Proposal for a COUNCIL REGULATION (EC) amending Regulation (EEC) No 3759/92 on the common organization of the market in fishery products and aquaculture
Date: 1994-09-30
Institutions: European Commission
Subjects: animal disease, health control, marketing, mollusc, shellfish farming, veterinary inspection

COMMISSION  OF  THE  EUROPEAN  COIVMUNITIES 

C0M(94) 401 final 
Brussels, 23.09.1994 

94/0213  (CNS) 

Proposal  for a 

COUNCIL DIRECTIVE 

introducing minimum Community  measures necessary 

for the control of diseases affecting bivalve moJIuses 

(presented by the Commission) 

EXPLANATORY  MEMORANDUM 

Outbreaks  of  certain  diseases  affecting  bivalve  molluscs  (e.g.  oysters,  mussels) 
can  quicfcly  take  epizootic  proportions  causing  mortality  and  disturbances  on  a 
scale  liable  to  severely  reduce  the  profitability  of  mollusc  farming,  and 
consequently  have  an  Influence  on  the  internal  market  in bivalve molluscs.  It  is 
therefore  necessary  to  establish  at  Community  level  control  measures  tor  the 
event  of  an outbreak  of  such  disease. 

The  proposed  measures  aim  at  preventing  the  spread  of  diseases  likely  to  cause 
important  losses-  For  that  purpose  it  Is  intended  to  establish  a  surveillance 
system  for  mollusc  diseases  occurring  in  farms  or  natural  growing  beds.  Such 
system  must  allow  to  identify  the  sites  where  problems  occur.  In  such  event, 
samples  will  have  to  be  taken  for  examination  in  an  approved  laboratory.  If  the 
presence  of  a disease  is confirmed,  the official  service  shall  take  the  necessary 
actions  to control  the  situation. 

It  is  further  proposed  that  in  order  to  ensure  an  efficient  application  of  the 
control  system,  the  diagnosis  of  the  diseases  must  be  harmonised  and  must  be 
carried  out  under  the  auspices  of  approved  laboratories,  the  coordination  of 
which  may  be  carried  out  by  a  reference  laboratory  designated  and  financed  by  the 
Community.  This  laboratory  can  obtain  such  financial  contribution  under  Council 
Decision  90/424/EEC  on  expenditure  in  the  veterinary  field*1). 

The  proposed  measure  comes  under  the  Common  Agricultural  Policy,  in  order  to 
obtain  the measures  objectives,  it  is necessary  to adopt  a Directive. 

The  measures  take  the  form  of  a  Directive,  its  implementation  will  be  the 
responsabiMty  of  the Member  States. 

(1) OJ  No  L  224 of  18.08.1990  p.  19 

A 

Proposal  for a 

COUNCIL DIRECTIVE 

of 

introducing minimum Community measures 

for the control of diseases affecting bivalve molluscs 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  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 molluscs are  listed  in Annex  II to the Treaty; whereas  the marketing of 

molluscs constitutes an  important source of revenue for the aquaculture sector; 

Whereas  the  molluscs  diseases  referred 

to  in  Annex A, 

list  II  to 

Directive 91/67/EEC concerning  the animal  health conditions governing  the placing 

on  the  market  of  aquaculture  animals  and  products*4),  amended  by 

Directive 93/54/EEC*5)  have  a  devastating  effect  on  the  shellfish  industry; 

whereas other diseases having a similar effect occur  in third countries; 

Whereas  an  outbreak  of  such  diseases  can  quickly  take on  epizootic  proportions 

causing  mortality  and  disturbances  on  a  scale  liable  to  reduce  severely  the 

profitability of the shellfish growing sector; 

(1) OJ NO L 
(2) OJ NO L 
(3) OJ NO L 
(4) OJ No L  46 Of 19. 2.1991, p. 1 
(5) OJ No L 175 of 19.07.1993, p. 34 

Whereas  it  is  therefore  necessary  to  establish  at  Community  level  the  control 

measures  to be  taken  in the event  of outbreaks of  disease,  in order  to ensure a 

rational  development  of  the  shellfish  growing  sector  and  to  contribute  to  the 

protection of animal  health  in the Community; 

Whereas member  States should  report  to the Commission and  the other member  States 

all cases of  important mortalities  in bivalve molluscs; 

Whereas  in  such  event  control  measures  must  be  taken  aiming  at  preventing  the 

spread  of  the disease,  in particular  with  regard  to  the  removal  of  live bivalve 

molluscs from the zones or  farms concerned; 

Whereas  a  thorough  epidemiological  investigation  is  essential  to  reveal  the 

origin of the disease and to prevent  the further  spread  thereof; 

Whereas  in  order  to  ensure  an  effective  system  of  control,  diagnosis  of  the 

diseases  must  be  harmonized  and  carried  out  under  the  auspices  of  responsible 

laboratories,  the  coordination  of  which  may  be  carried  out  by  a  reference 

laboratory designated by the Community; 

Whereas,  in order  to ensure uniform  implementation of  this Directive, a Community 

inspection procedure should be established; 

Whereas  common  measures  for  the  control  of  diseases  form  a  minimum  basis  for 

maintaining  a uniform standard of animal  health; 

Whereas  the  Commission  should  be  entrusted  with  the  task  of  adopting  the 

necessary  implementing measures, 

HAS ADOPTED THIS DECISION: 

Art te le 1 

This Directive defines the minimum Community measures  for  the control  of diseases 

affecting bivalve molluscs. 

Art icle  2 

For  the  purpose  of  this  Directive,  the  definitions  laid  down  in  Article  2  of 

Directive  91/67/EEC  shall  apply. 

Ar t i cIe  3 

Member  States  shall  ensure  that  all  farms  rearing  or  growing  bivalve  molluscs: 

1.  are  registered  by  the  official  service;  this  registration  must  be  kept 

constantly  up  to  date; 

2.  keep  a  record  of: 

(a)  bivalve  molluscs  entering  the  farm,  containing  all  information  relating  to 

their  delivery,  their  number  or  weight,  their  size,  their  origin-, 

(b) bivalve  molluscs 

leaving  the  farm  for  reimmersion,  containing  all 

information  relating  to  their  dispatch,  their  number  or  weight,  their  size 

and  dest inat ion; 

(c) observed  abnormal  mortality. 

This  record  shall  be  open  to  scrutiny  by  the  official  service. 

Art icle  4 

1. Member  States  shall  ensure  that  a  permanent  monitoring  and  sampling  programme 

is applied  in bivalve  mollusc  farms  and  natural  beds. 

This  programme  aims  at: 

establishing  a  list  of  sites  where  the  diseases  referred  to  in  Annex  A, 

list  I I of  Directive  91/67/EEC  are  present; 

monitoring  the  evolution  and  the  geographical  spread  of  the  diseases 

referred  to  in  the  first  indent. 

2.  The  detailed  rules  for  the  application  of  this  Article,  and  in  particular  the 

rules  to  be  applied  for  establishing  the  programme  referred  to  in  paragraph  1, 

are  laid  down  in accordance  with  the  procedure  provided  for  in Article  10. 

rV?S^TrZi*&m 

\ 

Art icle 5 

1. Member  States  'shall  ensure  that  any  abnormally  high  mortality  of  bivalve 

molluscs  in  farms  or  in natural  beds  is notified  as  soon  as  possible  to the 

official  service. 

2.  In  the  case  referred  to  in  paragraph  1  the  official  service  in  the  Member 

States  shall  ensure  that: 

a)  samples  are taken  for examination  in an approved  laboratory; 

b)  pending  the result  of the examination  referred  to in a ), no molluscs  leave 

the  farm,  the affected  area  or the natural  beds  for reimmersion  in another 

farm  or  in  the  aquatic  environment,  unless  authorized  by  the  official 

service; 

3.  If  the examination  referred  to in paragraph  2 shows  the presence  of a  disease, 

an  epizootic  investigation  must  be  carried  out  in  order  to  determine  the 

possible  ways of  introduction  of a disease  and to  investigate  whether  molluscs 

have  left  the  farm  or  the natural  beds  for  reimmersion  elsewhere  during  the 

period  proceeding  the mortalities. 

4.  If  the  examination  referred  to  in  paragraph  2a)  fails  to  demonstrate  the 

presence  of  a  disease,  the  restrictions  referred  to  in  paragraph  2b) are 

l i f t e d. 

5. The  official  service  shall  ensure  that  the Commission  and  the other  Member 

States  are  informed  without  delay  of abnormally  high  mortalities  related  to a 

disease,  the  actions  taken  to  investigate  the  matter  and  to  control  the 

situation,  and the cause of the mortalities. 

Art icle 6 

1.  Sampling  and  laboratory  testing  for the determination  of the cause  of  abnormal 

mortalities  of  bivalve  molluscs  shall  be  carried  out  using  the  methods 

established  in  accordance  with  the procedure  laid  down  in Article  10 of the 

present  Direct ive. 

2.  The  testing  referred  to  in  point  1  shall  be  carried  out  by  a  laboratory 

approved  by  the  official  service.  The  official  service  of  a  Member  State  may 

designate  a  laboratory  approved  in another  Member  State  for  carrying  out  these 

tests.  Where  necessary,  and  in  any  case  where  the  cause  of  the  mortalities 

remains  unresolved,  the  approved  laboratory  shall  cooperate  with  the  Community 

reference  laboratory  referred  to  in Article  7. 

3.  The  Member  States  shall  communicate  the  list  of  approved  laboratories  to  the 

Commission  and  to  the  other  Member  States. 

Art icle  7 

1. The  Community  reference  laboratory  for  diseases  of  bivalve  molluscs  is 

indicated  in Annex  A. 

2.  Without  prejudice  to  Decision  90/424/EEC,  and  in  particular  Article  28 

thereof,  the  functions  and  duties  of  the  laboratory  referred  to  in paragraph  1 

shall  be  those  laid  down  in Annex  B. 

Art icle  8 

Commission  experts  may,  in  collaboration  with  the  competent  authorities,  and  in 

so  far  as  is  necessary  to  ensure  uniform  application  of  this  Directive,  make 

on-the-spot  checks.  The  Commission  shall  inform  the  Member  States  of  the  result 

of  the  checks  carried  out. 

A Member  State  in whose  territory  a  check  is being  carried  out  shall  give  all  the 

necessary  assistance  to  the  experts  in carrying  out  their  duties. 

The  detailed  rules  for  implementing  this  Article  shall  be  determined  in 

accordance  with  the  procedure  laid  down  in Article  10. 

Art icle  9 

The  Annexes  to  this  Directive  may  be  amended  in  accordance  with  the  procedure 

laid  down  i n  Ar t i cIe  10. 

Article  10 

1. The  Commission  shall  be  assisted  by  the  Standing  Veterinary  Committee  set  up 

by  Council 

Decision 

68/361/EEC*1), 

hereinafter 

referred 

to  as 

"the 

Committee". 

2.  Where  the  procedure  laid  down  in  this  Article  is  to  be  used,  the  following 

rules  shalI  apply: 

The  representative  of  the  Commission  shall  submit  to  the  Committee  a  draft  of 

the measures  to  be  taken.  The  Committee  shall  deliver  its opinion  on  the  draft 

within  a  time  limit  which  the  Chairman  may  lay  down  according  to  the  urgency 

of  the  matter,  if  necessary  by  taking  a  vote. 

The  opinion  shall  be  recorded  in  the  minutes;  in  addition,  each  Member  State 

shall  have  the  right  to  ask  to  have  its  position  recorded  in  the  minutes. 

The  Commission  shall  take  the  utmost  account  of  the  opinion  delivered  by  the 

Committee.  It  shall  inform  the  Committee  of  the  manner  in  which  its  opinion 

has  been  taken  into  account. 

Article  11 

1.  The  Member  States  shall  bring 

into  force  the 

laws,  regulations  and 

administrative  provisions  necessary  to  comply  with  the  provisions  of  this 

Directive  not  later  than  1 July  1996;  they  shall  notify  the  Commission 

thereof. 

When  Member  States  adopt  these  measures,  they  shall  contain  a  reference  to 

this  Directive  or  shall  be  accompanied  by  such  reference  on  the  occasion  of 

their  official  publication.  The  methods  of  making  such  reference  shall  be  laid 

down  by  the  Member  States. 

(1) OJ  N'  L  255,  18.10.1968,  p.  23 

6 

2. Member  States  shall  communicate  to  the  Commission  the  texts  of  the  main 

provisions  of  national  law  which  they  adopt  in  the  field  governed  by  this 

Directive. 

Article  12 

This  directive  shall  enter  into  force  20 days  after  its  publication  in  the 

Official  Journal  of  the  European  Communities. 

Article  13 

This  Directive  is addressed  to  the Member  States. 

Done  at  Brussels, 

For  the  Council, 

**9 \)>-. W^m»^*^mmmmiÊimm 

Annex A 

Community  reference  laboratory 
for diseases of bivalve molluscs 

IFREMER 
Boite Postale 133 
17390 LA TREMBLADE 
FRANCE 

Annex  B 

Functions  and  duties  of  the 
Community  reference  laboratory  for  diseases  of  molluscan  shellfish 

The  function  and  duties  of  the  Community  reference  laboratory  shall  be: 

1. To  coordinate,  in  consultation  with  the  Commission,  the  methods  employed  in 
the Member  States  for  diagnosing  diseases  of  molluscan  shellfish,  specifically 
by 

(a) building  up  and  retaining  a  collection  of  histological  slides,  strains  or 
isolates  of  the  relevant  pathogens  and  making  these  available  to  approved 
laboratories  in  the  Member  States; 

(b) organizing  periodic  comparative 

tests  of  diagnostic  procedures  at 

Commun i ty  levé I ; 

(c) collecting  and  collating  data  and  information  on  the  methods  of  diagnosis 

used  and  the  results  of  tests  carried  out  in  the  Community; 

(d) characterizing 

and 
isolates  of  pathogens  by  the  most 
appropriate  methods  to allow  greater  understanding  of  the  epizootiology  of 
the  disease; 

up-to-date 

(e) keeping  abreast  of  developments  in  the  surveillance,  epizootiology  and 

prevention  of  the  relevant  diseases  throughout  the  world; 

(f)  retaining  expertise  on  relevant  disease  pathogens  to  enable  rapid 

differential  diagnosis; 

2.  to  assist  actively  in  the  diagnosis  of  disease  outbreaks  in  Member  States  by 
receiving  pathogen  isolates  for  confirmatory  diagnosis,  characterization  and 
epizootic  studies; 

3.  to  facilitate  the  training  or  retraining  of  experts  in  laboratory  diagnosis 
with  a  view  to  the  harmonization  of  diagnostic  techniques  throughout  the 
Commun11 y ; 

4.  to  collaborate  as  regards  methods  of  diagnosing  exotic  diseases,  with  the 
competent  laboratories  in third  countries  where  those  diseases  are  prevalent. 

9 

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COM(94) 401 final 

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