Proposal for a Council Regulation amending Regulation (EC) No 708/2007 concerning use of alien and locally absent species in aquaculture {SEC(2009)1347}
Date: 2009-10-15
Institutions: European Commission
Subjects: administrative formalities, agricultural production, aquaculture, biodiversity, common fisheries policy, ecological balance, environmental protection, fishery management, health control

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.10.2009 
COM(2009) 541 final 

2009/0153 (CNS) 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EC) No 708/2007 concerning use of alien and locally absent 
species in aquaculture  

{SEC(2009)1347} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

Council Regulation (EC) No 708/2007 concerning use of alien and locally absent species in 
aquaculture was adopted on 11 June 2007. It establishes a framework governing aquaculture 
practices  in  relation  to  alien  and  locally  absent  species  to  assess  and  minimise  the  possible 
impact  of  these  species  and  any  associated  non-target  species  on  aquatic  habitats.  The 
Regulation provides for a permit system to be established at national level.  

According to  its Article 2(7), introductions and translocations  for use  in 'closed aquaculture 
facilities' may at a future date be exempted from the permit requirement of Chapter III of the 
Regulation, based on new scientific information and advice. 

Under  the  Sixth  Framework  Programme  a  concerted  action  was  funded  with  the  title 
"Environmental  impacts  of  alien  species  in  aquaculture"  (the  IMPASSE  project).  Its  overall 
goal  was  to  develop  guidelines  for  environmentally  sound  practices  for  introductions  and 
translocations  in  aquaculture.  In  addition,  special  attention  would  be  given  to  assessing 
whether modern land-based closed aquaculture facilities could be considered biosecure and to 
what extent movements into these facilities can be differentiated from movements into open 
aquaculture facilities under Community rules. 

The  recently  submitted  final  report  on  the  IMPASSE  project  has  delivered  an  operational 
definition of 'closed aquaculture facilities' for which the degree of risk associated with alien 
species  could  be  reduced  considerably,  possibly  to  an  acceptable  level,  if  the  potential  for 
escape  of  target  and  non-target  organisms  is  addressed  during  transportation  and  by  well-
defined protocols at the receiving facility. This means that introductions and translocations for 
use in such facilities could be exempted from the permit requirement under certain conditions. 
The  definition  of  'closed  aquaculture  facility'  provided  by  IMPASSE  is  more  detailed  and 
stricter than the current definition given by Article 3(3) of Council Regulation 708/2007. The 
IMPASSE  definition  sets  out  the  main  characteristics  that  a  'closed  aquaculture  facility' 
should possess in order to ensure its biosecurity.  

According  to  the  IMPASSE  results:  A  "closed  system"  is  an  aquaculture  facility  with  a 
discharge(s) that does not connect in any way to open waters prior to being screened, filtered 
or percolated and treated to prevent cultured stock or associated organisms from escaping.  

Closed  containment  systems  involve  a  barrier  technology  that  ensures  no  contact  between 
wild  and  farmed  aquatic  organisms.  Closed  facilities  are  usually  based  on  recirculation 
systems.  These  systems  carry  a  very  low  risk  of  escape  (Occhipinti  et  al.  2008),  with  the 
greatest problems arising when organisms are moved to or from the facility. 

These systems eliminate: release of solid waste to the aquatic environment; escapes of target 
and  non-target  organisms  from  the  facility;  they  are  expected  to  eliminate:  disease  and 
parasite  transfer  between  wild  and  farmed  aquatic  organisms;  farm  losses  due  to 
environmental factors, such as flooding, predators (e.g. birds), theft and vandalism. 

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The  key  elements  are:  a  physical  barrier  between  wild  and  farmed  organisms;  treatment  of 
solid waste; appropriate disposal of dead organisms; monitoring and treatment of incoming 
and outgoing water. 

In defining these systems, it should be recognised that water is not the only medium by which 
parasites, diseases and other species can be transferred. There are mechanisms of dispersal 
through, for example, transport systems or the inappropriate disposal of wastes.  

Therefore,  under  certain  conditions  movements  of  alien  or  locally  absent  species  for  use  in 
well-defined  and  biosecure  closed  aquaculture  facilities  can  be  considered  of  low  and 
acceptable  risk  and  can  thus  be  exempted  from  the  permit  procedure.  The  objective  of  this 
proposal  is  to  make  the  necessary  technical  changes  to  the  definition  of  'closed  aquaculture 
facility' in order to exempt introductions and translocations for use in such facilities from the 
permit requirement of Chapter III of Council Regulation 708/2007. The aim is to remove red 
tape while ensuring adequate environmental protection in the use of alien and locally absent 
species in aquaculture. 

•  General context 

The  introduction  of  species  beyond  their  natural  range  is  expanding  rapidly  as  a  result  of 
increased transport, trade, travel and tourism. Invasions by non-indigenous species are widely 
recognised  as  one  of  the  main  causes  of  global  biodiversity  loss.  They  can  have  adverse 
environmental,  economic  and  social  impacts.  Alien  species  can  act  as  vectors  for  novel 
diseases, alter ecosystems, compete with native species, etc.  

Council Regulation 708/2007 addresses a limited part of the problem. In terms of the general 
context,  the  data  arising  from  some  recent  Community  projects  (IMPASSE  and  DAISY) 
should be borne in mind. According to these data the main pathways likely to be responsible 
for  the  introduction  of  alien  species  in  European  coastal  seas  and  inland  waters  are:  "ships' 
ballast  water  and  fouling"  (30%  of  all  introduction  events);  "via  marine  and  inland  canals" 
(24%);  and  "aquaculture  and  stocking  practices",  which  represent  20%.  Other  pathways 
categorised as ornamental, research, etc. or  unknown  represent  26%.  In  December  2008  the 
Commission  published  the  Communication  "Towards  an  EU  strategy  on  invasive  species" 
with  the  aim  of  developing  a  global  strategy  at  EU  level  to  tackle  the  negative  impacts  of 
invasive species. 

The Community "Strategy for the sustainable development of European aquaculture" (2002) 
had  already  identified  the  need  to  reduce  the  risks  associated  with  the  introduction  of  non-
indigenous  species  in  aquaculture.  As  a  consequence  Council  Regulation  708/2007 
concerning  use  of  alien  and  locally  absent  species  in  aquaculture  was  adopted  on  11  June 
2007.  However,  at  that  time  no  decision  was  taken  regarding  the  biosecurity  of  'closed 
aquaculture facilities'. The Member States' views were divergent and no scientific advice was 
available  to  support  a  decision.  For  this  reason  the  possible  exemption  of  introductions  and 
translocations for use in such facilities from the permit obligation was postponed.  

•  Existing provisions in the area of the proposal 

Council Regulation (EC) No 708/2007 concerning use of alien and locally absent species in 
aquaculture.  

•  Consistency with other policies and objectives of the Union 

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The proposal is consistent with other policies and objectives of the Union seeking to ensure a 
high  level  of  environmental  protection  as  well  as  to  simplify  and  reduce  the  administrative 
burden. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Collection and use of expertise 

The results of the IMPASSE project have been used as the technical basis for drawing up the 
proposal. This concerted action was carried out by 14 partners coordinated by the University 
of  Hull.  The  FEAP,  Federation  of  European  Aquaculture  Producers,  also  participated  in  the 
project. Under IMPASSE two well-attended workshops (Hungary 2007 and Italy 2008) were 
held.  The  question  of  'closed  aquaculture  facilities'  was  one  of  the  subjects  covered.  The 
results of the reviews and discussions as summarised in section 1 led the consortium to draft a 
stricter definition of 'closed aquaculture facility'. 

•  Impact assessment and consultation of interested parties 

Council Regulation 708/2007 applies to all aquaculture facilities. However, at the time of its 
adoption,  no  decision  was  taken  regarding  the  biosecurity  of  'closed  aquaculture  facilities'. 
Nevertheless,  movements  into  these  facilities  are  differentiated  from  movements  into  other 
kinds  of  facilities  and,  normally,  are  considered  as  'routine  movements'  for  which  the 
requirement of a prior environmental assessment is not compulsory (Article 2(6)).  

The  IMPASSE  project  has  delivered  a  definition  of  'closed  aquaculture  facility'  which 
includes the characteristics necessary to consider these facilities as biosecure. This definition 
is  stricter  and  ensures  better  environmental  protection.  The  modification  of  the  current 
definition of 'closed aquaculture facility' given in Article 3(3) by establishing a new definition 
based  on  the  IMPASSE  results  would  make  it  possible  to  exempt  introductions  and 
translocations for use in such facilities from the permit requirement. However, this implies an 
amendment  of  Council  Regulation  708/2007,  which  cannot  be  carried  out  by  Comitology. 
Nevertheless, the results of the IMPASSE project regarding closed aquaculture facilities were 
presented  within  the  Management  Committee  for  Fisheries  and  Aquaculture  and  a  large 
number of Member States were in favour of improving the current definition in order to allow 
the said exemption. Therefore, the present proposal  amending Council Regulation 708/2007 
was prepared. Its aim is to remove the red tape associated with the permit procedure for those 
'closed aquaculture facilities' which can be considered as biosecure.  

The proposed modification does not represent a major or substantial change to the Regulation. 
Technical  adjustments  need  to  be  made  to  the  definition  of  'closed  aquaculture  facility'  and 
related provisions to allow the envisaged exemption.  

The  proposal  for  Council  Regulation  708/2007  was  accompanied  by  its  own  Impact 
Assessment (SEC (2006)421). The IMPASSE concerted action already provides the technical 
basis  to  take  the  decision  to  exempt  introductions  and  translocations  for  use  in  'closed 
aquaculture facilities' from the permit obligation. Moreover, the consequences of the proposal 
will  be  very  limited  as  it  applies  only  to  'closed  aquaculture  facilities'.  However,  these 
facilities will benefit from the proposed simplification, as time-consuming permit procedures 
which  tie  up  resources  will  be  eliminated.  This  amendment  will  ensure  that  environmental 
protection  is  maintained  and,  at  the  same  time,  will  help  to  produce  positive  social  and 

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economic impacts since  the  facilities  concerned can be freed  from the costs associated with 
the permit procedures. A specific Impact Assessment addressing this limited modification of 
the Regulation would not therefore provide any added value as it represents just an executive 
decision  on  a  technical  issue  with  marginal  consequences.  It  would  not  be  proportionate  to 
invest additional effort and time in carrying out a formal Impact Assessment. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

According  to  Article  2(7)  of  Council  Regulation  708/2007,  introductions  and  translocations 
for  use  in  'close  aquaculture  facilities'  may  at  a  future  date  be  exempted  from  the  permit 
requirement of Chapter III of the Regulation, based on new scientific information and advice. 

The proposed action aims to exempt biosecure 'closed aquaculture facilities' from the permit 
requirement  of  Chapter  III  of  the  Regulation.  Taking  into  account  the  scientific  advice,  the 
proposal includes modification of the current definition of 'closed aquaculture facility', adding 
the  appropriate  characteristics  to  guarantee  that  such  facilities  do  not  allow  the  escape  of 
target  and  non-target  organisms  to  the  wild  environment.  In  addition,  a  new  provision 
regarding the transport of alien and locally absent species to 'closed aquaculture facilities' is 
included. Consequently, the Member States shall set up a list of closed aquaculture facilities. 
This list shall be published and regularly updated on a website which has been created under 
Commission  Regulation  (EC)  No  535/2008.  Some  articles  and  Annex  I  are  amended 
accordingly to reflect the new provisions. 

•  Legal basis  

Articles 37 and 299(2) of the Treaty establishing the European Community provide the legal 
basis. 

•  Subsidiarity principle 

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. The modification represents a good 
balance  between  environmental  protection  and  the  needs  of  the  aquaculture  industry. 
Movements  into  'closed  aquaculture  facilities'  which  comply  with  the  standards  that  ensure 
adequate  environmental  protection  should  be  exempted  from  the  administrative  burden  and 
costs associated with the permit procedure established by the Regulation. Simplification and 
reduction of red tape are important objectives. 

•  Choice of instruments 

Article 2(7) of Council Regulation 708/2007 states that the relative decision on whether or not 
to  exempt  movements  of  alien  and  locally  absent  species  into  'closed  aquaculture  facilities' 
from  the  permit  obligation  established  by  the  Regulation  would  be  taken  following  the 
procedure  referred  to  in  Article  30(2)  of  Regulation  (EC)  No  2371/2002  (Comitology). 
However,  the  possibility  to  exempt  these  movements  from  the  permit  obligation  requires  a 

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modification of the definition of 'closed aquaculture facility' and hence a modification of the 
Council Regulation, which cannot be carried out by Comitology.  A Council Regulation can 
only be amended by another Regulation. 

4. 

BUDGETARY IMPACT 

The proposal has no implications for the Community budget. 

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2009/0153 (CNS) 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EC) No 708/2007 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 and Article 299(2) 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, 

Whereas: 

(1) 

(2) 

Regulation  (EC)  No  708/20074  establishes  a  framework  governing  aquaculture 
practices  in  relation  to  alien  and  locally  absent  species  to  assess  and  minimise  the 
possible  impact  of  those  species  and  of  associated  non-target  species  on  aquatic 
habitats. It provides in its Article 2(7) that introductions and translocations for use in 
closed  aquaculture  facilities  may  at  a  future  date  be  exempted  from  the  permit 
requirement of Chapter III of that Regulation, based on new scientific information and 
advice. 

The Community-funded concerted action, "Environmental impacts of alien species in 
aquaculture"  (IMPASSE),  has  delivered  a  new  operational  definition  of  'closed 
aquaculture facilities'. For such facilities the degree of risk associated with alien and 
locally  absent  species  could  be  reduced  to  an  acceptable  level  if  the  potential  for 
escape of the organisms to be farmed and of non-target organisms is addressed during 
transportation  and  if  well-defined  protocols  are  applied  at  the  receiving  facility. 
Introductions and translocations for use in closed aquaculture facilities should only be 
exempted from the permit requirement if those conditions are met. 

(3) 

It  is  therefore  necessary  to  amend  the  definition  of  'closed  aquaculture  facility'  in 
Article  3,  paragraph  3,  of  Regulation  (EC)  No  708/2007  by  adding  specific  features 
intended to ensure the biosecurity of those facilities. 

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, , p. . 
, , p. . 
, , p. . 
OJ L 168, 28.6.2007, p. 1. 

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(4)  Member  States  should  set  up  a  list  of  closed  aquaculture  facilities  located  in  their 
territory.  For  reasons  of  transparency,  that  list  should  be  published  and  regularly 
updated  on  a  website  created  in  accordance  with  Commission  Regulation  (EC)  No 
535/20085. 

(5) 

(6) 

Following these amendments certain other adaptations are needed to the Regulation. 

The Council Regulation 708/2007 should therefore be amended accordingly. 

HAS ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 708/2007 is hereby amended as follows: 

(1) 

In Article 2, paragraph 7 is replaced by the following: 

"7.  Chapters  III  to  VI  shall  not  apply  to  movements  of  alien  or  locally  absent 
species  to  be  held  in  closed  aquaculture  facilities,  provided  that  the  transport  is 
carried out under conditions that prevent the escape of those species and of the non-
target species. 

Member  States  shall  set  up  a  list  of  closed  aquaculture  facilities  in  their  territory 
complying with the definition of the Article 3 (3) and update that list regularly. The 
list shall be published on the website set up in accordance with Article 4 (2) of the 
Commission Regulation (EC) No 535/2008." 

(2) 

Article 3 is amended as follows 

(a) 

point 3 is replaced by the following: 

"3. 

'Closed aquaculture facility' means a facility 

(a)  where aquaculture is conducted in an aquatic medium, which 
involves  recirculation  of  water  and  with  a  discharge(s)  that 
does  not  connect  in  any  way  to  open  waters  prior  of  being 
screened,  filtered  or  percolated  and  treated  to  prevent  the 
release  of  solid  waste  to  the  aquatic  environment  and  the 
escape  of the farmed  species and of non-target species from 
the facility that might survive and subsequently reproduce; 

and 

(b)  which  prevents  farm  losses  due  to  environmental  factors, 
such  as  flooding,  predators  (e.g.  birds),  theft  and  vandalism 
and ensures appropriate disposal of dead organisms;" 

(b)  point 16 is replaced by the following: 

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OJ L 156, 14.6.2008, p. 6. 

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"16.  'routine  movement'  means  the  movement  of  aquatic  organisms  from  a 
source which has a low risk of transferring non-target species and which, 
on  account  of  the  characteristics  of  the  aquatic  organisms  and/or  the 
method of aquaculture to be used, does not give rise to adverse ecological 
effects;" 

(3) 

Article 14 is replaced by the following: 

"Article 14 

Release into aquaculture facilities in case of routine introductions 

In the case of routine introductions, the release of aquatic organisms into aquaculture 
facilities shall be allowed without quarantine or pilot release, unless, in exceptional 
cases, the competent authority decides otherwise on the basis of specific advice given 
by the advisory committee. Movements from a closed aquaculture facility to an open 
aquaculture facility shall not be regarded as routine." 

(4) 

Annex I is amended as follows:  

(a)  The text of the first paragraph is replaced by the following: 

"Wherever  possible,  information  is  to  be  supported  with  references  from  the 
scientific  literature,  and  notations  to  personal  communications  with  scientific 
authorities and fisheries experts". 

(b)  Section D (Interaction with native species) is amended as follows:  

- 

point 1 is replaced by the following: 

"(1)  What  is  the  potential  for  survival  and  establishment  of  the 

introduced organism if it escapes?" 

- 

point 6 is replaced by the following:  

"(6) Will the introduced organisms survive and successfully reproduce in 
the  proposed  area  of  introduction  or  will  annual  stocking  be 
required?" 

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

Article 2 

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

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Done at Brussels,  

For the Council 
The President 

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