1993D0383 — EN — 01.05.2004 — 003.001 — 1
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►B COUNCILDECISION
of14June1993
onreference laboratoriesforthemonitoringofmarinebiotoxins
(93/383/EEC)
(OJ L 166, 8.7.1993, p. 31)
Amended by:
Official Journal
No page date
►M1Council Decision 1999/312/EC of 29 April 1999 L 120 37 8.5.1999
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
►A2Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the Slovak
Republic and the adjustments to the Treaties on which the European
Union is foundedL 236 33 23.9.2003
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COUNCILDECISION
of14June1993
onreference laboratoriesforthemonitoringofmarinebiotoxins
(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 of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas 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 (4) lays down, and in particular in the Annex
thereto, various rules regarding biotoxins affecting live bivalvemolluscs;
Whereas Council Directive 91/493/EEC of 22 July 1991 laying down
the health conditions for the production and placing on the market offishery products (
5), sets out, inparticular inArticle 5 an d Chapter V,
point II.B of the Annex thereto, certain rules on marine biotoxins
affecting fishery products;
Whereas the monitoring of marine biotoxins is especially important to
ensure the placing on the market of live bivalve molluscs and fisheryproducts which comply with the requirements of the 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 of the Community reference laboratory should be laiddown;
Whereas the laboratory of the ‘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 incharge of the laboratory have un dertakento carry out the taskslaid downinthis Decisiononthe terms set out herein ;
Whereas this Community reference laboratory is eligible for Commu-
nity aid in accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (
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 — 01.05.2004 — 003.001 — 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 of the 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 of marine 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 of new 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 of analyses are contestedbetweenMember States,
— helping the national reference laboratories to implement an appro-
priate system of quality assurance based on the principles of goodlaboratory 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 of marine biotoxins,
— that the equipment and substances necessary for carrying out the
tasks laid downinArticle 4 are available,
— that anappropriate admin istrative structure is inplace,
— that the confidential nature of certain subjects, results and reports is
observed by staff,
— that the principles of good laboratory practice accepted internation-
ally are followed,1993D0383 — EN — 01.05.2004 — 003.001 — 3
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— that an up-to-date list of the reference substances held by the
Community Bureau of References is available, along with an up todate list of the manufacturers and suppliers of these 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 of the national reference labora-
tories and any updates to it in the Official Journal of the European
Communities.
Article 6
This Decisionis addressed to the Member States.1993D0383 — EN — 01.05.2004 — 003.001 — 4
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ANNEX
Belgium and Luxembourg:
— 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 Wytsman14
B-1050 Bruxelles
Czech Republic:
— Státní veterinární ústav Jihlava
Rantí řovská 93
586 05 Jihlava
Denmark:
— The Danish Veterinary and Food Administration
Institute of Food Research and Nutrition
Mørkhøj Bygade 19
DK-2860 Søborg
Germany:
— Bundesinstitut für gesundheitlichen
Verbraucherschutz und Veterinärmedizin
Postfach 330013
D-14191 Berlin
Estonia:
— Veterinaar- ja Toidulaboratoorium,
Kreutzwaldi 30
51006 Tartu
Greece:
—Ινστιτούτο Υγιεινής Τροφίµων Θεσσαλονίκης
28ης Οκτωβρίου 80
GR-54627Θεσσαλονίκη
Spain:
— Laboratorio de Biotoxinas Marinas
Area de Sanidad
EstaciónMarítima s/n
E-36271 Vigo
France:
— Laboratoire central d'hygiène alimentaire
43, rue de Dantzig
F-75015 Paris
Ireland:
— Fisheries Research Center
AbbotstownIRL-Dublin15
Italy:
— Centro Ricerche Marine
Viale Vespucci 2
I-47042 Cesenatico (FO)1993D0383 — EN — 01.05.2004 — 003.001 — 5
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Cyprus:
—Ινστιτούτο Υγιεινής Τροφίµων,
Κέντρο Κτηνιατρικών Ιδρυµάτων80,Οδός 26
ηςΟκτωβρίου
GR-54627Θεσσαλονίκη
(Institute of Food Hygiene Center of Veterinary Institutes
80, 26thOctober Street
GR-54627 Thessaloniki)
Latvia:
— Valsts veterin ārmedic īnas diagnostikas centrs
Lejupes iela 3LV-1076 R īga
Lithuania:
— Klaip ėdos apskrities valstybin ės maisto ir veterinarijos tarnybos laboratorija
Kretingos g. 62
LT-5809 Klaip ėda
Hungary:
— Országos Élelmiszervizsgáló Intézet (OÉVI)
Pf. 1740.Mester u. 81.
HU-1465 Budapest
Malta:
— Istituto Zooprofilattico Sperimentale delle Venezie
Basaldella di Campoformido (UD)Italy
Netherlands:
— Postbus 1
Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM)NL-3720 BA Bilthoven
Poland:
— Laboratorium Zakładu Higieny Żywno ści Pochodzenia Zwierz ęcego
Państwowego Instytutu Weterynaryjnego
Al. Partyzantów 57
PL-24-100 Puławy
Portugal:
— Laboratório do Instituto Nacional de Investigaçao das Pescas (INIP)
Av. Brasília s/n
P-1400 Lisbon
Slovenia:
— Nacionalni veterinarski inštitut
Gerbi čeva 60
SI-1000 Ljubljana
Slovakia:
— Štátny veterinárny a potravinový ústav
Janoškova 1611/58SK-026 01 Dolný Kubín
Finland:
— Tullilaboratorio/Tullaboratoriet
PL/PB 531993D0383 — EN — 01.05.2004 — 003.001 — 6
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FIN-02151 Espoo/Esbo
Sweden:
— Institutionen för klinisk bakteriologi
Göteborgs universitet
S-41124 Göteborg
United Kingdom:
— Marine Laboratory
P.O. Box 101,
Victoria Road
UK AberdeenAB11 9DB1993D0383 — EN — 01.05.2004 — 003.001 — 7