Proposal for a Council Directive on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals {SEC(2005) 1047}
Date: 2005-08-23
Institutions: European Commission
Subjects: aquaculture, consumer protection, fish disease, fish product, health legislation, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 23.8.2005 
COM(2005) 362 final 

2005/0153 (CNS) 
2005/0154 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

on animal health requirements for aquaculture animals and products thereof, and on 
the prevention and control of certain diseases in aquatic animals 

{SEC(2005) 1047} 

Proposal for a 

COUNCIL DECISION 

amending Decision 90/424/EEC on expenditure in the veterinary field 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

(cid:121) 

Grounds for and objectives of the proposal 

The  purpose  of  this  proposal  is  to  update,  recast  and  consolidate  the  animal 
health rules in relation to the trade in aquaculture products, including disease 
prevention  and  control,  in  order  to  improve  the  competitiveness  of  EU 
aquaculture producers.  

Aquaculture  is  a  very  important  industry  in  the  Community,  particularly  in 
rural  and  coastal  areas.  In  2004,  EU  aquaculture  produced  fish,  molluscs  and 
crustaceans  worth  more  than  €2,5  billion.  However,  financial  losses  due  to 
disease  (mortalities,  reduced  growth  and  reduced  quality)  are  estimated  to  be 
20  %  of  the  production  value.  The  proposal  aims  to  introduce  modern  and 
targeted legislation that reduces these costs; if they could be reduced by only 
20%, the result would be an added value of €100 million per year. 

The existing legislation was developed two decades ago when the EU had only 
12  Member  States.  It  was  primarily  designed  to  protect  the  main  EU 
aquaculture  at  that  time,  namely  salmonid  (trout  and  salmon)  and  oyster 
farming. The legislation now needs to be updated to reflect the broader range 
of aquaculture practises and species that are found in the expanded EU, and to 
take  account  of  the  significant  developments  within  the  industry,  the 
experience gained through 15 years of application of the existing legislation, as 
well as scientific advances in this field. The rules must also be updated to bring 
EU  rules  in  line  with  international  agreements  and  standards  (like  WTO/SPS 
and OIE). 

This proposal corresponds to the Commission legislative Working Programme 
project 2004/SANCO/0025 

(cid:121) 

General context 

This  proposal  will  repeal  the  existing  primary  legislation  (Council  Directives 
91/67/EEC, 93/53/EEC and 95/70/EC) and replace those three Directives with 
one  new  Directive.  This  much  needed  revision  and  consolidation  will  update 
the  legislation  to  reflect  the  EU  aquaculture  industry  in  the  21st  century,  and 
simplify and modernise existing rules to provide more flexibility, and delegate 
more  operational  responsibility  to  Member  States  so  that,  for  example, 
effective  local  or  regional  approaches  can  be  taken  to  prevent  and  contain 
diseases. 

(cid:121) 

Existing provisions in the area covered by the proposal 

This proposal will replace  

– 

Council Directive 91/67/EEC of 28 January 1991 concerning the animal 
health  conditions  governing  the  placing  on  the  market  of  aquaculture 
animals and products; 

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– 

– 

Council  Directive  93/53/EEC  of  24  June  1993  introducing  minimum 
Community measures for the control of certain fish diseases; 

Council Directive 95/70/EC of 22 December 1995 introducing minimum 
Community measures for the control of certain diseases affecting bivalve 
molluscs. 

The  general  principles  laid  down  in  the  three  Directives  in  question  will  be 
maintained. 

In  addition,  there  are  13  implementing  Decisions  which  have  been  adopted 
pursuant to those Directives. The implementing Decisions will remain in force 
until  they  are  repealed  by  a  specific  Decision,  or  replaced  by  a  Decision 
adopted pursuant to this proposal.  

(cid:121) 

Consistency with other policies 

The aquaculture industry falls under the Common Fisheries Policy (CFP). The 
main  interaction  between  this  proposal  and  the  legislation  related  to  the  CFP 
concerns the financial support (see also Com (2004) 497 - final). It is proposed 
that  the  same  principle  applied  for  terrestrial  animal  diseases,  namely  that  a 
financial  contributions  from  the  Community  should  be  made  available  where 
Community  law  requires  a  slaughter/eradication  policy  to  be  carried  out, 
should also be applied to aquatic animal diseases.  

The  proposal  upholds  the  principle  laid  down  in  existing  legislation  that  the 
animal  health  provisions  shall  apply  without  prejudice  to  national  or 
international  provisions  on  the  conservation  of  species  or  the  introduction  of 
non-native species. More stringent rules may therefore be applied where this is 
necessary for the protection of species from an environmental or conservation 
point  of  view.  The  proposal  would  therefore  not  conflict  with  Council 
Directive 92/43/EEC on the conservation of natural habitats and of wild fauna 
and  flora.  Furthermore,  major  change  in  policy  to  concentrate  more  on,  - 
allowing  Member  States  to  allocate  more  resources  to  -  disease  prevention, 
should  reduce  the  environmental  impact  of  the  aquaculture  industry  by 
reducing outbreaks of disease.  

Public health concerns are not dealt with in this proposal, as it is regulated by 
the  "hygiene  package".  None  of  the  diseases  or  pathogens  covered  by  this 
proposal is known to have zoonotic potential. 

The  welfare  of  farmed  fish  falls  within  the  scope  of  the  existing  general 
provisions of Community legislation concerning the protection of animals kept 
for  farming  purposes.  Scientific  advice  from  the  European  Food  Safety 
Authority,  in  addition  to  Council  of  Europe  recommendations  concerning  the 
welfare of fish (within the scope of the European Convention for the protection 
of animals kept for farming purposes) will influence future policy initiatives in 
this area.  

The present animal health provisions relating to third countries will in principle 
remain unchanged. 

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2. 

CONSULTATION  OF 
ASSESSMENT 

INTERESTED 

PARTIES  AND 

IMPACT 

(cid:121) 

Consultation of interested parties 

Consultation  methods,  main  sectors 
respondents. 

targeted  and  general  profile  of 

Written consultations took place in 2000 and 2001 via the Advisory Committee 
on  Fisheries  and  Aquaculture  (ACFA).  In  this  Committee  the  following 
organisations  are  represented:  Federation  of  European  Aquaculture  Producers 
(FEAP),  European  Mollusc  Producers  Association  (EMPA/AEPM),  Comité 
des  Organisations  Professionnelles  Agricoles  de  l'UE  (COPA/COGECA), 
Organisation  of  the  workers  unions  (ETF),  NGO  for  consumer  and  NGO  for 
environment.  The  Commission’s  services  have  regularly  reported  on 
developments in the project in the ACFA Working Group 2 (Aquaculture). 

Bilateral meetings have been held with FEAP and EMPA/AEPM during 2003, 
2004 and 2005. 

Stakeholder consultations were held in September and December 2004. There 
have been several technical working group meetings with representatives from 
the Member States and EFTA/EEA states. 

Summary of responses and how they have been taken into account. 

The main comments from the Member States and stakeholders have been taken 
into account in the framing of the proposal. 

For the stakeholders, it is essential that the Directive contains a mechanism that 
will enable farms to maintain and, where possible improve, their health status, 
and also to encourage farms to make their health status known as a means of 
facilitating safe trade. An appropriate categorisation of health status will be the 
only  way  to  prevent  a  degradation  of  the  aquatic  animal  health  status  in  the 
Community. The concept of categorisation has been introduced in the proposal. 

The  aquaculture  industry's  need  for  economic  compensation  for  disease 
eradication and control measures is also of importance to stakeholders, and is 
the  Member  States.  This 
acknowledged  by 
acknowledgement is further discussed in a proposal for a Council Regulation - 
European Fisheries Fund (COM(2004) 497).  

the  Commission  and 

Where the requests from the stakeholders have not been taken into account, it 
has been due to the international commitments of the Community or due to the 
need for cross-compliance with other Community legislation, in particular the 
WTO/SPS agreement and the EU Food Law. 

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(cid:121) 

Collection and use of expertise 

Scientific/expertise domains concerned. 

Aquatic animal health. 

Methodology used. 

The opinions have been considered in the draft proposal 

Main organisations/experts consulted. 

The scientific platform for the proposal was established by a working group of 
experts on aquatic animal health from EU and EFTA/EEA Member States. In 
addition experts from the industry were consulted. 

Level of scientific certainty: high. 

Advice received and used. 

Yes 

Means used to make the expert advice publicly available. 

Advice  from  expert  working  group  meetings  and  stakeholder  consultation 
meetings has not been made publicly available. However, the advice has been 
discussed with competent authorities and stakeholders in meetings. 

(cid:121) 

Impact assessment 

The  main  provisions  for  placing  on  the  market  an  import  remains  largely 
unchanged. However, some existing trade barriers have been removed without 
jeopardising  the  health  status  of  aquaculture  animals.  The  general  disease 
control  provisions  will  remain  unchanged,  with  some  minor  adjustments.  All 
diseases  considered  exotic  to  the  Community  will  be  subject  to  eradication 
provisions in order to maintain the Community’s free status. Under the present 
legislation  such  measures  are  applied  for  fish  disease  but  not  for  mollusc 
diseases.  The  importation  provisions  are  harmonised  with  the  relevant 
provisions of Council Directive 2002/99/EC (the most recent Directive laying 
down animal health import provisions).  

Positive impacts 

Positive impacts will arise from an updated Community legislative framework 
which  takes  into  account  current  scientific  knowledge  and  the  structure  of 
today's aquaculture industry in the Community. 

There will be positive shift in focus away from preventing the spread disease 
and  towards  the  occurrence  of  disease.  Significant  resources  are  now  being 
used to maintain disease-free status in farms and zones that have been declared 
disease-free. The proposal would allow the Member State to re-allocate some 
of these resources to disease preventive activities. 

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The  proposal  implements  the  philosophy  that  the  best  solution  is  often  found 
closest  to  the  problem,  and  delegates  more  operational  responsibility  to  the 
Member States.  

By introducing general risk-based animal health surveillance, a better overview 
of the disease situation can be achieved. At the same time the risk of spreading 
diseases to farms or areas where the disease has not yet been found is reduced.  

The  proposal  takes  into  account  the  potential  for  exchange  of  disease  agents 
between farmed and wild aquatic animals. 

The  new  legislation  will  be  consistent  with  the  International  Aquatic  Animal 
Health  Code  of  the  World  Organisation  for  Animal  Health  (OIE),  and  will 
reduce  existing  trade  barriers  between  third  countries,  including  developing 
countries, and the Community.  

Negative impacts 

The  negative  impact  will  be  limited,  as  the  proposal  will  to  a  large  extent  be 
founded on the existing legislation. Some new elements and requirements will 
have an administrative and economic impact on the Member States and on the 
industry.  

The  proposal  for  authorisation  of  aquaculture  production  business  will  cause 
extra work for the competent authorities in the Member States. However, since 
all  mollusc  farms  and  the  majority  of  fish  farms  are  already  registered,  the 
authorisation requirement is achievable for the Member States. 

The introduction of a general risk-based animal health surveillance in all farms 
or  farming  areas,  is  an  extension  of  the  requirements  in  the  present  mollusc 
legislation,  under  which  all  Member  States  must  have  a  monitoring  and 
sampling program.  

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

(cid:121) 

Summary of the proposed action 

The proposal includes  

– 

– 

– 

General  requirements  directed  towards  the  aquaculture  production 
business  and  processing  establishments,  such  as  authorisations,  and 
provisions related to their operation; 

Animal  health  provisions  for  placing  on  the  market  of  aquaculture 
animals and products thereof; 

Animal health provisions for introduction of aquaculture animals into the 
Community from third countries; 

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– 

– 

– 

Provisions  for  notification  and  control  of  certain  diseases  in  aquatic 
animal; 

Provisions for declaration of disease-free status; 

Requirements directed towards the competent authorities of the Member 
States, and laboratories; 

– 

Technical requirements and guidelines laid down in Annexes. 

(cid:121) 

Legal basis 

Article 37 of the Treaty 

(cid:121) 

Subsidiarity principle 

The  proposal  falls  within  the  exclusive  competence  of  the  Community.  The 
subsidiarity principle therefore does not apply. 

(cid:121) 

Proportionality principle 

The  proposal  complies  with  the  proportionality  principle  for  the  following 
reason(s).  

For  the  sake  of  the  completion  of  the  internal  market,  the  animal  health 
provisions  applicable  to  the  placing  on  the  market  of  aquaculture  animals 
should be fully harmonised.  

Some of the diseases subject to harmonised trade provisions are widespread in 
parts of the Community. It is however not realistic to enforce the same level of 
control  measures  in  Member  States  that  are  free  of  these  diseases,  as  in 
Member States where these diseases are widespread.  

The introduction of the principle of compartmentalisation will allow for more 
flexibility.  

The administrative and economic burden imposed will result in a higher health 
status,  reduction  of  losses  due  to  diseases  and  more  open  trade.  Increased 
financial  burden  on  the  Community  budget  will  be  limited  to  the  financial 
contribution  in  relation  to  the  control  and  eradication  of  diseases  which  are 
subject to compulsory eradication measures. 

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(cid:121) 

Choice of instruments 

Proposed instruments: Directive. 

Other means would not be adequate for the following reason(s). 

Experience  since  1964  with  harmonised  veterinary 
the 
Community,  and  in  particular  since  1991  with  specific  aquatic  animal  health 
legislation,  have  shown  that  a  Directive  gives  sufficient  flexibility  for  the 
Member States to apply Community veterinary legislation in the framework of 
national legislation and administration. 

legislation 

in 

4. 

BUDGET IMPLICATIONS 

The  economic  impact  on  Community  budget  is  expected  to  be  limited,  and  will 
mainly be in two areas: 

(a)  Economic compensation in relation to disease control. 

The  proposal  should  not  affect  the  future  development  of  the  Community 
policy on animal health and the veterinary fund.  

Council  Decision  90/424/EEC  on  expenditure  in  the  veterinary  field  already 
Infectious 
allows 
Haematopoietic Necrosis (IHN) and Infectious Salmon Anaemia (ISA), under 
Regulation (EC) No 2792/1999 solely. 

financial  support 

to  outbreaks  of 

relation 

for 

in 

It  is  proposed  that  financial  contribution  for  aquatic  animal  disease  control 
from  the  Community  should  be eligible through the  European  Fisheries  Fund 
(Article 32 of COM (2004) 497).  

In the proposal, compulsory slaughter/eradication will  only be  required under 
Community rules in relation to outbreaks of diseases that are considered exotic 
to the Community. With respect to non-exotic diseases it is proposed that the 
Member  States  may  decide  whether  an  outbreak  should  be  subject  to 
eradication  measures  or  containment  measures.  Community  funding  under 
European Fisheries Fund may be made available for control measures of such 
diseases if the Member State so decides. 

If  an  exotic  disease  did  occur  in  the  Community,  it  would  have  no  financial 
impact on Community budget. The same would occur in case of compensation 
for  eradication  of  non-exotic  diseases,  since  the  allocation  of  funds  for  the 
eradication  are  made  within  the  Operational  Programmes,  whose  budget  is 
fixed by the Council at the beginning of the programming period. 

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In the interest of Member States, it would be convenient to assess the financial 
impact  of  eradication  on  their  Operational  Programmes.  However,  the  costs 
related to such eradication measures are difficult to estimate, as there is limited 
experience  in  the  Community  of  stamping  out  policy  involving  economic 
compensation in aquaculture. In the court case following the outbreaks of ISA 
in the UK and Ireland, one company owning five of the thirteen infected farms 
claimed  total  losses  in  the  region  of  €  20-25  million.  Sweden  paid  out 
compensation  under  national  legislation  totalling  of  1,5  mill  SEK  (€165  000) 
over a period of three years in relation to four cases of VHS in 1998.  

It is therefore difficult to estimate the impact of the proposal on the European 
Fisheries Fund, as this will depend on the size of the farm(s) affected, the value 
of the animals kept at the farm(s), etc. However, the figures above can give an 
indication. 

(b) 

Implementation  of  primary  legislation  and  adoption  and  management  of 
secondary legislation 

Once  the  Council  has  adopted  the  proposal,  it  will  be  necessary  to  draw  up, 
adopt  and  maintain  secondary  legislation.  It  will  be  necessary  to  arrange  a 
number of working group meetings with Member States and stakeholders, the 
latter  normally  without  any  additional  cost  for  the  Community  budget.  The 
number of working  groups  is  impossible  to determine, as this will depend  on 
the complexity of the items, and the views of the Member States. 

After  the  act’s  entry  into  force,  FVO  inspections  of  Member  States' 
implementation will be necessary in 2008 and 2009 (13 or 14 inspections per 
year).  Such  inspections  should  as  far  as  possible  be  combined  with  public 
health inspections for "fishery products" and "live bivalve mollusc" pursuant to 
Article 11 of Regulation (EC) No 854/2004. It should be possible to reduce the 
number of missions in subsequent years.  

5. 

ADDITIONAL INFORMATION 

(cid:121) 

Simplification 

The  proposal  provides  for  simplification  of  legislation,  simplification  of 
administrative procedures for public authorities (EU or national). 

Three directives will be merged into one. 

Most of the current provisions in Council Directive 93/53/ECC on the control 
of fish diseases are duplicated in Council Directive 95/70/EC on the control of 
mollusc diseases. 

Delegating  the  power  to  declare  individual  compartments  and  zones  free  of 
disease  to  the  Member  States  will  lead  to  a  simplification  of  administrative 
procedures in the Member States and in the Commission services. 

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(cid:121) 

Repeal of existing legislation 

The  adoption  of  the  proposal  will  lead  to  the  repeal  of  the  three  existing 
Directives. 

(cid:121) 

European Economic Area 

The proposed act is of EEA relevance and should therefore be extended to the 
EEA. 

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2005/0153 (CNS) 

Proposal for a 

COUNCIL DIRECTIVE 

on animal health requirements for aquaculture animals and products thereof, and on 
the prevention and control of certain diseases in aquatic animals 

(Text with EEA relevance) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Parliament2, 

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

Having regard to the opinion of the Committee of the Regions4, 

Whereas: 

(1) 

(2) 

Aquaculture  animals  and  products  are  included  in  Annex  I  to  the  Treaty  as  live 
animals, fish, molluscs and crustaceans. The breeding, rearing and the placing on the 
market of aquaculture animals and products thereof constitutes an important source of 
income for persons working in this sector. 

In the context of the internal market, specific animal health rules were laid down for 
the  placing  on  the  market  and  introduction  from  third  countries  of  the  products 
concerned by Council Directive 91/67/EEC of 28 January 1991 concerning the animal 
health  conditions  governing  the  placing  on  the  market  of  aquaculture  animals  and 
products5. 

1 
2 
3 
4 
5 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ  L  46,  19.2.1991,  p.  1.  Directive  as  last  amended  by  Regulation  (EC)  No  806/2003  (OJ  L  122, 
16.5.2003, p. 1). 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

Outbreaks of diseases in aquaculture animals could cause severe losses to the industry 
concerned.  Minimum  measures  to  be  applied  in  case  of  outbreaks  of  the  most 
important  diseases  in  fish  and  molluscs  were  established  by  Council  Directive 
93/53/EEC  of  24  June  1993  introducing  minimum  Community  measures  for  the 
fish  diseases6,  and  Council  Directive  95/70/EC  of 
control  of  certain 
22 December 1995  introducing  minimum  Community  measures  for  the  control  of 
certain diseases affecting bivalve molluscs7.  

Existing Community legislation was drafted mainly to take into account the farming of 
salmon,  trout  and  oysters.  Since  that  legislation  was  adopted,  the  Community 
aquaculture industry has developed significantly. A number of additional fish species, 
particularly  marine  species,  are  now  used  in  aquaculture.  New  types  of  farming 
practices  involving  other  fish  species  have  also  become  increasingly  common, 
particularly  following  the  recent  enlargement  of  the  Community.  Furthermore, 
farming  of  crustaceans,  mussels,  clams  and  abalones  is  becoming  increasingly 
important.  

All  disease  control  measures  have  an  economic  impact  on  aquaculture.  Inadequate 
controls  can  lead  to  a  spread  of  pathogens,  which  can  cause  major  losses  and 
compromise  the  animal  health  status  of  fish,  molluscs  and  crustaceans  used  in 
Community aquaculture. On the other hand, over-regulation could place unnecessary 
restrictions on free trade.  

The  Communication  from  the  Commission  to  the  Council  and  the  European 
Parliament  dated  19  September  2002  (COM/2002/0511  final)  sets  out  a  strategy  for 
the sustainable development of European Aquaculture. That Communication proposed 
a  series  of  measures  designed  to  create  long-term  employment  in  the  aquaculture 
sector, 
including  promoting  high  animal  health  and  welfare  standards,  and 
environmental  actions  to  ensure  a  sound  industry.  Those  measures  should  be  taken 
into account. 

Since  the  adoption  of  Directive  91/67/EEC,  the  Community  has  ratified  the  World 
Trade Organisation (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS-
Agreement). The SPS Agreement refers to the Guidelines of the World Organisation 
of Animal Health (OIE). The animal health requirements for placing live aquaculture 
animals  and  products  thereof  on  the  market  within  the  Community  in  Directive 
91/67/EEC are more stringent than those Guidelines.  

In order to ensure the rational development of this sector and to increase productivity, 
aquatic animal health rules should be laid down at Community level. These rules are 
necessary, among other things, in order to contribute to the completion of the internal 
market and to avoid the spread of infectious diseases. Legislation should be flexible to 
take  into  account  the  continuing  developments  in  and  diversity  of  the  aquaculture 
sector, as well as the health status of aquatic animals within the Community. 

6 
7 

OJ L 175, 19.7.1993, p. 23. Directive as last amended by the 2003 Act of Accession. 
OJ L 332, 30.12.1995, p. 33. Directive as last amended by the 2003 Act of Accession. 

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(9) 

This  Directive  should  cover  aquaculture  animals,  and  those  environments  which  can 
affect  the  health  status  of  such  animals.  In  general  the  provisions  of  this  Directive 
should  only  apply  to  wild  aquatic  animals  where  the  environmental  situation  may 
impinge  on  the  health  status  of  aquaculture  animals,  or  where  necessary  in  order  to 
fulfil  the  purpose  of  other  Community  legislation,  such  as  Council  Directive 
92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna 
and  flora8  or  to  protect  species  referred  to  in  the  list  draw  up  by  the  Convention  on 
International  Trade  in  Endangered  Species  of  Wild  Fauna  and  Flora  (CITES).  This 
Directive should not prejudice the adoption of more stringent rules on the introduction 
of non-native species. 

(10)  The competent authorities designated for the purpose of this Directive should perform 
their  functions  and  duties  in  accordance  with  the  general  principles  laid  down  in 
Regulation  (EC)  No  854/2004  of  European  Parliament  and  of  the  Council  of 
29 April 2004  laying  down  specific  rules  for  the  organisation  of  official  controls  on 
products  of  animal  origin  intended  for  human  consumption9,  and  Regulation  (EC) 
No 882/2004 of European Parliament and of the Council of 29 April 2004 on official 
controls  performed  to  ensure  the  verification  of  compliance  with  feed  and  food  law, 
animal health and animal welfare rules10. 

(11) 

It is  necessary  for the  development of aquaculture  in  the  Community to  increase  the 
awareness  and  preparedness  of  the  competent  authorities  and  aquaculture  production 
business  operators  in  Member  States  with  respect  to  the  prevention,  control  and 
eradication of aquatic animal diseases.  

(12)  The competent authorities of Member States should have access to, and apply, state-
of-the-art  techniques  and  knowledge  in  the  fields  of  risk  analysis  and  epidemiology. 
This  is  of  increasing  importance  because  international  obligations  within  the 
framework of the World Trade Organisation now focus on risk analysis in relation to 
the adoption of sanitary measures. 

8 

9 

10 

OJ L 206, 22.7.1992, p. 7. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 139, 30.4.2004, p. 206; corrected version (OJ L 226, 25.6.2004, p.83). Regulation as last amended 
by Regulation (EC) No 882/2004 (OJ L 165, 30.4.2004, p. 1); corrected version (OJ L 191, 28.5.2004, 
p. 1). 
OJ L 165, 30.4.2004, p. 1. 

EN 

13 

   EN 

 
                                                 
(13) 

It  is  appropriate  to  introduce  at  Community  level  a  system  of  authorisation  of 
aquaculture  production  businesses.  Such  authorisation  would  enable  the  competent 
authorities to establish a complete overview of the aquaculture industry, which would 
assist  in  the  prevention,  control  and  eradication  of  aquatic  animal  diseases. 
Furthermore, authorisation allows the laying down of specific requirements that must 
be  fulfilled  by  the  aquaculture  production  business  in  order  to  operate.  Such 
authorisation should, where possible, be combined with or included in an authorisation 
regime which the Member States may already have established for other purposes, for 
example under environmental legislation. In addition, such authorisation would not be 
an  extra  burden  to  the  aquaculture  industry,  taking  into  account  the  Proposal  of  13 
January 2004 for a Directive of the European Parliament and the Council on services 
in the internal market11, and in particular Article 6 thereof. 

(14)  Member States should refuse to issue an authorisation if the activity in question would 
pose an unacceptable risk of spreading diseases to other aquaculture animals or to wild 
stocks  of  aquatic  animals.  Before  deciding  to  refuse  an  authorisation,  consideration 
should  be  given  to  risk  mitigation  measures  or  alternative  siting  of  the  activity  in 
question.  

(15)  The rearing of aquaculture animals for the purpose of human consumption falls within 
the  scope  of  Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the 
Council  of  29  April  2004  on  the  hygiene  of  foodstuffs12,  as  primary  production. 
Obligations  imposed  on  individual  aquaculture  production  businesses  under  this 
Directive,  such  as  record  keeping,  and  internal  systems  enabling  the  aquaculture 
production  business  to  demonstrate  to  the  competent  authority  that  relevant 
requirements of this Directive are being fulfilled, should where possible be combined 
with the obligations laid down in Regulation (EC) No 852/2004. 

(16)  More attention should be paid to preventing disease occurrence than to controlling the 
disease  once  it  has  occurred.  It  is  therefore  appropriate  to  lay  down  minimum 
measures  of  disease  prevention  and  risk  mitigation  which  should  be  applied  to  the 
whole production chain in aquaculture, from fertilisation and hatching of eggs to the 
processing of aquaculture animals for human consumption, including transportation. 

(17) 

In order to improve general animal health and assist in the prevention and control of 
animal  disease  through  improved  traceability,  the  movement  of  aquaculture  animals 
should be recorded  using a  harmonised electronic  animal  movement  system,  such  as 
that currently laid down in Council Directive 90/425/EEC of 26 June 1990 concerning 
veterinary and zootechnical checks applicable in intra-Community trade in certain live 
animals  and  products  with  a  view  to  the  completion  of  the  internal  market13.  Where 
appropriate, such movements should also be subject to animal health certification. 

11 
12 
13 

COM/2004/2/Final. 
OJ L 139, 30.4.2004, p. 1; corrected version (OJ L 226, 25.6.2004, p. 3). 
OJ  L  224,  18.8.1990.  p.  29  Directive  as  last  amended  by  Directive  2002/33/EC  of  the  European 
Parliament and of the Council (OJ L 315, 19.11.2002, p. 14). 

EN 

14 

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(18) 

(19) 

In order to have an overview of the disease situation, to facilitate a rapid reaction in 
the case of a suspicion of disease and to protect farms or mollusc farming areas having 
a  high  animal  health  standard,  a  risk-based  animal  health  surveillance  should  be 
applied in all such farms and mollusc farming areas.  

It is necessary to ensure that the main aquatic animal diseases at Community level do 
not  spread.  Harmonised  animal  health  provisions  for  placing  on  the  market  should 
therefore  be  laid  down  with  specific  provisions  applicable  to  species  susceptible  to 
those diseases. Therefore a list of such diseases and susceptible species should be laid 
down. 

(20)  The  prevalence  of  such  aquatic  animal  diseases  is  not  the  same  throughout  the 
Community.  Reference  should  therefore  be  made  to  the  concept  of  Member  States 
which  are  declared  disease-free,  and  when  dealing  with  parts  of  the  territory 
concerned,  zones  or  compartments.  General  criteria  and  procedures  for  the  granting, 
maintenance,  suspension,  restoration  and  withdrawal  of  such  status  should  be  laid 
down. 

(21) 

In  order  to  maintain  and  improve  the  general  aquatic  animal  health  status  in  the 
Community, Member States, zones or compartments declared free of one or more of 
the  listed  diseases  should  be  protected  against  the  introduction  of  such  disease. 
However, in order to avoid the creation of unnecessary trade restrictions, the exchange 
of aquaculture animals between Member States, zones or compartments where one or 
more  such  diseases  are  present  should  be  allowed,  provided  that  risk  mitigation 
measures are taken during transport. 

(22)  The  slaughter  and  processing  of  aquaculture  animals  which  are  subject  to  disease 
control  measures  may  spread  the  disease,  inter  alia  as  a  result  of  the  discharge  of 
effluents containing pathogens from processing plants. It is therefore necessary for the 
Member  States  to  have  access  to  processing  establishments  that  have  been  duly 
authorised to undertake such slaughter and processing without jeopardising the health 
status  of  farmed  and  wild  aquatic  animals,  including  in  respect  of  the  discharge  of 
effluents.  

(23)  The  designation  of  Community  and  national  reference  laboratories  should  contribute 
to the high quality and uniformity of diagnostic results. That objective can be achieved 
by activities such as the application of validated diagnostic tests and the organisation 
of comparative testing and training of staff from laboratories. 

(24)  Laboratories  involved  in  the  examination  of  official  samples  should  work  in 
accordance with internationally approved procedures or criteria based on performance 
standards  and  should  use  diagnostic  methods  that  have,  as  far  as  possible,  been 
validated.  For  a  number  of  activities  related  to  such  examination,  the  European 
Standardisation  Organisation 
for 
Standardisation  (ISO)  have  developed  European  Standards  (EN  Standards)  and  ISO 
Standards  respectively,  appropriate  for  the  purpose  of  this  Directive.  Such  standards 
relate in particular to the operation and assessment of laboratories and to the operation 
and accreditation of control bodies. 

International  Organisation 

(CEN), 

and 

EN 

15 

   EN 

 
(25) 

(26) 

In order to ensure early detection of any possible outbreak of aquatic animal disease, it 
is necessary to oblige those in contact with aquatic animals of susceptible species to 
notify  any  suspect  case  to  the  competent  authority.  Routine  inspections  should  be 
carried  out  in  the  Member  States  to  ensure  that  aquaculture  production  business 
operators  are  familiar  with,  and  apply,  the  general  rules  on  disease  control  and 
biosecurity laid down in this Directive. 

It is necessary to prevent the spread of non-exotic but serious diseases in aquaculture 
animals  as  soon  as  an  outbreak  occurs  by  carefully  monitoring  movements  of  live 
aquaculture  animals  and  products  thereof,  and  the  use  of  equipment  liable  to  be 
contaminated.  The  choice  of  the  measures  to  be  used  by  the  competent  authorities 
should depend on the epidemiological situation in the Member State concerned. 

(27) 

In order to advance the animal health status of the Community, it is appropriate that 
epidemiologically-based  programmes  to  control  and  eradicate  certain  diseases  are 
submitted by Member States for recognition at Community level. 

(28)  For  diseases  not  subject  to  Community  control  measures,  but  which  are  of  local 
importance,  the  aquaculture  industry  should,  with  the  assistance  of  the  competent 
authorities  of  the  Member  States,  take  more  responsibility  for  controlling  such 
diseases through self regulation and the development of “codes of practice”. However, 
it may be necessary, pending the establishment of such codes, for the Member States 
to  implement  certain  control  measures.  Such  national  control  measures  must  be 
justified, necessary and proportionate to the goals to be achieved, and should not affect 
the trade between the Member States. 

(29)  There  is  a  continuous  development  in  knowledge  with  respect  to  hitherto  unknown 
diseases in aquatic animals. It may therefore be necessary for a Member State to apply 
control measures in the case of such emerging disease. Such measures should be swift 
and  adapted  to  each  individual  case,  but  should  not  be  maintained  longer  than 
necessary  to  achieve  their  goal.  As  such  emerging  diseases  may  also  affect  other 
Member  States,  all  Member  States  and  the  Commission  should  be  informed  of  the 
presence of an emerging disease and any control measures taken. 

(30) 

It  is  necessary  and  appropriate  for  the  achievement  of  the  basic  objective  of 
maintaining and, in the event of an outbreak, quickly returning to a disease-free status 
in Member States, to lay down rules on the measures to increase disease preparedness. 
Outbreaks  should  be  controlled  as  speedily  as  possible,  if  necessary  by  emergency 
vaccination, in order to limit the adverse effects on the production of, and trade in, live 
aquaculture animals and products thereof. 

EN 

16 

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(31)  Directive  2001/82/EC  of  6  November  2001  of  the  European  Parliament  and  of  the 
Council  on  the  Community  code  relating  to  veterinary  medicinal  products 14  and 
Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council  of 
31 March  2004  laying  down  Community  procedures  for  the  authorisation  and 
supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Medicines Agency15, require that, with only minor exceptions, all veterinary 
medicinal products that are placed on the market within the Community are to hold a 
marketing authorisation. In general, all vaccines used in the Community should have a 
marketing authorisation. However, the Member States may permit the use of a product 
without a marketing authorisation in the event of a serious epidemic subject to certain 
conditions, in accordance with Regulation (EC) No 726/2004. Vaccines against exotic 
and emerging diseases in aquaculture animals may qualify for such derogation  

(32)  This  Directive  should  lay  down  provisions  to  ensure  the  necessary  level  of 
preparedness  to  effectively  tackle  the  emergency  situations  related  to  one  or  more 
outbreaks of serious exotic or emerging diseases affecting aquaculture, in particular by 
drawing  up  contingency  plans  to  combat  them.  Such  contingency  plans  should  be 
reviewed and updated regularly.  

(33)  Where  the  control  of  a  serious  aquatic  animal  disease  is  subject  to  harmonised 
Community  eradication  measures,  Member  States  should  be  allowed  to  make  use  of 
financial  contribution  from 
the  Community  under  Council  Regulation  (EC) 
No xxxx/200Y  on  the  European  Fisheries  Fund16.  Any  application  for  Community 
support  should  be  subject  to  scrutiny  as  regards  compliance  with  control  provisions 
laid down in this Directive. 

(34)  Live aquaculture animals and products thereof imported from third countries must not 
present  an  animal  health  hazard  for  aquatic  animals  in  the  Community.  To  that  end, 
this  Directive  should  set  out  measures  for  the  prevention  of  the  introduction  of 
epizootic diseases.  

(35) 

It  is  necessary  in  order  to  safeguard  the  aquatic  animal  health  situation  in  the 
Community to further ensure that consignments of live aquaculture animals transiting 
through  the  Community  comply  with  the  relevant  animal  health  requirements 
applicable to the species concerned. 

(36) 

Import conditions should be consistent with the SPS Agreement. This Directive should 
therefore  take  into  account  the  International  Aquatic  Animal  Health  Code  and  the 
Manual of Diagnostic Tests for Aquatic Animals of the OIE. 

14 

15 
16 

OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004 
p. 58). 
OJ L 136, 30.4.2004, p. 1. 
COM(2004) 497 final – Proposal for a Council Regulation European Fisheries Fund. 

EN 

17 

   EN 

 
                                                 
(37)  The  placing  on  the  market  of  ornamental  aquatic  animals  involves  a  wide  variety  of 
species,  often  tropical  species,  solely  for  ornamental  purposes.  Those  ornamental 
aquatic animals are normally kept in private aquariums or ponds, garden centres, or in 
exhibition  aquariums,  not  in  direct  contact  with  Community  waters.  Consequently, 
ornamental  aquatic  animals  held  under  such  conditions  do  not  pose  the  same  risk  to 
other sectors of Community aquaculture or to wild stocks. It is therefore appropriate 
not to lay down special provisions applicable to the placing on the market, transit and 
import of ornamental aquatic animals, kept under such conditions.  

(38)  However,  where  ornamental  aquatic  animals  are  kept  outside  closed  systems  or 
aquariums,  in  direct  contact  with  the  natural  waters  of  the  Community,  they  could 
pose a significant risk to Community aquaculture or wild stocks. That is particularly 
the case for the populations of carp (Cyprinidae), as popular ornamental fish such as 
koi-carp  are  susceptible  to  some  diseases  affecting  other  carp  species  farmed  in  the 
Community or found in the wild. In such cases, the general provisions of this Directive 
should apply. 

(39)  The  setting  up  of  electronic  means  of  exchange  of  information  is  vital  for 
simplification,  for  the  benefit  of  the  aquaculture  industry  and  of  the  competent 
authorities. In order to meet that obligation, common criteria need to be introduced.  

(40)  Member States should lay down rules on penalties applicable to infringements of the 
provisions  of  this  Directive  and  ensure  that  they  are  implemented.  Those  penalties 
must be effective, proportionate and dissuasive. 

(41) 

In accordance with the principle of proportionality, it is necessary and appropriate for 
the  achievement  of  the  basic  objectives  of  this  Directive  to  provide  for  the 
approximation of the concepts, principles and procedures forming a common basis for 
aquatic animal health legislation in the Community. This Directive does not go beyond 
what  is  necessary  in  order  to  achieve  the  objectives  pursued,  in  accordance  with  the 
third paragraph of Article 5 of the Treaty. 

(42)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission17. 

(43) 

It  is  appropriate  to  update  Community  animal  health  legislation  concerning 
aquaculture  animals  and  products  thereof.  Accordingly,  Directives  91/67/EEC, 
93/53/EEC and 95/70/EC should be repealed and replaced by this Directive, 

HAS ADOPTED THIS DIRECTIVE: 

17 

OJ L 184, 17.7.1999, p. 23. 

EN 

18 

   EN 

 
                                                 
Chapter I 
Subject matter, scope and definitions 

Article 1 
Subject matter 

1. 

This Directive lays down: 

(a) 

the animal health requirements to be applied for the placing on the market, the 
importation and the transit of aquaculture animals and products thereof; 

(b)  minimum  preventive  measures  aimed  at  increasing  the  awareness  and 
preparedness of the competent authorities, the aquaculture production business 
operators  and  others  related  to  this  industry,  for  diseases  in  aquaculture 
animals; 

(c)  minimum control measures to be applied in the event of a suspicion of, or an 

outbreak of certain diseases in aquatic animals.  

2. 

Member States shall remain free to take more stringent measures in the field covered 
by Chapter II, Article 13, and Chapter V, provided that such measures do not affect 
trade with other Member States. 

1. 

This Directive shall not apply to: 

Article 2 
Scope 

(a) 

ornamental aquatic animals reared in non-commercial aquaria; 

(b)  wild aquatic animals harvested or caught for direct entry into the food chain;  

(c) 

aquatic animals caught for the purpose of production of fishmeal, fish oil and 
similar products. 

2. 

Chapter II, Sections 1 to 4 of Chapter III, and Chapters IV and VII shall not apply to 
ornamental aquatic animals that are kept in pet-shops, garden centres or commercial 
aquaria: 

(a)  without any direct contact with natural waters in the Community; or 

(b)  which are equipped with effluent treatment systems. 

3. 

This  Directive  shall  apply  without  prejudice  to  provisions  on  the  conservation  of 
species or the introduction of non-native species. 

EN 

19 

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1. 

For the purposes of this Directive, the following definitions shall apply: 

Article 3 
Definitions 

(1)  “aquaculture”  means  the  rearing  or  cultivation  of  aquatic  organisms  using 
techniques designed to increase the production of those organisms beyond the 
natural  capacity  of  the  environment  and  where  the  organisms  remain  the 
property  of  one  or  more  natural  or  legal  persons  throughout  the  rearing  or 
culture stages, up to and including harvesting; 

(2)  “aquaculture animal” means all life stages, including eggs and sperm/gametes, 
of any aquatic animal reared in a farm or mollusc farming area, including any 
such animal from the wild intended for a farm or mollusc farming area; 

(3)  “aquaculture production business” means any undertaking, whether for profit 
or not and whether public or private, carrying out any of the activities related to 
the rearing of aquaculture animals; 

(4)  “aquaculture production business operator” means the natural or legal persons 
responsible for ensuring that the requirements of this Directive are met within 
the aquaculture production business under their control;  

(5)  “aquatic animal” means: 

(a) 

fish belonging to the classes Agnatha, Chondrichytes and Osteichtyes;  

(b)  molluscs belonging to the group Mollusca;  

(c) 

crustaceans belonging to the class Crustacea; 

(6)  “authorised processing establishment” means any food business: 

(a) 

approved or authorised in accordance with Article 4 of Regulation (EC) 
No 853/2004 for processing aquaculture animals for food purposes; and 

(b) 

authorised in accordance with Articles 4 and 5 of this Directive;  

(7)  “authorised  processing  establishment  operator”  means  the  natural  or  legal 
persons responsible for ensuring that the requirements of this Directive are met 
within the authorised processing establishment under their control; 

(8)  “farm”  means  any  premises,  enclosed  area,  or  installation  operated  by  an 
aquaculture production business in which aquaculture animals are reared with a 
view  to  their  being  placed  on  the  market,  but  excluding  those  where  wild 
aquatic animals harvested or caught for the purpose of human consumption are 
temporarily kept awaiting slaughter without being fed; 

EN 

20 

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(9) 

“farming” means the rearing of aquaculture animals in a farm or in a mollusc 
farming area;  

(10)  “mollusc farming area” means a production area or relaying area in which all 
aquaculture production businesses operate under a common biosecurity system; 

(11)  “ornamental  aquatic  animals”  means  aquatic  animals  which  are  reared,  or 

placed on the market for ornamental purposes only; 

(12)  “placing  on  the  market”  means  the  sale,  including  offering  for  sale  or  any 
other  form  of  transfer,  whether  free  of  charge  or  not,  and  any  form  of 
movement of aquaculture animals;  

(13)  “production area” means any sea, estuarine or lagoon area, containing natural 
beds of molluscs or sites used for the cultivation of molluscs, and from which 
molluscs are taken; 

(14)  “put  and  take  fisheries”  means  ponds,  lakes  or  unenclosed  waters  that  are 
sustained  by  the  introduction  of  aquatic  animals  primarily  for  recreational 
activities  rather  than  for  conservation  or  improvement  of  the  natural 
population;  

(15)  “relaying  area”  means  any  sea,  estuarine  or  lagoon  area  with  boundaries 
clearly  marked  and  indicated  by  buoys,  posts  or  any  other  fixed  means,  and 
used exclusively for the natural purification of live molluscs;  

(16)  “wild  aquatic  animals”  means  aquatic  animals  which  are  not  aquaculture 

animals. 

2. 

For  the  purposes  of  this  Directive,  the  technical  definitions  laid  down  in  Annex  I 
shall also apply.  

EN 

21 

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Chapter II 
Aquaculture production businesses and authorised processing 
establishments  

Article 4 
Authorisation of aquaculture production businesses and processing establishments  

1. 

Member  States  shall  ensure  that  every  aquaculture  production  business  is  duly 
authorised by the competent authority in accordance with Article 5. 

2. 

3. 

4. 

Where  appropriate,  such  authorisation  may  cover  several  aquaculture  production 
businesses for molluscs in a mollusc farming area. 

However, dispatch centres, purification centres or similar businesses located inside a 
mollusc farming area shall have an individual authorisation.  

Member States shall ensure that a sufficient number of processing establishments on 
their  territory  are  authorised  for  the  slaughtering  and  processing  of  aquaculture 
animals being harvested and slaughtered for disease control purposes, in accordance 
with Chapter V. 

Those authorised processing establishments shall have an authorisation issued by the 
competent authority in accordance with Article 5. 

Member  States  shall  ensure  that  aquaculture  production  businesses  and  authorised 
processing establishments have a unique authorisation number.  

Member  States  may  require  that  installations  other  than  aquaculture  production 
businesses, where aquatic animals are kept without the intention of being placed on 
the market, and put and take fisheries must be registered by the competent authority.  

In that case, the provisions of this Directive shall apply mutatis mutandis taking into 
account  the  nature,  characteristics  and  situations  of  the  installation  or  put  and  take 
fishery  concerned  and  the  risk  of  spreading  aquatic  animal  diseases  to  other 
populations of aquatic animals as a result of its operation.  

5. 

In  the  case  of  non-compliance  with  the  provisions  of  this  Directive,  the  competent 
authority shall act in accordance with Article 54 of Regulation (EC) No 882/2004. 

EN 

22 

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Article 5 
Authorisation conditions 

1. 

Member  States  shall  ensure  that  authorisations,  as  provided  for  in  Article  4(1)  and 
(3),  are  only  granted  by  the  competent  authority  if  the  aquaculture  production 
business operator or authorised processing establishment operator: 

(a) 

fulfils the relevant requirements of Articles 8, 9 and 10; 

(b)  has  a  system  in  place  which  enables  the  operator  to  demonstrate  to  the 
competent authority that those relevant requirements are being fulfilled; 

(c) 

remains under the supervision of the competent authority, which shall perform 
the duties laid down in Article 54(1).  

An  authorisation  shall  not  be  granted  if  the  activity  in  question  would  lead  to  an 
unacceptable  risk  of  spreading  diseases  to  farms,  mollusc  farming  areas  or  to  wild 
stocks of aquatic animals in the vicinity of the farm or mollusc farming area.  

However, before  a  decision  to refuse authorisation is taken,  considerations  shall  be 
given to risk mitigation measures including possible alternative siting of the activity 
in question.  

Member  States  shall  ensure  that  the  aquaculture  production  business  operator  or 
authorised processing establishment operator submit all relevant information in order 
to  allow  the  competent  authority  to  assess  that  the  conditions  for  authorisation  are 
fulfilled,  including  supplying  the  competent  authority  with  information  required  in 
accordance with Annex II. 

2. 

3. 

Article 6 
Register 

The  Member  States  shall  establish  and  keep  up-to-date  a  register  of  aquaculture  production 
businesses  and  authorised  processing  establishments  containing  at  least  the  information  set 
out in Annex II. 

For the purpose of the traceability requirements provided for in Article 14, the contents of that 
register shall be made available to the other Member States and the Commission. 

EN 

23 

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Article 7 
Supervision 

The  competent  authority  shall  supervise  aquaculture  production  businesses  and  authorised 
processing establishments.  

Such supervision shall at least consist of regular visits and audits. The frequency of such visits 
and audits shall be determined taking account of the risk the aquaculture production business 
and  authorised  processing  establishment  poses  in  relation  to  the  spreading  of  disease  to 
aquatic animals in the vicinity of the aquaculture production business or authorised processing 
establishment. 

Article 8 
Recording obligations  

1. 

Member States shall ensure that aquaculture production businesses keep a record of: 

2. 

3. 

(a) 

(b) 

(c) 

all movements of aquaculture animals and products thereof, into and out of the 
farm or mollusc farming area;  

the  mortality  in  each  epidemiological  unit  as  relevant  for  the  type  of 
production; 

the results of the risk-based animal health surveillance scheme provided for in 
Article 10. 

Member States shall ensure that authorised processing establishments keep a record 
of  all  movement  of  aquaculture  animals  and  products  thereof,  into  and  out  of  such 
establishments.  

Member States shall ensure that when aquaculture animals are transported, a record 
is kept by the transporters of: 

(a)  mortality  during  transport,  as  practicable  for  the  type  of  transport  and  the 

species transported; 

(b) 

(c) 

farms,  mollusc  farming  areas  and  processing  establishments  visited  by  the 
means of transport; 

any water exchange during transport, in particular the sources of new water and 
release of water. 

Article 9 
Good hygiene practice 

Member States shall ensure that aquaculture production businesses and authorised processing 
establishments  implement  good  hygiene  practice,  as  relevant  for  the  activity  concerned,  to 
prevent the introduction and spreading of diseases. 

EN 

24 

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Article 10 
Animal health surveillance scheme 

1. 

Member  States  shall  ensure  that  a  risk-based  animal  health  surveillance  scheme  is 
applied  in  all  farms  and  mollusc  farming  areas,  as  appropriate  for  the  type  of 
production.  

2. 

The risk-based animal health surveillance scheme shall aim at the detection of:  

(a) 

(b) 

any increased mortality in all farms and mollusc farming areas as appropriate 
for the type of production;  

the diseases listed in Part II of Annex III, in farms and mollusc farming areas 
were species susceptible to those diseases are present.  

3. 

Minimum  requirements  for  the  animal  health  surveillance  scheme,  for  the  diseases 
listed in Part II of Annex III, based on the principles laid down in Annex IV, may be 
adopted in accordance with the procedure referred to in Article 62(2) 

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Chapter III 
Animal health requirements for placing on the market of 
aquaculture animals and products thereof  

SECTION 1 
GENERAL PROVISIONS 

Article 11 
Scope 

1. 

2. 

1. 

2. 

Unless  otherwise  provided,  this  Chapter  shall  only  apply  to  the  diseases  and  the 
species susceptible thereto listed in Part II of Annex III. 

Member  States  may  allow  the  placing  on  the  market  for  scientific  purposes  of 
aquaculture  animals  and  products  thereof,  which  do  not  comply  with  this  Chapter 
under the strict supervision of the competent authority. 

The  competent  authority  shall  ensure  that  such  placing  on  the  market  does  not 
jeopardise the health status with regard to the diseases listed in Part II of Annex III of 
aquatic animals at the place of destination or at places of transit.  

Any  such  movements  between  Member  States  shall  not  take  place  without  the 
competent authorities of the Member States concerned being given prior notification. 

Article 12 
General requirements for the placing of aquaculture animals on the market 

Member States shall ensure that the placing on the market of aquaculture animals and 
products  thereof  does  not  jeopardise  the  health  status  with  regard  to  the  diseases 
listed in Part II of Annex III of aquatic animals at the place of destination. 

Aquaculture animals shall only be introduced into another farm or mollusc farming 
area  with  a  recognised  health  status  equivalent  or  lower  than  the  farm  or  mollusc 
farming area of origin. 

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Article 13 
Disease prevention requirements in relation to transport 

1. 

Member States shall ensure that: 

(a) 

(b) 

the necessary disease prevention measures are applied during the transport of 
aquaculture  animals  in  order  not  to  alter  the  health  status  of  those  animals 
during transport, and to reduce the risk of spreading diseases;  

aquaculture animals are transported under conditions which neither alter their 
health  status  nor  jeopardise  the  health  status  of  the  place  of  destination,  and 
where appropriate of places of transit.  

This  paragraph  shall  also  apply  to  diseases  and  the  species  susceptible  thereto  not 
listed in Part II of Annex III.  

2. 

Member States shall ensure that any water exchanges during transport are carried out 
at places and under conditions which do not jeopardise the health status of: 

(a) 

the aquaculture animals being transported;  

(b) 

any aquatic animals at the place of water exchange;  

(c) 

aquatic animals at the place of destination. 

Article 14 
Traceability and certification  

1. 

2. 

3. 

Member  States  shall  ensure  that  placing  on  the  market  of  aquaculture  animals  for 
farming and restocking purposes, including movement of molluscs between mollusc 
farming  areas,  are  reported  using  the  computerised  system  provided  for  in 
Article 20(1) of Council Directive 90/425/EEC. 

Paragraph  1  of  this  Article  shall  also  apply  to  aquaculture  animals  placed  on  the 
market  for  human  consumption  in  accordance  with  point  (a)  of  Article  18(1), 
point (a) of Article 18(2) and Article 19(2). 

Paragraph  1  shall  not  apply  when  aquaculture  animals  are  moved  inside  a  mollusc 
farming  area  or  between  different  farms  belonging  to  one  aquaculture  production 
business, provided that the  mollusc  farming areas or  the  farms are within  the same 
Member  State  and,  where  applicable,  within  the  same  disease-free  zone  or 
compartment.  

Such movements shall be recorded by the aquaculture production business operator. 

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4. 

5. 

Member States shall ensure that introduction of aquaculture animals for farming and 
restocking  purposes  into  other  Member  States,  zones  or  compartments  declared 
disease-free  in  accordance  with  Articles  49  and  50  are  subject  to  animal  health 
certification.  

This Article shall also apply to diseases and the species susceptible thereto not listed 
in Part II of Annex III. 

SECTION 2 
AQUACULTURE ANIMALS INTENDED FOR FARMING AND RESTOCKING  

Article 15 
General requirements for the placing of aquaculture animals on the market for farming and 
restocking 

1. 

2. 

3. 

Member  States  shall  ensure  that  aquaculture  animals  placed  on  the  market  for 
farming do not come from a farm or mollusc farming area where there has been any 
increased mortality or a clinical outbreak of any disease within 31 days prior to the 
date of placing on the market, unless such animals originate from a part of the farm 
or  mollusc  farming  area  epidemiologically  independent  of  the  part  where  the 
increased mortality or clinical signs of disease have occurred.  

This  paragraph  shall  also  apply  in  relation  to  diseases  and  the  species  susceptible 
thereto not listed in Part II of Annex III.  

Member  States  shall  ensure  that  aquaculture  animals  intended  for  destruction  or 
slaughter in accordance with the disease control measures provided for in Chapter V 
are not placed on the market for farming and restocking purposes. 

Aquaculture  animals  may  only  be  released  into  the  wild  and  into  put  and  take 
fisheries for restocking purposes if they: 

(a) 

comply with the requirements in paragraph 1; 

(b) 

come  from  a  farm  or  mollusc  farming  area  with  a  health  status  at  least 
equivalent to the health status of the waters in which they are to be released.  

However, Member States may decide that the aquaculture animals shall come from a 
zone or compartment, declared disease-free in accordance with Articles 49 or 50.  

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Article 16 
Introduction of aquaculture animals of susceptible species into disease-free areas 

In  order  to  be  introduced  for  farming  or  restocking  into  a  Member  State,  zone  or 
compartment declared free of a specific disease in accordance with Articles 49 or 50, 
aquaculture  animals  of  susceptible  species  shall  originate  from  another  Member 
State, zone or compartment also declared free of that disease.  

Paragraph  1  shall  not  apply  where  it  can  be  scientifically  justified  that  susceptible 
species at certain life stages do not transmit the specific disease in question.  

A list of species and life stages to which the first subparagraph may apply, shall be 
adopted and when necessary amended to take account of scientific and technological 
developments in accordance with the procedure referred to in Article 62(2). 

Article 17 
Introduction of aquaculture animals of non-susceptible species into disease-free areas 

Where  scientific  data  or  practical  experience  substantiates  that  species  other  than 
those referred to in Part II of Annex III as susceptible species can be responsible for 
the  passive  transmission  of  a  specific  disease,  such  carrier  species  shall,  where 
introduced into a Member State, zone or compartment declared free of that specific 
disease in accordance with Articles 49 or 50:  

(a) 

originate from another Member State, zone or compartment also declared free 
of that specific disease; or 

(b)  be held in quarantine facilities in water free of the pathogen in question for a 
period  of  time  sufficient  to  reduce  to  an  acceptable  level  the  risk  of  passive 
transmission of the specific disease.  

Paragraph 1 shall not apply where scientific data or practical experience substantiates 
that  carrier  species  at  certain  life  stages  do  not  transmit  the  specific  disease  in 
question.  

A  list  of  carrier  species  and  life  stages  to  which  this  Article  shall  apply,  shall  be 
adopted and when necessary amended to take account of scientific and technological 
developments in accordance with the procedure referred to in Article 62(2)  

1. 

2. 

1. 

2. 

3. 

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SECTION 3 
AQUACULTURE ANIMALS AND PRODUCTS THEREOF INTENDED FOR 
HUMAN CONSUMPTION 

Article 18 
Aquaculture animals and products thereof placed on the market for further processing before 
human consumption  

1. 

2. 

Member States shall ensure that aquaculture animals of species susceptible to one or 
more of the non-exotic diseases listed in Part II of Annex III, and products thereof, 
may only be placed on the market for further processing in a Member State, zone or 
compartment declared free of those diseases in accordance with Articles 49 or 50, if 
they comply with one of the following conditions: 

(a) 

(b) 

they originate from another Member State, zone or compartment declared free 
of the disease in question; 

they are processed in an authorised processing establishment under conditions 
which prevents the spreading of diseases; 

(c) 

as regards fish: they are slaughtered and eviscerated before dispatch; 

(d) 

as  regards  molluscs  and  crustaceans:  they  are  dispatched  as  unprocessed  or 
processed products. 

Member States shall ensure that aquaculture animals of species susceptible to one or 
more of the non-exotic diseases listed in Part II of Annex III which are placed on the 
market for further processing in a Member State, zone or compartment declared free 
of those disease in accordance with Articles 49 or 50, may only be temporarily stored 
at the place of processing if: 

(a) 

(b) 

they originate from another Member State, zone, or compartment declared free 
of the disease in question; or 

they  are  temporarily  kept  in  dispatch  centres,  purification  centres  or  similar 
businesses  which  are  equipped  with  an  effluent  treatment  system  capable  of 
inactivating the pathogens in question, or where the effluent is subject to other 
types  of  treatment  reducing  the  risk  of  transmitting  diseases  to  the  natural 
waters to an acceptable level.  

Article 19 
Aquaculture animals and products thereof placed on the market for human consumption 
without further processing  

1. 

This Section shall not apply where aquaculture animals, of species susceptible to one 
or more of the diseases listed in Part II of Annex III, or products thereof, are placed 
on the market for human consumption without further processing, provided that they 
are  packed  in  retail-sale  packages  which  comply  with  the  provisions  for  packaging 
and labelling provided for in Regulation (EC) No 853/2004. 

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2. 

Where  live  molluscs  and  crustaceans  of  species  susceptible  to  one  or  more  of  the 
diseases listed in Part II of Annex III, are temporarily relayed in Community waters, 
or  introduced  into  dispatch  centres,  purification  centres  or  similar  businesses,  they 
shall comply with Article 18(2).  

SECTION 4 
WILD AQUATIC ANIMALS 

Article 20 
Release of wild aquatic animals in Member States, zones or compartments declared disease-
free 

1. 

2. 

Wild aquatic animals of species susceptible to one or more of the diseases listed in 
Part II of Annex III caught in a Member State or zone or compartment not declared 
disease-free in accordance with Articles 49 or 50, shall be placed in quarantine under 
the supervision of the competent authority in suitable facilities, for a period of time 
sufficient  to  reduce  to  an  acceptable  level  the  risk  of  transmission  of  the  disease, 
before  they  can  be  released  into  a  farm  situated  in  a  Member  State,  zone,  or 
compartment  declared  free  from  the  disease  in  question  in  accordance  with 
Articles 49 or 50.  

The  Member  States  may  allow  traditional  extensive  lagoon  aquaculture  practice, 
without  the  quarantine  provided  for  in  paragraph  1,  provided  a  risk  analysis  is 
undertaken and that the risk is considered not higher than what is expected from the 
application of paragraph 1.  

SECTION 5 
ORNAMENTAL AQUATIC ANIMALS 

Article 21 
Placing on the market of ornamental aquatic animals 

1. 

Member  States  shall  ensure  that  the  placing  on  the  market  of  ornamental  aquatic 
animals  does  not  jeopardise  the  health  status  of  aquatic  animals  with  regard  to  the 
diseases listed in Part II of Annex III.  

2. 

This Article shall apply also in relation to diseases not listed in Part II of Annex III. 

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Chapter IV 
Introduction of aquaculture animals and products thereof into the 
Community from third countries 

Article 22 
General requirements for introduction of aquaculture animals and products thereof from 
third countries 

Member States shall ensure that aquaculture animals and products thereof are introduced into 
the Community only from third countries or parts of third countries that appear on a list drawn 
up and updated in accordance with the procedure referred to Article 62(2). 

Article 23 
Lists of third countries and parts of third countries from which introduction of aquaculture 
animals and products thereof is permitted 

1. 

2. 

3. 

A third country, or a part of a third country, shall appear on the list provided for in 
Article  22,  only  if  a  Community  assessment  of  that  country,  or  that  part  of  a  third 
country,  has  demonstrated  that  the  competent  authority  provides  appropriate 
guarantees  as  regards  compliance  with  the  relevant  animal  health  requirements  of 
Community legislation. 

The  Commission  may  decide  if  an  inspection  as  referred  to  in  Article  58(2)  is 
necessary  to  complete  the  assessment  of  the  third  country,  or  part  of  the  third 
country, provided for in paragraph 1.  

When drawing up or updating the lists provided for in Article 22, particular account 
shall be taken of: 

(a) 

the legislation of the third country; 

(b) 

(c) 

(d) 

the  organisation  of  the  competent  authority  and  its  inspection  services  in  the 
third country, the powers  of these services, the supervision to which they  are 
subject, and the means at their disposal, including staff capacity, to apply their 
legislation effectively; 

the  actual  aquatic  animal  health  requirements  applying  to  the  production, 
manufacture,  handling,  storage  and  dispatch  of  live  aquaculture  animals 
intended for the Community; 

the  assurances  which  the  competent  authority  of  the  third  country  can  give 
regarding  compliance  or  equivalence  with  the  relevant  aquatic  animal  health 
conditions; 

(e) 

any  experience  of  marketing  live  aquaculture  animals  from  the  third  country 
and the results of any import controls carried out; 

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(f) 

(g) 

(h) 

the  results  of  the  Community  assessment,  in  particular  the  results  of  the 
assessment  of  the  competent  authorities  of  the  third  country  concerned  or, 
where  the  Commission  so  requests,  the  report  submitted  by  the  competent 
authorities of the third country on any inspections carried out; 

the health status of farmed and wild aquatic animals in the third country, with 
particular  regard  to  exotic  animal  diseases  and  any  aspects  of  the  general 
aquatic  animal  health  situation  in  the  country  which  might  pose  a  risk  to 
aquatic animal health in the Community; 

the  regularity,  speed  and  accuracy  with  which  the  third  country  supplies 
information  on  the  existence  of  infectious  or  contagious  aquatic  animal 
diseases in its territory, particularly the notifiable diseases listed by the World 
Organisation for Animal Health (OIE); 

(i) 

the  rules  on  the  prevention  and  control  of  aquatic  animal  diseases  in  force  in 
the  third  country  and  their  implementation,  including  rules  on  imports  from 
other countries. 

The  Commission  shall  arrange  for  up-to-date  versions  of  all  lists  drawn  up  or 
updated in accordance Article 22 to be available to the public.  

Lists  drawn  up  in  accordance  with  Article  22  may  be  combined  with  other  lists 
drawn up for animal and public health purposes. 

Article 24 
Documents 

A  document  containing  an  animal  health  certificate  shall  accompany  consignments 
of aquaculture animals and products thereof upon their entry into the Community. 

The animal health certificate shall certify that the consignment satisfies: 

(a) 

the requirements laid down for such commodities under this Directive; and 

(b) 

any  special  import  conditions  established  in  accordance  with  point  (a)  of 
Article 25. 

The  document  may  include  details  required  under  other  provisions  of  Community 
public and animal health legislation. 

4. 

5 

1. 

2. 

3. 

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Article 25 
Detailed rules 

Where  necessary  detailed  rules  for  the  application  of  this  Chapter  may  be  established  in 
accordance  with  the  procedure  referred  to  in  Article  62(2).  Those  rules  may  concern  in 
particular: 

(a) 

(b) 

(c) 

(d) 

(e) 

special  import  conditions  for  each  third  country,  parts  thereof  or  group  of  third 
countries; 

the  criteria  for  classifying  third  countries  and  parts  thereof  with  regard  to  aquatic 
animal diseases;  

the use of electronic documents; 

model animal health certificates and other documents; 

procedures and certification for transit. 

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Chapter V 
Notification and minimum measures for control of diseases of 
aquatic animals 

SECTION 1 
DISEASE NOTIFICATION 

Article 26 
National notification 

1. 

Member States shall ensure that:  

(a)  when there are any reasons to suspect the presence of a disease listed in Part II 
of  Annex III,  or  a  confirmation  of  such  disease  in  aquatic  animals,  the 
suspicion is immediately notified to the competent authority; 

(b)  when  increased  mortality  occurs  in  aquaculture  animals,  the  mortality  is 
immediately  notified  to  the  competent  authority  or  private  veterinarian  for 
further investigations. 

2. 

Member  States  shall  ensure  that  the  obligations  to  notify  the  matters  referred  to  in 
paragraph 1 are imposed on: 

(a) 

the owner and any person attending aquatic animals;  

(b) 

any person accompanying aquaculture animals during transport;  

(c) 

veterinary  practitioners  and  other  professionals  involved  in  aquatic  animal 
health services;  

(d)  official  veterinarians,  senior  staff  of  veterinary  or  other  official  or  private 

laboratories;  

(e) 

any  other  person  with  an  occupational  relationship  to  aquatic  animals  of 
susceptible species or to products of such animals. 

Article 27 
Notification of the other Member States, the Commission and EFTA Member States  

Member States shall notify the other Member States, the Commission and the European Free 
Trade Association (EFTA) Members within 24 hours in case of confirmation of: 

(a) 

(b) 

an exotic disease listed in Part II of Annex III;  

a non-exotic disease listed in Part II of Annex III where the Member State concerned, 
zone, or compartment has been declared free of that disease. 

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SECTION 2 
SUSPICION OF A LISTED DISEASE 

Article 28 
Initial control measures 

Member States shall ensure that in case of suspicion of an exotic disease listed in Part II of 
Annex III or, in the case of suspicion of a non-exotic disease listed in Part II of Annex III in 
Member States, zones or compartments declared free of such disease: 

(a) 

appropriate samples are taken and examined in a laboratory designated in accordance 
with Article 57;  

(b) 

pending the result of the examination provided for in point (a):  

(i) 

the farm, or mollusc farming area, in which the disease is suspected, is placed 
under  official  surveillance  and  relevant  control  measures  are  implemented  to 
prevent the disease spreading to other aquatic animals; and 

(ii)  no  aquaculture  animals  are  allowed  to  leave  or  enter  the  affected  farm  or 
mollusc  farming  area  in  which  the  disease  is  suspected,  unless  authorised  by 
the competent authority. 

Article 29 
Epizootic investigations 

1. 

Member  States  shall  ensure  that  an  epizootic  investigation  is  carried  out  by  the 
competent authority if the examination provided for in point (a) of Article 28 shows 
the presence of  

(a) 

an exotic disease listed in Part II of Annex III in any Member State; or 

(b) 

a non-exotic disease listed in Part II of Annex III in Member States, zones or 
compartments declared free of such disease.  

2. 

The epizootic investigation provided for in paragraph 1 shall be aimed at:  

(a) 

determining the possible means of contamination; and  

(b) 

investigating  whether  aquaculture  animals  have  left  the  farm  or  mollusc 
farming  area  during  the  relevant  period  preceding  the  notification  of  the 
suspicion in accordance with Article 26(1).  

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3. 

Where the epizootic investigation provided for in paragraph 1 shows that the disease 
may  have  been  introduced  into  one  or  more  farms,  mollusc  farming  areas  or 
unenclosed  waters,  the  Member  State  concerned  shall  ensure  that  the  measures 
provided  for  in  Article  28  are  applied  in  such  farms,  mollusc  farming  areas  or 
unenclosed waters. 

In  the  case  of  extensive  water  catchment  areas  or  coastal  areas,  the  competent 
authority may decide to limit the application of Article 28 to a less extensive area in 
the  vicinity  of  the  farm,  or  the  mollusc  farming  area  suspected  of  being  infected, 
where it considers that such less extensive area is sufficiently large to guarantee that 
the disease does not spread.  

4. 

Where  necessary,  the  competent  authority  of  neighbouring  Member  States  or  third 
countries shall be informed of the suspected case of disease.  

In  that  event,  the  competent  authorities  of  the  Member  States  involved  shall  take 
appropriate  action  to  apply  the  measures  provided  for  in  this  Article  within  their 
territory.  

Article 30 
Lifting restrictions 

The competent authority shall lift the restrictions provided for in point (b) of Article 28 where 
the examination provided for in point (a) of that Article fails to demonstrate the presence of 
the disease. 

SECTION 3 
MINIMUM CONTROL MEASURES IN THE CASE OF CONFIRMATION OF 
EXOTIC DISEASES IN AQUACULTURE ANIMALS 

Article 31 
Introductory provision  

This  Section  shall  apply  in  the  case  of  confirmation  of  an  exotic  disease  listed  in  Part  II  of 
Annex III in aquaculture animals. 

Article 32 
General measures  

Member States shall ensure that:  

(a) 

(b) 

the farm or mollusc farming area is officially declared infected;  

a containment area appropriate to the disease in question, is established, including a 
control zone and surveillance zone, around the farm or mollusc farming area declared 
infected; 

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(c) 

no restocking takes place and no aquaculture animals are moved into, within, and out 
of the containment area unless authorised by the competent authority.  

Article 33 
Harvesting and further processing 

1. 

2. 

3. 

Aquaculture  animals  which  have  reached  commercial  size  and  exhibit  no  clinical 
sign of disease may be harvested under the supervision of the competent authority for 
human consumption, or further processing. 

Harvesting,  introduction  into  dispatch  centres  or  purification  centres,  further 
processing  and  any  other  related  operations  involved  in  the  preparation  of  the 
aquaculture  animals  for  entry  into  the  food  chain  shall  be  carried  out  under 
conditions  which  prevent  the  spread  of  the  pathogen  responsible  for  causing  the 
disease.  

Dispatch centres, purification centres or similar businesses shall be equipped with an 
effluent  treatment  system  capable  of  inactivating  the  pathogen  referred  to  in 
paragraph 2, or the effluent must be subject to other types of treatment reducing the 
risk of transmitting diseases to the natural waters to an acceptable level. 

4. 

Further processing shall be performed in authorised processing establishments.  

Article 34 
Removal and disposal 

1. 

2. 

Member  States  shall  ensure  that  dead  fish  and  crustaceans,  as  well  as  live  fish  and 
crustaceans  exhibiting  clinical  signs  of  disease  are  removed  and  disposed  of  under 
the  supervision  of  the  competent  authority  in  accordance  with  Regulation  (EC) 
No 1774/2002 of the European Parliament and of the Council18, as soon as possible 
in accordance with the contingency plan provided for in Article 47 of this Directive. 

Aquaculture  animals  which  have  not  reached  commercial  size  and  do  not  exhibit 
clinical  signs  of  disease  shall,  in  an  appropriate  timeframe  taking  into  account  the 
type of production and the risk such animals pose for further spread of the disease, be 
removed  and  disposed  of  under  the  supervision  of  the  competent  authority  in 
accordance with Regulation (EC) No 1774/2002, and the contingency plan provided 
for in Article 47 of this Directive.  

18 

OJ L 273, 10.10.2002, p. 1. 

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Article 35 
Fallowing 

Where possible, an infected farm or mollusc farming area shall undergo an appropriate period 
of fallowing after being emptied and, where appropriate, cleansed and disinfected.  

For farms or mollusc farming areas rearing aquaculture animals not susceptible to the disease 
in question, decisions on fallowing shall be based on a risk assessment. 

Article 36 
Protection of aquatic animals 

Member  States  shall  take  the  necessary  measures  to  prevent  the  spreading  of  the  disease  to 
other aquatic animals.  

Article 37 
Lifting measures 

The measures provided for in this Section shall be maintained until: 

(a) 

(b) 

1. 

2. 

the eradication measures provided for in this Section have been carried out; and 

sampling and surveillance as appropriate for the disease in question and the types of 
aquaculture  production  businesses  affected  has  been  carried  out  in  the  containment 
area with negative results.  

SECTION 4 
MINIMUM CONTROL MEASURES IN THE CASE OF CONFIRMATION OF  
NON –EXOTIC DISEASES IN AQUACULTURE ANIMALS 

Article 38 
General provisions  

In the case of confirmation of a non-exotic disease listed in Part II of Annex III in a 
Member State, zone or compartment declared free of that disease, the Member State 
concerned shall apply the measures provided for in Section 3 in order to regain such 
disease-free status.  

Where  the  Member  State  concerned  does  not  wish  to  regain  disease-free  status, 
Article 39 shall apply. 

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Article 39 
Containment measures  

In the case of confirmation of a non-exotic disease listed in Part II of Annex III in a Member 
State,  zone  or  compartment  free  of  that  disease,  the  Member  State  concerned  shall  take 
measures to contain the disease. 

Those measures shall at least consist of: 

(a) 

(b) 

(c) 

(d) 

declaring the farm or mollusc farming area to be infected; 

establishing  a  containment  area  appropriate  to  the  disease  in  question,  including  a 
control zone and surveillance zone around the farm or mollusc farming area declared 
infected;  

restricting  the  movement  of  aquaculture  animals  from  the  containment  area  to  the 
effect that such animals may only be: 

(i) 

introduced 
Article12(2); or  

into  farms  or  mollusc  farming  areas 

in  accordance  with 

(ii)  harvested  and  slaughtered  for  human  consumption  in  accordance  with 

Article 33(1); 

the removal and disposal of dead fish and crustaceans, under the supervision of the 
competent  authority  in  accordance  with  Regulation  (EC)  No  1774/2002,  in  an 
appropriate  timeframe  taking  into  account  the  type  of  production  and  the  risk  such 
dead animals pose for further spread of the disease.  

SECTION 5 
 MINIMUM CONTROL MEASURES IN THE CASE OF CONFIRMATION OF 
DISEASES LISTED IN PART II OF ANNEX III IN WILD AQUATIC ANIMALS 

Article 40 
Control of diseases listed in Part II of Annex III in wild aquatic animals 

1. 

2. 

Where wild aquatic animals are infected or suspected of being infected with exotic 
diseases listed in Part II of Annex III, the Member State concerned shall monitor the 
situation,  and  take  the  necessary  measures  to  prevent  the  further  spreading  of  the 
disease.  

Where  wild  aquatic  animals  are  infected  or  suspected  of  being  infected  with  non-
exotic diseases listed in Part II of Annex III in a Member State, zone or compartment 
declared free of that disease, the Member State shall also monitor the situation and 
take the necessary measures to prevent the further spreading of the disease. 

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3. 

Member States shall inform the Commission and the other Member States, within the 
Committee referred to in Article 62(1) of the measures they have taken in accordance 
with paragraphs 1 and 2. 

SECTION 6 
 CONTROL MEASURES IN CASE OF EMERGING DISEASES 

1. 

2. 

3. 

Article 41 
Emerging diseases  

Member  States  shall  take  appropriate  measures  to  control  an  emerging  disease 
situation  and  prevent  that  disease  from  spreading,  where  the  emerging  disease  in 
question has the potential to jeopardise the health situation of aquatic animals. 

In  the  case  of  an  emerging  disease  situation,  the  Member  State  concerned  shall 
inform  the  Member  States,  the  Commission  and  the  European  Free  Trade 
Association 
findings  are  of 
epidemiological significance to another Member State. 

(EFTA)  Members  without  delay  where 

the 

Within  four  weeks,  the  matter  shall  be  brought  to  the  attention  of  the  Committee 
referred  to  in  Article  62(1).  The  measures  taken  by  the  Member  State  concerned 
pursuant  to  paragraph  1  of  this  Article  may  be  extended,  amended  or  repealed  in 
accordance with the procedure referred to in Article 62(3). 

SECTION 7 
ALTERNATIVE MEASURES AND NATIONAL PROVISIONS 

Article 42 
Procedure for adoption of ad hoc epidemiological measures for diseases listed in Part II of 
Annex III 

A Decision may be adopted in accordance with the procedure referred to in Article 62(2) to 
authorise  the  implementation  of  ad  hoc  measures  for  a  limited  period  of  time,  under 
conditions appropriate to the epidemiological situation where: 

(a) 

(b) 

the  measures  provided  for  in  this  Chapter  are  found  not  to  be  suited  to  the 
epidemiological situation; or 

the  disease  appears  to  be  spreading  despite  the  measures  taken  in  accordance  with 
this Chapter. 

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Article 43 
National provisions for limiting the impact of diseases not listed in Part II of Annex III 

1. 

2. 

3. 

Where a disease not listed in Part II of Annex III constitutes a significant risk for the 
aquatic animal health situation or the environment in a Member State, the Member 
State concerned may take measures to control that disease. 

Member  States  shall  ensure  that  the  national  control  measures  referred  to  in 
paragraph 1 do not exceed the limits of what is appropriate and necessary in order to 
control the disease as referred to in paragraph 1.  

Member States shall ensure that any national measures referred to in paragraph 1 that 
may affect trade between Member States are not applied before they are approved in 
accordance with the procedure referred to in Article 62(2).  

Such approval may only be granted where: 

(a) 

(b) 

the establishment of intra-Community trade restrictions is unavoidable in order 
to control the disease; 

those  intra-Community  trade  restrictions  are  consistent  with  the  Standards 
issued by the World Organisation for Animal Health (OIE). 

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Chapter VI 
Control programmes and vaccination  

SECTION 1 
CONTROL AND ERADICATION PROGRAMMES 

1. 

2. 

3. 

Article 44 
Drawing up and approval of control and eradication programmes 

Where a Member State not declared free of one or more of the non-exotic diseases 
listed  in  Part  II  of  Annex  III,  draws  up  a  control  and  eradication  programme  (‘the 
programme’)  for  achieving  disease-free  status  for  one  or  more  of  those  diseases,  it 
shall submit that programme for approval in accordance with the procedure referred 
to in Article 62(3).  

Such  programmes  may  also  be  amended  or  terminated  in  accordance  with  that 
procedure. 

However,  where  a  programme  provided  for  in  paragraph  1  is  to  cover  individual 
compartments or zones, which comprise less than 75% of the territory of the Member 
State,  and  the  zone  or  compartment  consists  of  a  water  catchment  area  not  shared 
with  another  Member  State  or  third  country,  the  procedure  referred  to  in 
Article 50(1)  shall  apply  for  any  approval,  or  amendment  or  termination  of  such 
programme. 

An  overview  of  the  programmes  approved  in  accordance  with  paragraph  1  of  this 
Article  shall  be  made  available  at  Community  level  in  accordance  with  the 
procedures provided for in Article 51.  

From  the  date  of  approval  of  the  programme  in  accordance  with  this  Article,  the 
requirements  and  measures  provided  for  in  Article  14,  Sections  2,  3,  4  and  5  of 
Chapter  III,  Section  2 of Chapter V, and Article 38(1) in relation to  areas declared 
disease free shall apply to the areas which are covered by the programme.  

Article 45 
Content of programmes 

Programmes shall not be approved unless they contain at least the following:  

(a) 

a  description  of  the  epidemiological  situation  of  the  disease  before  the  date  of 
commencement of the programme; 

(b) 

an analysis of the estimated costs and the anticipated benefits of the programme;  

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(c) 

(d) 

the  likely  duration  of  the  programme  and  the  objective  to  be  attained  by  the 
completion date of the programme;  

a description and demarcation of the geographical and administrative area in which 
the programme is to be applied. 

Article 46 
Period of application of programmes 

1. 

Programmes shall continue to be applied until: 

(a) 

(b) 

the  requirements  laid  down  in  Annex  V  have  been  fulfilled,  and  the  Member 
State, zone or compartment is declared free of the disease; or 

the programme is withdrawn, namely if it no longer fulfils its purpose, by the 
competent authority of the Member State concerned, or by the Commission. 

2. 

If the programme is withdrawn as provided for in paragraph 1 (b), the Member State 
concerned  shall  apply  the  containment  measures  in  Article  39  from  the  date  of 
withdrawal of the programme. 

SECTION 2 
CONTINGENCY PLAN FOR EMERGING AND EXOTIC DISEASES 

Article 47 
Contingency plan for emerging and exotic diseases 

1. 

Each  Member  State  shall  draw  up  a  contingency  plan  specifying  the  national 
measures  required  to  maintain  a  high  level  of  disease  awareness  and  preparedness 
and to ensure environmental protection. 

2. 

The contingency plan shall: 

(a) 

(b) 

(c) 

provide  the  competent  authority  with  the  authority  and  means  to  access  all 
facilities,  equipment,  personnel  and  other  appropriate  materials  necessary  for 
the rapid and efficient eradication of an outbreak; 

ensure  coordination  and  compatibility  with  neighbouring  Member  States  and 
encourage cooperation with neighbouring third countries;  

give  a  precise  indication  of  the  vaccine  requirements  and  vaccination 
conditions considered necessary in the event of emergency vaccination, where 
relevant. 

3. 

Member  States  shall  comply  with  the  criteria  and  requirements  laid  down  in 
Annex VII when drawing up contingency plans.  

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4. 

5. 

1. 

2. 

3. 

4. 

Member  States  shall  submit  the  contingency  plans  for  approval  in  accordance  with 
the procedure referred to in Article 62(2).  

Every  five  years,  each  Member  State  shall  update  its  contingency  plan  and  submit 
the updated plan for approval in accordance with that procedure. 

The contingency plan shall be implemented in the event of an outbreak of emerging 
diseases and of exotic diseases listed in Part II of Annex III. 

SECTION 3 
VACCINATION 

Article 48 
Vaccination 

Member  States  shall  ensure  that  vaccination  against  the  exotic  diseases  listed  in 
Part II of Annex III is prohibited unless such vaccination is approved in accordance 
with Articles 41, 42, 44, or 47. 

Member States shall ensure that vaccination against the non-exotic diseases listed in 
Part II of Annex III is prohibited in any parts of their territory declared free of the 
diseases in question, or covered by approved control and eradication programmes.  

Member  States  may  allow  such  vaccination  in  parts  of  their  territory  not  declared 
free from the diseases in question, or where vaccination is a part of approved control 
and eradication programmes. 

Member States shall ensure that the vaccines used are authorised in accordance with 
Directive 2001/82/EC and Regulation (EC) No 726/2004.  

Paragraphs 1 and 2 shall not apply to scientific studies for the purpose of developing 
and testing vaccines under controlled conditions.  

During  such  studies,  Member  States  shall  ensure  that  the  appropriate  measures  are 
taken  to  protect  other  aquatic  animals  from  any  adverse  effect  of  the  vaccination 
carried out within the framework of the studies.  

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Chapter VII 
Disease-free status 

Article 49 
Disease-free Member State 

1. 

A  Member  State  shall  be  declared  free  of  one  or  more  of  the  non-exotic  diseases 
listed  in  Part  II  of  Annex  III  in  accordance  with  the  procedure  referred  to  in 
Article 62(2) if paragraph 2 of this Article is complied with, and :  

2. 

3. 

1. 

(a) 

none of the susceptible species are present in its territory;  

(b) 

the pathogen is known not to be able to survive in the Member State, and in its 
water source; or 

(c) 

the Member State meets the conditions laid down in Part I of Annex V.  

Where  neighbouring  Member  States,  or  water  catchment  areas  shared  with 
neighbouring Member States, are  not declared disease-free, the Member State  shall 
establish  appropriate  buffer  zones  in  its  territory.  The  demarcation  of  buffer  zones 
must  be  such  that  they  protect  the  disease-free  Member  State  from  passive 
introduction of the disease. 

The  specific  requirements  for  surveillance,  sampling  and  diagnostic  methods  that 
shall be used by Member States to declare disease-free status in accordance with this 
Article shall be adopted in accordance with the procedure referred to in Article 62(2).  

Article 50 
Disease-free zone or compartment 

The central competent authority of a Member State may, after having informed the 
Commission  and  the  other  Member  States  thereof,  and  after  having,  on  request, 
submitted the supporting evidence therefore, declare the disease-free status of a zone 
or compartment within its territory of one or more of the non-exotic diseases listed in 
Part II of Annex III where: 

(a) 

(b) 

(c) 

none of the susceptible species are present in the zone or compartment, and in 
its water source;  

the  pathogen  is  known  not  to  be  able  to  survive  in  the  zone  or  compartment, 
and where relevant in its water source; or 

the zone or compartment complies with the conditions laid down in Part II of 
Annex V.  

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2. 

3. 

1. 

2. 

Where the zone(s) or compartment(s) referred to in paragraph 1 comprise more than 
75% of the territory of the Member State, or if the zone or compartment consists of a 
water catchment area shared by another Member State or third country, the procedure 
referred  to  in  paragraph  1,  shall  be  replaced  by  the  procedure  referred  to  in 
Article 62(2). 

The specific requirements of the surveillance, sampling and diagnostic methods used 
by Member States to declare disease-free status in accordance with this Article shall 
be laid down in accordance with the procedure referred to in Article 62(2). 

Article 51 
Lists of disease-free Member States, zones or compartments 

Each  Member  State  shall  establish  and  maintain  an  updated  list  of  zones  and 
compartments declared disease-free in accordance with Article 50(1). Such lists shall 
be made available to the other Member States and the Commission. 

The  Commission  shall  draw  up  and  update  a  list  of  Member  States,  zones  or 
compartments declared disease-free in accordance with Article 49 or 50(2), and shall 
make this list public. 

Article 52 
Maintenance of disease-free status 

A Member State that is declared free from one or more non-exotic diseases listed in Part II of 
Annex III in accordance with Article 49 may discontinue targeted surveillance and maintain 
its  disease-free  status  provided  that  the  conditions  conducive  to  clinical  expression  of  the 
disease in question exist, and the relevant provisions of this Directive are implemented.  

However, for disease-free zones or compartments in Member States not declared disease-free, 
and  in  all  cases  where  conditions  are  not  conducive  to  clinical  expression  of  the  disease  in 
question, targeted  surveillance shall be continued in accordance with the methods provided 
for in Articles 49(3) or 50(3) as appropriate, but at a level commensurate with the degree of 
risk. 

Article 53 
Suspension and restoration of disease free status 

1. 

2. 

Where  a  Member  State  has  reason  to  believe  that  any  of  the  conditions  for 
maintaining  its  status  as  a  disease-free  Member  State,  zone  or  compartment  have 
been  breached,  that  Member  State  shall  immediately  suspend  trade  in  susceptible 
species and carrier species to other Member States, zones or compartments declared 
free  of  the  disease  in  question,  and  apply  the  provisions  of  Sections  2  and  4  of 
Chapter V.  

Where  the  epizootic  investigation  provided  for  in  Article  29(1)  confirms  that  the 
suspected  breach  has  not  taken  place,  the  disease-free  status  of  the  Member  State, 
zone or compartment shall be restored. 

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3. 

Where the epizootic investigation confirms a significant likelihood that infection has 
occurred, the disease-free status of the Member State, zone or compartment shall be 
withdrawn, in accordance with the procedure under which that status was declared. 
The requirements laid down in Annex V shall be complied with before the disease-
free status is restored. 

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Chapter VIII 
Competent authorities and laboratories 

1. 

2. 

3. 

1. 

2. 

3. 

Article 54 
General obligations 

Each Member State shall designate its competent authorities for the purposes of this 
Directive and notify the Commission thereof.  

The competent authorities shall operate and perform their duties in accordance with 
Regulation (EC) No 882/2004.  

Each Member State shall ensure that effective and continuous co-operation based on 
the free exchange of information relevant to the implementation of this Directive is 
established  between  the  competent  authorities  it  designates  for  the  purposes  of  this 
Directive and any of its other authorities involved in regulating aquaculture, aquatic 
animals, and food and feed of aquaculture origin. 

Information shall also be exchanged to the extent necessary between the competent 
authorities of the different Member States.  

Each  Member  State  shall  ensure  that  the  competent  authorities  have  access  to 
adequate  laboratory  services  and  state  of  the  art  know-how  in  risk  analysis  and 
epidemiology,  and  that  there  is  a  free  exchange  of  any  information  relevant  to  the 
implementation of this Directive between the competent authorities and laboratories. 

Article 55 
Community reference laboratories 

Community  reference  laboratories  for  the  aquatic  animal  diseases  relevant  to  this 
Directive  shall  be  designated  in  accordance  with  the  procedure  referred  to  in 
Article 62(2) for a period to be defined in accordance with that procedure.  

Community reference laboratories for aquatic animal diseases shall comply with the 
functions and duties laid down in Part I of Annex VI.  

The  Commission  shall  review  the  designation  of  the  Community  reference 
laboratories by the end of the period referred to in paragraph 1 at the latest, or earlier, 
in  the  light  of  their  compliance  with  the  functions  and  duties  referred  to  in 
paragraph 2.  

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Article 56 
National reference laboratories 

1. 

Member States shall arrange for the designation of a national reference laboratory for 
each of the Community reference laboratories referred to in Article 55.  

2. 

3. 

4. 

5. 

Member  States  may  designate  a  laboratory  situated  in  another  Member  State  or 
European Free Trade Association (EFTA) Member, and a single laboratory may be 
the national reference laboratory for more than one Member State. 

Member States shall communicate the name and address of each designated national 
reference  laboratory  to  the  Commission,  the  relevant  Community  reference 
laboratory and other Member States, including any updates hereto. 

The national reference laboratory shall liaise with the relevant Community reference 
laboratory provided for in Article 55.  

In  order  to  ensure  an  efficient  diagnostic  service  throughout  the  territory  of  a 
Member  State  in  accordance  with  the  requirements  of  this  Directive,  the  national 
reference  laboratory  shall  collaborate  with  any  laboratory  designated  in  accordance 
with Article 57 situated in the territory of the same Member State. 

Member States shall ensure that any national reference laboratory on their territory is 
adequately equipped and staffed with the appropriate numbers of trained personnel to 
carry out the laboratory investigations required in accordance with this Directive and 
to comply with the functions and duties laid down in Part II of Annex VI.  

Article 57 
Diagnostic services and methods 

Member States shall ensure that: 

(a) 

(b) 

(c) 

laboratory  examinations  for  the  purposes  of  this  Directive  are  carried  out  in 
laboratories designated for such purpose by the competent authority; 

laboratory examinations in the case of suspicion and to confirm the presence of the 
diseases  listed  in  Part  II  of  Annex  III  are  carried  out  by  diagnostic  methods  to  be 
established in accordance with the procedure referred to in Article 62(2);  

laboratories  designated  for  diagnostic  services  in  accordance  with  this  Article  shall 
comply with the functions and duties laid down in Part III of Annex VI. 

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Chapter IX 
Inspections, electronic management and penalties 

Article 58 
Community inspections and audits 

Experts  from  the  Commission  may  carry  out  on-the-spot  inspections,  including 
audits, in cooperation with the competent authorities of the Member States, insofar as 
they are necessary for the uniform application of this Directive.  

The  Member  States,  in  whose  territory  such  inspections  and  audits  are  made,  shall 
provide the experts with all the assistance necessary for carrying out their duties.  

The  Commission  shall  inform  the  competent  authority  of  the  results  of  any  such 
inspections and audits. 

Experts from the Commission may also carry out on-the-spot inspections, including 
audits, in third countries, in cooperation with the competent authorities of the third 
country concerned, in order to verify conformity with or equivalence to Community 
aquatic animal health rules.  

Where a serious animal health risk is identified during a Commission inspection, the 
Member State concerned shall immediately take all measures necessary to safeguard 
animal health.  

Where such measures are not taken, or where they are considered to be insufficient, 
the  measures  necessary  to  safeguard  animal  health  shall  be  adopted  in  accordance 
with the procedure referred to in Article 62(3) and the Member State concerned shall 
be informed thereof. 

Article 59 
Electronic management 

Member States shall, by 1 January 2007 at the latest, ensure that all procedures and 
in  Article  6, 
the 
formalities  relating 
Article 51(1), and Article 56(2) available by electronic means, are in place. 

information  provided  for 

to  making 

The Commission shall, in accordance with the procedure referred to in Article 62(2), 
adopt detailed rules for the implementation of paragraph 1 in order to facilitate the 
interoperability  of  information  systems  and  use  of  procedures  by  electronic  means 
between Member States. 

1. 

2. 

3. 

1. 

2. 

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Article 60 
Penalties 

The Member States shall lay down the rules on penalties applicable to infringements of the 
national provisions adopted pursuant to this Directive and shall take all measures necessary to 
ensure that they are implemented. The penalties provided for must be effective, proportionate 
and  dissuasive.  The  Member  States  shall  notify  those  provisions  to  the  Commission  by  the 
date specified in Article 65(1) at the latest and shall notify it without delay of any subsequent 
amendment affecting them.  

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Chapter X 
Amendments, detailed rules and committee procedure 

1. 

2. 

3. 

1. 

2. 

3. 

Article 61 
Amendments and detailed rules 

Article  15(1)  may  be  amended  in  accordance  with  the  procedure  referred  to  in 
Article 62(2), after consultation of the appropriate scientific committee. 

The  Annexes  to  this  Directive  may  be  amended  in  accordance  with  the  procedure 
referred to in Article 62(2). 

Any detailed rules necessary for the implementation of this Directive may be adopted 
in accordance with the procedure referred to in Article 62(2). 

Article 62 
Committee procedure 

The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health (‘the Committee’). 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply.  

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply.  

The  period  laid  down  in  Article  5(6)  of  Decision  1999/468/EC  shall  be  set  at 
15 days. 

4. 

The Committee shall adopt its Rules of Procedure. 

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Chapter XI 
Transitional and final provisions 

Article 63 
Repeal 

1. 

2. 

Directives  91/67/EEC,  93/53/EEC  and  95/70/EC  shall  be  repealed  as  from 
1 January 2007  

References  to  the  repealed  Directives  shall  be  construed  as  references  to  this 
Directive  and  shall  be  read  in  accordance  with  the  correlation  table  laid  down  in 
Annex VIII. 

Article 64 
Transitional provisions 

Transitional  provisions  may  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 62(2) for a period of four years from the date of entry into force of this Directive. 

Article 65 
Transposition  

1. 

Member  States  shall  adopt  and  publish,  by  [30  June  2006]  at  the  latest,  the  laws, 
regulations  and  administrative  provisions  necessary  to  comply  with  this  Directive. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

They shall apply those provisions from [1 January 2007]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

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

Article 66 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union 

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Article 67 
Addresses 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the Council 
The President 

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In addition to the definitions in Article 3, the following technical definitions shall apply: 

ANNEX I 
Definitions 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

‘Compartment’  means  one  or  more  farms  under  a  common  biosecurity  system 
containing an aquatic animal population with a distinct health status with respect to a 
specific disease.  

‘Common  biosecurity  system’  means 
surveillance, disease prevention, and disease control measures are applied. 

the  same  aquatic  animal  health 

that 

‘Containment area’ means an area around an infected farm or mollusc farming area 
where disease control measures are applied with the purpose of preventing the spread 
of the disease. 

‘Disease’  means  a  clinical  or  non-clinical  infection  with  one  or  more  aetiological 
agents in aquatic animals.  

‘Disease-free  zones  or  compartments’  means  zones  or  compartments  declared 
disease free in accordance with Articles 49 or 50. 

‘Emerging  disease’  means  a  newly  recognised  serious  disease,  the  cause  of  which 
may  or  may  not  yet  be  established,  that  has  the  potential  to  be  spread  within  and 
between  populations,  such  as  by  way  of  trade  in  aquatic  animals  and/or  aquatic 
animal products. It may also mean the recognition of a known disease in a new host 
species. 

‘Epidemiological  unit’ means  a  group  of  aquatic  animals  that  share  approximately 
the same risk of exposure to a disease agent within a defined location. This risk may 
be  because  they  share  a  common  aquatic  environment,  or  because  management 
practices make it likely that a disease agent in one group of animals would quickly 
spread to another group of animals. 

‘Fallowing’ means for disease management purposes, an operation where a farm is 
emptied of aquaculture animals susceptible to the disease of concern or known to be 
capable of transferring the disease agent, and, where feasible, of the carrying water.  

‘Further  processing’  means  processing  of  aquaculture  animals  before  human 
consumption  by  any  type  of  measures  and  techniques,  affecting  anatomical 
wholeness,  such  as  bleeding,  gutting/evisceration,  heading,  slicing  and  filleting, 
which produces waste or by-products and could cause a risk of spreading diseases. 

‘Increased mortality’ means unexplained mortalities significantly above the level of 
what  is  considered  to  be  normal  for  the  farm  or  mollusc  farming  area  in  question 
under the prevailing conditions; what is considered to be increased mortality must be 
decided in cooperation between the farmer and the competent authority.  

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(k) 

(l) 

(m) 

(n) 

(o) 

‘Infection’ means propagation of the disease agent in the host. 

‘Infected zone or compartment’ means zones or compartments where the infection is 
known to occur. 

‘Quarantine’  means  maintaining  a  group  of  aquatic  animals  in  isolation  with  no 
direct or indirect contact with other aquatic animals, in order to undergo observation 
for a specified length of time and, where appropriate, testing and treatment, including 
proper treatment of the effluent waters. 

‘Susceptible species’ means any species in which a certain disease agent can multiply 
or otherwise develop. 

‘Zone’ means a precise geographical area with a homogeneous hydrological system 
comprising part of a water catchment area from the source(s) to a natural or artificial 
barrier that prevents the upward migration of aquatic animals from lower stretches of 
the  water  catchment  area,  an  entire  water  catchment  area  from  its  source(s)  to  its 
estuary, or more than one water catchment area, including their estuaries, due to the 
epidemiological link between the catchment areas through the estuary. 

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ANNEX II 
Information required in the official register of aquaculture production businesses and 
authorised processing establishments  

PART I 
AUTHORISED AQUACULTURE PRODUCTION BUSINESS 

1. 

The following minimum information on each aquaculture production business shall 
be kept by the competent authority in a register, as provided for in Article 6: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the  name  and  addresses  of  the  aquaculture  production  business,  and  contact 
details (telephone, facsimile, e-mail); 

the registration number and particulars of the authorisation delivered, (i.e. dates 
identification  codes-  or  numbers,  specified 
for  specific  authorisations, 
conditions for production, any other matter relevant to the authorisation(s)); 

the  geographical  position  of  the  farm  defined  by  a  suitable  system  of  co-
ordinates of all farm-sites (if possible GIS coordinates); 

the  purpose,  type  (i.e.  type  of  culture  system,  or  facilities,  like  land  based 
facilities,  sea  cages,  earth  ponds)  and  maximum  volume  of  production  where 
this is regulated; 

for  continental  farms,  dispatch  centres  and  purification  centres:  details  on  the 
farm’s water supply and discharges; 

the species of aquaculture animals reared at the farm (for multi-species farms 
or  ornamental  farms,  it  must  as  a  minimum  be  registered  whether  any  of  the 
species are known to be susceptible to diseases listed in Annex III, or known 
carriers of such diseases) 

(g)  updated  information  on  the  diseases  status  (i.e.  if  the  farm  is  disease-free 
(located  in  a  Member  State,  zone  or  compartment),  where  the  farm  is  under 
programme with a view of achieving such status, or where the farm is declared 
infected by a disease referred to in Annex III). 

2. 

Where  an  authorisation  is  granted  to  a  mollusc  farming  area  in  accordance  with 
Article 4(2), the data required under point 1(a) of this Part shall be recorded for all 
aquaculture  production  businesses  which  operate  inside  the  mollusc  farming  area. 
The data required under points 1 (b) to 1 (g) of this Part, shall be recorded at mollusc 
farming area level. 

EN 

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PART II  
AUTHORISED PROCESSING ESTABLISHMENTS 

The  following  minimum  information  on  each  authorised  processing  establishment  shall  be 
kept by the competent authority in a register, as provided for in Article 6: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  name  and  addresses  of  the  authorised  processing  establishment,  and  contact 
details (telephone, facsimile, e-mail); 

the  registration  number  and  particulars  of  the  authorisation  delivered  (i.e.  dates  for 
specific  authorisations,  identification  codes-  or  numbers,  specified  conditions  for 
production, any other matter relevant to the authorisation(s)); 

the  geographical  position  of  the  processing  establishment  defined  by  a  suitable 
system of co-ordinates (if possible GIS coordinates); 

details  on  the  authorised  processing  establishment’s  water  effluent  treatment 
systems; 

the  species  of  aquaculture  animals  handled 
establishment. 

in 

the  authorised  processing 

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ANNEX III 
Disease listing 

PART I 
CRITERIA FOR LISTING DISEASES 

A. 

Exotic diseases shall meet the following criteria laid down in point 1 and 2 or 3. 

1. 

2. 

3. 

The  disease  is  exotic  to  the  Community,  as  the  disease  is  not  established  in 
Community  aquaculture,  and  the  pathogen  is  not  known  to  be  present  in 
Community waters.  

It  has  potential  for  significant  economic  impact  if  introduced  into  the 
Community,  either  by  production  losses  in  Community  aquaculture  or  by 
restricting the potential for trade in aquaculture animals and products thereof. 

It  has  potential  for  detrimental  environmental  impact  if  introduced  into  the 
Community, to wild aquatic animal populations of species, which are an asset 
worth protecting by Community or international provisions. 

B. 

Non-exotic diseases shall meet the following criteria laid down in point 1, 4, 5, 6, 7, 
and 2 or 3. 

1. 

2. 

3. 

4. 

5. 

Several  Member  States,  or  regions  in  several  Member  States,  are  free  of  the 
disease. 

It  has  potential  for  significant  economic  impact  if  introduced  into  a  Member 
State  that  is  free  of  the  disease,  either  by  production  losses,  and  annual  costs 
associated  with  the  disease  and  its  control  exceeding  5%  of  the  value  of  the 
production  of  the  susceptible  aquaculture  animal  species  production  in  the 
region,  or  by  restricting  the  possibilities  for  international  trade  in  aquaculture 
animals and products thereof. 

The  disease  has  shown,  where  it  occurs,  to  have  a  detrimental  environmental 
impact if introduced into a disease-free Member State, to wild aquatic animal 
populations  of  species  that  by  Community  or  international  provisions  is  an 
asset worth protecting. 

The  disease  is  difficult  to  control  and  contain  at  farm  level  without  stringent 
control measures and trade restrictions. 

The disease can be controlled at Member State level, experience having shown 
that disease-free compartments can be established and maintained, and that this 
maintenance is cost beneficial. 

6.  During  placing  on  the  market,  there  is  a  likely  risk  that  the  disease  will 

establish itself in a previously uninfected area. 

7. 

Reliable and simple tests for infected animals are available. The tests must be 
specific and sensitive and the testing method harmonised at Community level. 

EN 

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PART II 
LISTED DISEASES 

EXOTIC DISEASES 

DISEASE 

SUSCEPTIBLE SPECIES 

FISH 

Epizootic haematopoietic necrosis 

Redfin perch (Perca fluviatilis), rainbow trout 
(Oncorhynchus mykiss), Macquarie perch (Macquaria 
australasica), silver perch (Bidyanus bidyanus), 
mountain galaxias (Galaxias olidus), sheatfish (Silurus 
glanis), catfish (Ictalurus melas) and mosquito fish 
(Gambusa affinis) and other species belonging to the 
family Poeciliidae 

Epizootic ulcerative syndrome 

Genera Channa, Mastacembelus, Puntius, Trichogaster, 
Catla, Mugil, Labeo. 

MOLLUSCS 

Infection with Bonamia exitiosa 

Ostrea chilensis and O. angasi 

Infection with  
Xenohaliotis californiensis 

Members of the genus Haliotis including black abalone 
(H. cracherodii), red abalone (H. rufescens), pink 
abalone (H. corrugata), green abalone (H. fulgens) and 
white abalone (H. sorenseni). 

Infection with Perkinsus marinus 

Crassostrea virginica and C. gigas 

Infection with Microcytos mackini 

Crassostrea gigas, C. virginica, Ostrea edulis and 
O. conchaphila. 

CRUSTACEANS 

Taura syndrome 

Yellowhead disease 

Pacific white shrimp (Penaeus vannamei), Pacific blue 
shrimp (P. stylirostris) and Gulf white shrimp 
(P. setiferus). 

Black tiger shrimp (Penaeus monodon), Pacific white 
shrimp (P. vannamei), Pacific blue shrimp (P. 
stylirostris), Gulf white shrimp (P. setiferus), Gulf 
brown shrimp (P. aztecus), Gulf pink shrimp (P. 
duorarum), and Kuruma prawn (P. japonicus 

EN 

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NON-EXOTIC DISEASES 

DISEASE 

SUSCEPTIBLE SPECIES 

FISH 

Spring viraemia of carp 

Viral haemorrhagic septicaemia  

Common carp and koi carp (Cyprinus carpio), grass 
carp (Ctenopharyngodon idellus), silver carp 
(Hypophthalmichthys molitrix), bighead carp 
(Aristichthys nobilis), crucian carp (Carassius 
carassius), goldfish (Carassius auratus), tench (Tinca 
tinca) and sheatfish (Silurus glanis) 

Fish belonging to the family Salmonideae, grayling 
(Thymallus thymallus), white fish (Coregonus spp.), 
pike (Esox lucius), turbot (Scophthalmus maximus), 
herring and sprat (Clupea spp.), Pacific salmon 
(Oncorhynchus spp.), Atlantic cod (Gadus morhua), 
Pacific cod (G. macrocephalus), haddock (G. 
aeglefinus) and rockling (Onos mustelus). 

Infectious haematopoietic necrosis 

Fish belonging to the family Salmonidae, pike (Esox 
lucius) 

Koi herpes virus 

Common carp and koi carp (Cyprinus carpio). 

Infectious salmon anaemia 

Atlantic salmon (Salmo salar), rainbow trout 
(Oncorhynchus mykiss), brown trout (Salmo trutta), 

MOLLUSCS 

Infection with Marteilia refringens 

Ostrea edulis, O. angasi and Ostrea chilensis 

Infection with Bonamia ostreae 

Ostrea edulis, O. angasi, O. denselammellosa, O. 
puelchana, Ostreola conchaphila (= O. lurida) and O. 
chilensis (= Tiostrea lutaria), 

CRUSTACEANS 

White spot disease 

Most commercially cultivated penaeid (Family 
Penaeidae) shrimps and prawns. 

EN 

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ANNEX IV 

Surveillance and inspections in farms and mollusc farming areas 

Species present 

Disease status 

Risk level 

Surveillance 

Recommended inspection frequency 
by competent authority 

Recommended inspection frequency by 
private services 

Comments 

Species susceptible to one 
or more of the diseases 
listed in Annex III 

Declared  disease-free  in  accordance 
with Articles 49 or 50 

High 

Active, targeted or passive  

To be adopted by secondary legislation. 

To be adopted by secondary legislation. 

Will be adopted by implementing legislation, taking into account 
the OIE Guidelines, the relevant disease and type of aquaculture 
production. 

Targeted 

To be adopted by secondary legislation. 

To be adopted by secondary legislation. 

Under programme for declaration of 
freedom 
accordance  with 
Article 44 

in 

Not declared disease-free 

Medium 

Low 

High 

Medium 

Low 

High 

Medium 

Low 

Active 

1 every year 

1 every year 

1 every 2 years 

3 every year 

2 every year 

1 every year 

1 every year 

Detailed  rules  should  be  adopted  by  implementing  legislation 
and contain 

– 

– 

further inspection frequencies 

what  investigation  and  sampling  should  take 
place,  taking  into  account  the  relevant  disease 
and type of aquaculture production. 

Declared 
with Article 38 

infected 

in  accordance 

High 

Passive 

1 every year 

No species susceptible to 
the listed diseases 

Declared  disease-free  in  accordance 
with  point  (a)  of  Article 49(1)  or 
point (a) of Article 50(1) 

Medium 

Low 

High 

Medium 

Low 

Passive 

1 every 2 years 

1 every 2 years 

1 every 4 years 

1 every 4 years 

1 every 4 years 

1 every 4 years 

1 every 2 years 

1 every year 

1 every 2 years 

1 every 4 years 

Aim of surveillance is to detect increased mortality 

Main aim of inspections by private services is to check health 
standards  

Main aim of inspections by competent authority is to check 
compliance with Directive 

EN 

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Risk levels 

A high-risk farm or mollusc farming area is a farm or mollusc farming area which:  

(a) 

(b) 

has  a  high  risk  of  spreading  or  contracting  diseases  to/from  other  farms  or  wild 
stocks; 

operates under farming conditions which could increase the risk of disease outbreaks 
(high biomass, low water quality), taking into account the species present; 

(c) 

sells live aquatic animals for further farming or restocking. 

A medium-risk farm or mollusc farming area is a farm or mollusc farming area which: 

(a) 

(b) 

has  medium  risk  of  spreading  or  contracting  diseases  to/from  other  farms  or  wild 
stocks; 

operates under farming conditions which not necessarily would increase the risk of 
disease  outbreaks  (medium  biomass  and  water  quality),  taking  into  account  the 
species present; 

(c) 

sells live aquatic animals mainly for human consumption.  

A low risk farm of mollusc farming area is a farm or mollusc farming area which 

(a) 

(b) 

has  a  low  risk  of  spreading  or  contracting  diseases  to/from  other  farms  or  wild 
stocks,  

operates  under  farming  conditions  which  would  not  increase  the  risk  of  disease 
outbreaks (low biomass, good water quality), taking into account the species present, 

(c) 

sells live aquatic animals for human consumption only. 

EN 

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Types of health surveillance 

Passive  surveillance  includes  mandatory  immediate  notification  of  the  occurrence  or 
suspicion  of  specified  diseases  or  of  any  increased  mortalities.  Investigation  in  accordance 
with Section 2 of Chapter V is required.  

Active surveillance shall include:  

(a) 

(b) 

(c) 

(d) 

Routine  inspection  by  competent  authority  or  by  other  qualified  health  services  on 
behalf of the competent authorities.  

Examination  of  the  aquaculture  animal  population  on  the  farm  or  in  the  mollusc 
farming area for clinical disease.  

Diagnostic  samples  to  be  collected  on  suspicion  of  a  listed  disease  or  observed 
increased mortality during inspection. 

Mandatory immediate notification of occurrence or suspicion of specified diseases or 
of any increased mortalities. 

Targeted surveillance shall include:  

(a) 

(b) 

(c) 

Routine  inspection  by  competent  authority  or  by  other  qualified  health  services  on 
behalf of the competent authorities.  

Prescribed  samples  of  aquaculture  animals  to  be  taken  and  tested  for  specific 
pathogen(s) by specified methods. 

Mandatory immediate notification of occurrence or suspicion of specified diseases or 
of any increased mortalities. 

EN 

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ANNEX V 
Requirements for declaring disease-free Member State, zone or compartment 

PART I 
DISEASE-FREE MEMBER STATE 

1. 

On historical grounds 

1.1.  A Member State where susceptible species are present, but where there has not 
been any observed occurrence of the disease for at least for a period of 25 years 
before  the  date  of  entry  of  force  of  this  Directive  despite  conditions  that  are 
conducive to its clinical expression may be considered disease-free where: 

(a)  basic  disease  control  conditions have been in place continuously for at 
least  a  period  of  10  years  before  the  date  of  entry  into  force  of  this 
Directive; and 

(b) 

infection is not known to be established in wild populations; and 

(c) 

the  implementation  of  trade  and  imports  conditions  to  prevent  the 
introduction of the disease into the Member State is effective.  

A Member State wishing to benefit from a disease-free status as provided for in 
this  point,  must  submit  an  application  in  accordance  with  Article  49  no  later 
than 2 years after entry into force of this Directive.  

1.2.  The basic disease control conditions referred to in point 1.1(a) shall consist, as 

a minimum of the following: 

(a) 

(b) 

the  disease  is  compulsorily  notifiable  to  the  competent  authority, 
including notification of suspicion; and 

an  early  detection  system  is  in  place  throughout  the  Member  State, 
to  undertake  effective  disease 
enabling 
investigation and reporting, and ensuring in particular: 

the  competent  authority 

(i) 

(ii) 

the  rapid  recognition  of  any  clinical  signs  consistent  with 
suspicious of a disease, emerging disease, or unexplained mortality 
in farms or molluscs farming area s, and in the wild; and  

the  rapid  communication  of  the  event  to  the  competent  authority 
with  the  aim  to  activating  diagnostic  investigation  with  minimum 
delay. 

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1.3.  The early detection system referred to in point 1.2 (b) must at least include the 

following: 

(a) 

the  personnel  employed 

broad  awareness,  among 
in  aquaculture 
businesses  or  involved  in  the  processing  of  aquaculture  animals,  of  any 
signs  consistent  with  the  presence  of  a  disease,  and  training  of 
veterinarians  or  aquatic  animal  health  specialists  in  detecting  and 
reporting unusual disease occurrence; and 

(b)  veterinarians  or  aquatic  animal  health  specialists  trained  in  recognising 

and reporting suspicious disease occurrence; and 

(c) 

access  by  the  competent  authority  to  laboratories  with  the  facilities  for 
diagnosing and differentiating listed and emerging diseases. 

2. 

Based on targeted surveillance 

A Member State where the last known clinical occurrence was within the period of 
25 years before the  date of  entry into force of  this  Directive  or where  the  infection 
status  prior  to  targeted  surveillance  was  unknown,  because  of  the  absence  of 
conditions conducive to clinical expression, may be considered free from the disease 
where: 

(a) 

(b) 

the  Member  State  meets  the  basic  disease  control  conditions  laid  down  in 
point 1.2.; and 

targeted  surveillance  in  accordance  with  methods  adopted  pursuant  to 
Article 49(3),  has  been  in  place  for  at  least  a  period  of  two  years  before  the 
date of entry into force of this Directive without detection of the disease agent 
on farm, or in mollusc farming areas that rears any of the susceptible species.  

Where  there  are  parts  of  the  Member  State  in  which  the  number  of  farms,  or 
molluscs  farming  areas  are  limited,  and  consequently  targeted  surveillance  in  these 
parts do not to provide sufficient epidemiological  data, but in which there  are wild 
populations  of  any  of  the  susceptible  species,  those  wild  populations  must  be 
included in the targeted surveillance.  

EN 

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PART II 
DISEASE-FREE ZONE OR COMPARTMENT 

1. 

Zones 

1.1.  A zone may comprise: 

(a) 

an entire water catchment area from its source to its estuary; or 

(b)  part of a water catchment area from the source(s) to a natural or artificial 
barrier that prevents the upward migration of aquatic animals from lower 
stretches of the water catchment area; or  

(c)  more than one water catchment area, including their estuaries, due to the 

epidemiological link between the catchment areas through the estuary.  

The geographical demarcation of the zone shall be clearly identified on a map.  

1.2.  Where  a  zone  extends  over  more  than  one  Member  State,  it  can  only  be 
declared  a  disease-free  zone  if  the  conditions  outlined  in  point  1.3,  point  1.4 
and point 1.5 apply to all areas of that zone. In that case both Member States 
concerned shall apply for approval for the part of the zone situated in their 
territory. 

1.3.  A zone where susceptible species are present, but where there has not been any 
observed occurrence of the disease for at least a period of 25 years before the 
date of entry into force of this Directive, despite conditions that are conducive 
to its clinical expression may be considered disease-free if it complies mutatis 
mutandis with the requirements in Part I.1.  

A Member State wishing to benefit from a disease-free status as provided for in 
this  point  must  notify  its  intention  in  accordance  with  Article  50(1)  no  later 
than 2 years after the entry into force of this Directive 

1.4.  A  zone  where  the  last  known  clinical  occurrence  was  within  a  period  of 
25 years  before  the  date  of  entry  into  force  of  this  Directive  or  where  the 
infection  status  prior  to  targeted  surveillance  was  unknown,  because  of  the 
absence of conditions conducive to clinical expression, may be considered free 
from the disease where it complies mutatis mutandis with the requirements in 
Part I.2. 

1.5.  A  buffer  zone  in  which  a  monitoring  programme  is  carried  out  must  be 
established, as appropriate. The demarcation of the buffer zones must be such 
that it protects the disease-free zone from passive introduction of the disease.  

EN 

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2. 

Compartments comprising one or more farms or mollusc farming areas where 
the  disease  status  is  dependent  on  the  disease  status  of  surrounding  natural 
waters 

2.1.  A compartment may comprise one or more farms, a group or cluster of farms 
or a mollusc farming area that can be considered as one epidemiological  unit 
due  to  geographical  localisation  and  distance  to  other  groups  or  clusters  of 
farms,  or  molluscs  farming  areas,  provided  that  all  farms  comprising  the 
compartment  are  under  a  common  biosecurity  system.  The  geographical 
demarcation of a compartment shall be clearly identified on a map.  

2.2.  A compartment where susceptible species are present, but where there has not 
been any observed occurrence of the disease for at least for a period of 25 years 
before  the  date  of  entry  of  force  of  this  Directive  despite  conditions  that  are 
conducive  to  its  clinical  expression  may  be  considered  disease-free  if  it 
complies  mutatis  mutandis  with  the  requirements  in  Part  I.1  of  this  Annex. 
Member  States  wishing  to  benefit  from  this  provision  must  notify  their 
intention in accordance with Article 50(1) no later than 2 years after the entry 
into force of this Directive.  

2.3.  A compartment where the last known clinical occurrence was within a period 
of  25  years  before  the  date  of  entry  into  force  of  this  Directive  or  where  the 
infection  status  prior  to  targeted  surveillance  was  unknown,  because  of  the 
absence of conditions conducive to clinical expression, may be considered free 
from the disease where it complies mutatis mutandis with the requirements in 
Part  I.2,  and  the  disease  is  not  known  to  occur  in  the  waters  surrounding  the 
compartment. 

2.4.  Each  farm  or  mollusc  farming  area  in  a  compartment  shall  be  subject  to 
additional  measures  imposed  by  the  competent  authority,  when  considered 
necessary to prevent the introduction of diseases. Such measures may include 
the  establishment  of  a  buffer  zone  around  the  compartment  in  which  a 
monitoring  programme  is  carried  out,  and  the  establishment  of  additional 
protection against the intrusion of possible pathogen carriers or vectors. 

3. 

Compartments  comprising  one  or  more  individual  farms  where  the  disease 
status is independent of the disease status of the surrounding natural waters 

3.1.  A compartment may comprise:  

(a) 

an individual farm which can be considered as a single epidemiological 
unit, as it is not influenced by the animal health status in the surrounding 
waters; or  

(b)  more than one farm where each farm in the compartment complies with 
the  criteria  laid  down  in  point  3.1.(a)  and  points  3.2  to  3.6,  but,  due  to 
extensive movement of animals between farms, must be considered as a 
single  epidemiological  unit,  and  where  all  farms  are  under  a  common 
biosecurity system.  

EN 

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3.2.  A compartment must be supplied with water:  

(a)  Through  a  water  treatment  plant  capable  of  inactivating  the  relevant 
pathogen; however, such water treatment is not considered acceptable for 
use in a disease-free compartment where the disease is known to occur in 
the water feeding the treatment plant. 

(b)  Directly from a well, a borehole or a spring. Where such water supply is 
situated  outside  the  premises  of  the  farm,  the  water  must  be  supplied 
directly to the farm, and be channelled through a pipe. 

3.3.  There  must  be  natural  or  artificial  barriers  that  prevent  aquatic  animals  from 
entering each farm in a compartment from the surrounding watercourses. 

3.4.  The  compartment  must,  where  appropriate,  be  protected  against  flooding  and 

infiltration of water from the surrounding watercourses. 

3.5.  The  compartment  must  comply,  mutatis  mutandis,  with  the  requirements  laid 

down in Part I.2 of this Annex.  

3.6.  A  compartment  shall  be  subject  to  additional  measures  imposed  by  the 
competent authority, when considered necessary to prevent the introduction of 
diseases. Such measures may include the establishment of additional protection 
against the intrusion of possible pathogen carriers or vectors. 

4. 

Special provisions for individual farms which commence or recommences their 
activities 

4.1.  A new farm, which meets the requirements referred to in points 3.1.(a) and 3.2 
–  to  3.6  of  this  Part,  but  which  commences  its  activities  with  aquaculture 
animals  from  a  declared  disease-free  compartment  may  be  declared  disease-
free without undergoing the sampling required for approval. 

4.2.  A  farm  which  recommences  its  activities  after  a  break  with  aquaculture 
animals from a declared disease-free compartment, and meets the requirements 
referred to in points 3.1.(a) and points 3.2 to 3.6 of this Part, may be declared 
disease-free  without  undergoing  the  sampling  required  for  approval  provided 
that: 

(a) 

(b) 

(c) 

the health history of the farm over the last four years of its operation is 
known  to  the  competent  authority;  however,  if  the  farm  concerned  has 
been  in  operation  for  less  than  four  years,  the  actual  period  in  which  it 
has been in operation will be taken into account; and 

the farm has not been subject to animal-health measures in respect of the 
diseases listed in Part II of Annex III and there have been no antecedents 
of those diseases on the farm; and 

prior to the introduction of the aquaculture animal, eggs or gametes, the 
farm  is  cleaned  and  disinfected,  followed,  as  necessary,  by  a  period  of 
fallowing.

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ANNEX VI 
Functions and duties of laboratories 

PART I 
COMMUNITY REFERENCE LABORATORIES 

1. 

In  order  to  be  designated  as  a  Community  reference  laboratory  in  accordance  with 
Article 55, the laboratories must fulfil the following requirements. They must: 

(a) 

have suitably qualified staff with adequate training in diagnostic and analytical 
techniques  applied  in  their  area  of  competence,  including  trained  personnel 
available for emergency situations occurring within the Community; 

(b)  possess the equipment and products needed to carry out the  tasks assigned to 

them; 

(c) 

have an appropriate administrative infrastructure; 

(d) 

ensure that their staff respect the confidential nature of certain subjects, results 
or communications; 

(e) 

have sufficient knowledge of international standards and practices; 

(f) 

have available, as appropriate, an updated list of available reference substances 
and  reagents  and  an  updated  list  of  manufacturers  and  suppliers  of  such 
substances and reagents; 

(g) 

take account of research activities at national and Community level; 

2. 

However,  the  Commission  may  only  designate  laboratories  that  operate  and  are 
assessed  and  accredited  in  accordance  with  the  following  European  Standards, 
account  being  taken  of  the  criteria  for  different  testing  methods  laid  down  in  this 
Directive: 

(a)  EN  ISO/IEC  17025  on  “General  requirements  for  the  competence  of  testing 

and calibration laboratories”; 

(b)  EN 45002 on “General criteria for the assessment of testing laboratories”; 

(c)  EN 45003 on “Calibration and testing laboratory accreditation system-General 

requirements for operation and recognition”. 

3. 

The  accreditation  and  assessment  of  testing  laboratories  referred  to  in  paragraph  2 
may relate to individual tests or groups of tests.  

EN 

71 

   EN 

 
4. 

For one or more of the diseases under their responsibility, the Community reference 
laboratories  may  take  advantage  of  the  skills  and  capacity  of  laboratories  in  other 
Member States or EFTA Member States provided the laboratories concerned comply 
with  the  requirements  in  points  1,  2  and  3  of  this  Annex.  Any  intention  to  take 
advantage of such cooperation must be part of the information provided as a basis for 
the designation in accordance with Article 55(1). However, the Community reference 
laboratory shall remain the contact point for the National reference laboratories in the 
Member States, and for the Commission. 

5. 

The Community reference laboratories shall: 

(a) 

coordinate, in consultation with the Commission, the methods employed in the 
Member States for diagnosing the disease concerned, specifically by: 

(i) 

(ii) 

typing, storing and, where appropriate, supplying strains of the pathogen 
of  the  relevant  disease  to  facilitate  the  diagnostic  service  in  the 
Community, 

supplying  standard  sera  and  other  reference  reagents  to  the  national 
reference laboratories in order to standardise the tests and reagents used 
in each Member State, where serological tests are required, 

(iii)  organising  periodic  comparative 

tests)  of  diagnostic 
procedures  at  Community  level  with  the  national  reference  laboratories 
designated by the Member States, in order to provide information on the 
methods  of  diagnosis  used  and  the  results  of  tests  carried  out  in  the 
Community; 

tests  (ring 

(iv)  retaining  expertise  on  the  relevant  disease  pathogen  and  other  pertinent 

pathogens to enable rapid differential diagnosis; 

assist actively in the diagnosis of outbreaks of the relevant disease in Member 
States  by 
for  confirmatory  diagnosis, 
characterisation and epizootic studies; 

receiving  pathogen 

isolates 

facilitate  the  training  or  retraining  of  experts  in  laboratory  diagnosis  with  a 
view to harmonising diagnostic techniques throughout the Community; 

collaborate,  as  regards  methods  of  diagnosing  animal  diseases  falling  within 
their  areas  of  competence,  with  the  competent  laboratories  in  third  countries 
where those diseases are prevalent; 

collaborate  with  the  relevant  OIE  reference  laboratories  with  regard  to  exotic 
diseases listed in Part II of Annex III for which they are responsible; 

collate  and  forward  information  on  exotic  and  endemic  diseases,  that  are 
potentially emerging in Community aquaculture. 

(b) 

(c) 

(d) 

(e) 

(f) 

EN 

72 

   EN 

 
PART II 
NATIONAL REFERENCE LABORATORIES 

1. 

The  national  reference  laboratories  designated  pursuant  to  Article  56  shall  be 
responsible for coordinating the diagnostic standards and methods within their field 
of  responsibility  in  the  respective  Member  State.  These  national  reference 
laboratories must: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

undertake  to  notify,  without  delay,  the  competent  authority  whenever  the 
laboratory  is  aware  of  a  suspicion  of  any  of  the  diseases  referred  to  in 
Annex III; 

coordinate, in consultation with the relevant Community reference laboratory, 
the methods employed in Member States for diagnosing the diseases concerned 
for which they are responsible; 

assist actively in the diagnosis of outbreaks of the relevant disease by receiving 
pathogen  isolates  for  confirmatory  diagnosis,  characterisation  and  epizootic 
studies; 

facilitate  the  training  or  retraining  of  experts  in  laboratory  diagnosis  with  a 
view to harmonising diagnostic techniques throughout the Member State; 

ensure confirmation of positive results of all outbreaks of exotic diseases listed 
in Part II of Annex III, and of primary outbreaks of non-exotic diseases listed 
in that Annex; 

organise  periodic  comparative  tests  (ring  tests)  of  diagnostic  procedures  at 
national  level  with  the  laboratories  designated  by  the  Member  States  in 
accordance with Article 57, in order to provide information on the methods of 
diagnosis used and the results of tests carried out in the Member State; 

(g) 

cooperate  with  the  Community  reference  laboratory  referred  to  in  Article  55 
and participate in the comparative tests organised by the Community reference 
laboratories; 

(h) 

ensure a regular and open dialogue with their national competent authorities;  

(i) 

operate  and  be  assessed  and  accredited  in  accordance  with  the  following 
European  Standards  account  being  taken  of  the  criteria  for  different  testing 
methods laid down in this Directive: 

(i)  EN  ISO/IEC  17025  on  “General  requirements  for  the  competence  of 

testing and calibration laboratories”, 

(ii)  EN 45002 on “General criteria for the assessment of testing laboratories”, 

(iii)  EN  45003  on  “Calibration  and  testing  laboratory  accreditation  system-

General requirements for operation and recognition”. 

EN 

73 

   EN 

 
2. 

3. 

4. 

The accreditation and assessment of testing laboratories referred to in paragraph 1(i) 
may relate to individual tests or groups of tests.  

The  Member  States  may  designate  national  reference  laboratories  which  do  not 
comply with the requirements in point 1 (i) (i) of this Part, where operation under EN 
ISO/IEC 17025 is practically difficult, provided the laboratory operates under quality 
assurance in line with the guidelines in ISO 9001. 

Member  States  may  authorise  a  national  reference  laboratory  situated  on  their 
territory to take advantage of the skills and capacity of other laboratories designated 
pursuant  to  Article  57,  for  one  or  more  of  the  diseases  under  their  responsibility, 
provided that these laboratories comply with the relevant requirements of this Part. 
However,  the  national  reference  laboratory  shall  remain  the  contact  point  for  the 
central competent authority of the Member State, and for the Community reference 
laboratory.  

PART III 
DESIGNATED LABORATORIES IN MEMBER STATES 

1. 

The  competent  authority  of  a  Member  State  shall  only  designate  laboratories  for 
diagnostic services pursuant to Article 57 that fulfil the following requirements. They 
must: 

(a) 

undertake  to  notify,  without  delay,  the  competent  authority  whenever  a 
laboratory  is  aware  of  a  suspicion  of  any  of  the  diseases  referred  to  in 
Annex III;  

(b)  undertake  to  participate  in  comparative  tests  (ring-tests)  of  diagnostic 

procedures arranged by the national reference laboratory; 

(c) 

operate  and  be  assessed  and  accredited  in  accordance  with  the  following 
European  Standards  account  being  taken  of  the  criteria  for  different  testing 
methods laid down in this Directive: 

(i)  EN  ISO/IEC  17025  on  “General  requirements  for  the  competence  of 

testing and calibration laboratories”; 

(ii)  EN  45002  on  “General  criteria  for 

the  assessment  of 

testing 

laboratories”; 

(iii)  EN  45003  on  “Calibration  and  testing  laboratory  accreditation  system-

General requirements for operation and recognition”. 

2. 

The accreditation and assessment of testing laboratories referred to in paragraph 1(c) 
may relate to individual tests or groups of tests.  

EN 

74 

   EN 

 
3. 

4. 

The  Member  States  may  designate  laboratories  which  do  not  comply  with  the 
requirements in point 1 (c) (i) of this Part, where operation under EN ISO/IEC 17025 
is  practically  difficult,  provided  the  laboratory  operates  under  quality  assurance  in 
line with the guidelines in ISO 9001. 

The competent authority shall cancel the designation where the conditions referred to 
in this Annex are no longer fulfilled. 

EN 

75 

   EN 

 
ANNEX VII 
CRITERIA AND REQUIREMENTS FOR CONTINGENCY PLANS 

Member States shall ensure that contingency plans meet at least the following requirements: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

Provision must be made to ensure the legal powers needed to implement contingency 
plans and put into effect a rapid and successful eradication campaign. 

Provision must be made to ensure access to emergency funds, budgetary means and 
financial resources  in  order  to  cover  all  aspects  of  the  fight  against  exotic  diseases 
listed in Part II of Annex III. 

A  chain  of  command  must  be  established  to  guarantee  a  rapid  and  effective 
decision-making  process  for  dealing  with  exotic  diseases  listed  in  Annex  III  or 
emerging diseases. A central decision-making unit must be in charge of the overall 
direction of control strategies. 

Detailed plans must be available for Member States to be prepared for the immediate 
establishment  of  local  disease  control  centres  in  the  event  of  an  outbreak  of  exotic 
diseases listed in Part II of Annex III or emerging diseases and to implement disease 
control and environment protection measures at a local level. 

Member  States  must  ensure  cooperation  between  the  competent  authorities  and 
competent  environmental  authorities  and  bodies  in  order  to  ensure  that  actions  on 
veterinary and environmental safety issues are properly coordinated. 

Provision  must  be  made  for  adequate  resources  to  ensure  a  rapid  and  effective 
campaign, including personnel, equipment and laboratory capacity. 

An up-to-date operations manual must be available, with a detailed, comprehensive 
and  practical  description  of  all  the  actions,  procedures,  instructions  and  control 
measures to be employed in handling exotic diseases listed in Part II of Annex III or 
emerging diseases. 

Detailed plans must be available for emergency vaccination, where appropriate. 

Staff must be regularly involved in training in clinical signs, epidemiological enquiry 
and  control  of  epizootic diseases,  in  real-time  alert  exercises,  and  in  training  in 
communication  skills  to  provide  ongoing  disease  awareness  campaigns  for 
authorities, farmers and veterinarians. 

10. 

Contingency  plans  must  be  prepared  and  take  into  account  the  resources  needed  to 
control a large number of outbreaks occurring within a short period of time. 

EN 

76 

   EN 

 
11. 

Without  prejudice  to  veterinary  requirements  in  Regulation  (EC)  No  1774/2002, 
contingency  plans  must  be  prepared  to  ensure  that,  in  the  event  of  an  outbreak  of 
diseases, any mass disposal of aquatic animal carcasses and aquatic animal waste is 
done  without  endangering  animal  and  human  health,  using  processes  or  methods 
which prevent damage to the environment and in particular: 

(i)  with  minimum  risk  to  soil,  air,  surface  and  groundwater,  and  to  plants  and 

animals; 

(ii)  with minimum nuisance through noise or odours; 

(iii)  with minimum adverse effects on the nature or places of special interest. 

12. 

Such plans must include the identification of appropriate sites and undertakings for 
the  treatment  or  disposal  of  animal  carcasses  and  animal  waste  in  the  event  of  an 
outbreak in accordance with Regulation (EC) No 1774/2002. 

EN 

77 

   EN 

 
ANNEX VIII 
Correlation table 

This Directive 

Repealed Council Directives 

91/67/EEC 

93/53/EEC 

95/70/EC 

Article 1 (1) a 

Article 1, paragraph 1 

Article 1 (1) b 

Article 1 (1) c 

Article 1 (2) 

Article 2 (1) 

Article 2 (2) 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 2 (3) 

Article 1, paragraph 2 

_________ 

_________ 

_________ 

_________ 

Article 1 

Article 1 

Article 20 (2)  

Article 12 (2) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 2 

Article 2 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 (1) 

Article 8 (2) 

Article 8 (3) 

Article 9 

Article 10 

Article 11 

Article 12 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 3 (2) 

Article 3 (2) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 4 (1) 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 13 (1) 

Article 4, paragraph 1 

Article 13 (2) 

Article 4, paragraph 2 

Article 14  

Article 
paragraph 2 

16 

(1), 

EN 

78 

   EN 

 
 
Article 14 (2) 

Article 14 (3) 

_________ 

_________ 

Article 14 (4) 

Article 7 (1) 

Article 8 (1)  

Article 15 (1) 

Article 3 (1) a 

Article 15 (2) 

Article 3 (1) b 

Article 15 (3) 

Article 16 (1) 

_________ 

Article  7  (1)  a,  1st 
sentence 

Article 7 (1) b 

Article 8 (1) a 

Article 8 (1) b 

Article 16 (2) 

_________ 

Article 17 

Article 14 (1) 

Article 14 (2) 

Article 14 (4) 

Article 18 

Article 9 (1) and (2) 

Article 19 

_________ 

Article 20 

Article 14 (3) 

Article 21 

_________ 

Article 22 

Article 19 (1) 

Article 23(1) 

Article 23(2) 

_________ 

_________ 

Article 23(3) 

Article 19 (2) 

Article 23(4) 

Article 19 (3) 

Article 23(5) 

_________ 

Article 24 

Article 21 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

EN 

79 

   EN 

 
Article 25 (a) 

Article 20 

Article 25 (b) 

Article 25 (c) 

Article 25 (d) 

Article 25 (e) 

Article 26 

Article 27 

Article 28 (a) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 4 

Article 5 (1) 

_________ 

Article 5 (5) 

Article 5 (1) 

Article 5 (2) a 

Article 10 (1) a 

Article 28 (b) 

_________ 

Article 5(2)b 

Article 5 (2) b 

Article 29 (1) 

_________ 

Article 5 (2)h 

Article 10 (1)c 

Article  6  (a),  7th 
indent 

Article 8(1) 

Article  9  (1),  1st 
sentence 

Article 10 (1) b 

Article  4  (1),  paragraph 
3, 3rd indent 

Article 5 (4), paragraph 1 

Article 29(2) 

Article 29(3) 

_________ 

_________ 

Article 5(2)i 

Article 5(4), paragraph 2 

_________ 

Article 6(b) 

Article 6(d) 

Article 8(2) 

Article 8(3) 

Article 9 (2) 

Article 29 (4) 

Article 30 

Article 31 

_________ 

_________ 

_________ 

Article  5  (i)  2nd 
indent 

_________ 

Article 5(4) 

Article 5(3) 

_________ 

_________ 

EN 

80 

   EN 

 
Article 32(a) 

_________ 

_________ 

Article 4(1), paragraph 3 

Article 32(b) 

Article 32(c) 

_________ 

_________ 

1st and 2nd indent 

_________ 

_________ 

Article 5 (2) b 

Article 5 (2) b 

Article 5 (4), paragraph 3 

Article 33 (1) 

Article 3 (3) 

Article  6  (a)  4th 
indent 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 33 (2) 

Article 33 (3) 

Article 33 (4) 

Article 34 (1) 

Article 34 (2) 

Article 35 

Article 36 

Article 37 (a) 

Article 37 (b) 

Article 38 (1) 

Article 38 (2) 

Article 39 (a) 

Article 39 (b) 

Article 39 (c) 

Article 39 (d) 

Article 40 

EN 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 5(2)c 

Article  6(a)  1st  and 
3rd indent 

Article 
indent 

6(a) 

4th 

_________ 

Article  6(a)  2nd,  5th 
and 6th indent 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 5 (4) 

Article 5 (3) 

Article  9  (1),  2nd 
sentence 

_________ 

Article 10 (1) c 

_________ 

Article 10 (1) c 

_________ 

Article 7 

81 

_________ 

_________ 

Article 4 (1) paragraph 3, 
1st indent 

_________ 

_________ 

_________ 

_________ 

   EN 

 
Article 41 

Article 42 

Article 43 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 44  

Article 10 

Article 10 (2) 

Article 45 

Article 10 (1) 

Article 46 

Article 47 

Article 48 (1) 

Article 48 (2) 

Article 48 (3) 

Article 48 (4) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 49(1) 

Article 5  

Article 6 

_________ 

_________ 

Article 15  

Article 14 (1) 

Article 14 (1) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 49(2) 

Article 5  

_________ 

_________ 

Article 6 

Article 49(3) 

Article 5  

_________ 

_________ 

Article 6 

Article 15 

Article 50(1) 

Article 5  

_________ 

_________ 

Article 6 

Article 50(2) 

Article 5  

_________ 

_________ 

Article 6 

Article 50(3) 

Article 5  

_________ 

_________ 

Article 6 

Article 15 

Article 51(1) 

_________ 

_________ 

_________ 

EN 

82 

   EN 

 
Article 51(2) 

Article 5 (2) 

Article 52 

Article 53 (1) 

Article 53 (2) 

Article 53 (3) 

Article 54 (1) 

Article 54 (2) 

Article 54 (3) 

Article 55 (1) 

Article 55 (2) 

Article 55 (3) 

Article 56 (1) 

Article 56 (2) 

Article 56 (3) 

Article 56 (4) 

Article 56 (5) 

Article 57 a 

Article 57 b 

Article 57 c 

_________ 

_________ 

_________ 

Article  9 
sentence 

(1),  2nd 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 6 (d) 

Article 8 (3) 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 13 (1) 

Article 7 (1) 

Article 13 (2) 

Article 7 (2) 

_________ 

_________ 

Article 12 (1) 

Article 6 (2) 

Article 12 (4) 

Article 6 (3) 

_________ 

_________ 

Article 12 (6) 

Article 6(5) 

_________ 

_________ 

Article 12 (1) 

Article 6 (2) 

Article 12 (3) 

Article 11 (2) 

_________ 

Article 11 (1) 

Article 6 (1) 

_________ 

_________ 

Article 58 

Article 17 

Article 16 

Article 8 

Article 59 

Article 60 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

EN 

83 

   EN 

 
 
Article 61 

Article 9 (3) 

Article 10 (4) 

Article 4 (2) 

Article 25 

Article 12 (7) 

Article 9 

Article 18 

Article 62 

Article 26 

Article 19 

Article 10 

Article 63 

Article 64 

Article 27 

_________ 

_________ 

_________ 

_________ 

_________ 

_________ 

Article 65 

Article 29  

Article 20 

Article 12 

Article 66 

_________ 

_________ 

Article 13 

Article 67 

Article 30 

Article 21 

Article 14 

EN 

84 

   EN 

 
 
LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Health and Consumers Protection 

Activity: Food safety, animal health, animal welfare and plant health  

TITLE OF ACTION: PROPOSAL FOR A COUNCIL DIRECTIVE ON ANIMAL HEALTH REQUIREMENTS 
FOR AQUACULTURE ANIMALS AND PRODUCTS THEREOF, AND ON THE PREVENTION AND 
CONTROL OF CERTAIN DISEASES IN AQUATIC ANIMALS 

1. 

BUDGET LINE(S) + HEADING(S) 

17 01: Administrative expenditure of health and consumer protection policy area 

17 04 02: Other measures in the veterinary, animal welfare and public-health field 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): 2.094 € million for commitment 

2.2. 

Period of application: 

Action is open ended 

2.3. 

Overall multiannual estimate of expenditure: 

(a)  Schedule  of  commitment  appropriations/payment  appropriations  (financial 

intervention) (see point 6.1.1) 

€ million (to three decimal places) 

Year 
[2007] 

[n+1]

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years] 

Commitments 

0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

Payments 

0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

(b)  Technical 

and 
(see point 6.1.2) 

Commitments 

Payments 

administrative 

assistance 

and 

support 

expenditure 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

EN 

85 

   EN 

 
 
 
 
 
 
Subtotal a+b 

Commitments 

0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

Payments 

0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

(c)  Overall  financial  impact  of  human  resources  and  other  administrative 

expenditure (see points 7.2 and 7.3) 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

Payments 

0.243 

0.243 

0.243 

0.243 

0.193 

0.193 

1.358 

0.592 

0.592 

0.592 

0.592 

0.542 

0.542 

3.452 

0.592 

0.592 

0.592 

0.592 

0.542 

0.542 

3.452 

2.4. 

Compatibility with financial programming and financial perspective 

Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue: 

Proposal  has  no  financial  implications  (involves  technical  aspects  regarding 
implementation of a measure) 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Heading in 
financial 
perspective 

Comp 

Non-diff 

NO 

NO 

NO 

No 5 – 1a 

4. 

LEGAL BASIS  

Article 37 of the Treaty and Council Decision 90/424/EEC  

EN 

86 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention  

5.1.1.  Objectives pursued 

It  is  envisaged  to  update  current  Community  legislation  on  diseases  in  aquaculture 
animals laid down in Council Directives 91/67/EEC, 93/53/EEC and 95/70/EC, with 
the  objective  to  achieve  better  prevention  and  control  of  disease  outbreaks  in 
aquaculture animals and, the costs and losses and the negative impact to the whole of 
society due to aquatic animal diseases.  

Since fish, molluscs and crustaceans are listed in Annex II of the Treaty, one of the 
Community's  tasks  in  the  veterinary  field  is  to  improve  the  health  status  of  such 
animals,  thereby  facilitating  trade  in  aquaculture  animals  and  products  thereof  to 
ensure the development of this sector.  

Furthermore,  thanks  to  the  adoption  of  other  disease  control  measures  envisaged 
under  the  current  proposal,  other  savings  should  result  from  the  expected  reduced 
occurrence of diseases in aquaculture animals. It is, however, extremely difficult to 
quantify these savings. 

As  mentioned  already,  these  actions  as  such  have  no  financial  implications  for  the 
EU-budget. 

However, in combination with Council Decision 90/424/EC, as it is already the case 
with  existing  aquatic animal health legislation, has  financial impact on Community 
budget: 

Objective 1:  establishment of Community Reference Laboratories for aquatic animal 

diseases 

5.1.2.  Measures taken in connection with ex ante evaluation  

In 2000 the Advisory Committee for Fisheries and Aquaculture (ACFA) proposed to 
initiate  a  project  to  update  existing  Community  legislation  on  aquaculture  animal 
health. The initiative was endorsed in the Communication from the Commission on a 
strategy 
aquaculture 
the 
((Com (2002) 511).  

of  European 

development 

sustainable 

for 

The designation of Community and national reference laboratories should contribute 
to  the  high  quality  and  uniformity  of  diagnostic  results.  That  objective  can  be 
achieved  by  activities  such  as  the  application  of  validated  diagnostic  tests  and  the 
organisation of comparative testing and training of staff from laboratories. 

5.1.3.  Measures taken following ex post evaluation 

Not applicable 

EN 

87 

   EN 

 
 
5.2. 

Action envisaged and budget intervention arrangements 

Not applicable 

5.3.  Methods of implementation 

Not applicable 

6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

(The  method  of  calculating  the  total  amounts  set  out  in  the  table  below  must  be 
explained by the breakdown in Table 6.2.) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

[2007] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years] 

Operational objective Nr 1 

0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

TOTAL  0.349 

0.349 

0.349 

0.349 

0.349 

0.349 

2.094 

EN 

88 

   EN 

 
6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

[Year 
n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
years] 

1. 

Technical 
administrative 
assistance 

and 

(a) 

(b) 

Technical 
assistance 
offices 

Other 
technical  and 
administrative 
assistance: 

– 

– 

intra 
mu-
ros: 

extra 
mu-
ros: 

which 

of 
construction 
maintenance 
computerised 
management systems 

for 
and 
of 

Subtotal 1 

2. 

Support expenditure 

(a) 

Studies 

(b) 

(c) 

Meetings  of 
experts 

Information 
and 
publications 

Subtotal 2 

TOTAL 

EN 

89 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2. 

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire 
programming period) 

Commitments (in € million to three decimal places) 

Breakdown  

Type  
of outputs 
(projects, files ) 

Number of 
outputs 

Average unit 
cost 

(total for years 
1…n)  

Total cost 

(total for years 
1…n) 

1 

2 

3 

4=(2X3) 

Action 1 

- Measure 1 

- Measure 2  

Action 2 

- Measure 1 

- Measure 2 

- Measure 3 

etc. 

TOTAL COST 

7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Types of post 

Officials 
temporary staff 

or 

A 

B 

C 

Other human resources 

Total 

EN 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Total 

Number of 
permanent posts 

Number of 
temporary posts 

Description of tasks deriving from the 
action 

1 

- 

- 

1 

1 

- 

- 

- 

1 

- 

- 

- 

- 

- 

90 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

108,000 

1 full time official per year 

(specify budget line) 

Total 

108,000 

The amounts are total expenditure for twelve months. 

7.3. 

Other administrative expenditure deriving from the action 

Budget line 

Amount € 

Method of calculation 

Overall allocation (Title A7) 

1701021101 – Missions 

1701021102 – Meetings 

A07031 – Compulsory committees* 

A07032 – Non-compulsory committees * 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems (A-5001/A-4300) 

Other expenditure - Part A (specify) 

35,000 

- 

100,000 

- 

- 

- 

- 

- 

- 

Based  on  5  missions  per  year  at  an 
average of 7000 Euro per mission 

- 

4 expert working group meetings of the 
Standing committee on Food Chain and 
Animal  Health  only  on  the  subject  of 
aquatic animal diseases during the first 
4  years,  and  then  2  meetings  each 
year19 

- 

- 

- 

- 

- 

Total 

135,000 

The amounts are total expenditure for twelve months. 

*Specify the type of committee and the group to which it belongs. 

19 

See Part II, point 3.2 of Impact Assessment. 

EN 

91 

   EN 

 
 
 
 
 
 
 
 
 
 
 
                                                 
I a. 

Annual total year n to n+3 (7.2 + 7.3) 

243,000 € 

I b.  Annual total year n+4 and n+5 (7.2 + 7.3) 

193,000 € 

II. 

Duration of action 

III. 

Total cost of action (I x II) 

6 years 

1,358,000 € 

The  human  and  administrative  resources  requirements  will  be  met  within  the  appropriation 
allocated to DG SANCO, within the framework of the annual allocation procedure. 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

The Commission will have at its disposal several ways to evaluate the impact of the 
proposal:  

– 

– 

– 

the  occurrence  of  future  diseases  in  aquaculture  animals  giving  an  overall 
indication on the effectiveness of the new measures,  

results of the risk based animal health surveillance programmes, 

control measures on aquatic animal disease outbreaks. 

Already  at  this  stage  the  Commission  has  the  basic  tools  to  monitor,  such  as  the 
Standing  Committee  for  the  Food  Chain  and  animal  health  and  the  network  of 
Community and national reference laboratories. 

8.2. 

Arrangements and schedule for the planned evaluation 

As mentioned above, the Commission has at its disposal tools, such as the Standing 
Committee  for  the  Food  Chain  and  Animal  Health  and  the  network  of  Community 
and  national  reference  laboratories;  these  instruments  will  allow  for  the  proper 
evaluation of the measures proposed. 

9. 

ANTI-FRAUD MEASURES 

Not relevant 

EN 

92 

   EN 

 
EXPLANATORY MEMORANDUM 

1. 

Context of the proposal 

• 

Grounds for and objectives of the proposal 

– 

– 

– 

The  proposal  from  the  Commission  for  a  new  Council  Directive  on 
animal health requirements for aquaculture animals and products thereof, 
and on the prevention and control of certain diseases in aquatic animals, 
updates current disease control measures laid down in Council Directives 
93/53/EEC and 95/70/EC, with the objective to achieve better control of 
outbreaks and to reduce the costs and losses and the negative impact to 
aquaculture industry due to diseases. 

The  proposal  for  a  Council  Regulation  European  Fisheries  Fund  (COM 
(2004)  497),  allows  Member  States  to  allocate  financial  resources  from 
the  Operational  Programmes  set  up  in  accordance  with  Title  III  of  that 
Regulation,  to  control  diseases  in  aquaculture  animals,  provided  the 
diseases are referred to in Council Decision 90/424/EEC of 26 June 1990 
on expenditure in the veterinary field  

By  this  proposal,  the  Commission  envisages  therefore  the  necessary 
amendments  of  the  current  procedures  governing  the  Community’s 
financial  contribution  towards  veterinary  measures  in  aquaculture 
animals, laid down in Council Decision 90/424/EEC, in order to take into 
account the proposals for a new aquatic animal health Directive and the 
European Fisheries Fund. 

• 

General context 

– 

– 

The  proposed  changes  in  Community  legislation  on  animal  health 
requirements  for  aquaculture  animals  and  products  thereof  should  be 
made  in  parallel  with  amendments  to  Council  Decision  90/424/EEC  on 
Community expenditure in the veterinary field to bring it in line with the 
proposed  new  Directive  and  the  proposal  for  the  European  Fisheries 
Fund  (2007-2013),  to  ensure  adequate  financial  support  to  the  Member 
States in relation to the most serious diseases in aquaculture animals. 

At  present,  Article  24  of  Council  Decision  90/424/EEC  provides  for  a 
Community  financial  contribution  eligible  under  Regulation  (EC) 
No 2792/1999  to  be  granted  to  the  Member  States  for  some  of  the 
expenditure  which  they  may  incur  when  eradicating  infectious  salmon 
anaemia and infectious haematopoietic necrosis.  

EN 

93 

   EN 

 
• 

Consistency with other policies 

– 

– 

The proposal would not affect the future development of the Community 
policy on animal health and the veterinary fund.  

This  proposal  is  in  line  with  the  proposal  from  the  Commission  to  the 
Council 
for  Council  Regulation  European  Fisheries  Fund 
(COM (2004) 497). 

2. 

Consultation of interested parties and impact assessment 

• 

Consultation of interested parties 

– 

On  the  Proposal  for  a  new  Council  Directive  on  animal  health 
requirements  for  aquaculture  animals  and  products  thereof,  consultation 
with  Member  States  in  Commission  Working  Group,  stakeholder 
consultations  and  consultations  with  the  aquaculture  industry  in  the 
Advisory Committee for Fisheries and Aquaculture has taken place.  

• 

Impact assessment 

– 

Impact assessments of the newly envisaged Council Directive on animal 
health requirements for aquaculture animals and products thereof and of 
the amendments proposed by means of this proposal to Council Decision 
90/424/EEC has been produced. 

3. 

Legal elements of the proposal 

• 

Summary of the proposed actions 

– 

The  current  proposal  envisages  the  following  changes  to  Decision 
90/424/EEC: 

– 

– 

to allow Member States to use the budget set up under Operational 
Programmes according to Title III of the European Fisheries Fund 
for  the  control  and  eradication  of  certain  diseases  in  aquaculture 
animals. 

to  ensure  that  the  procedures  for  such  financial  support,  is  in  line 
with the current procedures applicable to financial contribution for 
control and eradication of terrestrial animal diseases. 

• 

Legal basis 

– 

Treaty  establishing 
Article 37 thereof. 

the  European  Community,  and 

in  particular 

EN 

94 

   EN 

 
• 

Subsidiarity principle 

– 

The  measures  laid  down  in  this  proposal  falls  under  the  competence  of 
the Community.  

• 

Proportionality principle 

– 

The proposal sets out the procedures and sources of Community financial 
support  to  Member  States  for  the  control  and  eradication  of  certain 
diseases in aquaculture animals. 

• 

Choice of instruments 

– 

The  proposed  instrument  is  a  Decision.  This  proposal  concerns 
amendments to existing provisions on expenditure in the veterinary field 
that are laid down in a Council Decision. The legal instrument chosen to 
amend those provisions is therefore another Council Decision. 

4. 

Budget implications 

– 

– 

– 

– 

Council  Decision  90/424/EEC  already  allows  for  financial  support  in  relation 
to  outbreaks  of  Infectious  Haematopoietic  Necrosis  (IHN)  and  Infectious 
Salmon Anaemia (ISA). Disease control actions for these diseases are currently 
eligible  for  a  Community  financial  contribution  under  Regulation  (EC) 
No 2792/1999 solely. 

It  is  proposed  that  future  financial  contributions  for  aquatic  animal  disease 
control from the Community should be eligible through the European Fisheries 
Fund (Article 32 of COM (2004) 497).  

In the  proposal, compulsory slaughter/eradication  will only  be required  under 
Community rules in relation to outbreaks of diseases that are considered exotic 
to the Community. With respect to non-exotic diseases it is proposed that the 
Member  States  may  decide  whether  an  outbreak  should  be  subject  to 
eradication measures or containment measures. Community funding under the 
European Fisheries Fund may be made available for control measures of such 
diseases if the Member State so decides. 

If an exotic disease did occur in the Community, it would have no additional 
financial  impact  on  Community  budget.  The  same  would  occur  in  case  of 
compensation  for  eradication  of  non-exotic  diseases,  since  the  allocation  of 
funds for the eradication are made within the Operational Programmes, whose 
budget is fixed by the Council at the beginning of the programming period. 

EN 

95 

   EN 

 
– 

– 

In the interest of Member States, it would be convenient to assess the financial 
impact  of  eradication  measures  on  their  Operational  Programmes.  However, 
the costs related to such eradication measures are difficult to estimate, as there 
is  limited  experience  in  the  Community  of  stamping  out  policy  involving 
economic  compensation  in  aquaculture.  In  the  court  case  following  the 
outbreaks  of  ISA  in  the  UK  and  Ireland,  one  company  owning  five  of  the 
thirteen  infected  farms  claimed  total  losses  in  the  region  of  €  20-25  million. 
Sweden  paid  out  compensation  under  national  legislation  totalling  of 
1.5 million  SEK  (€165  000)  over  a  period  of  three  years  in  relation  to  four 
cases of VHS in 1998.  

It is therefore difficult to estimate the impact of the proposal on the European 
Fisheries Fund, as this will depend on the size of the farm(s) affected, the value 
of the animals kept at the farm(s), etc. However, the figures above can give an 
indication. 

EN 

96 

   EN 

 
2005/0154 (CNS) 

Proposal for a 

COUNCIL DECISION 

amending Decision 90/424/EEC on expenditure in the veterinary field 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having regard to the proposal from the Commission20, 

Having regard to the opinion of the European Parliament21, 

Having regard to the opinion of the European Economic and Social Committee22, 

Having regard to the opinion of the Committee of the Regions23, 

Whereas: 

(1) 

(2) 

Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field24 
provides  for  the  possibility  of  a  financial  contribution  from  the  Community  to  the 
Member States for the eradication of certain animal diseases. Currently, that Decision 
also  provides  for  the  possibility  to  grant  such  contribution  for  the  eradication  of  the 
diseases  infectious  salmon  anaemia  (ISA)  and  infectious  haematopoietic  necrosis 
(IHN), both affecting salmonides. 

Disease  control  actions  for  ISA  and  IHN  are  eligible  for  Community  financial 
contributions under Regulation (EC) No 2792/1999 of 17 December 1999 laying down 
the detailed rules and arrangements regarding Community structural assistance in the 
fisheries sector25 solely.  

20 
21 
22 
23 
24 

25 

OJ C ,, p.. 
OJ C ,, p.. 
OJ C ,, p.. 
OJ C ,, p.. 
OJ  L  224,  18.8.1990,  p.  19.  Decision  as  last  amended  by  Regulation  (EC)  No  806/2003  (OJ  L  122, 
16.5.2003, p. 1). 
OJ L 337, 30.12.1999, p. 10. 

EN 

97 

   EN 

 
                                                 
(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

In  the  light  of  the  adoption  of  Council  Directive  200Y/xxx  on  animal  health 
requirements for aquaculture animals and products thereof, and on the prevention and 
control  of  certain  diseases  in  aquatic  animals26,  it  is  appropriate  to  amend  Decision 
90/424/EEC  so  that  Community  financial  contribution  should  also  be  granted  for 
eradication  measures  carried  out  by  the  Member  States  to  combat  other  diseases  in 
aquaculture animals, subject to Community control provisions. 

The Member States have been granted financial contributions to support their national 
fisheries  and  aquaculture  sector  under  Regulation  (EC)  No  xxxx/2005  of  zz/zz  2005 
on the European  Fisheries Fund27. Article 30a of that Regulation authorises Member 
States to allocate funds for the eradication of diseases in aquaculture under the terms 
of Decision 90/424/EC. 

The  funds  for  the  eradication  of  diseases  in  aquaculture  animals  should  be  allocated 
within  the  Operational  Programmes  set  up  under  Regulation  (EC)  No  xxxx/2005, 
whose budget is fixed at the beginning of the programming period. 

Financial  contributions  from  the  Community  budget  for  disease  control  purposes  in 
aquaculture  animals  should  be  subject  to  scrutiny  regarding  compliance  with  the 
control  provisions  laid  down  in  Directive  200Y/xxx,  in  accordance  with  the  same 
procedures  that  apply  for  such  scrutiny  and  control  for  certain  terrestrial  animal 
diseases. 

It is therefore appropriate to apply the procedures for financial contributions laid down 
in  Decision  90/424/EEC,  also  to  the  use  of  financial  contribution  for  the  control  of 
diseases in aquaculture animals under Regulation (EC) No xxxx/2005. 

It  is  appropriate  that  the  amendments  proposed  herein  should  enter  into  force  at  the 
same time as Directive 200Y/xxx and Regulation (EC) No XXXX/2005. 

(9) 

Decision 90/424/EEC should therefore be amended accordingly, 

HAS ADOPTED THIS DECISION:  

26 
27 

COM (2005) 362 final. 
COM (2004) 497. 

EN 

98 

   EN 

 
                                                 
Article 1 

Decision 90/424/EEC is amended as follows: 

1. 

In Article 3(1), the following indents shall be added: 

“ 

-Epizootic haematopoietic necrosis in fish (EHN), 
-Epizootic ulcerative syndrome in fish (EUS), 
-Infection with Bonamia exitiosa, 
-Infection with Xenohaliotis californiensis, 
-Infection with Perkinsus marinus, 
-Infection with Microcytos mackini, 
-Taura syndrome in crustaceans, 
-Yellowhead disease in crustaceans.” 

2. 

The following Article 3b shall be inserted: 

“Article 3b 

Member States may allocate funds within the Operational Programmes drawn up in 
accordance  with  Article  18  of  Regulation  (EC)  No  xxxx/2005  to  the  eradication  of 
the exotic diseases in aquaculture animals referred to in Article 3(1) of this Decision, 
under the procedures laid down in Article 3(3), (4) and (5) of this Decision, provided 
that the minimum disease control and eradication measures laid down in Section 3 of 
Chapter V of Directive 200Y/xxx are complied with”. 

3. 

Article 5(2) shall be replaced by the following: 

“2. 

In  accordance  with  the  procedure  laid  down  in  Article  41,  the  list  in 
Article 3 (1) may be supplemented in line with developments in the situation, 
to  include  diseases  which  must  be  notified  in  accordance  with  Directive 
82/894/EEC and diseases which can be transmitted to aquaculture animals, or 
amended  or  shortened  to  take  account  of  progress  made  with  the  measures 
decided at Community level to control certain diseases.” 

4. 

In Article 24, the following paragraph shall be added: 

“12.  Member States may allocate funds within the Operational Programmes drawn 
up  in  accordance  with  Article  18  of  Regulation  (EC)  No  xxxx/2005  for  the 
eradication of the diseases in aquaculture animals referred to in the Annex  

The  funds  shall  be  allocated  in  accordance  with  the  procedures  laid  down  in 
this Article. 

The  eradication  must  be  carried  out  in  accordance  with  Article  38(1)  of 
Directive  200Y/xxx,  or  under  an  eradication  programme  drawn  up,  approved 
and carried out in accordance with Article 44 of that Directive.  

EN 

99 

   EN 

 
 
 
5. 

The following indents shall be added to the Annex: 

“ 

-Spring viraemia of carp (SVC) 
-Viral haemorrhagic septicaemia (VHS) 
-Koi herpes virus infection 
-Infection with Bonamia ostreae 
-Infection with Marteilia refringens  
-White spot disease in crustaceans“ 

This Decision shall apply from 1 January 2007. 

Article 2 

Article 3 

This Decision is addressed to the Member States. 

Done at Brussels 

For the Council 
The President 

EN 

100 

   EN 

 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Health and Consumers Protection 

Activity: Food safety, animal health, animal welfare and plant health  

TITLE  OF  ACTION:  PROPOSAL  FOR  A  COUNCIL  DECISION  AMENDING  COUNCIL  DECISION 

90/424/EEC ON EXPENDITURE IN THE VETERINARY FIELD 

1. 

BUDGET LINE(S) + HEADING(S) 

– 

– 

European Fisheries Fund 

17  01:  Administrative  expenditure  of  health  and  consumer  protection  policy 
area 

2. 

OVERALL FIGURES  

2.1. 

Total allocation for action (Part B): 0 € million for commitment 

2.2. 

Period of application: 

Action is open ended 

2.3. 

Overall multiannual estimate of expenditure: 

(a)  Schedule  of  commitment  appropriations/payment  appropriations  (financial 

intervention) (see point 6.1.1) 

€ million (to three decimal places) 

Year 
[2006] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years] 

Commitments 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

(b)  Technical 

and 
(see point 6.1.2) 

administrative 

assistance 

and 

support 

expenditure 

Commitments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

EN 

101 

   EN 

 
 
 
 
 
Subtotal a+b 

Commitments 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

(c)  Overall  financial  impact  of  human  resources  and  other  administrative 

expenditure (see points 7.2 and 7.3) 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

Payments 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

2.4. 

Compatibility with financial programming and financial perspective 

Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue:28 

Proposal  has  no  financial  implications  (involves  technical  aspects  regarding 
implementation of a measure) 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
form applicant 
countries 

Heading in 
financial 
perspective 

Comp 

Non-diff 

YES 

NO 

NO 

No 1a 

4. 

LEGAL BASIS  

Council Decision 90/424/EEC 

28 

For further information, see separate explanatory note. 

EN 

102 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention  

5.1.1.  Objectives pursued 

Objective 1:  EXTENSION  of  emergency  measures  (Article  3  of  Decision 
90/424/EEC)  to  all  exotic  aquaculture  animal  diseases  subject  to 
harmonised Community measures 

Objective 2:  EXTENSION of control and eradication measures related to non-exotic 
diseases  (Article  24  of  Decision  90/424/EEC)  to  all  non-exotic 
aquaculture  animal  diseases  subject 
to  harmonised  Community 
measures 

5.1.2.  Measures taken in connection with ex ante evaluation 

Since fish, molluscs and crustaceans are listed in Annex II of the Treaty, one of the 
Community's  tasks  in  the  veterinary  field  is  to  improve  the  health  status  of  such 
animals,  thereby  facilitating  trade  in  aquaculture  animals  and  products  thereof  to 
ensure the development of this sector.  

The necessity of establishing financial contribution for the eradication and control of 
diseases in aquaculture animals is presented in the proposal for a Council Regulation 
European Fisheries Fund 2007-2013.  

5.1.3.  Measures taken following ex post evaluation 

Not applicable 

5.2. 

Action envisaged and budget intervention arrangements 

Not applicable 

5.3.  Methods of implementation 

Not applicable 

EN 

103 

   EN 

 
 
 
 
 
 
6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

(The  method  of  calculating  the  total  amounts  set  out  in  the  table  below  must  be 
explained by the breakdown in Table 6.2.) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

[2006] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
Years] 

Operational objective Nr 1 

The diseases listed in Part II of Annex III to the proposal for Council Directive 200Y/xxx 
are  all  exotic  to  the  Community.  Taking  into  account  the  import  provisions  laid  down  in 
that proposal, the likelihood of the occurrence of such disease is small.  

0.000 

Operational objective Nr 2 

It is impossible to predict when and where there will be an outbreak of the disease and the 
relative costs. 

0.000 

The overall financial contribution from the Community is fixed by the Council Regulation 
European Fisheries Fund. 

The impact assessment annexed to the proposal has considered various scenarios. 

TOTAL  0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

EN 

104 

   EN 

 
6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

[Year 
n] 

[n+1] 

[n+2] 

[n+3] 

[n+4] 

Total 

[n+5 
and 
subs. 
years] 

1. 

Technical 
administrative 
assistance 

and 

(a) 

(b) 

Technical 
assistance 
offices 

Other 
technical  and 
administra-
tive 
assistance: 

– 

– 

intra 
mu-
ros: 

extra 
mu-
ros: 

which 

of 
construction 
maintenance 
computerised 
management systems 

for 
and 
of 

Subtotal 1 

2. 

Support expenditure 

(a) 

Studies 

(b) 

(c) 

Meetings  of 
experts 

Informa-tion 
and  publica-
tions 

Subtotal 2 

TOTAL 

EN 

105 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2. 

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire 
programming period)29 

Commitments (in € million to three decimal places) 

Breakdown  

Type  
of outputs 
(projects, files ) 

Number of 
outputs 

Average unit 
cost 

(total for years 
1…n)  

Total cost 

(total for years 
1…n) 

1 

2 

3 

4=(2X3) 

Action 1 

- Measure 1 

- Measure 2  

Action 2 

- Measure 1 

- Measure 2 

- Measure 3 

etc. 

TOTAL COST 

29 

For further information, see separate explanatory note. 

EN 

106 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Types of post 

Officials 
temporary staff 

or 

A 

B 

C 

Other human resources 

Total 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Total 

Number of 
permanent posts 

Number of 
temporary posts 

Description of tasks deriving from the 
action 

The management of the action will be 
undertaken by existing staff described 
under COM(2005) 171 

2 

- 

- 

2 

- 

- 

- 

- 

- 

2 

- 

- 

- 

2 

7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

216,000 

1 full time official per year 

(specify budget line) 

Total 

216,000 

The amounts are total expenditure for twelve months. 

EN 

107 

   EN 

 
 
 
 
 
 
 
 
 
 
7.3. 

Other administrative expenditure deriving from the action 

Amount € 

Method of calculation 

Budget line 

Overall allocation (Title A7) 

1701021101 – Missions 

1701021102 – Meetings 

A07031 – Compulsory committees 1 

A07032 – Non-compulsory committees 1 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems (A-5001/A-4300) 

Other expenditure - Part A (specify) 

Total 

The amounts are total expenditure for twelve months. 

1 Specify the type of committee and the group to which it belongs. 

I. 

II. 

Annual total (7.2 + 7.3) 

Duration of action 

III. 

Total cost of action (I x II) 

216,000 € 

6 years 

1,296,000 € 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

The Commission will have at its disposal several ways to evaluate the impact of the 
proposal:  

– 

– 

– 

the  occurrence  of  future  diseases  in  aquaculture  animals  giving  an  overall 
indication on the effectiveness of the new measures,  

results of the risk based animal health surveillance programmes, 

control measures on aquatic animal disease outbreaks. 

Already  at  this  stage  the  Commission  has  the  basic  tools  to  monitor,  such  as  the 
Standing  Committee  for  the  Food  Chain  and  animal  health,  in  addition  to  the 
evaluation instruments described under the European Fisheries Fund. 

EN 

108 

   EN 

 
 
 
 
 
 
 
 
 
8.2. 

Arrangements and schedule for the planned evaluation 

As mentioned above, the Commission has at its disposal tools, such as the Standing 
Committee  for  the  Food  Chain  and  Animal  Health  and  the  network  of  Community 
and  national  reference  laboratories;  these  instruments  will  allow  for  the  proper 
evaluation of the measures proposed. 

9. 

ANTI-FRAUD MEASURES 

Not relevant 

EN 

109 

   EN