Proposal for a European Parliament and Council Decision on reference laboratories for monitoring bacteriological and viral contamination of bivalve molluscs
Date: 1997-06-25
Institutions: European Commission
Subjects: animal disease, health control, mollusc, research body, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES 

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Brussels, 25.06.1997 
COM(97) 310  final 

97/0182 (COD) 

Proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DECISION 
on reference laboratories for monitoring bacteriological and viral contamination 
of bivalve molluscs 

(presented by the Commission) 

EXPLANATORY  MEMORANDUM 

Council  Directive  91/492/EEC  of  15  July  1991  laying  down  the  health  conditions  for  the 
production  and placing on the market  of live bivalve molluscs1  stipulates that,  in the absence 
of  routine  virus  testing  procedures  and  the  establishment  of  virological  standards,  health 
checks  of  bivalve  molluscs  must  be  based  on  faecal  bacteria  counts.  However,  scientific 
studies  since the  adoption  of the Directive  have  shown the unreliability  of faecal  bacteria  as 
indicators of pathogenic viruses in bivalve molluscs. 

Several  hundred  consumers  of  oysters  in  the  Community  were  affected  by  an  outbreak  of 
gastro-enteritis  in  January  1997.  Investigations  showed  that  the  oysters  complied  with  the 
standards  on  faecal  bacteria  laid  down  in  Directive  91/492/EEC.  New  analytical  techniques 
revealed the presence of a pathogenic virus in the oysters and helped to evaluate a better virus 
indicator  for  routine use. This epidemic has demonstrated  the urgent  need  for  a new type of 
check for viral and microbial contaminations of bivalve molluscs. 

The development and application of these new techniques will require the network of national 
laboratories responsible for checking viral and microbial contaminations of bivalve molluscs to 
coordinate  their  efforts.  With  this  in  mind,  a  Community  reference  laboratory  should  be 
designated  to  coordinate the activities of the national reference  laboratories  so as to  ensure a 
standard  inspection  system  and  an equivalent  level of consumer  health protection  throughout 
the  Community.  Among  laboratories  specializing  in  bacteriological  and  viral  techniques,  the 
laboratory of the Centre for Environment, Fisheries and Aquaculture  Science, Weymouth, has 
volunteered to assume the task of coordinating the national laboratories. 

The laboratory of the Centre for Environment, Fisheries and Aquaculture Science, Weymouth, 
fulfils  the  conditions  laid  down  for  taking  on  the  responsibilities  and  functions  of  the 
Community reference  laboratory  and is also entitled to receive Commumty funding  under the 
terms  laid  down  in  Council  Decision  90/424/EEC  of  26  June  1990  on  expenditure  in  the 
veterinary  field2. 

1  OJ  No  L268,  24.9.1991,  p.  1,  as  last  amended  by  the  Treaty  of  Accession  for  Austria,  Finland 

and Sweden. 

2X  OJ  No  L224,  18.8.1990,  p.  19,  as  last  amended  by  Council  Decision  94/370/EC  of  21  June  1994 

(OJ No L 168, 2.7.1994, p. 94). 

2 

Proposal  for a 
EUROPEAN  PARLIAMENT AND COUNCIL  DECISION 
on reference  laboratories for monitoring bacteriological  and viral  contamination 
of bivalve molluscs 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article  100a thereof, 

Having regard to the proposal  from  the  Commission3, 

Having regard to the opinion of the Economic and  Social  Committee4, 

Acting in accordance with the procedure laid down in Article  189b of the  Treaty5, 

Whereas  implementation  of the  single  market  requires,  for  health  protection  in the  veterinary 
and plant  health  sectors,  standardized  checks on product  cleanliness; whereas this  requirement 
applies especially to the viral and bacteriological  contamination  of bivalve molluscs; 

Whereas the  Annex to  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  molluscs6,  as 
amended  by  the  Act  of  Accession  of  Austria,  Finland  and  Sweden,  lays  down  in  particular 
requirements on bacteriological  and viral contamination  of live bivalve molluscs; 

Whereas  Chapter  V(8)  of  the  Annex  to  that  Directive  states  that,  in  the  absence  of  routine 
virus testing  procedures  and the  establishment  of virological  standards,  health  checks  must  be 
based on faecal  bacteria counts; 

Whereas  scientific  progress  has  shown  faecal  bacteria  to  be  an  unreliable  indicator  of  the 
presence  of  viruses  in  live  bivalve  molluscs;  whereas  to  protect  public  health  it  is  therefore 
necessary to base the health check on some other  indicator; 

Whereas  the  development  of  new  analytical  techniques  for  viruses  and  reliable  indicators  of 
bivalve  mollusc  contamination  requires  coordination  of  the  activities  of  the  network  of 
national laboratories; 

Whereas  to  ensure  an  effective  system  of  monitoring  checks  for  viruses,  each  Member  State 
should  designate a national reference  laboratory responsible for  coordinating the requisite  tests 
in that  State; 

3  OJ No C 
4  OJNoC 
5  OJ No C 
6  OJ No L 268, 24.9.1991, p. 1. 

Whereas  to  ensure  a  standardized  system  throughout  the  Community,  the  Community 
reference  laboratory  responsible  for  coordinating  the  checks  on  viral  and  bacteriological 
contamination  carried  out  by  each  national  laboratory  should  be  designated;  whereas  the 
operating  terms  and  functions  of the  Community  reference  laboratory  should  be  laid  down; 
whereas those responsible for the laboratory  must undertake to carry out the tasks laid down 
in this Decision under the terms provided for herein; 

Whereas  the  reference  laboratory  can  be  granted  Community  financial  assistance  under  the 
terms of Article 28  of Council  Decision  90/424/EEC  of 26 June  1990 on expenditure  in the 
veterinary field7, as last amended by Decision 94/370/EC8, 

HAVE ADOPTED THIS DECISION: 

Article 1 

Each Member State shall designate one or more national reference  laboratories for monitoring 
viral and bacteriological  contaminations  of bivalve molluscs. It  shall inform  the Commission, 
which  shall publish the list of the national reference  laboratories  and  any updates to  it in the 
Official Journal of the European Communities. 

1. 

Each national reference laboratory shall be responsible for: 

Article 2 

(a)  coordinating  the  activities  of  the  national  laboratories  responsible  for  viral  and 

bacteriological analyses of bivalve molluscs in the relevant Member State; 

(b)  assisting  the  competent  authority  in  the  Member  State  to  organize  a  system  for 

monitoring viral and bacteriological contamination of bivalve molluscs; 

(c)  organizing  on  a  regular  basis  comparative  tests  between  the  various  national 
laboratories responsible for the viral and bacteriological testing of bivalve molluscs; 

(d)  disseminating  the  information  provided  by  the  Community  reference  laboratory 
referred  to  in  Article  3  to  the  competent  authorities  and  national  laboratories 
responsible for the viral and bacteriological testing of bivalve molluscs. 

2. 

The  national  laboratories  shall  collaborate  with  the  Community  reference  laboratory 
referred to in Article 3. 

Article 3 

The  laboratory  of  the  Centre  for  Environment,  Fisheries  and  Aquaculture  Science  at 
Weymouth  in  the  United  Kingdom  is  hereby  designated  as  the  Community  reference 
laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs. 

7  OJ No L 224, 18.8.1990, p. 19. 
8  OJ No L 168, 2.7.1994, p.  31. 

The Community reference laboratory shall be responsible for: 

Article 4 

(a) 

supplying  information  on  analytical  methods  and  comparative  testing  to  the  national 
reference laboratories; 

(b) 

(c) 

coordinating  the  application  by  the  national  reference  laboratories  of  the  methods 
referred to in point (a), by organizing comparative testing in particular; 

coordinating  research  into new analytical methods and informing  the national  reference 
laboratories of progress made in this area; 

(d)  organizing 

training  and  advanced  courses 

for 

the 

staff  of 

the  national 

reference laboratories; 

(e) 

(f) 

collaborating with the  laboratories  responsible  for  the bacteriological  and  viral  analysis 
of bivalve molluscs in third countries; 

providing scientific and technical assistance to the Commission, especially in cases where 
test results are contested between Member States. 

Article 5 

The Community reference laboratory shall satisfy the following operating conditions: 

(a) 

staff  must  be  qualified  and  have  sufficient  knowledge  of the  techniques  applied  in the 
bacteriological and viral analysis of bivalve molluscs; 

(b) 

the equipment and substances necessary for carrying out the tasks laid down in Article 4 
must be available; 

(c) 

an appropriate administrative structure must be in place; 

(d) 

the  confidential  nature  of  certain  subjects,  results  and  reports  must  be  observed  by 
the staff; 

(e) 

the principles of good laboratory practice accepted internationally must be followed; 

(f) 

an  up-to-date  list  of  the  reference  substances  held  by  the  Community  Bureau  of 
References  must  be  available,  along  with  an  up-to-date  list  of  the  manufacturers  and 
suppliers of these substances. 

This Decision shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Communities. 

Article 6 

This Decision is addressed to the Member States. 

Article 7 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

ISSN 0254-1475 

COM(97) 310  final 

DOCUMENTS 

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03  15  05 

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Catalogue  number  :  CB-CO-97-297-EN-C 

ISBN  92-78-21520-1 

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