Proposal for a Council Regulation concerning use of alien and locally absent species in aquaculture {SEC(2006) 421}
Date: 2006-04-04
Institutions: European Commission
Subjects: aquaculture, biodiversity, common fisheries policy, environmental protection, fishery management, fishery produce, sustainable development

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.4.2006 
COM(2006) 154 final 

2006/0056 (CNS) 

Proposal for a 

COUNCIL REGULATION 

concerning use of alien and locally absent species in aquaculture 

{SEC(2006) 421} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

Aquaculture is a fast-growing sector, where innovation and new outlets are being explored. In 
order  to  adapt  production  to  market  conditions,  it  is  important  that  the  aquaculture  industry 
should diversify the species reared. 

In the past, aquaculture has benefited economically from the introduction of alien species (e.g. 
rainbow trout, Pacific oyster) and from the farming of species which do not occur in an area 
owing  to  biogeographical  barriers.  It  is  therefore  likely  that  the  aquaculture  industry  will 
continue  to  use  new  species  in  order  to  satisfy  the  needs  of  the  market.  It  would  thus  be 
prudent to decouple this economic growth from the potential threats to ecosystems posed by 
alien  species  by  anticipating  and  preventing  negative  biological  interaction  with  indigenous 
populations, including genetic change, and by restricting the spread of non-target species and 
other detrimental impacts. This is the main objective of this proposal. 

It  should  be  noted  that  there  is  a  significant  trade  in  alien  organisms,  mainly  fish,  as 
ornamental  species,  but  the  keeping  of  these  organisms  in  pet  shops,  garden  centres  and 
commercial  and  private  aquaria  is  not  covered  by  the  Common  Fisheries  Policy  and, 
consequently, falls outside the scope of this proposal.  

Invasive alien species are identified as one of the key causes of loss in biodiversity for the EU 
and the world at large. Alien species can also have significant economic and social impacts. 
All this may undermine the attainment of the EU's sustainable development objectives. In its 
Biodiversity  action  plan  for  fisheries  (COM(2001)  162,  Vol.  IV),  under  Action  IX  on 
'Limiting introduction of new species and securing animal health', the Commission undertook 
to  thoroughly  evaluate  the  potential  impact  of  non-indigenous  species in  aquaculture  and  to 
promote  the  application  of  the  International  Council  for  the  Exploration  of  the  Sea  (ICES) 
Code of Practice on introductions and transfer of marine organisms and the European Inland 
Fisheries  Advisory  Commission  (EIFAC)  Code  of  Practice  and  Manual  of  Procedures  for 
consideration of introductions and transfers of marine and freshwater organisms. 

Furthermore,  in  its  strategy  for  the  sustainable  development  of  European  aquaculture 
(COM(2002) 511), the Commission  committed  itself  to  proposing  management rules on the 
introduction of alien species in aquaculture. This proposal for a Regulation seeks to introduce 
an  EU  framework  to  ensure  adequate  protection  of  the  aquatic  environment  from  the  risks 
associated  with  the  use  of  alien  species  in  aquaculture,  building  on  the  existing  voluntary 
ICES  and  EIFAC  rules.  For  the  purpose  of  the  Regulation,  aquaculture  is  taken  to  include 
activities such as bottom cultivation of mussels and both stocking and put-and-take fisheries, 
which use aquaculture techniques as their basis. 

•  120General context 

The  book  'Invasive  aquatic  species  in  Europe'  (E.  Leppäkoski  et  al,  2002)  lists  69  alien 
species introduced into Europe for aquaculture or restocking  since  the  late  19th century. Of 
these, 28 are bivalve shellfish, 27 are fish, ten are algae, three are gastropod molluscs, and one 
is  a  flowering  plant.  Two  of  these  -  rainbow  trout  and  Pacific  oyster  -  are  among  the  top 

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European aquaculture species today, which indicates that the introduction of alien species in a 
controlled manner can be beneficial for the industry. The Pacific oyster is now so widespread 
that it accounts for an estimated 80% of world oyster production. Nowadays the Pacific oyster 
is spreading and in some areas is tending to overgrow mussel (Mytilus edulis) beds. 

Movement  of  non-native  species  can  also  often  result  in  the  spreading  of  parasites  and 
pathogens.  For  example,  the  sporozoan,  Bonamia  ostreae,  which  scientists  believe  was 
introduced  to  the  Community  via  the  movement  of  European  oysters  from  the  North 
American  Pacific  Coast,  has  resulted  in  the  decimation  of  native  oyster  stocks  in  the 
Community.  However,  the  spreading  of  pathogens  already  falls  within  the  scope  of  the 
Community  legislation  on  animal  health  and  is  therefore  not  covered  by  this  proposal. 
Likewise, parasites which fall within the scope of the animal health rules are not covered by 
the alien species rules. 

Movement  of  bivalves  can  also  result  in  damage  to  ecosystems  owing  to  the  spread  of 
accompanying non-target alien species. Some examples of pests moved with oysters include 
the  slipper  limpet,  Crepidula  fornicata,  and  the  sea  squirt,  Styela  clava.  The  Community  is 
fortunate  that  these  introductions  to  marine  and  freshwaters  have  not  caused  more  serious 
damage,  given  the  number  of  species  and  locations  of  origin.  There  can  be  no  room  for 
complacency, however, and for this reason the introduction of the current rules is timely.  

•  130Existing provisions in the area of the proposal 

A  relevant  provision  in  this  area  in  Community  law  is  Directive  92/43/EC,  the  Habitats 
Directive,  which  requires  Member  States  to  "ensure  that  the  deliberate  introduction  into  the 
wild  of  any  species  which  is  not  native  to  their  territory  is  regulated  so  as  not  to  prejudice 
natural  habitats  within  their  natural  range  or  the  wild  native  fauna  and  flora  and,  if  they 
consider  it  necessary,  prohibit  such  introduction”.  However,  it  is  unclear  how  both  the 
accidental, non-deliberate introductions and the introductions into non-wild environments are 
covered by this legislation. 

While  there  is  a  possibility  of  some  duplication  or  overlap  between  the  administrative 
measures already taken in compliance with the Habitats Directive and the new proposal for a 
Regulation, this is not necessarily a problem, as it is hoped that the experience gained with the 
former process will enhance the setting up and functioning of the new permit system required 
by this proposal for a Regulation. 

Other  Community  legislation,  such  as  the  Directives  on  assessment  of  the  effects  of  certain 
projects  on  the  environment  (Environmental  Impact  Assessment),  animal  health  for 
aquaculture and the framework for Community action in the field of water policy, do cover 
the harmful effects of alien species but are not specific to aquaculture and leave room for risks 
of spreading of alien species and consequent environmental damage. 

•  140Consistency with other policies and objectives of the Union 

For the above reasons, it is concluded that the existing provisions are not entirely adequate to 
govern the use of alien species in aquaculture at the present time. In any case, it is proposed 
that the granting of permits under this regulation should not remove the need for compliance 
with  any  of  the  existing  rules.  If  a  comprehensive  Community  framework  for  alien  species 
were  to  be  introduced  in  the  future,  this  Regulation  would  be  adapted, as  necessary,  to  that 
framework or would be subsumed into it. 

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The  measures  contained  in  this  proposal  are  a  major  step  in  the  process  of  integration  of 
environmental  concerns  into  the  Common  Fisheries  Policy,  in  line  with  Article  6  of  the 
Treaty. In this context, this proposal was already anticipated in specific policy texts adopted 
in the context of the CFP reform1.  

The proposal for a regulation implements actions envisaged in the EC Biodiversity Strategy 
and  in  the  Biodiversity  Action  Plan  for  Fisheries2,  and  is  expected  to  contribute  to  the 
objective of halting biodiversity loss set by the 6th Environmental Action Programme and by 
the  EC  Strategy  for  Sustainable  Development.  It  will  also  contribute  to  the  global  target  of 
significantly  reducing  the  rate  of  biodiversity  loss  as  established  under  the  Plan  of 
Implementation of the World Summit for Sustainable Development. 

Furthermore,  these  measures  are  consistent  with  the  Guiding  Principles  for  the  prevention, 
introduction  and  mitigation  of  impacts  of  alien  species  that  threaten  ecosystems,  habitats  or 
species, adopted in Decision VI/23 of the Convention on Biological Diversity, to which the 
European Community is a Contracting Party. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

Formal  consultation  took  place  with  an  expert  group  of  46  persons  representing  Member 
States  (15  government  experts  from  EU15  and  seven  from  EU10);  EEA-EFTA  (three 
government  experts),  industry  (six  nominated  by  the  Aquaculture  Working  Group  of  the 
Advisory  Committee  for  Fisheries  and  Aquaculture),  NGOs  (two  persons  from  the  UK  and 
one from the Netherlands) and ICES (five persons with experience of the Working Group on 
Introductions  and  Transfers),  EIFAC  (one  expert),  NASCO  (one  from  head  office  and  one 
from the industry liaison group) together with four additional private sector experts. A one-
day meeting with this group was held in Brussels in December 2003 to debate a previously 
circulated  discussion  paper  and  hear  a  series  of  presentations  by  private-sector  experts. 
Written comments on the draft legislation were received during 2004 and 2005. The proposal 
was presented and discussed on three occasions in 2004/5 in the Aquaculture Working Group 
of the Advisory Committee for Fisheries and Aquaculture.  

Summary of responses and how they have been taken into account 

The  initial  plan  was  to  incorporate  measures  for  containment  of  farmed  salmon  in  the 
proposal. As the  existing NASCO guidelines in this  area are  being evaluated in the  light of 
experience and scientific progress, the responses called for this aspect to be treated separately 
and not as part of alien species legislation. It was therefore considered appropriate to take this 
out  of  the  current  proposal.  The  consultees,  except  for  the  NGOs,  advised  against  an  over-

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Communication from the Commission setting out a Community Action Plan to integrate environmental 
protection requirements into the Common Fisheries Policy, COM(2002) 186; Communication from the 
Commission  to  the  Council  and  to  the  Parliament  “A  strategy  for  the  sustainable  development  of 
European Aquaculture”, COM(2002) 511. 
Communication  from  the  Commission  to  the  Council  and  the  European  Parliament  -  Biodiversity 
Action Plan for Fisheries, COM(2001) 162 final. 

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centralised  and  heavy-handed  approach,  and  the  proposal  was  modified  to  acknowledge  the 
competence of Member States in this field. On the other hand, there was a call for harmonised 
guidelines  for  the  application,  risk  assessment  and  quarantine  stages,  and  these  have  been 
provided in order to allow even application of the legislation across the Member States. The 
proposal is based to a large extent on these opinions. 

•  Collection and use of expertise 

Scientific fields/areas of expertise concerned 

The  fields  of  marine  and  freshwater  biology  and  ecology  and  aquaculture  technology  were 
included. 

Methodology used 

Formal meeting of stakeholders following circulation of a discussion document. Consultation 
of the Advisory Committee for Fisheries and Aquaculture and two follow-up rounds of e-mail 
consultations on draft texts. 

Main organisations/experts consulted 

i) 

ii) 

iii) 

International organisations such as ICES, EIFAC and NASCO; 

specialised  research  bodies  such  as  Marine  Organism  Investigations  and  Hull 
International Fisheries Institute; 

individual  experts  from  Member  States  administrations,  aquaculture  industry  and 
NGOs. 

Summary of advice received and used 

The main conclusion is that there is a broad consensus on the existence of potentially serious 
risks with irreversible consequences. More concrete technical aspects included the following: 

Containment  should  be  dealt  with  separately.  Care  should  be  taken  with  the  definitions, 
especially  to  distinguish  between  species  which  are  native  and  those  which  are  not  native. 
Stocking based on aquaculture and classic aquaculture should be covered by this legislation. 
A  risk  assessment  approach  incorporating  mitigation  and  protective  measures  should  be 
included  in  the  procedure,  specifying  who  is  to  carry  out  and  who  is  to  evaluate  the  risk 
assessment.  The  regulation  should  not  be  over-prescriptive,  so  that  detailed  management  is 
left  to  the  Member  States.  There  is  a  need  to  develop  European  expertise  on  quarantine 
stations.  GMOs  should  be  included,  and  triploids  should  not  be  regarded  as  harmless.  The 
proposal is largely based on these opinions, but GMOs were excluded from the scope as they 
are already covered by existing and developing Community legislation in the field. 

Means used to make the expert advice publicly available 

The main conclusions of the stakeholder meeting were presented to the Advisory Committee 
on  Fisheries  and  Aquaculture,  Working  Group  II,  Aquaculture;  the  minutes  of  their 
discussions  are  available  on  the  Fisheries  website.  During  the  e-mail  exchange,  most 
messages were copied to all other consultees without a warning about restricted distribution. 

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•  Impact assessment 

From among the various options examined in the impact assessment it would appear that the 
present  proposal  is  preferable  to  the  option  of  not  applying  the  legislation  to  movements 
within the Community but distinguishing between introductions, which apply to alien species, 
and  translocations,  which  apply  to  species  which  are  locally  absent  from  their  range  of 
distribution  for  biogeographical  reasons.  Industry  commented  that  the  cost  of  funding  the 
application,  risk  assessment  and  quarantine  would  preclude  future  applications  for  the 
introduction  of  alien  species.  Taking  this  into  account,  the  proposal  does  not  make  it 
mandatory  for  the  applicant  to  bear  the  cost  of  the  risk  assessment  in  all  cases  (see  Article 
9(1)).  As  stated  above,  a  large  proportion  of  current  aquaculture  practices  is  based  on  alien 
species (rainbow trout, Pacific oyster, carp) and operators can associate to share the costs of 
obtaining the information required both for drawing up the application and, where applicable, 
for  the  risk  analysis.  The  proposal  also  provides  for  the  issuing  of  permits  for  successive 
movements  within  a  period  of  up  to  five  years,  which  will  also  simplify  both  costs  and 
procedures. 

In  order  to  follow  current  EU  practice  on  risk  analysis,  it  was  decided  to  separate  the  risk 
assessment  function  (advisory  committee)  from  the  risk  management  function  (competent 
authority).  For  this  reason  the  original  option  of  combining  both  functions  within  the 
competent  authority  was  not  put  forward.  The  impact  assessment  addressed  the  question  of 
whether the proposal was premature, given that the IMO International Convention on ballast 
water - which was agreed in February 2004 - will also cover the problem of alien species. In 
view  of  the  uncertainty  of  the  date  of  entry  into  force  of  this  convention,  the  nature  of  the 
risks associated with alien species, and taking account of the precautionary principle, it was 
concluded that it was not premature to proceed. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The aim of the proposed legislation as it is currently formulated is to strike the correct balance 
with  regard  to  subsidiarity  and  proportionality.  Decision  making  is  left  to  Member  States, 
which will be able to assess under prescribed conditions the risks associated with proposals 
for  introductions.  Applicants  are  obliged  to  submit  an  application  giving  Member  State 
authorities sufficient information to make a judgment. The content of the application, which is 
obligatory  in  all  cases,  is  sufficiently  comprehensive  to  allow  an  evaluation  of  whether  the 
movement would be routine or non-routine. It also provides sufficient criteria for a decision to 
be  made  at  Member  State  level  on  whether  an  environmental  risk  assessment  (ERA)  is 
required and who will be involved in making such an assessment. Evaluation of the completed 
ERA will in turn inform the decision - as to whether a permit should or should not be granted. 
In  cases  where  a  movement  is  liable  to  affect  another  Member  State,  a  "Community 
procedure"  allows  the  Commission  to  consult  other  Member  States  and  the  relevant 
committees. In this case the Commission can decide to confirm, cancel or amend the decision 
within  a  period  of  six  months.  The  proposal  draws  heavily  on  the  existing  voluntary 
ICES/EIFAC  Codes  and  on  the  Canadian  National  Code  on  Introductions  and  transfers  of 
aquatic  organisms  which  develop  the  ICES  code  significantly.  It  does  not  rule  out  the 
voluntary application of the ICES/EIFAC codes at Member State level. 

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•  Legal basis 

Article  37  of  the  Treaty  is  taken  as  the  legal  basis,  given  the  specificity  of  aquaculture 
activities  and  the  objective  of  conservation  of  living  aquatic  resources  within  the  Common 
Fisheries  Policy  (Articles  1(1)  and  1(2)(a)  and  (f)  of  Council  Regulation  (EC)  No 
2371/20023). 

•  Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the  exclusive 
competence of the Community.  

As stated above, this proposal falls within the ambit of the Common Fisheries Policy, which is 
the  exclusive  competence  of  the  Community.  Therefore,  the  subsidiarity  principle  does  not 
apply. 

•  Proportionality principle 

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

•  One of the strong messages taken from the December 2003 Consultation meeting 
was  the  need  for  proportionality  and  the  need  to  ensure  that  the  new  legislation 
will  be  embraced  by  industry  and  not  regarded  as  just  another  unworkable 
legislative burden. Rather than looking for the simplest solution to ban all uses of 
alien species, the proposal seeks a balance between environmental protection and 
the needs of the aquaculture industry. 

•  The proposal reflects a fair distribution of the financial and administrative burden 

between all actors. 

•  Choice of instruments 

The legislation is proposed in the form of a Regulation. Although a Directive would also be 
possible in principle, it was felt that in view of the dynamic nature of the aquaculture sector 
there is a common interest in prescribing detailed rules in the form of a Regulation rather than 
establishing the obligation of an end-result. 

4. 

BUDGETARY IMPACT 

The Regulation may have some implications in terms  of  staff time to  make  applications  for 
prospective movements of alien species and in terms of the resources needed for consulting 
STECF and the Advisory Committee for Fisheries and Aquaculture, but this is routine work 
for these committees. 

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OJ L 358, 31.12.2002, p. 59 

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2006/0056 (CNS) 

Proposal for a 

COUNCIL REGULATION 

concerning use of alien and locally absent species in aquaculture  

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 Commission4, 

Having regard to the opinion of the European Parliament5, 

Having regard to the opinion of the European Economic and Social Committee6 

Whereas: 

(1) 

(2) 

(3) 

(4) 

In  accordance  with  Article  6  of  the  Treaty,  environmental  protection  requirements 
must be integrated into the definition and implementation of the Community policies 
and activities, in particular with a view to promoting sustainable development. 

Aquaculture  is  a  fast-growing  sector  where  innovation  and  new  outlets  are  being 
explored.  In  order  to  adapt  the  production  to  the  conditions  of  the  market,  it  is 
important for the aquaculture industry to diversify the species reared. 

Aquaculture  has  benefited  economically  from  the  introduction  of  alien  species  and 
translocation of locally absent species in the past (for example rainbow trout, Pacific 
oyster  and  salmon)  and  the  policy  objective  for  the  future  is  to  maximise  benefits 
associated  with  introductions  and  translocations  while  at  the  same  time  avoiding 
alterations to ecosystems, preventing negative biological interaction, including genetic 
change,  with  indigenous  populations  and  restricting  the  spread  of  non-target  species 
and detrimental impacts on natural habitats. 

Invasive  alien  species  have  been  identified  as  one  of  the  key  causes  of  loss  of  bio-
diversity. Article 8(h) of the Convention on Biological Diversity (CBD), to which the 
Community  is  a  Party,  each  Contracting  Party  is  required,  as  far  as  possible  and  as 
appropriate,  to  prevent  the  introduction  of,  control  or  eradicate  those  alien  species 
which  threaten  ecosystems,  habitats  or  species.  In  particular,  the  Conference  of  the 
Parties  to  the  CBD  has  adopted  Decision  VI/23  on  alien  species  that  threaten 
ecosystems, habitats or species, the annex to which sets out Guiding Principles for the 

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5 
6 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 

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prevention,  introduction  and  mitigation  of  impacts  of  such  alien  species.  (see: 
http://www.biodiv.org/decisions/default.aspx?m=COP-06&id=7197&lg=0). 

The translocation of species within their natural range to areas where they are locally 
absent for specific bio-geographical reasons may also induce risks for the ecosystems 
that  have  become  established  in  these  areas  and  should  also  be  covered  by  this 
Regulation. 

The  Community  should  therefore  develop  its  own  framework  to  ensure  adequate 
protection  of  the  aquatic  environment  from the  risks  associated  with  the  use  of  non-
native  species  in  aquaculture.  This  framework  should  include  procedures  for  the 
analysis  of  the  potential  risks,  the  taking  of  measures  based  on  the  prevention  and 
precautionary  principles  and  the  adoption  of  contingency  plans  where  necessary. 
These  procedures  should  build  on  experience  gained  through  the  existing  voluntary 
frameworks,  and  notably  the  International  Council  for  the  Exploration  of  the  Sea 
(ICES) Code of Practice on the Introductions and Transfers of Marine Organisms and 
the  European  Inland  Fisheries  Advisory  Commission  (EIFAC)  Code  of  Practice  and 
Manual  of  Procedures  for  consideration  of  introduction  and  transfer  of  marine  and 
freshwater organisms. 

The measures provided for in this Regulation should be without prejudice to Council 
Directive  92/43/EEC  of  21  May  1992  on  the  conservation  of  natural  habitats  and  of 
wild  fauna  and  flora7,  Council  Directive  85/337/EEC  of  27  June  1985  on 
environmental  impact  assessment8,  Council  Directive  2006/XX/EC  of  on  animal 
health  requirements  for  aquaculture  animals  and  products  thereof,  and  on  prevention 
and  control  of  certain  diseases  in  aquatic  animals9  and  Directive  2000/60/EC  of  the 
European Parliament and the Council of 23 October 2000 establishing a framework for 
Community action in the field of water policy10. 

The  potential  risks,  which  may  in  some  cases  be  on  a  large  geographical  scale,  are 
more evident initially in local areas. The characteristics of local aquatic environments 
throughout  the  Community  may  be  very  diverse  and  Member  States  have  the 
appropriate knowledge, monitoring systems and expertise to evaluate and manage the 
risks to the aquatic environments falling within their sovereignty or jurisdiction. It is 
therefore  appropriate  that  the  implementation  of  the  measures  provided  for  in  this 
Regulation falls primarily under the responsibility of Member States.  

However, in cases where risks are not negligible and may affect other Member States 
there  should  be  a  Community  system  for  consultation  of  interested  parties  and 
validation  of  permits  prior  to  their  granting  by  Member  States.  The  Scientific, 
Technical and Economic Committee for Fisheries (STECF) established under Article 
33  of  Council  Regulation  (EC)  No  2371/2002  of  20  December  2002  on  the 
conservation  and  sustainable  exploitation  of  fisheries  resources  under  the  Common 

OJ L 206, 22.7.1992, p. 7. Directive as last amended by Regulation (EC) 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) 
OJ L 175, 5.7.1985, p. 4. Directive as last amended by Directive 2003/35/EC (OJ L 156, 25.6.2003, p. 
17. 
OJ No insert official number of Council Directive (adopted by the Commission 23.8.2005, COM(2005) 
362) 
OJ L 327, 22.12.2000, p. 1. 

(5) 

(6) 

(7) 

(8) 

(9) 

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Fisheries  Policy11  should  provide  the  scientific  advice  in  this  consultation  and  the 
Advisory  Committee  for  Fisheries  and  Aquaculture  set  up  by  Commission  Decision 
1999/478/EEC12 should give the advice of stakeholders in the field of aquaculture and 
environmental protection. 

HAS ADOPTED THIS REGULATION: 

Chapter I 
Subject matter, scope and definitions 

Article 1 
Subject matter 

This Regulation establishes a framework governing aquaculture practices in relation to alien 
and locally absent species to assess and minimise the possible impact of these on the aquatic 
environment and in this manner contribute to the sustainable development of the sector. 

Article 2 
Scope 

This  Regulation  shall  apply  to  the  introduction  of  alien  species  and  to  the 
translocation of locally absent species for their use in aquaculture in the Community.  

This  Regulation  shall  not  apply  to  translocations  of  aquatic  organisms  within  a 
Member States, except for: 

a) 

b) 

translocations  to,  from  or  between  the  non-European  territories  of  a  Member 
State; 

translocations  which  take  place  between  waters  in  different  ecoregions  as 
defined in Annex II to Directive 2000/60/EC of the European Parliament and 
of  the  Council  of  23  October  2000  establishing  a  framework  for  Community 
action in the field of water policy13, and 

c) 

cases where, on the basis of scientific advice, there are grounds for foreseeing 
environmental threats due to the translocation. 

By  way  of  derogation  from  paragraph  2,  Member  States  may  decide  that  this 
Regulation applies to translocations within their territory in other cases too. 

This Regulation shall cover all aquaculture facilities located within the jurisdiction of 
Member States irrespective of their size or characteristics or of the species of aquatic 
organism farmed. It shall cover aquaculture using any form of aquatic medium.  

OJ L 358, 31.12.2002, p. 59. 
OJ L 187, 20.7.1999, p. 70. 
OJ No L 327, 22.12.2000, p. 1. 

1. 

2. 

3. 

4. 

11 
12 
13 

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10 

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5. 

This  Regulation  shall  not  apply  to  the  keeping  of  ornamental  aquatic  animals  or 
plants in pet-shops, garden centres or aquaria without any direct contact with natural 
waters in the Community or in facilities which are equipped with effluent treatment 
systems which fulfil the aims set out in Article 1.  

For the purpose of this Regulation the following definitions shall apply: 

Article 3 
Definitions 

(1) 

(2) 

(3) 

(4) 

(5) 

‘aquaculture’  means  the  rearing  or  culture  of  aquatic  organisms  using  techniques 
designed to increase the production of the organisms in question beyond the natural 
capacity  of  the  environment,  the  organisms  remaining  the  property  of  a  natural  or 
legal person throughout the rearing or culture stage, up to and including harvesting; 

‘open  aquaculture  facility’  means  a  facility  where  aquaculture  is  conducted  in  an 
aquatic  medium  not  separated  from  the  wild  aquatic  medium  by  impenetrable 
barriers preventing the escape of reared specimens or biological material that might 
survive and subsequently reproduce; 

‘closed  aquaculture  facility’  means  a  facility  where  aquaculture  is  conducted  in  an 
aquatic  medium  separated  from  the  wild  aquatic  medium  by  impenetrable  barriers 
preventing the escape of reared specimens or biological material that might survive 
and subsequently reproduce; 

‘aquatic  organisms’  means  any  aquatic  living  thing  belonging  to  the  Kingdoms 
Animalia,  Plantae  and  Protista,  including  any  part,  gametes,  seeds,  eggs  or 
propagules of their individuals that might survive and subsequently reproduce; 

‘polyploid  organisms’  means  aquatic  organisms 
chromosomes in the cells has been changed through cell manipulation techniques; 

in  which 

the  number  of 

(6) 

‘alien species’ means: 

(a) 

a species, subspecies or a lower taxon of an aquatic organism occurring outside 
its  known  natural  range  and  the  area  of  its  dispersal  potential  as  a  result  of 
deliberate or accidental introduction by humans; 

(b)  polyploid organisms, irrespective of their natural range or dispersal potential; 

(7) 

(8) 

‘locally absent species’ means a species or subspecies of an aquatic organism which 
is  locally  absent  from  a  zone  within  its  natural  range  of  distribution  for 
biogeographical reasons; 

‘non-target species’ means any species or subspecies of an aquatic organism that is 
moved  accidentally  together  with  an  aquatic  organism  that  is  being  introduced  or 
translocated; 

(9) 

‘movement’ means introduction and/or translocation;  

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11 

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(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

‘introduction’ means the process by which an alien species is intentionally moved for 
its use in aquaculture;  

‘translocation’  means  the  process  by  which  an  aquatic  organism  is  intentionally 
moved  within  its  natural  range  for  its  use  in  aquaculture  to  an  area  where  it 
previously did not exist because of biogeographical reasons; 

‘pilot  release’  means  the  release  of  aquatic  organisms  on  a  limited  scale  to  assess 
ecological  interaction  with  native  species  and  habitats  in  order  to  test  the  risk 
assessment assumptions; 

‘applicant’  means  the  natural  or  legal  person  or  entity  proposing  to  conduct  the 
introduction or translocation of an aquatic organism; 

‘quarantine’  means  a  process  by  which  aquatic  organisms  any  of  their  associated 
organisms  can  be  maintained 
the  surrounding 
in  complete 
environment; 

isolation  from 

‘quarantine  facility’  means  a  facility  in  which  aquatic  organisms  and  any  of  their 
associated organisms can be maintained in complete isolation from the surrounding 
environment; 

‘routine movement’ means the movement from a known source of aquatic organisms 
classified as low risk, following longstanding experience in a Member, State which 
shows no adverse ecological effects and is not liable to affect other Member States; 

‘non-routine movement’ shall mean any movement of aquatic organisms which does 
not fulfil the criteria for routine movement; 

‘receiving Member State’ shall mean the Member State into the territory of which the 
alien species is introduced or the locally absent species is translocated; 

‘sending  Member  State’  means  the  Member  State  from  the  territory  of  which  the 
alien species are introduced or the locally absent species are translocated. 

Chapter II 
General obligations of the Member States 

Article 4 
Measures for avoiding adverse effects 

Member States shall ensure that all appropriate measures are taken to avoid adverse effects to 
biodiversity,  and  especially  to  species,  habitats  and  ecosystem  functions  which  might  arise 
from  the  introduction  or  translocation  of  aquatic  organisms  and  non-target  species  in 
aquaculture and from the spreading of these species into the wild. 

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12 

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Article 5 
Decision making and advisory bodies 

Member  States  shall  designate  the  competent  authority  responsible  for  ensuring  compliance 
with  the  requirements  of  this  Regulation  (‘the  competent  authority’).  Each  competent 
authority  shall  appoint  to  assist  it  an  advisory  committee,  which  shall  include  appropriate 
biological and ecological expertise (‘the advisory committee’). 

Chapter III 
Permits 

Article 6 
Permit 

1. 

2. 

Anyone  intending  to  undertake  the  introduction  or  translocation  of  an  aquatic 
organism  shall  apply  for  a  permit  from  the  competent  authority  of  the  receiving 
Member State. Applications may be submitted for multiple movements to take place 
over a period of not longer than five years. 

The applicant shall submit with the application the information listed in Annex I. The 
advisory committee shall give an opinion on whether the application contains all the 
required  information  and  is  therefore  admissible  and  shall  inform  the  competent 
authority. 

Article 7 
Type of the proposed movement 

The advisory committee shall give its opinion on whether the proposed movement is a routine 
movement  or  a  non-routine  movement  and  whether  the  movement  must  be  preceded  by 
quarantine or pilot release and shall inform the competent authority. 

Article 8 
Routine movement 

In  the  case  of  routine  movements,  the  competent  authority  may  grant  a  permit,  indicating, 
where applicable, the requirement for quarantine or pilot release as set out in Chapters IV and 
V. 

Article 9 
Non-routine movement 

1. 

In  the  case  of  non-routine  movements,  an  environmental  risk  assessment  shall  be 
carried out as outlined in Annex II. The competent authority shall decide whether the 
applicant  or  an  independent  body  is  responsible  for  conducting  the  environmental 
risk assessment and who should bear the cost. 

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13 

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2. 

3. 

4. 

1. 

2. 

1. 

2. 

3. 

On the basis of the environmental risk assessment, the advisory committee shall give 
its opinion on the risk to the competent authority, using the summary report form set 
out  in  Annex  II,  Part  3.  If  the  advisory  committee  finds  that  the  risk  is  low,  the 
competent authority may grant a permit without further formalities. 

If the advisory committee finds that the risk associated with the proposed movement 
of  aquatic  organisms  is  high  or  medium,  it  shall  examine  the  application  in 
consultation  with  the  applicant  to  see  if  there  are  mitigation  procedures  or 
technologies  available  to  reduce  the  level  of  risk  to  low.  The  advisory  committee 
shall forward the results of its appraisal to the competent authority, detailing the level 
of risk and specifying the reasons for any reduction in risk in the form specified in 
Annex II, Part 3. 

The competent authority may only issue permits for non-routine movements in cases 
where the risk assessment, including any mitigation measures, show a low risk to the 
environment. Any refusal of a permit must be justified on scientific grounds. 

Article 10 
Decision period 

The applicant shall be informed in writing of the decision to issue or refuse a permit 
within a reasonable time and in any case not later than one year from the date of the 
submission of the application. 

Member States which are signatories to ICES may request to have applications and 
risk assessments regarding marine organisms reviewed by ICES prior to the issuing 
of  an  opinion  by  the  advisory  committee.  In  such  cases  an  additional  period  of  six 
months shall be allowed. 

Article 11 
Movements affecting other Member States 

Where the potential or known environmental effects of a proposed movement of an 
organism  are  liable  to  affect  other  Member  States,  the  competent  authority  shall 
notify the Member State or States concerned and the Commission of its intention to 
grant  a  permit  by  sending  a  draft  decision,  accompanied  by  an  explanatory 
memorandum  and  a  summary  of  the  environmental  risk  assessment  as  specified  in 
Annex II, Part 3. 

Within  two  months  of  the  date  of  notification,  the  other  Member  States  concerned 
may submit written comments to the Commission.  

Within six months of the date of notification, the Commission shall, after consulting 
the  Scientific,  Technical  and  Economic  Committee  for  Fisheries  (STECF), 
established under Article 33 of Regulation 2371/2002 and the Advisory Committee 

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14 

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for  Fisheries  and  Aquaculture,  established  by  Decision  1999/478/EEC14,  confirm, 
cancel or amend the proposed decision to grant a permit.  

4. 

Within  30  days  of  the  date  of  the  Commission’s  decision,  the  Member  States 
concerned may refer that decision to the Council. Within a further 30 day period, the 
Council, acting by qualified majority, may take a different decision. 

Article 12 
Withdrawal of permit 

At any point in time the Competent Authority can withdraw the permit if unforeseen events 
with negative effects on the environment or on native populations occur. 

Chapter IV 
Conditions for introduction after issue of a permit 

Article 13 
Compliance with other Community provisions 

After a permit is issued under this Regulation, the introduction may only take place if other 
permits required under Community law have been obtained and if other conditions laid down 
under the Community rules are fulfilled, and in particular: 

(a) 

the animal health conditions set out in Council Directive 2006/XX/EC15 

(b) 

the  conditions  set  out  in  Council  Directive  2000/29/EC  of  8  May  2000  on 
protective measures against the introduction into the Community of organisms 
harmful  to  plants  or  plant  products  and  against  their  spread  within  the 
Community16. 

Article 14 
Release into aquaculture facilities in case of routine introductions 

In  the  case  of  routine  introductions  the  release  of  aquatic  organisms  into  open  aquaculture 
facilities  shall  normally  be  allowed  without  quarantine,  unless  the  competent  authority 
decides otherwise on the basis of specific advice given by the advisory committee. 

14 
15 
16 

OJ L 187, 20.7.1999, p. 70, as amended by Decision 2004/864/EC (OJ L 370, 17.12.2004, p. 91) 
see footnote 9 
OJ L 169, 10.7.2000, p. 1 

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15 

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Article 15 
Release into aquaculture facilities in case of non-routine introductions 

1. 

2. 

3. 

4. 

In the case of non-routine introductions, the release of aquatic organisms into open 
and  closed  aquaculture  facilities  shall  be  subject  to  the  conditions  set  out  in 
paragraphs 2, 3 and 4. 

The aquatic organisms shall be placed in a designated quarantine facility within the 
territory of the Community in accordance with the conditions set out in Annex III for 
the purpose of constituting a brood-stock. 

The  quarantine  facility  may  be  located  in  a  Member  State  other  than  the  receiving 
Member State, provided that all Member States concerned agree and that this option 
has been included in the environmental risk assessment under Article 9. 

Only  progeny  of  the  introduced  aquatic  organisms  may  be  used  in  aquaculture 
facilities  of  the  receiving  Member  State,  unless  the  organisms  in  question  are  fully 
reproductively  sterile  and  providing  that  no  non-target  species  are  found  during 
quarantine. 

Article 16 
Pilot release into open aquaculture facilities 

The  competent  authority  may  require  that  the  release  of  the  aquatic  organisms  into  open 
aquaculture systems be preceded by an initial pilot release subject to specific containment and 
to preventive measures based on the advice and recommendations of the advisory committee.  

Article 17 
Contingency plans 

For  all  non-routine  introductions  and  pilot  releases,  the  advisory  committee  shall,  in 
consultation with the applicant, draw up contingency plans, which shall include inter alia the 
removal  of  the  introduced  species  from  the  environment,  or  a  reduction  in  density,  for 
unforeseen events with negative effects on the environment or on native populations. If such 
an event occurs, the contingency plans shall be implemented immediately and the permit shall 
be withdrawn as per Article 12. 

Article 18 
Monitoring  

1. 

Alien species shall be monitored after their release for a period of two years or a full 
generation cycle, whichever is longer, to assess whether the impacts were accurately 
predicted  or  if  there  are  additional  or  different  impacts.  The  level  of  spread  or 
containment  of  the  species  shall  be  studied  in  particular.  The  competent  authority 
shall  decide  whether  the  applicant  has  the  adequate  expertise  or  whether  another 
body is to carry out the monitoring. 

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16 

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2. 

3. 

Subject  to  the  opinion  of  the  advisory  committee,  the  competent  authority  may 
require longer monitoring periods to assess any possible long-term ecosystem effects 
not easily detectable in the period laid down in paragraph 1. 

The advisory committee shall evaluate the results of the monitoring programme and 
note  in  particular  any  event  not  correctly  anticipated  in  the  environmental  risk 
assessment.  The  results  of  that  evaluation  shall  be  sent  to  the  competent  authority 
which  shall  include  a  summary  of  the  results  in  the  national  register  established 
under Article 23. 

Chapter V 
Conditions for translocations after issue of a permit 

Article 19 
Compliance with other Community provisions 

After  a  permit  has  been  issued  under  this  Regulation,  translocation  may  only  take  place  if 
other permits required under Community law have been obtained and if other conditions laid 
down in Community rules are fulfilled, and in particular: 

(a) 

the animal health conditions set out in Directive 2006/XX/EC17 

(b) 

the conditions set out in Directive 2000/29/EC18.  

Article 20 
Non-routine translocation 

In  the  case  of  non-routine  translocations  into  open  aquaculture  facilities,  the  competent 
authority may require that release of aquatic organisms be preceded by an initial pilot release 
with specific containment and preventive measures based on the advice and recommendations 
of the advisory committee. 

Article 21 
Quarantine  

The  receiving  Member  State  may  in  exceptional  cases  and  subject  to  approval  by  the 
Commission require quarantine in accordance with Article 15 (2), (3) and (4) before release of 
species from non-routine translocations into open or closed aquaculture facilities. The request 
for approval from the Commission shall indicate the reasons why quarantine is required. The 
Commission shall reply to such requests within 30 days. 

17 
18 

see footnote 9 
see footnote 15 

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Article 22 
Monitoring following translocation  

Following  a  non-routine  translocation,  the  species  shall  be  monitored  in  accordance  with 
Article 18. 

Chapter VI 
Register 

Article 23 
Register 

Member States shall keep a register of introductions and translocations containing a historical 
record of all applications made and the associated documentation gathered before the issue of 
a permit and during the monitoring period. 

The register shall be made available to the public in accordance with Directive 2003/4/EC of 
the  European  Parliament  and  of  the  Council  of  28  January  2003  on  public  access  to 
environmental information19. 

Chapter VII 
Final provisions 

Article 24 
Adaptation to technical progress 

Amendments  to  Annexes  I,  II  and  III  necessary  in  order  to  adapt  them  to  technical  and 
scientific  progress  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in  Article 
30(3) of Regulation (EC) No 2371/200220. 

19 
20 

OJ L 41, 14.02.2003, p. 26 
see footnote 11 

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Article 25 
Entry into force 

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the Council 
The President 

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ANNEX I  

Application 

(To be completed by applicant) 

Wherever  possible,  information  is  to  be  supported  with  references  from  the  scientific 
literature,  and  notations  to  personal  communications  with  scientific  authorities  and  fisheries 
experts. Applications lacking detail may be returned to the applicant for additional material, 
resulting in a delay in assessing the proposal. 

For the purpose of this Annex when an application refers to a proposed translocation, rather 
replaced  by 
than  an 
translocation/translocated.  

introduction/introduced  are 

introduction, 

to  be 

terms 

the 

A) 

Executive summary 

Provide a brief summary of the document including a description of the proposal, the potential 
impacts  on  native  species  and  their  habitats  and  mitigation  steps  to  minimise  the  potential 
impacts on native species. 

B) 

1) 

2) 

3) 

4) 

5) 

6) 

7) 

Introduction  

Name  (common  and  scientific)  of  the  organism  proposed  for  introduction  or 
translocation,  indicating  the  genus,  species,  subspecies  or  lower  taxonomic 
classification where applicable. 

Describe the characteristics, including distinguishing characteristics, of the organism. 
Include a scientific drawing or photograph. 

Describe  the  history  in  aquaculture,  enhancement  or  other  introductions  (if 
appropriate). 

Describe  the  objectives  and  rationale  for  the  proposed  introduction,  including  an 
explanation as to why such an objective cannot be met through the utilization of an 
indigenous species.  

What alternate strategies have been considered in order to meet the objectives of the 
proposal? What are the implications of a “do nothing” option? 

What is the geographic area of the proposed introduction? Include a map. 

Describe the numbers of organisms it is proposed introducing (initially, ultimately). 
Can  the  project  be  broken  down  into  different  sub-components?  If  so,  how  many 
organisms are involved in each sub-component? 

8) 

Describe the source(s) of the stock (facility) and genetic stock (if known). 

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C) 

1) 

2) 

3) 

4) 

5) 

6) 

7) 

8) 

9) 

10) 

11) 

D) 

1) 

2) 

3) 

4) 

5) 

6) 

Lifehistory  information  of  the  species  to  be  introduced  -  for  each  life  history 
stage 

Describe the native range and range changes due to introductions.  

Record  where  the  species  was  introduced  previously  and  describe  the  ecological 
effects on the environment of the receiving area (predator, prey, competitor, and/or 
structural/functional elements of the habitat). 

What factors limit the species in its native range. 

Describe  the  physiological  tolerances  (water  quality,  temperature,  oxygen,  and 
salinity)  at  each  life  history  stage  (early  life-history  stages,  adult  and  reproductive 
stages). 

Describe the habitat preferences and tolerances for each life-history stage.  

Describe the reproductive biology. 

Describe the migratory behaviour. 

Describe the food preferences for each life-history stage. 

Describe the growth rate and lifespan (also in the area of the proposed introduction, 
if known). 

Describe the known pathogens and parasites of the species or stock. 

Describe the behavioural traits (social, territorial, aggressive). 

Interaction with native species  

What is the potential for survival and establishment of the introduced organism if it 
escapes?  (This  question  applies  to  movements  into  open  and  closed  aquaculture 
facilities.) 

What habitat(s) will the introduced species be likely to occupy in the proposed area 
of introduction and will this overlap with any vulnerable, threatened or endangered 
species?  (Indicate  if  the  proposed  area  of  introduction  also  includes  contiguous 
waters.). 

With  which  native  species  will  there  be  a  niche  overlap?  Are  there  any  unused 
ecological resources of which the species would take advantage?  

What will the introduced organism eat in the receiving environment? 

Will this predation cause any adverse impacts on the receiving ecosystem? 

Will  the  introduced  organisms  survive  and  successfully  reproduce  in  the  proposed 
area  of  introduction  or  will  annual  stocking  be  required?  (This  question  applies  to 
species not intended for closed aquaculture facilities.) 

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7) 

8) 

E) 

1) 

2) 

3) 

4) 

Will  the  introduced  organisms  hybridize  with  native  species?  Is  local  extinction  of 
any  native  species  or  stocks  possible  as  a  result  of  the  proposed  introduction?  Are 
there  any  possible  effects  of  the  introduced  organisms  on  the  spawning  behaviour 
and spawning grounds of local species? 

Are there any potential impacts on habitat or water quality as a result of the proposed 
introduction? 

Receiving environment and contiguous waters  

Provide  physical  information  on  the  receiving  environment  and  contiguous 
waterbodies  such  as  seasonal  water  temperatures,  salinity,  and  turbidity,  dissolved 
the 
oxygen,  pH,  nutrients 
tolerances/preferences  of  the  species  to  be  introduced,  including  conditions  needed 
for reproduction? 

those  parameters  match 

and  metals.  Do 

List species composition (major aquatic vertebrates, invertebrates and plants) of the 
receiving waters.  

Provide  information  on  habitat  in  the  area  of  introduction,  including  contiguous 
waters,  and  identify  critical  habitat.  Which  of  those  parameters  match  the 
tolerances/preferences  of  the  organisms  to  be  introduced?  Can  the  introduced 
organisms disturb any of the habitats described? 

Describe the natural or man-made barriers that should prevent the movement of the 
introduced organisms to adjacent waters. 

F) 

Monitoring 

Describe the plans for follow-up assessments of the proposed introduced species’ success and 
how any negative impacts on native species and their habitats will be assessed. 

G) 

1) 

Management plan  

Describe the management plan for the proposed introduction. This should include but 
not be restricted to the following information: 

(a)  measures taken to ensure that no other species (non-target species) accompany 

the shipment; 

(b)  who will be permitted to use the proposed organisms and under what terms and 

conditions; 

(c)  will there be a pre-commercial phase for the proposed introduction? 

(d)  description of the quality assurance plan for the proposal, and, 

(e) 

other legislative requirements that need to be met. 

2) 

Describe the chemical, biophysical and management measures being taken to prevent 
accidental escape of the organism and non-target species, to and their establishment 
in,  non-target  recipient  ecosystems.  Give  details  of  the  water  source,  effluent 

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destination, any effluent treatment, proximity to storm sewers, predator control, site 
security and measures to prevent escapes, if necessary. 

Describe  contingency  plans  to  be  followed  in  the  event  of  an  unintentional, 
accidental  or  unauthorised  liberation  of  the  organisms  from  rearing  and  hatchery 
facilities or an accidental or unexpected expansion of the range of colonisation after 
release. 

If this proposal is intended to create a fishery, give details of the fishery objective. 
Who would benefit from such a fishery? Give details of the management plan and, if 
appropriate,  include  changes  in  the  management  plans  for  species  which  will  be 
impacted. 

Business data  

Provide the name of the owner and/or company, the aquaculture licence number and 
the  business  licence  (if  applicable)  or  the  name  of  the  government  agency  or 
department with a contact name, telephone, fax and email information. 

Provide an indication as to the economic viability of the proposed project.  

References  

Provide a detailed bibliography of all references cited in the course of preparing the 
application. 

Provide  a  list  of  names,  including  addresses,  of  scientific  authorities  and  fisheries 
experts consulted.  

3) 

4) 

H) 

1) 

2) 

I) 

1) 

2) 

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ANNEX II 

Procedures and minimum elements to be addressed in an environmental risk assessment 

To evaluate risks associated with the introduction or translocation of aquatic organisms it is 
necessary  to  assess  the  probability  that  the  organisms  will  become  established  and  the 
consequences of that establishment.  

The  process  addresses  the  major  environmental  components.  It  provides  a  standardised 
approach for evaluating the risk of genetic and ecological impacts as well as the potential for 
introducing  a  non-target  species  that  might  impact  the  native  species  of  the  proposed 
receiving waters. 

During the review process, emphasis is not on the ratings but on the detailed biological and 
other relevant information statements that motivate them. In case of scientific uncertainty, the 
precautionary principle should be applied. 

For  the  purpose  of  this  Annex,  where  an  application  refers  to  a  proposed  translocation  the 
terms “introduction/introduced” are to be replaced by “translocation/translocated”.  

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PART 1– ECOLOGICAL AND GENETIC RISK ASSESSMENT PROCESS 

Step  1:  Likelihood  of  establishment  and  spreading  beyond  the  intended  area  of 
introduction 

Event 

Likelihood 
(H, M, L)(1) 

Certainty 

(VC, RC, 
RU, VU)(2) 

Comments in 
support of 
assessment(4) 

In the case of closed aquaculture 
systems, the introduced or 
translocated species escapes to 
the surrounding environment. 

The introduced or translocated 
species, escaped or dispersed, 
successfully colonises and 
maintains a population in the 
intended area of introduction 
beyond the control of the 
aquaculture facility. 

The introduced species or 
translocated, escaped or 
dispersed, spreads beyond the 
intended area of introduction. 
Final rating(3) 

(1) 

(2) 

(3) 

H= High, M= Medium, L= Low 

VC= Very certain, RC= Reasonably certain, RU= Reasonably uncertain, VU= Very uncertain 

The  final  rating  for  the  likelihood  of  establishment  and  spreading  is  assigned  the  value  of  the 
element  with  the  lowest  rating  (for  example,  High  and  Low  ratings  for  the  above  elements  would 
result in a final Low rating). Again, both events – probability of the organism successfully colonizing 
and maintaining a population in the intended area of introduction (be it a confined environment such 
as  a  facility,  or  a  natural  habitat)  and  the  probability  of  spreading  beyond  the  intended  area  of 
introduction (estimated as explained above) – need to occur in order to have establishment beyond the 
intended area of introduction. 

The final rating for the level of Certainty is assigned the value of the element with the Lowest level 
of certainty (e.g., Very Certain and Reasonably Certain ratings would result in a final Reasonably 
Certain rating).  

(4) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

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Step 2: Consequences of establishment and spreading  

Event 

Likelihood 

(H, M, L)  

Certainty 

(VC, RC, 
RU, VU)  

Comments in 
support of 
assessment(2) 

Genetic mixing with local 
populations leads to a loss of 
genetic diversity. 

Competition (food, space) with 
or predation on native 
populations leads to their 
extirpation.  

Other undesirable events of 
ecological nature 

Some of the above-mentioned 
events persist even after removal 
of the introduced species.  
Final rating(1) 

(1) 

The  final  rating  for  the  Consequences  of  establishment  and  spreading  is  assigned  the  value  of  the 
element (individual probability) with the highest rating and the final rating for the level of Certainty is 
assigned the value of the element with the lowest level of certainty. 

(2) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

Step 3 Risk Potential associated to the alien and locally absent species  

A single value is given based on the assessments done in Steps 1 and 2: 

Component 

Risk potential 

Certainty 

(H, M, L)  

(VC,  RC, 
RU, VU)  

Comments in 
support of 
assessment(2) 

Establishment and spreading 
(step 1) 

Ecological consequences (step 2) 

Final rating of overall risk 
potential(1) 

(1) 

The final categorisation of risk potential takes the value of the highest of the two probabilities when 
there  is  no  probability  increment  between  the  two  estimates  (i.e.  if  the  Risk  of  establishment  and 
spreading is high and the Risk of ecological consequences is medium, the final rating takes the value 
of the highest of the two probabilities which is high. When there is a probability increment between 
the two estimates (i.e. a mixture of high and low) the final value is medium. 

(2) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

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The result of this assessment should be expressed in terms of: 

High  =  Introduction  is  of  major  concern  (major  mitigation  measures  are  required).  It  is 
advised that the proposal be rejected unless mitigation procedures can be developed to reduce 
the risk to Low. 

Medium  =  Introduction  is  of  moderate  concern.  It  is  advised  that  the  proposal  be  rejected 
unless mitigation procedures can be developed to reduce the risk to Low. 

Low  =  Introduction  is  of  negligible  concern.  It  is  advised  that  the  proposal  be  approved. 
Mitigation is not needed. 

The  proposal  can  only  be  approved  as  presented  (no  mitigating  measures  required)  if  the 
overall estimated risk potential is Low and if the overall certainty for which the overall risk 
has been estimated is Very Certain or Reasonably Certain. 

If, as a result of a first analysis, a High or Medium category is attributed to the overall risk, 
then containment or mitigation proposals are to be incorporated in the application, which will 
be subject to subsequent risk analysis until the final rating for the overall risk becomes Low 
with a Very Certain or Reasonably Certain assessment. Descriptions of these additional steps, 
together with detailed specifications of the containment or mitigation measures, will become 
an integral part of the Risk Assessment. 

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PART 2 –NON-TARGET SPECIES ASSESSMENT PROCESS 

Step  1:  Likelihood  of  establishment  and  spreading  of  non-taget  species  beyond  the 
intended area of introduction 

Event 

Likelihood 

(H, M, L)  

Certainty 

(VC, RC, 
RU, VU)  

Comments in 
support of 
assessment(2) 

A non-target species is 
introduced as a consequence of 
the introduction or translocation 
of the aquatic organisms. 

The introduced non-target 
species encounters susceptible 
habitats or host organisms. 
Final rating(1) 

(1) 

The final rating under Likelihood is assigned the value of the element with the lowest risk rating and 
the final rating for the level of Certainty is also assigned the value of the element with the lowest level 
of certainty. 

(2) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

Step 2 Consequences of non-target species establishment and spreading  

Event 

Likelihood 

(H, M, L)  

Certainty 

(VC, RC, 
RU, VU)  

Comments in 
support of 
assessment(2) 

The non-target species compete 
with or predate on native 
populations, leading to their 
extirpation.  

Genetic mixing of the non-target 
species with local populations 
leads to a loss of genetic 
diversity. 

Other undesirable events of 
ecological or pathological nature 

Some of the above-mentioned 
events persist even after removal 
of the non-target species. 
Final rating(1) 

(1) 

The final rating for the Consequences is assigned the value of the highest risk rating and final rating 
for the level of Certainty is also assigned the value of the element with the lowest level of certainty. 

(2) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

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Step 3 Risk potential associated with non-target species  

A single value is given based on the assessments performed in Steps 1 and 2: 

Component 

Risk potential 

Certainty 

(H, M, L)  

(VC, RC, 
RU, VU)  

Comments in 
support of 
assessment(2) 

Establishment and spreading 
(step 1) 

Ecological consequences (step 2) 
Final rating(1) 

(1) 

The final rating under risk potential is assigned the value of the element with the lowest risk rating and 
the final rating for the level of Certainty is also assigned the value of the element with the lowest level 
of certainty. 

(2) 

The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of practice. 

The  conditions  applicable  to  the  assessment  of  risk  potential  associated  to  the  alien  species 
(part  1)  are  to  also  apply  mutatis  mutandis  to  this  risk  potential  associated  with  non-target 
species (part 2), including the obligation to introduce containment and mitigation measures.  

PART 3 – OVERALL ENVIRONMENTAL RISK ASSESSMENT - SUMMARY REPORT 

•  History, background and rationale for the request: 

•  Risk assessment summary information 

•  Summary of the ecological and genetic risk assessment 

•  Summary of the non-target species risk assessment 

•  Comments: 

•  Mitigation measures: 

•  Concluding statement on Total organism potential risk: 

•  Advice to competent authority:  

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ANNEX III 

Quarantine 

Quarantine is the means by which live animals or plants and any of their associated organisms 
are  maintained  in  complete  isolation  from  the  surrounding  environment  so  as  to  prevent 
impact on wild and farmed species and undesirable changes to natural ecosystems. 

It is necessary to keep alien or locally absent species in quarantine long enough to detect all 
non-target  species  and  to  confirm  the  absence  of  pathogens  or  diseases.  The  unit  is  to  be 
constructed in accordance with the specifications of the competent authority in the Member 
State  of  its  location  which  is  to  be  responsible  for  approving  it.  The  duration  of  quarantine 
must be indicated in the permit. If the facility is not located of the receiving Member State, 
the  advisory  committee  responsible  for  the  facility  and  the  advisory  committee  in  the 
receiving Member State must agree on the duration.  

Operators  are  to  run  quarantine  facilities  in  accordance  with  the  following  conditions.  In 
addition the operator must have a quality assurance programme and an operating manual. 

For  the  purpose  of  this  Annex  where  an  application  refers  to  a  proposed  translocation,  the 
terms introduction/introduced are to be replaced by translocation/translocated.  

Effluent and waste disposal 

All  effluents  and  wastes  generated  within  the  facility  must  be  treated  in  a  manner  that 
effectively  destroys  all  possible  target  species  and  associated  organisms.  To  ensure 
continuous operation and complete containment, quarantine effluent treatment systems must 
be equipped with fail-safe backup mechanisms. 

Treated effluent and waste may contain substances which are harmful to the environment (e.g. 
antifouling  agents)  and  must  be  disposed  of  in  a  manner  which  minimises  environmental 
impact. 

Details  of  effluent  and  solid  waste  treatment  must  be  prepared,  listing  the  personnel 
responsible  for  treatments  and  timing.  The  system  must  be  monitored  to  ensure  effective 
operation and early detection of possible failures. 

Physical separation 

The  organisms  which  have  been  transferred  must  be  kept  separate  from  other  organisms  to 
ensure containment. This excludes sentinel species which are specifically included to test the 
effects  of  the  introduced  species.  The  entry  of  birds,  other  animals,  disease  agents  and 
contaminants must be prevented. 

Personnel 

Access must be restricted to trained, authorised personnel. Footwear, hands and any material 
used within the facility should be disinfected (see below) before exiting the facility. 

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Equipment 

Upon receipt, all life-stages, tanks, water, shipping containers and equipment in contact with 
the introduced species, including the transport vehicles, must be handled is such a way as to 
ensure that there is no escape of the species or associated non-target species from the facility. 
All shipping and packing material must be disinfected, or burned if burning of the material is 
authorised. 

Mortalities and disposal 

Daily records or mortalities must be maintained and must be available for inspection by the 
competent authority. All mortalities must be kept on site. No mortalities, tissue or shells are to 
be discarded without approved treatment to ensure complete disinfection. Heat treatment such 
as autoclaving or chemical sterilisation may be employed. 

Mortalities must be reported to the competent authority and Member States must investigate 
the  cause  of  mortalities  in  a  timely  manner.  Mortalities  must  be  stored,  transported  and 
disposed  of,  in  accordance  with  Regulation  (EC)  No  1774/2002  laying  down  health  rules 
concerning animal by-products not intended for human consumption21.  

Inspection and testing 

Regular  inspections  must  be  carried  out  for  non-target  species.  If  such  a  species  or  a 
previously  undetected  disease  or  parasite  is  identified  in  an  organism,  actions  necessary  to 
control the situation must be taken. These actions may include destruction of the organisms 
and disinfection of the facility. 

Duration 

The  required  duration  of  quarantine  will  vary  according  to  the  organism  in  question, 
seasonality of non-target species of concern and the rearing conditions. 

Record keeping 

Quarantine facilities must maintain accurate records of the following: 

•  entry/exit times of personnel; 

•  number of mortalities and method of storage or disposal; 

•  treatment of incoming water and of effluent  

•  samples submitted to experts to test for non-target species; 

•  any  abnormal  conditions  affecting  quarantine  operation  (power  cuts,  building 

damage, serious weather conditions, etc.). 

21 

OJ L 273, 10.10.2002, p. 1 

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Disinfection 

Disinfection  involves  the  application  of  disinfectants  in  sufficient  concentrations  and  for 
sufficient time to kill harmful organisms. The disinfectants and concentrations for quarantine 
disinfection  must  be  based  on  complete  seawater  and  freshwater  disinfection.  Similar 
concentrations  must  be  used  for  routine  facility  disinfection.  It  is  recommended  that  all 
disinfectants  be  neutralised  before  release  into  the  surrounding  environment  and  facilities 
using  seawater  must  deal  with  residual  oxidants  produced  during  chemical  disinfection.  In 
case of an emergency, such as the finding of an imported parasite or disease agent, sufficient 
disinfectant must be available to enable treatment of the entire facility. 

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