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"B COUNCIL DIRECTIVE 95/70/EC
of 22 December 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
"M1 Commission Decision 2001/293/EC of 30 March 2001 L 100 30 11.4.20011995L0070 — EN — 11.04.2001 — 001.001 — 1
COUNCIL DIRECTIVE 95/70/EC
of 22 December 1995
introducing minimum Community measures for the control of certain
diseases affecting bivalve molluscs
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
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 for the aquaculturesector;
Whereas 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 andproducts (
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 Commission should be given the abilityto adjust that list in the light of developments in the animal-health field;
Whereas 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;
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 ensurerational development of shellfish-farming and to contribute to the 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 bivalve molluscs;
Whereas, 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;
Whereas a thorough epidemiological investigation is essential to determine
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 areference 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,
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.!B
(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 as last amended by Directive 95/22/EC (OJ
No L 243, 11. 10. 1995, p. 1).1995L0070 — EN — 11.04.2001 — 001.001 — 2
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 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 aperiod which included successive spawns from different broodstocks. Innursery 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 information
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 inorder to observe whether there is an abnormal mortality and keep track of thehealth 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.
If, during application of this programme, any abnormal mortality is observed,
or if the official service has information giving it reason to suspect thepresence 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 suchdiseases 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 giving it reason tosuspect the presence of diseases,
— monitoring of the evolution and geographical spread of the diseases
referred to in the first and second indents.
2. 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, proceduresfor taking samples (statistically representative volume) and methods of
diagnosis, shall be adopted in accordance with the procedure provided for in
Article 10.!B
(1) Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions
for 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.1995L0070 — EN — 11.04.2001 — 001.001 — 3
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 inpurification 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 orreimmersion in another farm or in the aquatic environment, unlessauthorized 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 belifted.
4. If the examination referred to in paragraph 2 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 inorder 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 reimmersion elsewhere during the period precedingobservation of the abnormal mortality.
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, authorize the movement of livebivalve 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 accordance
with the procedure in Article 10.
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 thesituation 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 the methodsestablished in accordance with the procedure laid down in Article 10.
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 anational 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 laboratories shall cooperate with the Community
reference laboratory referred to in Article 7.!B1995L0070 — EN — 11.04.2001 — 001.001 — 4
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
functions and duties of the laboratory referred to in paragraph 1 shall 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 thecompetent 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.
3. The Member State in whose territory the inspections 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 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. Where the procedure laid down in this Article is to be followed, matters
shall be referred without delay to the Standing Veterinary Committee,
(hereinafter referred to as ‘the Committee’), set up by decision
68/361/EEC (
2), by its Chairman, either on his own initiative or at the request
of a Member State.
2. The representative of the Commission shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver its opinion onthe draft within the time limit which the Chairman may lay down according to
the urgency of the matter. The opinion shall be delivered by the majority laid
down in Article 148 (2) of the Treaty in the case of decisions which theCouncil is required to adopt on a proposal from the Commission. The votes ofthe representatives of the Member States within the Committee shall be
weighted in the manner set out in that Article. The Chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee
(b) If the measures envisaged are not in accordance with the opinion of
the Committee, or if no opinion is delivered, the Commission shall,
without delay, submit to the Council a proposal relating to themeasures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months, from the date of referral to the
Council, the Council has not acted, the proposed measures shall be adopted by
the Commission, save where the Council has decided against the said
measures by a simple majority.!B
(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 No L 255, 18. 10. 1968, p. 23.1995L0070 — EN — 11.04.2001 — 001.001 — 5
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 this Directive and of technical and scientific developments,accompanied where appropriate by any proposals 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 Directive before 1June 1997. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to
this Directive or shall be accompanied by such reference on the occasion of
their official publication. The methods of making such reference 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 for theirproduction stricter provisions than those laid down by this Directive. Theyshall 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 by this
Directive.
Article 13
This Directive shall enter into force on the 20th day following that of its
publication in the Official Journal of the European Communities .
Article 14
This Directive is addressed to the Member States.!B1995L0070 — EN — 11.04.2001 — 001.001 — 6
ANNEX A
COMMMUNITY REFERENCE LABORATORY FOR DISEASES OF BIV AL VE
MOLLUSCS
IFREMER
Boîte Postale 13317390 La TrembladeFrance!
B1995L0070 — EN — 11.04.2001 — 001.001 — 7
ANNEX B
FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORA-
TORY FOR DISEASES OF BIV AL VE 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) organizing 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) characterizing 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, characterization and
epizootic studies;
3. to facilitate the training or retraining of experts in laboratory diagnosis with a view
to the harmonization 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.!B1995L0070 — EN — 11.04.2001 — 001.001 — 8
ANNEX C
NATIONAL REFERENCE LABORATORIES FOR DISEASES OF BIV AL VE
MOLLUSCS
Denmark: Danish Institute for Fisheries Research
Department of Marine Ecology and AquacultureFish Disease LaboratoryStigbøjlen 4DK-1870 Frederiksberg C
France: Laboratoire de Génétique et Pathologie
Ifremer, Ronce les bains
F-17390 La Tremblade
Germany: Bundesforschungsanstalt für Viruskrankheiten der Tiere
Boddenblick 5aD-17498 Insel Riems
Greece: Centre of Thessaloniki Veterinary Institutions
Department of Pathology of Aquatic Organisms
80, 26
thOctovriou str.
GR-54627 Thessaloniki
Ireland: Fish Health Unit
Marine InstituteAbbotstown, CastleknockDublin 15Ireland
Italy: Area Ittiopatologia Laboratorio Patologia Molluschi
Istituto Zooprofilattico Sperimentale delle VenezieVia della Roggia, 94I-33030 Basaldella di Campoformido (UD)
Netherlands: Fish Diseases Laboratory
ID-Lelystad, Institute for Animal Science and HealthEdelhertweg 15
PO box 65
8200 AB LelystadNederland
Spain: Instituto de Investigaciones Marinas
CSICEduardo Cabello, 6E-36208 Vigo
United Kingdom,
England:CEFAS Weymouth Laboratory
Barrack roadThe NotheWeymouth, Dorset DT4 8UBUnited Kingdom
United Kingdom,
Scotland:Fisheries Research Services Marine Laboratory
PO box 101 Victoria Road
Aberdeen AB11 9DB
United Kingdom!
M11995L0070 — EN — 11.04.2001 — 001.001 — 9
ANNEX D
Diseases Pathogens Sensitive species
Haplosporidiosis Haplosporidium nelsoni Crassostrea virginica
Haplosporidium costale Crassostrea virginica
Perkinosis Perkinsus marinus Crassostrea virginica
Perkinsus olseni Haliotis rubra
H. Laevigata
Mikrokytosis Mikrokytos mackini Crassostrea gigas
O. edulis
O. puelchana
O. denselomellosaTiostrea chilensis
Mikrokytos roughleyi Saccostrea commercialis
Iridovirosis Oyster velar virus Crassostrea gigas
Marteiliosis Marteilia sidneyi Saccostrea commercialis!
B1995L0070 — EN — 11.04.2001 — 001.001 — 10