Proposal for a COUNCIL DIRECTIVE amending, with regard to Gyrodactylus salaris, Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products
Date: 1996-06-19
Institutions: European Commission
Subjects: animal product, aquaculture, fishery product, health legislation, live animal, marketing

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

Brussels,  19.06.1996 
COM(96) 279 final 

96/0157 (CNS) 
96/0158 (CNS) 

Proposal 
for a 
COUNCIL  DIRECTIVE 

amending, with regard to  Gyrodactylus 

salaris, 

Directive 

91/67/EEC concerning the animal health conditions governing 
the placing on the market of aquaculture animals and products 

Proposal 
for a 
COUNCIL DIRECTIVE 
amending Directive 93/53/EEC introducing 
minimum Community measures for the control of certain fish 
diseases 

(presented  by the Commission) 

KXPT.ANATORY MKNIOUANPUM 

The creation of the internal market resulted in the establishment 
of Community rules concerning animal health questions  governing 
the placing on the market of aquaculture  animals and products1, 
and minimum measures  for the control of certain  fish diseases''. 
The  aim  of  the  present  proposals  is  to  amend  the  existing 
Community  rules in order: 

to  organise  trade  in  salmonid  fish  in  such  a  way  as  to 
prevent  the  introduction  of  the  parasite 
salaris 
parasite; 

Gyrodactylus 
into  regions  declared  officially  free  of  that 

to  introduce  a  certification  requirement  in  order  to 
infectious 
prevent 
haematopoietic  necrosis  (IHN)  and  viral  haemorrhagic 
septicaemia  (VHS); 

diseases 

spread 

the 

the 

of 

to  bring  EC  rules  more  in  line  with  the  requirements 
established  by  the  "Office  International  des  Epizooties" 
(OIE-World Organisation  for Animal Health) 

to  limit  the  scope  of  Directive  93/53/EEC  to  viral  fish 
diseases. 

The  first  three  objectives  are  achieved  by  amending  Council 
Directive 91/67/EEC: 

a) Gyrodactylosis 

Directive  91/67/EEC contains the Community rules for organising 
the trade  in aquatic animals  in order  to prevent  the spread of 
serious  diseases  ("List  II  diseases").  The  diseases  currently 
covered  by  these  rules  are  IHN  and  VHS  which  have  a  major 
economic  impact  on  fish  farming  when  introduced  into  a  region 
previously  free  of  these  diseases.  Movement  of  aquaculture 
animals is only possible from zones or certain farms with a high 
health status  (free of IHN and VHS) towards zones or farms with 
a lower health status. 

Recent  reports  have  shown  that  gyrodactylosis,  a  disease  of 
salmonids caused by the freshwater parasite  Gyrodactylus 
occurs  mainly  in  Scandinavia  (Sweden,  Finland,Norway).  It  has 
also  been  reported,  but  not  officially  confirmed,  in  certain 
causes  widespread 
other  Member  States.  Gyrodactylus 

salaris 

salaris, 

Council Directive 91/67/EEC of 28 January 1991  (OJ N" L 46 
of 19.02.1991, p. 1), as last amended by Directive 95/22/EEC  (OJ 
N" L 243 of 11.10.1995, p. 1) 

2Council Directive 93/53/EEC of 24 June 1993  (OJ N* L 175 of 

17.9.1993, p. 23) 

losses  in riverine  stocks of Atlantic  salmon. Other  salmonids, 
and  in particular  Baltic  salmon  (a strain of Atlantic  salmon), 
brown  trout  and  rainbow  trout  may  act.  as  non sympl onuii u-
carriers, and thus transfer the disease by commercial  transfers 
or  through  migration  within  and  possibly  between  rivers. 
Infection can be controlled in farmed stocks by chemotherapy, but 
it  is  virtually  impossible  to  control  it  in  the  wild.  It  is 
therefore important to prevent the spread of the disease towards 
zones in the Community for which there is proof of absence of the 
disease. 

Gyrodactylosis  has  thus  all  the  caracteristics  for  being 
considered  as  a  list  II  disease  for  which  Community  measures 
should be applied in the same way as is the case for IHN and VHS, 
The proposed measure therefore aims to categorise gyrodactylosis 
as a  list  II disease  and defines  the  rules under which  a  zone 
(water catchment area) or certain farms can be declared  free of 
and  for which  the same movement  patterns 
Gyrodactylus 
apply as for other list II diseases. 

salaris, 

b) Certification for IHN and VHS 

It appears necessary to introduce a certification requirement for 
fish,  eggs  and gametes  placed  on  the market  in a non  approved 
zone  (not officially declared  free of  IHN and VHS). Experience 
has  shown  that,  in the  absence  of  such  requirement,  fish  from 
infected  sites  have  been  moved  and  contaminated  non  infected 
farms situated in these zones, which has led to severe financial 
losses. The amendment requires that in future consignments must 
be  accompanied  by  a  certificate  issued  by  the  competent 
authority,  certifying  that  the  fish, eggs or gametes  originate 
in a farm not infected with either IHN or VHS. 

c) Sampling  requirements 

In accordance with current EC legislation, a zone can obtain the 
approved  status  free  of  disease  after  a  period  of  intensive 
sampling and testing of 4 years. The requirements adopted by OIE 
for  obtaining  approved  status  are  that  free  status  can  be 
obtained  after  a  two year period  of  sampling  and  testing.  The 
present proposal aims to aline the EC requirements with the OIE 
requirements 

The  last objective  is achieved by amending Directive  93/53/EEC 
and  is  a  consequence  of  grading  gyrodactylosis  as  a  list  II 
disease.  This  would  render  the  requirements  of  Directive 
93/53/EEC  applicable  to  Gyrodactylus 
However,  these 
measures  are  designed  for  the  control  of  virus  diseases,  and 
should  not  therefore  be  applied  as  such  to  the  parasite 
The  scope  of  Directive  93/53/EEC  must 
Gyrodactylus 
therefore be limited to viral diseases only. 

salaris. 

salaris. 

P r o p o s al 
f or  a 
COUNCIL  DIRECTIVE 
of 

^ j o i S T- 

( C K S) 

amending,  with  regard  to  Gyrodactylus 

salaris, 

Directive 

91/67/EEC  concerning  the  animal  health  conditions  governing 
the placing  on  the market  of  aquaculture  animals  and  products 

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  of  the  Commission1, 

Having  regard  to  the  opinion  of  the  European  Parliament2, 

Having  regard  to  the  opinion  of  the  Economic  and  Social 
Committee3, 

Whereas  Gyrodactylus 
is  a  fresh  water  parasite  of 
salmonids which  is able  of  causing  serious mortalities  in  Salmo 
salar  (Atlantic  salmon); 

salaris 

Whereas  the disease has a serious economic  impact would  it occur 
in  regions  containing  wild  riverine  stocks  of  Salmo 
salar 
previously  free  of  the  disease; 

Whereas  experience  has  shown  that  the  disease  can  spread  from 
infected regions through commercial transfers of salmon and other 
salmonids; 

Whereas  it  is  therefore  necessary  to  prevent  the  spread  of  the 
disease  from  regions  in  the  Community  where  the  absence  of  the 
disease  can not  be  certified,  towards  regions  with  a  documented 
history  of  absence  of  the parasite; 

Whereas prevention of spread of the disease can be achieved under 
the  procedures  applicable  to  diseases  of  list  II  of  Annex  A  of 
Directive  91/67/EEC  concerning  the  animal  health  conditions 
governing  the  placing  on  the  market  of  aquaculture  animals  and 
products4,  as  last  amended  by  Directive  95/22/EC5; 

X0J N'  C 

20J N"  C 

30J N'  C 

40J N°  L  46,  19.02.1991, p.  1 

5OJ  N°  L  243,  11.10.1995, p.l 

4 

Whereas 
Gyrodactylus 

Salmo 

salar 

salaris, 

being  the  species  most  susceptible  to 
the measures  must  apply  to  that  species; 

Whereas however the parasite can be transferred by other salmoiiid 
species and measures must therefore be extended  to such species; 

Whereas  the  criteria  to  certify  the  absence  of 
salaris 

must  be  established, 

Gyrodactylus 

Whereas  it is necessary  to ensure that the placing on the market 
of  fish  from  a  non  approved  zone  does  not  prejudice  the  health 
status  of  non  infected  farms  situated  in  a  non  approved  zone; 
whereas  this  can  be  achieved  through  certification  of 
consignments, 

Whereas  it  is  necessary  to  adapt  the  sampling  and  testing 
requirements  for  fish  diseases  to  international  standards; 

HAS ADOPTED  THIS  DIRECTIVE: 

Article  1 

Directive  91/67/EEC  is  amended  as  follows: 

1.In Article  7: 

a) 

the  introductory  sentence of paragraph  1 is replaced by  the 
following  text: 

"1.  The  placing  on  the  market  of  live  fish  belonging  to 
the  species  susceptible  to  IHN  and  VHS  as  listed  in 
Annex  A,  column  2,  list  II,  their  eggs  and  gametes, 
shall  be  subject  to  the  following 
additional 
guarantees :" 

b) 

the  following  paragraph  is added  to paragraph  1: 

11 (c) where  they  are  to  be  introduced  into  a  non  approved 
farm  situated  in  a  non  approved  zone,  they  must  be 
accompanied,  in  accordance  with  article  11,  by  a 
movement  document corresponding  to a model to be drawn 
up  in  accordance  with  the  procedure  laid  down  in 
article  26, certifying  that 

they  comply  with  the  requirements  of  article  3 
and  come  from  a  farm  which  is  not  infected  with 
IHN or VHS, or 
they  come  from  an  approved  zone  with  regard  to 
IHN and/or VHS, or 
they come  from an approved  farm situated  in a non 
approved  zone with  regard  to  IHN  and/or VHS." 

c) 

paragraph  2  is  replaced  by  the  following  paragraphs: 

"2.  The placing  on  the market  of  live  fish  belonging  to 
the species susceptible to gyrodactylosis as listed in 
Annex  A,  column  2,  list  II  shall  be  subject  to the 
following  additional  guarantees: 

a) 

b) 

where  they are to be introduced  into an approved 
zone  with  regard  to  Gyrodactylus 
they 
must,  in  accordance  with  Article  11,  be 
accompanied by a movement  document  corresponding 
to a model  to be drawn up in accordance  with the 
procedure  laid  down  in  article  26,  certifying 
that  they  come  from an approved  zone with  regard 
to  Gyrodactylus 

salaris, 

salaris; 

where  they  are  to  be  introduced  into  a  farm 
which, although not situated in an approved zone, 
fulfils the conditions  set out in Annex  CI, they 
must  in  accordance 
with  Article  11,  be 
accompanied by a movement  document  corresponding 
to a model  to be drawn up in accordance  with the 
procedure  laid  down  in  Article  26,  certifying 
that  they  come  from  an approved  zone  or  from an 
approved  farm  with  regard  to 
Gyrodactylus 
salaris. 

3. 

The Commission  may, in accordance  with  the  procedure 
laid  down  in  Article  26,  adapt  or  delete  the 
additional  guarantees  referred  to in paragraphs  1 and 
2,  depending  on  the  evolution  of  the  animal  health 
situation  in  the  Community  or  in  accordance  with 
scientific  evolution." 

2.In Article  9, the first  sentence of point 1 is replaced by the 
following  text: 

"Fish  susceptible  to  IHN and VHS must  be  slaughtered  and 
eviscerated  prior  to dispatch." 

3.In Annex A: 

a) 

the following  is added  to columns  1 and 2 of  list  II 
under  the heading  "fish": 

"Gyrodactylosis 
salaris)" 

(Gyrodactylus 

salar  (Atlantic 

"Salmo 
salmon) and other salmonid 
species" 

b) 

in  list  III,  under  "Fish",  the  words 
salaris" 

in column 1 are deleted. 

"Gyrodactylus 

4.In Annex B, point  I,B  is replaced by the following text 

"B. Grant of approval 

1. In  order  to  obtain  approved  status  with  regard  to  IHN 
and/or  VHS,  a  continental  zone  must  meet  the  following 
requirements : 

a) 

b) 

all  fish  are  free  for  at  least  four  years  from  any 
clinical or other sign of IHN and/or VHS. 

all farms in the continental zone are placed under the 
supervision  of  the  official  services.  Two  health 
inspections  per  year  for  two  years  must  have  been 
carried out. 

The health  inspections must  have been carried  out at 
the  times  of  the  year  when  the  water  temperature 
favours the development of these diseases. The health 
inspection must at least consist of: 

an inspection of fish showing abnormalities, 

the  taking  of  samples  in  accordance  with  a 
programme established under the procedure provided 
for in Article 15, which are to be sent as quickly 
as possible to an approved laboratory to be tested 
for the pathogens in question. 

However,  zones having  a historical  record  of  absence 
of IHN and /or VHS, may obtain approved  status if: 

i)their  geographical  situation  does  not  permit  easy 
introduction of disease; 

ii)an  official  disease  control  system  has  been  in 
place  for an extended period of time of at  least ten 
years, during which: 

there has been regular monitoring of all farms, 

a disease notification system has been applied, 

no case of disease has been reported, 

under  the  rules  in  force,  only  fish,  eggs  or 
gametes from non-infected zones or farms subject 
to  official  checks  and  presenting  equivalent 
health gurantees,were able to be introduced into 
the zone. 

The  period  of  10  years  referred  to  above  may  be 
reduced  to  five  years  as  a  result  of  the  testing 
carried out by the official service of the requesting 
Member  State,  provided  that,  in  addition  to  the 
requirements  referred  to  in  the  first  subparagraph, 
the regular monitoring of all farms referred to above 

has  included  at  least  two health  inspections  per  year 
involving  at  least : 

an  inspection  of  fish  showing  abnormalities, 

a  taking  of  samples  of  at  least  30  fish  at  each 
visit. 

c) 

d) 

e) 

Member  States  wishing  to  benefit  from  the  provisions 
relating  to  historical  records  must  submit  their 
request  no  later  than  31 December  1996. 

if  there  is  no  farm  in  a  continental  zone  to  be 
approved,  the  official  services  must  have  subjected 
fish  from  the  lower  part  of  the  catchment  area  to  a 
health  inspection  twice  a  year  for  four  years,  in 
accordance  with paragraph  b; 

the laboratory examinations of fish taken during health 
inspections  have produced  negative  results  as  regards 
the pathogens  in question. 

Where a Member State has requested approval for a water 
catchment  area  originating  in a neighbouring  Member 
State  , or common to two Member States  , the  following 
provisions  shall  apply: 

the two Member States concerned  shall  simultaneously 
submit  a request for approval  in accordance with the 
procedures  laid  down  in Articles  5 or 10, 

the Commission, in accordance with the procedure  laid 
down in Article  26, after examining and checking  the 
request  and  evaluating  the health  situation,  shall, 
if need  be,  lay down any other  provisions  necessary 
for granting  such  approval. 

The  Member  States,  in  accordance  with  Directive 
89/608/EEC6  shall  grant  each  other  mutual  assistance 
for  the  application  of  this  Directive,  and  in 
particular  of  this  paragraph; 

2.In  order  to  obtain  approved  status  with  regard  to 
a continental  zone must meet  approval 
Gyrodactylus 
conditions  established  in  accordance  with  the  procedure 
provided  for  in Article  26. 

salaris, 

However,  where  a Member  State  considers  that  its  territory 
or part  of  its territory  is free from  Gyrodactylus 
salaris, 
it may submit to the Commission appropriate  justifications, 

6  OJ  n*  L  351, 2.  12  1989, p 34; 

8 

setting out in particular: 

i)  the  results  of  surveillance  testing  carried  out 
over an extended period of time, and based on the 
identification of the parasite and the fact that 
the  disease  is  compulsorily  notifiable  to  the 
official service, 

ii)  the  period  over  which  the  surveillance  was 

carried out, 

Based on the above information, and in accordance with 
the  procedure  provided  for  in Article  26,  it may  be 
decided to grant the approved status to the territory 
or a part thereof of the applying Member State. 

5. 

In Annex B,I,C point 2 is replaced by the following text : 

"2.  a)  each farm must undergo, with regard to IHN and/or 
VHS,  two  health  inspections  annually  in 
accordance  with  point  B,l(b);  however,  samples 
will  be  taken  by  rotation  in  50%  of  the  fish 
farms in the continental  zone each year; 

b) 

the  surveilance  programme  for  maintenance  of 
approved status with regard to gyrodactylosis is 
established  in  accordance  with  the  procedure 
provided for in Article 2 6." 

6. 

In Annex  B,II,  paragraph  B  is  replaced  by  the  following 
text : 

"B.  Grant  of 

approval. 

In order to obtain approved status with regard to IHN 
and/or  VHS,  a  coastal  zone  for  fish  must  meet  the 
requirements laid down for continental  zones referred 
to in point  IB, first paragraph. 

Where  necessary,  the  requirements  for  obtaining  the 
approved  status  with  regard  to  gyrodactylosis  for 
coastal  zones  are  laid  down  in  accordance  with  the 
procedure provided  for in Article 2 6." 

7. 

In Annex C,I,A point 4 is replaced by the following text: 

"4.  it  must  comply,  mutatis 

mutandis, 

with  the 
requirements  set  out  in  Annex  B,I,B.  Furthermore, 
where  approval  with  regard  to  IHN  and/or  VHS  is 
requested on the basis of a historical record with an 
official control system for a 10-year period, it must 
have  been  submitted,  at  least  once  a  year,  to  a 
clinical  inspection  and  the  taking  of  samples  to be 
tested  for  the  pathogens  in question  in  an  approved 
laboratory;" 

8. 

In Annex C,I point B is replaced by the following text: 

"B.  Maintenance of approval 

Maintenance  of  approval  shall  be  subject  to  the 
requirements set out in Annex B I C. However, sampling 
with regard to IHN and/or VHS must be carried out once 
a year 

Article 2 

1.  Member States shall bring into force the laws, regulations 
and administrative provisions necessary to comply with this 
Directive  before  1 July  1997. They  shall  forthwith  notify 
the Commission thereof. 

When Member Sates 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. 

2.  Member States shall communicate to the Commission the text 
of the main provisions of national law which they adopt in 
the field governed by this Directive. 

Article 3 

This  Directive  shall  enter  into  force  20  days  after  its 
publication in the Official Journal of the European Communities. 

Article 4 

This Directive  is addressed to the Member States. 

Done at Brussels, 

For the Council 

10 

P r o p o s al 
f or  a 
COUNCIL DIRECTIVE 
amending Directive  93/53/EEC introducing minimum  Community 
measures for the control of certain fish diseases 

\ 
^k  oiSS 
x 

(CKS) 
J 

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 of the Commission1, 

Having regard to the opinion of the European Parliamant2, 

Having  regard  to  the  opinion  of  the  Economic  and  Social 
Committee3 

Whereas Council Directive 91/67/EEC OF 28 January 1991 concerning 
animal health conditions governing the placing on the market of 
aquaculture  animals  and products4 as  last  amended  by  Directive 
95/22//EC5 lays down the animal health conditions for the placing 
on  the  market  of  aquaculture  fish  susceptible  to  the  diseases 
listed in its Annex A; whereas this list includes viral diseases 
such  as  IHN  and  VHS,  as  well  as gyrodactylosis  caused  by 
the 
parasite  Gyrodactylus 

salaris; 

Whereas Council Directive 93/53/EEC of 24 June 1993  introducing 
minimum  Community  measures  for  the  control  of  certain  fish 
diseases6,  as  amended  by  the  Treaty  of  accession  of  Austria, 
Finland  and  Sweden,  lays  down  control  measures  for  infectious 
salmon anemia(ISA), infectious haematopoietic necrosis(IHN), and 
viral haemorrhagic septecemia  (VHS); 

Whereas  the  measures  provided  for  in  Directive  93/53/EEC  are 
designed  for  the  control  of  viral  diseases;  whereas  those 
measures are not appropriate for gyrodactylosis; 

'OJ N° 

20J N* 

30J N° 

40J N* L 46 of 19.2.1991, p 1 

50J N' L 234 of 11.10.1995, p.l 

60J N" L 175 of 19.7.1993,p 23 

11 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

Directive  93/53/EEC is amended as follows: 

1. Article  1 is replaced by the following text: 

" Article 1 

This Directive  defines the minimum  Community measures  for 
the control of the fish diseases referred to in Article 2, 
points 1 and 2." 

2.  In Article 2, point  1 is replaced by the following text: 

"1 List  I diseases: infectious  salmon anaemia  as referred 
to in Annex A, list I to Council Directive 91/67/EEC;" 

3. In Article 2, point 2 is replaced by the following text: 

"2. List II diseases: infectious haematopoietic necrosis and 
viral haemorrhagic septicaemia, as referred to in Annex A, 
list  II to Directive 91/67/EEC;" 

Article 2 

1.  Member States shall bring into force laws, regulations and 
administrative  provisions  necessary  to  comply  with  this 
Directive  before  1 July  1997. They  shall  forthwith notify 
the Commission thererof. 

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. 

2. 

Member States shall communicate to the Commission the text 
of the main provisions of national law which they adopt in 
the field governed by this Directive. 

Article 3 

This  Directive  shall  enter  into  force  20  days  after  its 
publication in the Official Journal of the European Communities. 

This Directive  is addressed to the Member States. 

Article 4 

Done at Brussels, 

For the Council 

12 

ISSN 0254-1475 

COM(96) 279  final 

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