and in particular Article 28 thereof,the functionsand dutiesof the laboratory referred to in paragraph 1shall be those laid down in Annex B.
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 therequirementsof thisDirective.
The Commission shall inform the Member States of the results of these
checks.
2. The checksreferred to in paragraph 1 s hall be carried out in
collaboration with the competent authority.
3. The Member State in whose territory the inspections are carried
out shall provide the experts with any assistance they require to accom-plish their task.
4. Detailed rulesfor the application of thisArticle s hall be adopted
in accordance with the procedure laid down in Article 10.
Article 9
Annex A shall be amended as necessary by the Council, acting by a
qualified majority on a proposal from the Commission.
Annexes B, C and D may be amended as necessary in accordance with
the procedure laid down in Article 10.
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 ofRegulation (EC) No 178/2002 (
2).
2. Where reference ismade to thisArticle, Articles5 and 7 of Deci-
sion 1999/468/EC (3) 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.1995L0070 — EN — 05.06.2003 — 003.001 — 5
(1) OJ No L 224, 18. 8. 1990, p. 19. Decision last amended by Decision 94/370/
EC (OJ No L 168, 2. 7. 1994, p. 31).
(2) OJ L 31, 1.2.2002, p. 1.
(3) OJ L 184, 17.7.1999, p. 23.▼M3
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Article 11
By 31 December 1999 at the latest, the Commission shall submit a
report to the Council which has been drawn up, if necessary after
consulting the Scientific and veterinary Committee, taking account of
experience acquired in applying thisDirective and of technical andscientific developments, accompanied where appropriate by any propo-sals for amendments.
The Council shall act by a qualified majority on any such proposals.
Article 12
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directivebefore 1 June 1997. They shall forthwith inform the Commissionthereof.
When Member States adopt these provisions, they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on the
occasion of their official publication. The methods of making suchreference shall be laid down by Member States.
2. However, from the date laid down in paragraph 1, Member States
may, subject to the general rules of the Treaty, maintain or apply fortheir production stricter provisions than those laid down by this Direc-
tive. They shall notify the Commission of any such measure.
3. Member States shall communicate to the Commission the main
provisions of national law which they adopt in the field governed bythisDirective.
Article 13
ThisDirective s hall enter into force on the 20th day following that of
itspublication in the Official Journal of the European Communities .
Article 14
This Directive is addressed to the Member States.1995L0070 — EN — 05.06.2003 — 003.001 — 6
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ANNEX A
COMMMUNITY REFERENCE LABORATORY FOR DISEASES OF
BIVALVEMOLLUSCS
IFREMER
Boîte Postale 13317390 La Tremblade
France1995L0070 — EN — 05.06.2003 — 003.001 — 7
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ANNEX B
FUNCTIONS ANDD UTIES OF THE COMMUNITY REFERENCE
LABORATORYFORDISEASESOFBIVALVEMOLLUSCS
The function and dutiesof the Community reference laboratory s hall 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
laboratoriesin the Member States ;
(b) organizing periodic comparative tests of diagnostic procedures at
Community level;
(c) collecting and collating data and information on the methodsof diagnos is
used and the results of tests carried out in the Community;
(d) characterizing isolates of pathogens by the most up-to-date and appro-
priate methodsto allow greater unders tanding 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 differen-
tial diagnosis;
2. to assist actively in the diagnosis of disease outbreaks in Member States by
receiving pathogen isolates for confirmatory diagnosis, characterization and
epizootic studies;
3. to facilitate the training or retraining of expertsin laboratory diagnos iswith a
view to the harmonization of diagnostic techniques throughout the Commu-
nity;
4. to collaborate as regards methods of diagnosing exotic diseases, with the
competent laboratories in third countries where those diseases are prevalent.1995L0070 — EN — 05.06.2003 — 003.001 — 8
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ANNEX C
NATIONALREFERENCELABORATORIESFORDISEASESOFBIVALVEMOLLUSCS
Denmark: Danish Institute for Fisheries Research
Department of Marine Ecology and Aquaculture
Fish Disease Laboratory
Stigbøjlen 4
DK-1870 Frederiksberg C
France: Laboratoire de Génétique et Pathologie
Ifremer, Ronce lesbains
F-17390 La Tremblade
Germany: Bundesforschungsanstalt für Viruskrankheiten der Tiere
Boddenblick 5a
D-17498 Insel Riems
Greece: Centre of Thessaloniki Veterinary Institutions
Department of Pathology of Aquatic Organisms
80, 26thOctovriou str.
GR-54627 Thessaloniki
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)
Netherlands: Fish Diseases Laboratory
ID-Lelystad, Institute for Animal Science and Health
Edelhertweg 15
PO box 65
8200 AB Lelystad
Nederland
Spain: Instituto de Investigaciones Marinas
CSIC
Eduardo Cabello, 6
E-36208 Vigo
UnitedKingdom,England: CEFAS Weymouth Laboratory
Barrack road
The Nothe
Weymouth, Dorset DT4 8UB
United Kingdom
UnitedKingdom,Scotland: Fisheries Research Services Marine Laboratory
PO box 101 Victoria Road
Aberdeen AB11 9DB
United Kingdom1995L0070 — EN — 05.06.2003 — 003.001 — 9
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ANNEX D
Disease Pathogen Susceptible host species
Bonamiosis Bonamia exitiosus Tiostrea chilensis andOstrea angasi
Mikrocytos roughleyi Saccostrea (Crassotrea) commercialis
Marteiliosis Marteilia sydneyi Saccostrea (Crassotrea) commercialis
Microcytosis Mikrocytos mackini Crassotrea gigas ;C .virginica; Ostrea
edulis;O .conchaphila
Perkinsosis Perkinsus marinus Crassotrea virginica and C.gigas
Perkinsus olseni/atlan-
ticusHaliotis ruber ;H .cyclobates ;H .scalaris ;
H.laevigata ;Ruditapes philippinarum
and R.decussates
MSX disease Haplosporidium nelsoni Crassotrea virginica and C.gigas
SSO disease Haplosporidium costale Crassotrea virginica
Withering syndrome of
abalonesCandidatus Xenohaliotis
californiensisMembersof the genus Haliotis including
black abalone (H. cracherodii) , red
abalone (H. rufescens ), pink abalone (H.
corruguta ), green abalone (H. fulgens)
and white abalone (H. sorenseni)
Note:Susceptible host species also includes any other species specified, for the pathogen in question, in the Inter-
national Office of Epizooties' (OIE) most recent edition of the International Aquatic Animal Health Code.1995L0070 — EN — 05.06.2003 — 003.001 — 10