COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(92) 551 final 
Brussels, 16 December 1992 
Proposal for a 
COUNCIL PECISIQN 
on reference laboratories for the monitoring of 
mar ine biotoxins 
(presented by the Commission) 
- 1-
EXPLANATORY MEMORANDUM 
Council Directives 91/492/EEC of 15 July 1991 laying down the health 
conditions for the production and placing on the market of live bivalve 
molluscs1 and 91/493/EEC of 22 July 1991 laying down the health conditions 
for the production and the placing on the market of fishery products2 lay 
down requirements concerning marine biotoxins with the aim of guaranteeing the 
who Iesomeness of products covered by these Directives. 
As a consequence, it is necessary to designate a Community reference 
laboratory capable of ensuring the effectiveness of the systems for monitoring 
marine biotoxins implemented in each Member State; this Community laboratory 
will also coordinate the activities of the national reference laboratories. 
The attached proposal defines the tasks and operating conditions of the 
Community reference laboratory and the national reference laboratories. 
The Community laboratory chosen, the "Laboratorio de Sanidad" in Vigo, fulfils 
all the conditions necessary to be designated a Community reference 
laboratory. 
It should be noted that the Community reference laboratory qualifies for 
Community assistance on the terms set out in Article 28 of Council 
Decision 90/424/EEC3 of 26 June 1990 on expenditure in the veterinary field. 
The financial impact of this draft proposal for a Council Decision has already 
been allowed for and will be defined in the implementing Decision to be 
adopted under Article 28 of Council Decision 90/424/EEC. 
1 OJ No L 268, 24.9.1991, p.1. 
2 OJ No L 268, 24.9.1991, p.15. 
3 OJ No L 224, 18.8.1990, p.19. 
— /} vn^t? — 
Proposal for a 
Counc11 Dec I s i on / /EEC 
on reference laboratories for the monitoring of 
mar ine biotox ins 
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 Commission1, 
Having regard to the opinion of the European Par Iiament2, 
Having regard to the opinion of the Economic and Social Committee3, 
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 
molluscs4 lays down, and in particular in the Annex thereto, various rules 
regarding biotoxins affecting live bivalve molluscs; 
Whereas Council Directive 91/493/EEC of 22 July 1991 laying down the health 
conditions for the production and placing on the market of fishery products5, 
sets out, in particular in Article 5 and Chapter V, point 11.3. 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 fishery products which 
conform to the requirements of the aforementioned Directives-, 
1 OJ No C 
2 OJ No C 
3 OJ No C 
4 OJ No L 268, 24.09.1991, p.1. 
5 OJ No L 268, 24.09.91, p.15. 
Whereas, in order to provide an efficient monitoring system to test for marine 
biotoxins, a national reference laboratory responsible for coordinating the 
necessary analyses in each Member State should be designated; 
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 operating conditions of the 
Community reference laboratory should be laid down; 
Whereas the laboratory of the "Ministerio de Sanidad y Consumo" in Vigo 
fulfils all the necessary conditions to be designated the Community reference 
laboratory for marine biotoxins; whereas the officials in charge of the 
laboratory have undertaken to carry out the tasks laid down in this Decision 
on the terms set out herein; 
Whereas this Community reference laboratory is eligible for Community aid in 
accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on 
expenditure in the veterinary field6, 
HAS ADOPTED THIS DECISION: 
Article 1 
The laboratories listed in the Annex hereto are designated national reference 
laboratories for the monitoring of marine biotoxins. 
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; 
6 0J L 224, 18.08.1990, p. 19. 
-3-
- assisting the competent authority in the Member State to organize the 
system for monitoring marine biotoxins; 
- organizing comparative tests between the various national laboratories 
responsible for analysing marine biotoxins; 
- ensuring that the information supplied by the Community reference 
laboratory is disseminated to the competent authority in the relevant' 
Member State and to the national laboratories responsible for analysing 
marine biotoxins. 
2. The national reference laboratories shall collaborate with the Community 
reference laboratory referred to in Article 3. 
Article 3 
The laboratory of the "Ministerio de Sanidad y Consumo" in Vigo is designated 
the Community reference laboratory for the monitoring 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 above, by organizing comparative 
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 contested between Member States. 
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 techniques 
applied in the analysis of marine biotoxins; 
- that the equipment and substances necessary for carrying out the tasks laid 
down in Article 4 are available, 
- that an appropriate administratve structure is in place, 
- that the confidential nature of certain subjects, results and reports is 
observed by staff, 
- that the principles of good laboratory practice accepted internationally 
are fol lowed, 
- that an up-to-date list of the reference substances held by the Community 
Bureau of References is available, along with an up-to-date list of the 
manufacturers and suppliers of these substances. 
Article 6 
This Decision is addressed to the Member States. 
Done at For the Counc i I 
ANNEX 
PPlflitf» and Uixeiafrcurfl 
Institut d'Hygiène et Epidemiologic 
Av. Juliette Vytsman 14-16 
1050 Brussels - BELGIUM 
Scandox 
Tornbjergveg 40 
Eyby, DK-4623 Lille Skensved - DENMARK 
Bundeageaundheitaaint (BOA) 
ThielaMee 88-02 
D-1000 Berlin 23 - GERMANY 
Qfeeçf 
The Institute of Hygiene 
lèse Odos 75 Botanicos 
11855 Athens - GREECE 
Spa. In 
Laborator Io del Ministerlo de Sanidad y Consuroo 
Uni dad AdministrâtWa de Vigo 
Estac Ion «writ he* s/n 
36210 VIgo - SPAIN 
France 
Laboratoire Centra* d'Hygien* Alimentaire 
Rue de Dantzig 43 
75015 Par l# - mmCM 
I retard 
Fisheries Research Centre 
Abbotstown 
Dublin 15 - IRELAND 
itajy 
Consorzio di Studi, Ricerche ed Interventi su lie Risorse Marine 
Via le Voopuccl 2 
47042 Cesenatico (FO) - ITALY 
-C-
Nethtriindi 
RiJksinstituut voor Volksgezonheid en Mi Iieuhygiëne (RIVM) 
P.O. Box 1 
3720 BA Bithoven - NETHERLANDS 
Portugal 
Laboratorlo do Instituto Naclonal de Investigaçâo das Pescas (INIP) 
Av. Bras 11ia s/n 
1400 Lisbon - PORTUGAL 
United Kingdom 
Torry Research Station 
P.O. BOX 31, 135 Abbey Road 
Aberdeen AB9 8DG, UK - UNITED KINGDOM 
~-1 __ ISSN 0254-1475 
COM(92) 551 final 
DOCUMENTS 
EN 03 10 
Catalogue number : CB-CO-92-573-EN-C 
ISBN 92-77-50690-3 
Office for Official Publications of the European Communities 
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