1993D0383 — EN — 08.05.1999 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DECISION
of 14 June 1993
on reference laboratories for the monitoring of marine biotoxins
(93/383/EEC)
(OJ L 166, 8.7.1993, p. 31)
Amended by:
Official Journal
No page date
►M1Council Decision 1999/312/EC of29 April 1999 L 120 37 8.5.1999
Amended by:
►A1Act ofAccession ofAustria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
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COUNCIL DECISION
of 14 June 1993
on reference laboratories for the monitoring of marine biotoxins
(93/383/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion ofthe European Parliament (2),
Having regard to the opinion ofthe Economic and Social
Committee (3),
Whereas Council Directive 91/492/EEC of15 July 1991 laying down
the health conditions for the production and the placing on the market
oflive bivalve molluscs (4) lays down, and in particular in the Annex
thereto, various rules regarding biotoxins affecting live bivalvemolluscs;
Whereas Council Directive 91/493/EEC of22 July 1991 laying down
the health conditions for the production and placing on the market offishery products (
5), sets out, in particular in Article 5 and Chapter V,
point II.B ofthe Annex thereto, certain rules on marine biotoxins
affecting fishery products;
Whereas the monitoring ofmarine biotoxins is especially important to
ensure the placing on the market oflive bivalve molluscs and f isheryproducts which comply with the requirements ofthe said Directives;
Whereas, in order to provide an efficient monitoring system to test for
marine biotoxins, a national reference laboratory responsible for coor-
dinating the necessary analyses in each Member State should bedesignated;
Whereas, to ensure a standardized system throughout the Community, a
Community reference laboratory should be designated which will be
responsible for coordinating the monitoring of marine biotoxins carried
out by each national reference laboratory; whereas the tasks and oper-ating conditions ofthe Community ref erence laboratory should be laiddown;
Whereas the laboratory ofthe ‘Ministerio de Sanidad y Consumo’ in
Vigo fulfils all the necessary conditions in order to be designated the
Community reference laboratory for marine biotoxins; whereas the offi-
cials in charge ofthe laboratory have undertaken to carry out the taskslaid down in this Decision on the terms set out herein;
Whereas this Community reference laboratory is eligible for Commu-
nity aid in accordance with Article 28 ofCouncil Decision 90/424/EEC of26 June 1990 on expenditure in the veterinary f ield (
6),
HAS ADOPTED THIS DECISION:
Article 1
The laboratories listed in the Annex hereto are hereby designated as
national reference laboratories for the monitoring of marine biotoxins.1993D0383 — EN — 08.05.1999 — 002.001 — 2
(1) OJ No C 15, 18. 1. 1993, p. 7.
(2) OJ No C 115, 26. 4. 1993.
(3) OJ No C 129, 10. 5. 1993, p. 7.
(4) OJ No L 268, 24. 9. 1991, p. 1.
(5) OJ No L 268, 24. 9. 1991, p. 15.
(6) OJ No L 224, 18. 8. 1990, p. 19.
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Article 2
1. Each national reference laboratory shall be responsible for the
following tasks:
— coordinating the activities ofthe national laboratories responsible
for analyses of marine biotoxins in the relevant Member State,
— assisting the competent authority in the Member State to organize
the system for monitoring marine biotoxins,
— organizing comparative tests between the various national labora-
tories responsible for analysing marine biotoxins,
— ensuring that the information supplied by the Community reference
laboratory is disseminated to the competent authority in the relevantMember State and to the national laboratories responsible foranalysing marine biotoxins.
2. The national reference laboratories shall collaborate with the
Community reference laboratory referred to in Article 3.
Article 3
The ‘Laboratorio de biotoxinas marinas del Area de Sanidad’ in Vigo
is hereby designated as the Community reference laboratory for themonitoring ofmarine biotoxins.
Article 4
The Community reference laboratory shall be responsible for the
following tasks:
— supplying information on analytical methods and comparative
testing to the national reference laboratories,
— coordinating the application by the national reference laboratories
of the methods referred to in the first indent, by organizingcomparative testing in particular,
— coordinating the development ofnew analytical methods and
informing the national reference laboratories of progress made in
this area,
— organizing training and advanced courses for the staff of the
national reference laboratories,
— collaborating with the laboratories responsible for analysing marine
biotoxins in third countries,
— providing scientific and technical assistance to the Commission,
especially in cases where the results ofanalyses are contestedbetween Member States,
— helping the national reference laboratories to implement an appro-
priate system ofquality assurance based on the principles ofgoodlaboratory practice (GLP) and the EN 45 000 criteria.
Article 5
The Community reference laboratory for marine biotoxins shall satisfy
the following operating conditions;
— that staff are qualified and have sufficient knowledge of the techni-
ques applied in the analysis ofmarine biotoxins,
— that the equipment and substances necessary for carrying out the
tasks laid down in Article 4 are available,
— that an appropriate administrative structure is in place,
— that the confidential nature of certain subjects, results and reports is
observed by staff,
— that the principles ofgood laboratory practice accepted internation-
ally are followed,1993D0383 — EN — 08.05.1999 — 002.001 — 3
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— that an up-to-date list ofthe ref erence substances held by the
Community Bureau ofRef erences is available, along with an up todate list ofthe manuf acturers and suppliers ofthese substances.
Article 5a
The Commission shall amend the Annex to this Decision where neces-
sary following any notification submitted to it by a Member Stateconcerning its national reference laboratory for the monitoring ofmarine biotoxins.
The Commission shall publish the list ofthe national ref erence labora-
tories and any updates to it in the Official Journal of the European
Communities.
Article 6
This Decision is addressed to the Member States.1993D0383 — EN — 08.05.1999 — 002.001 — 4
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ANNEX
Belgium andLuxembourg:
— Ministère des Affaires Sociales, de la Santé Publique et de l'Environnement
Institut Scientifique de la Santé Publique — Louis Pasteur
Section ‘Denrées alimentaires’
Département ‘Pharmaco-Bromatologie’Rue Juliette Wytsman 14
B-1050 Bruxelles
Denmark:
— The Danish Veterinary and Food Administration
Institute ofFood Research and Nutrition
Mørkhøj Bygade 19
DK-2860 Søborg
Germany:
— Bundesinstitut für gesundheitlichen
Verbraucherschutz und Veterinärmedizin
Postfach 330013
D-14191 Berlin
Greece:
—Ινστιτούτο Υγιεινής Τροφίµων Θεσσαλονίκης
28ης Οκτωβρίου 80
GR-54627 Θεσσαλονίκη
Spain:
— Laboratorio de Biotoxinas Marinas
Area de SanidadEstación Marítima s/n
E-36271 Vigo
France:
— Laboratoire central d'hygiène alimentaire
43, rue de Dantzig
F-75015 Paris
Ireland:
— Fisheries Research Center
Abbotstown
IRL-Dublin 15
Italy:
— Centro Ricerche Marine
Viale Vespucci 2
I-47042 Cesenatico (FO)
Netherlands:
— Postbus 1
Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM)
NL-3720 BA Bilthoven
Portugal:
— Laboratório do Instituto Nacional de Investigaçao das Pescas (INIP)
Av. Brasília s/n
P-1400 Lisbon
Finland:
— Tullilaboratorio/Tullaboratoriet
PL/PB 53
FIN-02151 Espoo/Esbo1993D0383 — EN — 08.05.1999 — 002.001 — 5
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Sweden:
— Institutionen för klinisk bakteriologi
Göteborgs universitet
S-41124 Göteborg
UnitedKingd om:
— Marine Laboratory
P.O. Box 101,
Victoria Road
UK Aberdeen AB11 9DB1993D0383 — EN — 08.05.1999 — 002.001 — 6