Proposal for a COUNCIL DECISION on reference laboratories for the monitoring of marine biotoxins
Date: 1992-12-16
Institutions: European Commission
Subjects: fishery product, health control, mollusc, research body, supervisory body, toxic substance

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 
2 
3 

OJ  No L 268, 24.9.1991,  p.1. 
OJ  No L 268, 24.9.1991, p.15. 
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 
2 
3 
4 
5 

OJ  No C 
OJ  No C 
OJ  No C 
OJ  No L 268, 24.09.1991,  p.1. 
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 

I n s t i t ut  d'Hygiène  et  Epidemiologic 
Av.  J u l i e t te  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 

Nethtriindi 

- C-

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 

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