Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the prevention and management of the introduction and spread of invasive alien species
Date: 2013-09-09
Institutions: European Commission
Subjects: border control, ecosystem, import restriction, living plant, pet shop, protection of animal life, protection of plant life, traceability













EUR-Lex - 52013PC0620 - EN











|



52013PC0620

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the prevention and management of the introduction and spread of invasive alien species /* COM/2013/0620 final - 2013/0307 (COD) */









EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
Invasive alien species (IAS) are species
that are initially transported through human action outside of their natural
range across ecological barriers, and that then survive, reproduce and spread,
and that have negative impacts on the ecology of their new location as well as
serious economic and social consequences. It has been estimated that of the
over 12 000 alien species that are found in the European environment,
10-15 % have reproduced and spread, causing environmental, economic and
social damage.
The impact of IAS on biodiversity is
significant. IAS are one of the major, and growing, causes of biodiversity loss
and species extinction. When it comes to social and economic impacts, IAS can
be vectors of diseases or directly cause health problems (e.g. asthma,
dermatitis and allergies). They can damage infrastructure and recreational
facilities, hamper forestry or cause agricultural losses, to mention but a few.
IAS are estimated to cost the Union at least € 12 billion per year and
damage costs are continuing to rise.
With the 2020 Biodiversity Strategy, the
Union undertook to halt the loss of biodiversity by 2020, in line with the
international commitments adopted by the parties to the Convention for Biological
Diversity in 2010 in Nagoya, Japan. Indeed, the problem of IAS is not limited
to Europe, but found throughout the world. Unlike some of its trading partners,
the European Union currently lacks a comprehensive framework to address the
threats posed by IAS..
Regulatory framework 
There is currently no EU framework for
tackling IAS comprehensively. Few IAS are addressed by
EU legislation. Disease agents and pests of animals and plants and their
products are covered respectively by the animal health regime (various
regulations and directives) and by the plant health regime (2000/29/EC). The
Wildlife Trade Regulation (338/97) restricts imports of endangered species,
including imports of seven IAS. The Regulation on the use of alien and locally
absent species in aquaculture (708/2007) addresses the release of alien species
for aquaculture purposes. The regulations on plant protection products
(1107/2009) and on biocides (528/2012) address the intentional release of
micro-organisms as plant protection products or biocide respectively. Finally,
the Birds Directive (2009/147/EC) and the Habitats Directive (92/43/EEC), the
Water Framework Directive (2000/60/EC) and the Marine Strategy Framework
Directive (2008/56/EC) require the restoration of ecological conditions and
refer to the need to take IAS into consideration. Nevertheless, existing Union
action leaves most IAS unaddressed. 
Member States are taking a number of
measures to tackle IAS, but such action remains predominantly reactive, seeking
to minimise the damage already being caused without paying sufficient attention
to prevention or to detecting and responding to new threats. Efforts are
fragmented, with substantial gaps in species coverage, and are often poorly
coordinated. IAS do not respect borders and can easily spread from one Member State to another. Thus, action taken at national level will be insufficient to
protect the Union from the threat of certain IAS. Moreover, this fragmented
approach can lead to action in one Member State being undermined by a lack of
action in neighbouring Member States. Furthermore, different
restrictions on the commercialisation of IAS between Member States are
highly ineffective, as species can easily be transported or spread across
borders throughout the Union. Moreover, such differentiated bans are hampering
the free circulation of goods in the internal market and disrupting the level
playing field for sectors which use or trade in alien species.
Problem
analysis
IAS are being introduced into the Union
through two channels: 1) some alien species are desirable and are brought into
the Union intentionally (e.g. commercial interests, ornamental purposes,
companion animals, biological control); 2) some alien species are introduced
unintentionally as contaminants of goods (trade in other commodities), as
hitchhikers or stowaways in transport vectors, or can be transported
unwittingly by travellers. Some IAS can also travel through transport
infrastructure (e.g. Danube-Main canal).
IAS affect businesses, citizens, public
authorities and the environment. In the case of small and micro
enterprises in particular, IAS often affects primary producers in
agriculture, animal husbandry, fisheries, aquaculture and forestry, suffering
considerable economic damage as a result. Businesses linked to tourism and
recreational activities, which rely on pristine landscapes, clean water bodies
and healthy ecosystems, are often also affected. However, other small and micro
enterprises, e.g. traders in companion animals and horticultural species, draw
benefits from IAS as they focus mainly on trade in alien species. IAS also affect society at large, causing a loss of
biodiversity and compromising the ability of ecosystems to provide ecosystem
services. Moreover, they may transmit diseases, damage property and affect
cultural heritage.
All the Member States are facing problems
caused by IAS. While some IAS affect most Member States, others are only a
problem in certain regions, or under certain ecological or climatic conditions.
Nevertheless, all the Member States do have IAS on their territory. IAS impacts
are relevant to the whole of the Union and all the Member States will be
equally affected by IAS, albeit at different times and by different species.
Coordinated action to tackle IAS would thus benefit all the Member States,
while clearly requiring efforts from all of them.
If no action is taken to tackle the
problem, it will get worse as new IAS establish themselves and those already
established spread further. This will result in an increase in damage costs and
management costs. 
Objectives of the proposal
This proposal aims to tackle the issues
highlighted above by establishing a framework for action to prevent, minimise
and mitigate the adverse impacts of IAS on biodiversity and ecosystem services.
Furthermore, it will seek to limit social and economic damage. This will be
achieved through measures to ensure coordinated action, focusing resources on
priority species and on increasing preventive measures, in accordance with the
Convention of Biological Diversity approach and with the Union’s plant and
animal health regimes. In practical terms, the proposal seeks to attain these
objectives through measures addressing the intentional introduction of IAS into
the Union and their intentional release into the environment, the unintentional
introduction and release of IAS, the need to set up an early warning and rapid
response system, and the need to manage the IAS spread throughout the Union.
2.           RESULTS OF CONSULTATIONS
WITH INTERESTED PARTIES AND IMPACT ASSESSMENTS
Consultation process
In 2008 the European Commission published a Communication
‘Towards an EU Strategy on Invasive Species (2008)’ setting out the case
for tackling IAS. The 2010 Communication ‘Our
life insurance, our natural capital: an EU biodiversity strategy to 2020’ proposes action on IAS. Both Communications were preceded and
followed by thorough consultations.
A series of intensive rounds of
stakeholder consultations took place between 2008 and 2012, which
attracted the whole spectrum of interested parties,
from nature conservation organisations to operators in the private sector,
including organisations representing Small and Medium-sized Enterprises (SMEs)
relying on alien species for their business. An online
public consultation was held in 2008 and a second one in 2012. A working group composed of Commission departments, Member States,
stakeholders and academics was convened in 2008 and produced a discussion paper[1] bringing together the latest information and summarising opinions
on key issues. This Working Group was then reconvened and reorganised into
three working groups in 2010-2011, which drew up possible policy options to
address prevention, early warning/rapid response and the management of
established species respectively. Finally a stakeholder consultation meeting
was held in September 2010.
The Commission’s work on IAS has also been supported by several
external studies and research[2].
Furthermore, all of the analysis set out in the impact assessment was based on
scientifically robust data, mostly retrieved from peer-reviewed scientific
articles. Information on damage cost, spread of species and the costs of
measures in place were also provided or checked by Member States. Special
efforts were made to contact directly the stakeholders involved in this issue,
including those sectors that might be negatively impacted by the introduction
of measures to tackle the IAS problem. Finally, the analysis also benefited
from the input of the world’s top experts on IAS within and beyond the Union.
Impact assessment
Various options were identified for addressing the IAS issue, and in
particular for addressing all aspects of the problem that were identified, but
with a different level of ambition.
Based on feedback
from the consultation, a number of levels of ambition and intervention were
identified for each of the operational objectives pinpointed through the
analysis of the problem, resulting in different sub-options for the design of
the legislative instrument. An initial screening led to
the discarding of sub-options that were not feasible, or simply not as
effective as others. For each option identified, each
of the operational objectives was addressed systematically, proposing practical
measures to tackle IAS.
In addition to the baseline option (option
0), which would maintain the status quo, the following options were identified:
Option 1 — Enhancing
cooperation and supporting voluntary action: This would include the development of guidelines, sectoral codes of
conduct and other awareness-raising and educational campaigns. This option
would also seek to encourage cooperation between Member States in setting up an
early warning and rapid response system. The Commission could promote existing
initiatives in this area through communication campaigns.
Option 2.1 — Basic legislative instrument: This involves a series of legal obligations banning the import, keeping, sale, purchase and exchange of certain
IAS listed as IAS of Union concern. Further obligations would be linked to
release into the environment of IAS of Union concern, rapid response to newly
establishing IAS of Union concern and management of widely spread IAS of Union
concern.
Option 2.2 —
Basic legislative instrument + permits for release of IAS of Member State
concern: This option would go beyond the list of
IAS of Union concern for the release into the environment, by requiring permits
for IAS deemed of concern by Member States.
Option 2.3 —
Basic legislative instrument + a strict general
ban on the release of alien species, unless found to be safe: This option would go beyond the list of
IAS of Union concern for release into the environment by prohibiting the
release of any alien species unless they are included in a Union list of alien
species approved for release.
Option 2.4 —
Basic legislative instrument + an obligation for the rapid eradication of newly
establishing IAS of Union concern: With this
option, when it comes to rapid response, Member States
would not have a choice, but rather an obligation to eradicate quickly any
newly establishing IAS of Union concern and share information. Derogations are
possible if approved by the Commission.
Option 2.4 was retained and informs the
present proposal.
3.           LEGAL ELEMENTS OF THE
PROPOSAL
Legal basis
The legal basis of this proposal is Article
192(1) of the Treaty on the Functioning of the European Union, implementing the
EU objectives of preserving, protecting and improving the quality of the
environment, protecting human health, ensuring prudent and rational utilisation
of natural resources, and promoting measures dealing with regional or worldwide
environmental problems.
Subsidiarity
Union-level action is necessary as IAS problems are increasing and are cross-border by nature. In view of
the lack of Union-level action, Member States are putting measures in place to
cope with the problem at national level. They are investing resources and
efforts in eradicating harmful IAS but such efforts can be undermined by a lack
of action in a neighbouring Member State where the species is also present.
Equally, there is no coordinated Union action to ensure
that when IAS first enter the Union, Member States take prompt measures for the
benefit of other Member States not yet affected. Furthermore, the protection of
the internal market — and the free circulation of goods — have to be taken into
consideration. A coordinated approach will ensure legal clarity and a level
playing field for those sectors using or trading alien species while avoiding a
fragmentation of the internal market due to different restrictions on the
commercialisation of IAS between Member States.
Current efforts are
highly fragmented and inconsistent, leaving considerable policy gaps. These
lead to ineffectiveness and do not solve the IAS
problem. A mixture of Union and national, regional and
local measures will be needed, in line with the principle of subsidiarity.
However, a coherent approach at Union level will
increase the effectiveness of the measures.
Guiding principles
This proposal puts forward measures based
on the following guiding principles:
Prioritisation — There are over 12,000 alien species in the EU out of which 10 to 15% are causing damage (which means 1200 to 1800
invasive alien species) and new ones keep arriving.
There is ample scope for a prioritised and proportionate approach, building
upon existing efforts and increasing the efficiency and effectiveness of
current action.
Shift towards prevention — Prevention is
internationally recognised as the most effective way of avoiding the IAS
problem. Measures focusing on prevention need to be accompanied by an effective
early warning system to take prompt action on species eluding the prevention
measures.
Building upon existing systems — Valuable
work is already being done in the Union both at national level and at Union level.
This proposal intends to maximise the efficiency of the system and to make full
use of what already exists.
Gradual and phased-in approach — Member
States need legal certainty and reassurance regarding the extent and costs of
the actions they will be expected to take. Therefore, this proposal includes a
prioritisation of invasive alien species based on very stringent listing
criteria, as well as an initial capping of the number of priority species to
the top 3% of some 1500 invasive alien species in Europe. Further, a review
clause will allow to develop the system progressively
and build upon the experience gained. Any extension of
the list of species of EU concern will only take place following this review. 
Structure of the proposal
Chapter I — General provisions. This section sets outs the subject matter, the scope and the basic
obligation of the proposal. It also provides the tools for prioritising IAS of
Union concern to enable Union resources to be prioritised on the basis of risk
and scientific evidence.
Chapter II — Prevention. This section sets out the measures necessary to prevent the
introduction into the Union and the introduction or release into the
environment of IAS.
Chapter III — Early detection and rapid
eradication. This section sets out the tools to
ensure that IAS of Union concern can be detected early in the environment and
at the Union borders and describes the measures that are triggered when these
IAS are detected.
Chapter IV — Management of IAS that are
widely spread. This section sets out the
obligations necessary to tackle IAS of Union concern that are already present
in the Union or new ones that have eluded the prevention measures and early
detection measures and managed to spread widely.
Chapter V — Final provisions. This section sets out reporting obligations and the legal tools
needed to ensure implementation, enforcement and review of the proposed
measures.
4.           BUDGETARY IMPLICATION
There will be only some limited financial
implication to be financed under Heading 5 of the Multi-annual Financing Framework
2014-2020 for the Committee under Article 22. See Financial Fiche attached.
2013/0307 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on the prevention and management of the
introduction and spread of invasive alien species
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 192(1) thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the European
Economic and Social Committee[3]
Having regard to the opinion of the
Committee of the Regions[4],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       The appearance of alien species,
whether animals, plants, fungi or micro-organisms, in new locations is not always
a cause for concern. However, a significant subset of alien species can become
invasive and have serious adverse impacts on biodiversity and ecosystem
services, as well as other economic and social impacts, which should be
prevented. Some 12 000 species in the environment in the Union and other
European countries are alien, of which roughly 10 to 15 % are estimated to
be invasive.
(2)       Invasive alien species
represent one of the primary threats to biodiversity and ecosystem services,
especially in geographically and evolutionary isolated ecosystems, such as
small islands, and the risks such species pose may be greater due to increased
global trade, transport, tourism and climate change.
(3)       The threat to biodiversity
and ecosystem services that invasive alien species pose can take different
forms such as impacting severely on native species and ecosystem structure and
function through alteration of habitat, predation, competition, transmission of
diseases, replacement of native species throughout a significant proportion of
range and genetic effects by hybridisation. Furthermore, invasive alien species
can also have a significant negative impact on human health and the economy. It
is only live specimens, or parts that can reproduce, that represent a threat to
biodiversity and ecosystem services, human health or the economy. 
(4)       The Union, as a party to
the Convention on Biological Diversity, approved by Council Decision 93/626/EEC[5], is bound by the provisions of
Article 8(h) therein, according to which the Parties shall, as far as possible
and as appropriate, 'prevent the introduction of, control or eradicate those
alien species which threaten ecosystems, habitats or species'.
(5)       The Union, as a party to
the Convention on the Conservation of European Wildlife and Natural Habitats
(the Bern Convention), approved by Council Decision 82/72/EEC[6], has undertaken to take all
appropriate measures to ensure the conservation of the habitats of the wild
flora and fauna species.
(6)       To support the achievement
of the objectives of Directive 2009/147/EC of the European Parliament and of the
Council of 30 November 2009 on the conservation of wild birds[7], Council Directive 92/43/EEC of
21 May 1992 on the conservation of natural habitats and of wild fauna and flora[8], Directive 2008/56/EC of the
European Parliament and of the Council of 17 June 2008 establishing a framework
for community action in the field of marine environmental policy (Marine
Strategy Framework Directive)[9]
and 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
policy[10],
the primary objective of this Regulation should be to prevent, minimise and
mitigate the adverse effects of invasive alien species on biodiversity and
ecosystem services, as well as to reduce their economic and social impact.
(7)       Some species migrate
naturally in response to environmental changes. Therefore they should not be
considered as alien species in their new environment and are thus excluded from
the scope of the new rules on invasive alien species.
(8)       At Union level, the
proposal for a new Regulation of the European Parliament and the Council on
Animal Health[11]
include provisions on animal diseases, and the new Regulation of the European
Parliament and the Council on protective measures against pests of plants [12]
provides rules for pests of plants, and Directive 2001/18/EC of the European
Parliament and of the Council of 12 March 2001 on the deliberate release into
the environment of genetically modified organisms and repealing Council
Directive 90/220/EEC[13] sets out the regime applicable to genetically modified organisms.
Therefore, the new rules on invasive alien species should align and not overlap
with those Union acts and shall not apply to the organisms targeted by those acts.
(9)       Council Regulation (EC) No
708/2007 of 11 June 2007 concerning use of alien and locally absent species in
aquaculture[14],
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22
May 2012 concerning the making available on the market and use of biocidal
products[15]
and Regulation (EC) No 1107/2009 of the European Parliament and of the Council
of 21 October 2009 concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and 91/414/EEC[16] provide for rules concerning
the authorisation for the use of certain alien species for particular purposes.
The use of certain species has already been authorised under those regimes at
the time of entry into force of these new rules as they do not pose
unacceptable risks to the environment, human health and the economy. In order
to ensure a coherent legal framework, those species should thus be excluded
from the new rules. 
(10)     As invasive alien species
are numerous, it is important to ensure that priority is afforded to addressing
the subset of invasive alien species considered to be of Union concern. A list
of such invasive alien species considered to be of Union concern should
therefore be drawn up. An invasive alien species should be considered of Union
concern if the damage it is causing in the affected Member States is so
significant that it justifies the adoption of dedicated measures the scope of
which extends across the Union, including in the Member States that are not yet
affected or even unlikely to be affected. In order to ensure that the subset of
invasive alien species of Union concern remains proportionate, the list should be
developed in line with a gradual and phased-in approach including an initial capping of the number of invasive alien species of Union
concern to the top 3% of some 1500 invasive alien species in Europe and be
focused on those species that cause or are likely to cause significant economic
damage, including that deriving from biodiversity loss.
(11)     The criteria to list invasive
alien species considered to be of Union concern is the core instrument to apply
these new rules. The Commission will do its utmost to submit a proposal for a
list based on those criteria within one year of the entry into force of this
legislation to the Committee. The criteria should include a risk assessment pursuant
to the applicable provisions under the Agreements of the World Trade
Organisation on placing trade restriction on species. 
(12)     In order to ensure
compliance with the rules of the World Trade Organisation and ensure the
coherent application of these new rules common criteria should be established
to perform the risk assessment. Those criteria should use when appropriate
existing national and international standards and should encompass different
aspects of the characteristics of the species, the risk and modes of entry into
the Union, the negative economic, social and biodiversity impacts of the
species, the potential benefits of uses and the costs of mitigation to weight
them against the negative impacts, as well as a quantified forecast of the
environmental, economic and social damage costs at Union level demonstrating
the significance for the Union, so as to further justify action. In order to
develop the system progressively and build upon the experience gained, the
overall approach should be evaluated after five years.
(13)     Some invasive alien animals
are included in Annex B to Council Regulation (EC) No 338/97 of 9 December 1996
on the protection of species of wild fauna and flora by regulating trade
therein[17],
and their import into the Union is prohibited because their invasive character
has been recognised and their introduction into the Union has a negative impact
on native species. These species are: Callosciurus erythraeus, Sciurus
carolinensis, Oxyura jamaicensis, Lithobates (Rana) catesbeianus, Sciurus
  niger, Chrysemys picta, Trachemys scripta elegans. To ensure a coherent
legal framework and uniform rules at Union level on invasive alien species, those
invasive alien animals should be considered as a matter of priority for listing
as invasive alien species of Union concern. 
(14)     Prevention is generally
more environmentally desirable and cost-effective than reaction after the fact
and should be prioritised, and as new species can be introduced continuously
into the Union and alien species present are spreading and expanding their
range, it is necessary to ensure that the list of invasive alien species of
Union concern is constantly revised and kept up-to-date. 
(15)     Some of the species that
are invasive in the Union may be native in some of the Union's Outermost
Regions and vice versa. In the Communication from the Commission on "The
outermost regions: an asset for Europe"[18]
it was recognised that the remarkable biodiversity of the outermost regions
calls for the development and implementation of measures to prevent and manage
invasive alien species in those regions as defined by the Treaty on the
Functioning of the European Union taking into account European Council
Decisions 2010/718/EU of 29 October 2010 amending the status with regard to the
European Union of the island of Saint-Barthélemy[19] and 2012/419/EU of 11 July
2012 amending the status of Mayotte with regard to the European Union[20]. Therefore all the provisions
of these new rules should apply to the Union's Outermost Regions except for
provisions relating to invasive alien species of Union concern which are native
to those regions. In addition, to allow for the necessary protection of the
biodiversity in such regions, it is necessary that the concerned Member States
draw up, as a complement to the list of invasive alien species of Union
concern, specific lists of invasive alien species for their Outermost Regions
to which these new rules should also apply.
(16)     The risks and concerns
associated with invasive alien species represent a cross-border challenge affecting
the whole of the Union. It is therefore essential to adopt at Union level a ban
on intentionally bringing into the Union, reproducing, growing, transporting,
buying, selling, using, exchanging, keeping and releasing invasive alien
species of Union concern, to ensure that consistent action is taken across the
Union so as to avoid distortions of the internal market and to prevent
situations where action taken in one Member State is undermined by inaction in
another Member State. 
(17)     With a view to enabling scientific
research and ex-situ conservation activities, it is necessary to provide specific
rules for the invasive alien species of Union concern subject to those
activities. Those activities should be carried out in closed facilities where
the organisms are in contained holding and with all the necessary measures taken
to avoid the escape or unlawful release of invasive alien species of Union
concern. 
(18)     There may be cases where alien
species not yet recognised as invasive alien species of Union concern appear at
the Union borders or are detected in the Union territory. Member States should therefore
be granted the possibility to adopt on the basis of available scientific
evidence certain emergency measures. Such emergency measures would allow immediate
reaction against species which may pose risks related to their introduction,
establishment and spread in those countries, while Member States assess the
effective risks posed by them, in line with the applicable provisions of the Agreements
of the World Trade Organisation, in particular with a view to having those
species recognised as invasive alien species of Union concern. There is a need
to couple national emergency measures with the possibility of adopting
emergency measures at Union level in order to comply with the provisions of the
agreements of the World Trade Organisation. Furthermore, Union level emergency
measures would equip the Union with a mechanism to act swiftly in case of
presence or imminent danger of entry of a new invasive alien species in
accordance with the precautionary principle. 
(19)     Member States should be
able to adopt more stringent measures to tackle invasive alien species and to take
measures proactively in respect of any species that are not listed as invasive
alien species of Union concern. In order to adopt a more proactive stance on
unlisted species, it should therefore be required that to release invasive
alien species into the environment that are not listed as invasive alien
species of Union concern, but for which Member States have found evidence that
they pose a risk, an authorisation for release should be issued. Detailed rules
for the authorisation of alien species to be used in aquaculture have already
been established by Regulation (EC) No 708/2007 and should be taken into
account by Member States in this context.
(20)     A large proportion of
invasive alien species are introduced unintentionally into the Union. It is therefore crucial to manage the pathways of unintentional introduction. Action
in this area would need to be gradual, given the relatively limited experience
in this field. Action should include voluntary measures, such as the actions
proposed by the International Maritime Organisation's Guidelines for the
Control and Management of Ships' Biofouling, and mandatory measures and should
build on the experience gained in the Union and in Member States in managing
certain pathways, including measures established through the International
Convention for the Control and Management of Ships Ballast Water and Sediments.
(21)     In order to develop an
adequate knowledge base to address the problems raised by invasive alien
species, it is important that Member States undertake research, monitoring and
surveillance of such species. As surveillance systems offer the most
appropriate means for early detection of new invasive alien species and for the
determination of the distribution of already established species, they should
include both targeted and general surveys and benefit from the involvement of
different sectors and stakeholders, including local communities. Surveillance
systems should imply paying continuous attention to any new invasive alien
species anywhere in the Union. In the interest of efficiency and
cost-effectiveness, existing systems of border control, surveillance and
monitoring already established in Union legislation should be applied, in
particular those set out Directives 2009/147/EC, 92/43/EEC, 2008/56/EC and
2000/60/EC. 
(22)     Official controls on
animals and plants should be carried out in order to prevent the intentional
introduction of invasive alien species. Live animals and plants should enter
the Union through border control posts designated by Member States in
accordance with Regulation (EU) No XXX/XXXX [on official controls
COM(2013)265]. In order to ensure efficiency gains and avoid creating parallel
systems of border controls, the verification whether these species are invasive
alien species of Union concern should also be carried out at the first Border
Control Post of arrival. Animal and plants, not falling under the scope of
Regulation (EU) No XXX/XXXX [on official controls COM(2013)265] or exempted
from official controls at border control posts, shall enter the customs
territory of the Community through other entry points and subject to checks
therein.
(23)     After the introduction of
an invasive alien species, early detection and rapid eradication measures are
crucial to prevent their establishment and spread. The most effective and cost
efficient response is often to eradicate the population, as soon as possible
while the number of specimens is still limited. In the event that eradication
is not feasible or the costs of eradication outweigh in the long term the
environmental, economic and social benefits, containment and control measures
should be applied. 
(24)     Eradicating and managing
some invasive alien species, while necessary, may induce pain, distress, fear
or other forms of suffering to the animals even when using the best available
technical means. For that reason, Member States and any operator involved in
the eradication, control or containment of invasive alien species should take
the necessary measures to minimise pain, distress and suffering of animals
during the process, taking into account in so far as possible the best
practices in the field, for example the Guiding Principles on Animal Welfare
developed by the World Organisation for Animal Health (OIE). 
(25)     Invasive alien species
generally cause damage to ecosystems and reduce their resilience. Therefore
restoration measures are required to strengthen the ecosystems' resilience
towards invasions, to repair the damage caused and to enhance the conservation
status of species and their habitats in accordance with Article 4 of Directive
2009/147/EC and Article 6 of Directive 92/43/EEC, the ecological status of
inland surface waters, transitional waters, coastal waters and groundwater in
accordance with Article 11 of Directive 2000/60/EC, and the environmental
status of marine waters in accordance with Article 13 of Directive 2008/56/EC. 
(26)     A system to address
invasive alien species should be underpinned by a centralised information
system collating the existing information on alien species in the Union and
allowing access to information on presence of species, their spread, their
ecology, invasion history and all other information necessary to underpin
policy and management decisions. 
(27)     Directive 2003/35/EC of the
European Parliament and of the Council of 26 May 2003 providing for public
participation in respect of the drawing up of certain plans and programmes
relating to the environment[21]
establishes a framework for public consultation in environment related
decisions. In defining action in the field of invasive alien species, effective
public participation should enable the public to express, and the
decision-maker to take account of, opinions and concerns which may be relevant
to those decisions, thereby increasing the accountability and transparency of
the decision-making process and contributing to public awareness of
environmental issues and support for the decisions taken. 
(28)     In order to ensure uniform
conditions for the application of this Regulation, for adopting and updating
the list of invasive alien species of Union concern, for granting derogations
from the obligation of rapid eradication and for the adoption of Union
emergency measures, implementing powers should be conferred on the Commission.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council of 16 February 2011 laying down
the rules and general principles concerning mechanisms for control by the
Member States of the Commission's exercise of implementing powers[22]. 
(29)     In order to take into
account the latest scientific developments in the environmental field, the
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission in
respect of determining how to conclude that invasive alien species are capable
of establishing viable populations and of spreading, as well as for setting out
the common elements for the development of risk assessments. It is of
particular importance that the Commission carry out appropriate consultations during
its preparatory work, including at expert level. The Commission, when preparing
and drawing up delegated acts, should ensure a simultaneous, timely and
appropriate transmission of relevant documents to the European Parliament and
to the Council.
(30)     In order to guarantee
compliance with this Regulation, it is important that Member States impose
dissuasive, effective and proportionate sanctions for infringements taking into
account the nature and gravity of the infringement. 
(31)     In order to enable non-commercial
owners to continue keeping their companion animals that belong to species
listed as invasive alien species of Union concern until the animal's natural
death, it is necessary to provide transitional measures, on the condition that
all measures are put in place to avoid escape or reproduction. 
(32)     In order to enable
commercial operators, who may have legitimate expectations, for instance those
who have received an authorisation in accordance with Regulation (EC) No. 708/2007,
to exhaust their stock of invasive alien species of Union concern when these new
rules enter into force, it is justified to allow them two years to slaughter,
sell or hand over the specimens to research or ex-situ conservation
establishments.
(33)     Since the objectives of the
proposed action, namely the prevention and management of invasive alien species,
cannot be sufficiently achieved by the Member States and can therefore, by
reason of the scale and effects of the measures, be better achieved at Union
level, the Union may adopt measures, in accordance with the principle of
subsidiarity as set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this act does not go beyond what is necessary in order to achieve that
objective,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation sets out rules to prevent,
minimise and mitigate the adverse impacts of the introduction and spread, both
intentional and unintentional, of invasive alien species on biodiversity and
ecosystem services. 
Article 2
Scope
1.           This Regulation applies to
all invasive alien species in the Union as defined in Article 3(2).
2.           This Regulation does not
apply to: 
(a)          
species changing their natural range without
human intervention, in response to changing ecological conditions and climate
change; 
(b)         
genetically modified organisms as defined in
Article 2 of Directive 2001/18/EC;
(c)          
animal disease regulated as defined in Article 4(1)(14)
of Regulation (EU) No XXX/XXXX [animal health law- COM(2013)
260 final]; 
(d)         
pests of plants listed pursuant to Article 5(2)
or Article 32(3) or subject to measures pursuant to
Article 29(1) of Regulation (EU) No XXX/XXXX [on plant
health COM(2013) 267 final]; 
(e)          
species listed in Annex IV of Regulation (EC) No
708/2007;
(f)           
micro-organisms manufactured or imported for use
in plant protection products already approved or for which an assessment is
on-going under Regulation (EC) No 1107/2009;
(g)          
micro-organisms manufactured or imported for use
in biocidal products already approved or which are being made available on the
Union market pursuant to Regulation (EU) No 528/2012.
Article 3
Definitions
For the
purposes of this Regulation, the following definitions shall apply:
(1)                   
'alien species' means any live specimens of species,
subspecies or lower taxon of animals, plants, fungi or micro-organisms
introduced outside its natural past or present distribution; it includes any
part, gametes, seeds, eggs, or propagules of such species, as well as any
hybrids, varieties or breeds that might survive and subsequently reproduce;
(2)                   
'invasive alien species' means an alien species
whose introduction or spread has been found, through risk assessment, to
threaten biodiversity and ecosystem services, and that may also have a negative
impact on human health or the economy;
(3)                   
'invasive alien species of Union concern' means invasive
alien species whose negative impact has been deemed such as to require
concerted action at the level of the Union pursuant to Article 4(2); 
(4)                   
'biodiversity' means the variability among
living organisms from all sources, including terrestrial, marine and other
aquatic ecosystems and the ecological complexes of which they are part; this
includes diversity within species, between species and of ecosystems; 
(5)                   
'ecosystem services' means the direct and
indirect contributions of ecosystems to human wellbeing;
(6)                   
'introduction' means the movement by human
intervention of a species outside its past or present natural distribution;
(7)                   
'research' means descriptive or experimental
work, undertaken under regulated conditions to acquire new knowledge or to
develop new products, including the initial phases of identification,
characterisation and isolation of genetic features, other than invasiveness, of
invasive alien species only insofar as essential for enabling the breeding of
those features into non-invasive species;
(8)                   
'contained holding' means keeping an organism in
closed facilities from which escape or spread is not possible;
(9)                   
'ex-situ conservation' means the conservation of
components of biological diversity outside their natural habitat; 
(10)               
'pathways' means the routes and mechanisms of
biological invasions;
(11)               
'early detection' means the confirmation of the
presence of specimens of an invasive alien species in the environment before it
has become widely spread; 
(12)               
'eradication' means the complete and permanent
removal of a population of invasive alien species by physical, chemical or
biological means; 
(13)               
'widely spread' means an invasive alien species
whose population has gone beyond the naturalisation stage, in which a
population maintains a self-sustaining population, and has spread to colonise a
large part of the potential range where it can survive and reproduce;
(14)               
'management' means any physical, chemical or
biological action aimed at the eradication, population control or containment
of a population of an invasive alien species;
(15)               
'containment' means actions aimed at creating
barriers which minimise the risk for a population of an invasive alien species
to disperse and spread beyond the invaded area;
(16)               
'population control' means physical, chemical or
biological actions applied to a population of invasive alien species with the
aim of keeping the number of individuals as low as possible, so that, while not
being able to eradicate the species, its invasive capacity and adverse impacts
on biodiversity and ecosystem services, or on human health and the economy, are
minimised.
Article 4
List of invasive alien species of Union concern
1.           A list of invasive alien
species of Union concern shall be adopted, and updated, by the Commission by
means of implementing acts on the basis of the criteria in paragraph 2. The implementing
acts shall be adopted in accordance with the examination procedure referred to
in Article 22(2). 
2.           Invasive alien species
shall only be included on the list referred to in paragraph 1 if they meet all
of the following criteria: 
(a)         
they are, having regard to scientific evidence
available, found to be alien to the territory of the Union excluding the outermost
regions; 
(b)         
they are, having regard to scientific evidence
available, found to be capable of establishing a viable population and
spreading in the environment under current or foreseeable climate change
conditions anywhere in the Union excluding the outermost regions; 
(c)         
it is demonstrated by a risk assessment
performed pursuant to Article 5(1) that action at Union level is required to
prevent their establishment and spread .
3.           Member States may submit
to the Commission requests for the inclusion of invasive alien species on the
list referred to in paragraph 1. Those requests shall include all of the
following criteria: 
(a)         
the name of the species;
(b)         
a risk assessment performed in accordance with
Article 5(1);
(c)         
evidence that the species complies with the
criteria set out in paragraph 2.
4.           The list referred to in
paragraph 1 shall comprise a maximum of fifty species including any species
which may be added as result of the emergency measures foreseen by Article 9.
Article 5
Risk assessment and delegated acts
1.           The Commission or the Member States, as relevant, shall carry out the risk assessment referred to in Article
4(2)(c) and (3)(b) having regard to the following elements:
(a)         
a description of the species with its taxonomic
identity, its history, native range, potential range;
(b)         
a description of its reproduction and spread
patterns including an assessment of whether the environmental conditions
necessary for reproduction and spread exist;
(c)         
a description of the potential pathways of entry
and spread, both intentional and unintentional, including where relevant the
commodities with which the species are generally associated;
(d)         
a thorough assessment of the risk of entry,
establishment, spread in relevant biogeographical regions in current conditions
and in foreseeable climate change conditions;
(e)         
a description of the current distribution of the
species including whether the species is already present in the Union or in neighbouring countries;
(f)           
a description of the negative impact on
biodiversity and ecosystem services, including on native species, protected
sites, endangered habitats, on human health and the economy including an
assessment of the magnitude of future impact;
(g)         
a quantified forecast of the damage costs at
Union level demonstrating the significance for the Union, so as to further
justify action because the overall damage would outweigh the cost of mitigation;

(h)         
a description of the possible uses and benefits
deriving from those uses of the species.
2.           The
Commission shall be empowered
to adopt delegated acts, in accordance with Article 23 to further specify the
type of admissible scientific evidence referred to in Article 4(2)(b) and to
provide a detailed description of the application of the elements set out in paragraph
1(a) to (h) of this Article, including the methodology to be applied in the
assessment of such elements, taking into account relevant national and
international standards and the need to prioritise action against species
associated with or that have the potential to cause significant economic damage,
including that deriving from biodiversity loss.
Article 6
Provisions for the outermost regions
1.           Species included on the
list referred to in Article 4(1) which are native in an outermost region shall
not be subject to the provisions of Articles 7, 8, 11 and 13 to 17 in the outermost
region where they are native. 
2.           By [12 months from the
entry into force of this Regulation – date to be inserted] at the latest, each
  Member State with outermost regions shall adopt a list of invasive alien
species of concern for each of its outermost regions, in consultation with
those regions.
3.           The species included on
the lists referred to in paragraph 2 shall within the respective outermost
regions be subject to Articles 7, 8, 11 and 13 to 17. 
4.           Member States shall
immediately notify the Commission and shall inform the other Member States of
the lists referred to in paragraph 2 and of any update of those lists.
Chapter II
Prevention
Article 7
Ban on invasive alien species of Union concern
1.           Species included on the
list referred to in Article 4(1) shall not be intentionally: 
(a)          
brought into or transited through the Union
territory;
(b)         
permitted to reproduce;
(c)          
transported, except for the transportation of
species to facilities for eradication;
(d)         
placed on the market;
(e)          
used or exchanged;
(f)           
kept or grown, including in contained holding; 
(g)          
released into the environment.
2.           Member States shall
prevent the unintentional introduction of invasive alien species of Union concern
in accordance with the provisions of Article 11(3) and (4).
Article 8
Permits for research and ex-situ conservation 
1.           By way of derogation from
the bans set out in points (a), (b), (c), (e) and (f) of Article 7(1), Member
States shall establish a permit system allowing establishments that are
authorised to carry out research or ex-situ conservation to perform such
activities on invasive alien species of Union concern. 
2.           Member States shall
empower the relevant competent authorities to issue the permits referred to in
paragraph 1 for activities carried out in contained holding that fulfil all of
the following conditions: 
(a)          
the invasive alien species of Union concern is
kept in and handled in closed facilities as referred to in paragraph 3; 
(b)         
the activity is to be carried out by personnel possessing
the scientific and technical qualifications prescribed by the competent
authorities; 
(c)          
transport to and from the closed facility is
authorised by the competent authority and is carried out under conditions that
exclude escape of the invasive alien species;
(d)         
in case of invasive alien species that are animals,
they are marked where possible;
(e)          
the risk of escape or spread or removal is effectively
managed, taking into account the identity, biology and means of dispersal of
the species, the activity and the closed facility envisaged, the interaction
with the environment and other relevant factors relating to the risk posed by
that species; 
(f)           
a continuous surveillance and a contingency plan
to cater for possible escape or spread is drawn up, including an eradication
plan.
(g)          
The permit referred to in paragraph 1 shall be
limited to the number of species and specimens that is necessary for the
research or ex-situ conservation concerned and shall not exceed the capacity of
the closed facility. It shall include the restrictions necessary to mitigate the
risk of escape or spread of the species concerned. It shall accompany the
invasive alien species to which it refers at all times when these are kept,
brought into and transported within the Union.
3.           Specimens shall be
considered to be kept in closed facilities if the following conditions are
fulfilled:
(a)          
they are physically isolated and they cannot
escape or spread or be removed from the facilities were they are kept by
unauthorised persons; cleaning and maintenance protocols shall ensure that no
specimens or reproducible parts can escape, spread or be removed by
unauthorised persons;
(b)         
their removal from the facilities or disposal or
destruction is done in such way as to exclude propagation or reproduction
outside of the facilities. 
4.           When applying for a
permit, the establishment shall provide all necessary evidence to allow the competent
authority to assess whether the conditions referred to in paragraphs 2 and 3
are fulfilled. 
Article 9
Emergency measures 
1.           Where a Member State has
evidence concerning the presence in, or imminent danger of entry into its
territory of an invasive alien species, which is not included on the list referred
to in Article 4(1) but which the relevant competent authorities have found, on
the basis of preliminary scientific evidence, to be likely to meet the criteria
set out in Article 4(2), it may immediately take emergency measures, consisting
of any of the bans set out in Article 7(1). 
2.           The Member State
introducing emergency measures in their national territory which include the
application of points (a), (c) or (d) of Article 7(1) shall immediately notify
to the Commission and the other Member States of the measures taken and the
evidence justifying those measures.
3.           The Member State concerned
shall carry out a risk assessment pursuant to Article 5 for the species subject
to the emergency measures without delay, given the available technical and
scientific information, and in any case within 24 months from the day of the
adoption of the decision to introduce emergency measures, with a view to
include those species on the list referred to in Article 4(1).
4.           Where the Commission
receives the notification referred to in paragraph 2 or has other evidence
concerning the presence in or imminent danger of entry into the Union of an
invasive alien species which is not included on the list referred to in Article
4(1) but is likely to meet the criteria set out in Article 4(2), it shall, by
means of an implementing act, conclude on the basis of preliminary scientific
evidence whether the species is likely to meet these criteria and adopt
emergency measures for the Union consisting of any of the bans set out in
Article 7(1) for a limited time as regards the risks posed by that species,
where it concludes that the criteria set out in Article 4(2) are likely to be
fulfilled. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 22(2).

5.           If provided for in the implementing
acts referred to in paragraph 4 the measures taken by the Member States
pursuant to paragraph 1 shall be repealed or amended.
6.           The Member State taking
emergency measures may maintain those measures until an implementing act has
been adopted, establishing emergency measures at Union level in accordance with
paragraph 4 or including the species on the list referred to in Article 4(1) on
the basis of the risk assessment performed by the Member State concerned
pursuant to paragraph 3.
Article 10
Restrictions on the intentional release of invasive
alien species of Member State concern
1.           Member States shall ban
any intentional release into the environment, that is the process by which an
organism is placed into the environment, for any purpose, without the necessary
measures to prevent its escape and spread, of invasive alien species other than
invasive alien species of Union concern for which Member States consider, on
the basis of scientific evidence, that the adverse impact from their release
and spread, even where not fully ascertained, is of significance on their national
territory ('invasive alien species of Member State concern'). 
2.           Member States shall inform
the Commission and the other Member States of the species it considers as
invasive alien species of Member State concern.
3.           The competent authorities
of Member States may issue authorisations for certain intentional releases of invasive
alien species of Member State concern, provided that the following conditions
have been fully taken into account: 
(a)         
there are no alternative non-invasive species
that can be used to obtain similar benefits;
(b)         
the benefits of the release are exceptionally
high in comparison to the risks of damage of the species concerned;
(c)         
the release will include risk mitigation
measures so as to minimise the impact on biodiversity and ecosystem services as
well as on human health and the economy;
(d)         
adequate surveillance is in place and a
contingency plan is drawn up to eradicate the species to be applied in case the
damage caused by the species is considered by the competent authority to be
unacceptable.
4.           Any authorisation for the
introduction of alien species for their use in aquaculture shall be issued in
accordance with the provisions of Regulation (EC) No 708/2007. 
Article 11
Action plans on the pathways of invasive alien species
1.           Member States shall, by [18
months from the entry into force of this Regulation – date to be inserted]
at the latest carry out a comprehensive analysis of the pathways of
unintentional introduction and spread of invasive alien species in their
territory and identify the pathways which require priority action ('priority
pathways'), because of the volume of species or of the damage caused by the
species entering the Union through them. In doing so, Member States shall in
particular focus on an analysis of the pathways of introduction of invasive
alien species of Union concern.
2.           By [3 years from the
entry into force of this Regulation - date to be inserted] at the
latest, each Member State shall establish and implement an action plan to address
the priority pathways it has identified pursuant to paragraph 1. That action plan
shall include a timetable for action and shall describe the measures to be
adopted to address the priority pathways and to prevent the unintentional
introduction and spread of invasive alien species into the Union and into or
within the environment. 
3.           The action plan referred
to in paragraph 2 shall include measures designed on the basis of an analysis
of costs and benefits with at least the following: 
(a)          
awareness raising measures; 
(b)         
regulatory measures to minimise contamination by
invasive alien species of goods and commodities, and any vehicle and equipment,
including measures tackling transport of invasive alien species from third
countries; 
(c)          
regulatory measures to ensure appropriate checks
at the Union borders, other than the official controls pursuant to Article 13; 
(d)         
the measures of the International Convention for
the Control and Management of Ships Ballast Water and Sediments. 
4.           The action plan developed
in accordance with paragraph 2 shall be transmitted to the Commission without
delay. Every four years after the last transmission, Member States shall review
the action plan and retransmit it to the Commission.
Chapter III
Early detection and rapid eradication
Article 12
Surveillance system
1.           By [18 months from the
date of entry into force of this Regulation – date to be inserted] at the
latest, Member States shall have an official surveillance system in place which
collects and records data on the occurrence in the environment of invasive
alien species by survey, monitoring or other procedures to prevent the spread
of invasive alien species into the Union.
2.           The surveillance system
referred to in paragraph 1 shall: 
(a)          
cover the territory of the Member States to
determine the presence and distribution of new as well as already established
invasive alien species of Union concern;
(b)         
include marine waters as defined in Article 3(1)
of Directive 2008/56/EC;
(c)          
be sufficiently dynamic to detect rapidly the
appearance in the environment of the territory or part of the territory of any
invasive alien species of Union concern, whose presence was previously unknown;
(d)         
make use of the information provided by the existing
systems of surveillance and monitoring set out in Article 11 of Directive 92/43/EEC,
Article 11 of Directive 2008/56/EC and Article 8 of Directive 2000/60/EC.
Article 13 
Official
controls at the Union borders
1.           By [12 months from the
date of entry into force of this Regulation – date to be inserted] at the
latest, Member States shall have in place fully functioning structures to
perform the official controls on animals and plants including their seeds,
eggs, or propagules, brought into the Union, necessary to prevent the
intentional introduction into the Union of invasive alien species of Union concern.
2.           Member States authorities
shall perform the official controls at the Union borders on the goods mentioned
in paragraph 1 being brought into the Union verifying that either of the
following requirements are fulfilled: 
(a)          
that they are not on the list referred to in
Article 4(1);
(b)         
that the permits referred to in Article 8 are
valid.
3.           The verifications, through
a documentary, identity and, where necessary, physical check, referred to in
paragraph 2 shall take place:
(a)          
at border control posts provided for in Article
57 of Regulation (EU) No XXX/XXXX [on official controls COM(2013)265] in the
case of goods mentioned in paragraph 1, falling under Article 45 of that
Regulation and subject to official controls at border control posts; in this
case Member States shall confer the responsibility to the competent authorities
provided for in Article 3 of Regulation (EU) No XXX/XXXX [on official controls
COM(2013)265]
(b)         
at the point of entry on the customs territory
of the Community in the case of goods mentioned in paragraph 1 to which Article
45 of Regulation (EU) No XXX/XXXX [on official controls COM(2013)265] does not
apply or exempted from official controls at border control posts according to
Article 46 of the same Regulation; in this case Member States shall confer the
responsibility to the customs authorities for the
placing under any customs procedure of these goods. 
4.           The authorities designated
for border controls shall also be empowered with the responsibility to seize
and confiscate the organisms not in compliance with the conditions pursuant to
paragraph 2. Where organisms are confiscated, they shall be entrusted to the
competent authority in charge of applying this Regulation. Member States may delegate specific functions to other authorities.
5.           The
record of the outcome of the official controls performed and any decisions
taken on that basis, including the decision to reject a consignment, shall take into account the compliance with requirements in
paragraph 2(a) and (b). 
6.           Member States shall put in
place procedures to ensure the exchange of information relevant to arriving
consignments and the efficient and effective coordination and cooperation for
the verifications referred to in paragraph 2 between all authorities involved
and the operator of the consignment.
7.           Member States shall
develop guidelines and training programmes to facilitate the identification and
detection of invasive alien species of Union concern through cooperation
between all authorities involved in the verifications referred to in paragraph
2. The training programmes for custom authorities shall include information on
filling the Single Administrative Document on which the customs declaration is
made.
Article 14 
Early detection notifications 
1.           Member States shall use
the surveillance system established in accordance with Article 12 and the information
collected at official controls provided for by Article 13 to support early
detection of the entry or presence of invasive alien species of Union concern.
2.           Member States shall notify
in writing without delay the early detection of the presence of invasive alien
species of Union concern to the Commission and inform the other Member States,
in particular: 
(a)          
the appearance on their territory or part of
their territory of any species included on the list referred to in Article 4(1)
whose presence was previously unknown in their territory or in part of their
territory; 
(b)         
the re-appearance on their territory or part of
their territory of any species included on the list referred to in Article 4(1)
after it has been reported as eradicated. 
Article 15
Rapid eradication at an early stage of invasion
1.           After early detection and
within three months after the transmission of the early detection notification
referred to in Article 14, Member States shall apply eradication measures and
notify those measures to the Commission and inform the other Member States. 
2.           When applying eradication
measures, Member States shall ensure that the methods used are effective in achieving
the complete and permanent removal of the population of the invasive alien
species concerned, with due regard to human health and the environment, and
ensuring that targeted animals are spared any avoidable pain, distress or
suffering. 
3.           The surveillance system
provided for in Article 12 shall be designed and used to monitor also the effectiveness
of the eradication. 
4.           Member States shall notify
the Commission and inform the other Member States when a population of an
invasive alien species of Union concern has been eradicated.
5.           Member States shall also inform
the Commission and the other Member States of the effectiveness of the measures
taken.
Article 16
Derogations from the rapid eradication obligation
1.           Member States may submit
to the Commission an application for a derogation from the obligation to apply the
eradication measures referred to in Article 15 for invasive alien species of
Union concern that have been subject to an early detection notification
referred to in Article 14. 
2.           Applications for derogations
shall be based on sound scientific evidence and only be submitted if the
following conditions are met: 
(a)          
eradication is demonstrated to be technically
unfeasible because the eradication methods available cannot be applied in the
environment where the species are established; 
(b)         
a cost-benefit analysis demonstrates on the
basis of the available data with reasonable certainty that the costs will, in
the long term, be exceptionally high and disproportionate to the benefits of
eradication;
(c)          
eradication methods are not available or are
available but have very serious negative impacts on human health or the
environment.
3.           Member States shall submit
applications for derogation, duly motivated and accompanied by the evidence
referred to in points (a), (b) and (c) of paragraph 2, to the Commission. 
4.           The Commission shall decide,
by means of implementing acts in accordance with paragraph 6, to approve or
reject the application referred to in paragraph 3.
5.           Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 22(2).
6.           Member States shall ensure
that containment measures are in place to avoid further spread of the species
until an implementing decision is adopted on the derogation pursuant to
paragraph 3.
7.           Where a derogation from
the eradication obligation is approved, the species shall be subject to the
management measures referred to in Article 17. If the application for
derogation is rejected, the Member State concerned shall apply the eradication
measures referred to in Article 15 without delay.
Chapter IV
Management of Invasive Alien Species that are widely
spread
Article 17
Management measures
1.           By 12 months of an
invasive alien species being included on the list referred to in Article 4(1)
at the latest, Member States shall have in place management measures for those
invasive alien species of Union concern which the Member States have found to
be widely spread on their territory, so that their impacts on biodiversity and
ecosystem services, human health and the economy are minimised. Those
management measures shall be based on an analysis of costs and benefits and also
include the restoration measures referred to in Article 18. 
2.           The management measures
shall consist of physical, chemical or biological actions aimed at the
eradication, population control or containment of a population of an invasive
alien species. Where appropriate, management measures shall include actions
applied to the receiving ecosystem aimed at increasing its resilience to
current and future invasions. 
3.           When applying management
measures, Member States shall ensure that the methods used have due regard for
human health and the environment and that, when animals are targeted, they are
spared any avoidable pain, distress or suffering. 
4.           The surveillance system
provided for in Article 12 shall be designed and used to monitor how effective eradication,
population control or containment measures are in minimising the impacts on
biodiversity and ecosystems services, human health or the economy. 
5.           Where there is a
significant risk that an invasive alien species of Union concern will spread to
a neighbouring Member State, the Member States in which the species is widely
spread shall immediately notify the neighbouring Member States and the
Commission. Where appropriate, the Member States concerned shall establish jointly
agreed management measures. In the cases where third countries may also be
affected by the spread, the Member State affected shall consider the need to
inform the concerned third countries.
Article 18
Restoration of the damaged ecosystems
1.           Member States shall take proportionate
restoration measures to assist the recovery of an ecosystem that has been
degraded, damaged, or destroyed by invasive alien species of Union concern. 
2.           The restoration measures
referred to in paragraph 1 shall include at least the following: 
(a)          
measures to increase the ability of an ecosystem
exposed to disturbance to resist, absorb, accommodate to and recover from the
effects of disturbance; 
(b)         
measures ensuring the prevention of reinvasion following
an eradication campaign.
Chapter V
Final provisions
Article 19
Reporting 
1.           By [three years from
the date of entry into force of this Regulation – date to be inserted] at
the latest, and every four years thereafter, Member States shall transmit to
the Commission updated information on the following: 
(a)          
a description of the surveillance system pursuant
to Article 12 and official control system on alien species entering the Union
pursuant to Article 13;
(b)         
the distribution of the invasive alien species
of Union concern present in their territory;
(c)          
information about the species considered as
invasive alien species of Member State concern pursuant to Article 10(2);
(d)         
the action plan referred to in Article 11(2); 
(e)          
aggregated information covering the entire
national territory on the eradication measures taken in accordance with Article
15 and the management measures provided for in Article 17 and their
effectiveness.
(f)           
the format of the permits referred to in Article
8.
2.           Member States shall notify
the Commission and inform the other Member States of the competent authorities
in charge of applying this Regulation. 
3.           Within 5 years from [date
of adoption], the Commission shall assess the effectiveness of the current
Regulation including the list referred to in Article 4(1), the action plans
referred to in Article 11(3), the surveillance system, border checks,
eradication obligation and management obligations, and submit a report to the
European Parliament and to the Council which may be accompanied by proposals for
its amendment including changes to the list in Article 4(1).
Article 20
Information support mechanism
1.           The Commission shall
gradually establish an information support mechanism necessary to facilitate
the application of this Regulation.
2.           In an initial phase the
system shall include a data support mechanism interconnecting existing data
systems on invasive alien species, paying particular attention to information
on the invasive alien species of Union concern so as to facilitate the
reporting pursuant to Article 19.
3.           In a second phase, the
data support mechanism referred to in paragraph 2 shall become a tool to assist
the Commission in handling the relevant notifications required in Article 14(2).
4.           In a third phase, the data
support mechanism referred to in paragraph 2 shall become a mechanism for exchanging
information on other aspects of the application of this Regulation. 
Article 21
Public participation
1.           Where action plans are
being established pursuant to Article 11 and where measures are being
established pursuant to Article 17, Member States shall ensure that the public
is given early and effective opportunities to participate in their preparation,
modification or review using the arrangements already determined by the Member
States in accordance with the second subparagraph of Article 2(3) of Directive
2003/35/EC. 
Article 22
Committee
1.           The Commission shall be
assisted by the Committee. That Committee shall be a committee within the
meaning of Regulation (EU) No 182/2011[23].
2.           Where reference is made to
this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 
Article 23
Exercise of the delegation
1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.
2.           The delegation of power
referred to in Article 5(2) shall be conferred on the Commission for an
undetermined period of time from the entry into force of this Regulation. 
3.           The delegation of power
referred to in Article 5(2) may be revoked at any time by the European
Parliament or by the Council. A decision to revoke shall put an end to the
delegation of the power specified in that decision. It shall take effect the
day following the publication of the decision in the Official Journal of the
European Union or at a later date specified therein. It shall not affect
the validity of any delegated act already in force.
4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.
5.           A delegated act adopted
pursuant to Article 5(2) shall enter into force only if no objection has been
expressed either by the European Parliament or the Council within a period of
two months of notification of that act to the European Parliament and the
Council or if, before the expiry period, the European Parliament and the
Council have both informed the Commission that they will not object. That
period shall be extended by two months at the initiative of the European
Parliament or of the Council. 
Article 24
Administrative measures and sanctions 
1.           Member States shall lay
down the rules on administrative measures and sanctions applicable to breaches of
this Regulation. Member States shall take all necessary measures to ensure that
they are enforced. The measures and sanctions provided for must be effective,
proportionate and dissuasive.
Article 25
Sanctioning powers 
1.           Competent authorities
shall have the power to impose administrative measures and sanctions on any
natural or legal person who does not comply with this Regulation. 
2.           Without prejudice to their
supervisory powers, competent authorities shall have the power to impose at
least the following administrative measures and sanctions:
(a)          
an order requiring the natural or legal person
responsible for the breach to cease the conduct and to desist from a repetition
of that conduct;
(b)         
an order requiring the confiscation of the non-compliant
invasive alien species of Union concern at issue;
(c)          
a temporary ban on an activity;
(d)         
permanent withdrawal of the authorisation of an
activity;
(e)          
administrative pecuniary sanctions;
(f)           
an order requiring the natural or legal person
to take remedial measures. 
3.           When determining the type
of administrative measures and sanctions, competent authorities shall take into
account all relevant circumstances, including:
(a)          
the gravity and duration of the breach;
(b)         
the degree of involvement of the person responsible
for the invasion;
(c)          
the profit the natural or legal person makes
from the breach;
(d)         
the environmental, social and economic damage
caused by the breach;
(e)          
the level of cooperation of the person responsible
with the competent authority;
(f)           
previous breaches by the
person responsible.
4.           Member States shall ensure
that decisions taken by the competent authorities in accordance with this
Article are subject to the right of appeal.
Article 26
Transitional provisions for non-commercial owners
1.           By way of derogation from
to Article 7(1)(c) and (f), owners of companion animals not kept for commercial
purposes that belong to the species included on the list referred to in Article
4(1) shall be allowed to keep them until the end of the animals' natural life, provided
the following conditions are met:
(a)          
the specimens were kept before their inclusion on
the list referred to in Article 4(1);
(b)         
the specimens are kept in contained holding and
all appropriate measures are put in place to ensure that reproduction or escape
are not possible.
2.           Competent authorities
shall inform non-commercial owners of the risks posed by keeping the specimens
referred to in paragraph 1 and the measures to be taken to minimise the risk of
reproducing and escaping through awareness-raising and education programmes
organised by Member States.
3.           For non-commercial owners
who cannot ensure that the conditions set out in paragraph 1 are met, Member
States shall offer to them the possibility of having their specimens taken over
from them and shall give due regard to animal welfare when handling them. 
Article 27
Transitional provisions for commercial stocks
1.           Keepers of a commercial
stock of specimens of invasive alien species acquired before their inclusion on
the list referred to in Article 4(1) shall be allowed up to two years after
inclusion of the species in that list to keep and transport in order to sell or
hand over live specimens or reproducible parts of those species to the research
or ex-situ conservation institutions referred to in Article 8, provided that
the specimens are kept and transported in contained holding and all appropriate
measures are put in place to ensure that reproduction or escape are not
possible, or to slaughter them to exhaust their stock.
2.           Where a permit has been
issued in accordance with Article 6 of Regulation (EC) No 708/2007 for an aquaculture
species that is subsequently included in the list of alien species of Union
concern, and the duration of the permit exceeds the period referred to in
paragraph 1, the Member State shall withdraw the permit in accordance with
Article 12 of Regulation (EC) No 708/2007 by the end of the period referred to
in paragraph 1. 
Article 28
Entry into force
This Regulation shall enter into
force on the [1 January or 1 July] following 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 European Parliament                       For
the Council
The President                                                 The
President
Simplified Financial Statement
Title of draft proposal:
Regulation of the European Parliament and of the Council on the
prevention and management of the introduction and spread of invasive alien
species.
Policy area(s) and ABB activity(ies)
concerned:
Title 07 Environment
07 01 02 External staff and other management expenditure in support
of Environment policy area
Legal basis
            ¨ Administrative autonomy                           X
Other: Article 192(1) TFEU
Description and grounds:
Invasive alien species (IAS) are species that are transported across
ecological boundaries, intentionally or unintentionally by human action,
outside of their natural distribution and that establish and spread in their
new location to an extent that they have a negative impact on biodiversity, but
also on human health and the economy. IAS are a major cause of biodiversity
loss, besides causing social and economic damage, and tackling them is crucial
to meet the EU target of halting the loss of biodiversity by 2020. Furthermore,
it has been estimated that IAS are costing €12 billion/year to the EU in terms
of damage and control costs. The purpose of this draft Regulation is thus to
establish an EU framework to prevent, minimise and mitigate the adverse impacts
of IAS on biodiversity and ecosystem services and to seek to mitigate social
and economic damage. Member States are already taking measures to tackle some
IAS, but action is predominantly reactive, seeking to minimise the damage
already being caused without sufficient attention to prevention or to detect
and respond to new threats. Efforts are fragmented, not covering the entire EU
and often poorly co-ordinated, which means that their overall effectiveness is
reduced. Currently a comprehensive legal framework to tackle IAS at EU level
does not exist. This draft Regulation aims to address this policy gap, in line
also with its international commitments under the Convention of Biological
Diversity.
Duration and estimated financial
impact:
Period of application:
¨      Proposal
with a limited duration: in force from [date] to [date]
X       Proposal with an indefinite duration:
in force from [forecasted 2015 tbc]
Estimated budgetary impact:
The draft proposal entails:
¨      savings
X       additional costs (if so, specify the heading(s) of the
multiannual financial framework concerned): Heading 5 of the MFF 2014-2020
Third-party contributions to the
financing of the draft proposal:
The proposal does not provide for
co-financing by third parties 
Explanation of figures:
Implementation of aspects of this draft Regulation will require the
running of a Committee. On the basis of the costs of running other similar
Committees, we estimated the following costs under heading 07 01 02 11 03 –
Committees (see table below):
- meetings/year
- 1 representative/MS
- maximum travel and subsistence cost of €800 euro/MS/meeting
This would bring the cost for the Commission to approximately
€80,000/year 
Compatibility with the current
multiannual financial framework:
X       The proposal is compatible with
existing financial programming.
¨      The proposal will entail reprogramming of the relevant heading
in the multiannual financial framework.
¨      The proposal requires use of the flexibility instrument or
revision of the multiannual financial framework[24].
Impact of savings or additional costs
on the allocation of resources:
¨      Resources to be obtained by means of internal redeployment
within departments
X       Resources already allocated to the
department(s) concerned
¨      Resources to be requested during the next allocation procedure
The human and administrative resources
required will be met by staff from the DG already assigned to the management of
the action, with the support of staff already deployed to work on aspects
linked to the implementation of this draft Regulation. The main tasks of the
assigned officials will be: the management of the Committee, the management of
the interaction with the Member States, to coordinate with the Joint Research
Centre (JRC) and in general support the correct implementation of this draft
Regulation. 
The system is designed to pool resources
and expertise from different services of the Commission, which will allow to
run the system with limited dedicated staff resources: in particular, the IAS
policy will benefit from the contribution of JRC staff involved in the EASIN
project[25],
as well as from the expertise of other Commission services and agencies working
in areas of relevance to IAS policy (in particular, the European Environment
Agency has dedicated staff working on IAS who will be mobilised in support of
implementation work). If necessary, staff will be redeployed on the basis of
the allocations which may be granted to the managing DG under the annual
allocation procedure in the light of existing budgetary constraints.
ESTIMATED FINANCIAL IMPACT (savings or
additional costs) FOR APPROPRIATIONS OF AN ADMINISTRATIVE NATURE OR FOR HUMAN
RESOURCES
 FTE in persons/year || Year || Year || Year || Year || Year || Year || Year || Total 
 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021 
 Heading 5 || FTE || approp. || FTE || approp. || FTE || approp. || FTE || approp. || FTE || approp. || FTE || approp. || FTE || approp. ||   ||   
 Establishment plan posts (officials and/or temporary staff) 
 07 01 01 01 (Headquarters and Commission’s Representation Offices) ||   || 0.199* ||   || 0.199 ||   || 0.199 ||   || 0.199 ||   || 0.199 ||   || 0.199 ||   || 0.199 ||   || 1.393 
 07 01 01 02 (Delegations) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 External staff ||   
 07 01 02 01 (‘Global envelope’) ||   || 0.002**  ||   || 0.002  ||   || 0.002  ||   || 0.002  ||   || 0.002  ||   || 0.002  ||   || 0.002  ||   || 0.014 
 07 01 02 02 (Delegations) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Other budget lines (specify) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal – Heading 5 ||   || 0.201  ||   ||  0.201 ||   ||  0.201 ||   ||  0.201 ||   ||  0.201 ||   ||  0.201 ||   ||  0.201 ||   || 1.407 
 Outside Heading 5 ||   
 Establishment plan posts (officials and/or temporary staff) 
 07 01 05 01 (Indirect research) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 10 01 05 01 (Direct research) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 External staff 
 07 01 04 yy ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 - Headquarters ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 - Delegations ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 05 02 (Indirect research) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 10 01 05 02 (Direct research) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Other budget lines (Specify) ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal – Outside Heading 5 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL ||   || 0.201 ||   || 0.201 ||   || 0.201 ||   || 0.201 ||   || 0.201 ||   || 0.201 ||   || 0.2014 ||   || 1.407 for the first 7 years 
FTE=Full-Time Equivalent                                                                                                           EUR
million (to 3 decimal places) 
"The human resources appropriations required
will be met by appropriations from the DG that are already assigned to
management of the action and/or have been redeployed within the DG,
together if necessary with any additional allocation which may be granted to
the managing DG under the annual allocation procedure and in the light of
budgetary constraints."
*The estimated
appropriation include staff from DG ENV as well as one FTE in JRC **Average
allowance of an END
Other administrative appropriations                                                                                          EUR
million (to 3 decimal places) 
   || Year || Year || Year || Year || Year || Year || Year || TOTAL 
 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021 
 Heading 5 ||   ||   ||   ||   ||   ||   ||   ||   
 Headquarters: ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 02 11 01 - Mission and representation expenses ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 02 11 02 - Conference and meeting costs ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 02 11 03 - Committees || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.56 for the first 7 years  
 07 01 02 11 04 - Studies and consultations ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 03 01 03 – ICT equipment[26] ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 03 01 04 – ICT services2 ||   ||   ||   ||   ||   ||   ||   ||   
 Other budget lines (specify where necessary) ||   ||   ||   ||   ||   ||   ||   ||   
 Delegations: ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 02 12 01 – Missions, conferences and representation expenses ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 02 12 02 - Further training of staff ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 03 02 01 – Acquisition, renting and related expenditure ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 03 02 02 Equipment, furniture, supplies and services ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal – Heading 5 || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.56 for the first 7 years  
 Outside Heading 5 ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 04 yy – Expenditure on technical and administrative assistance (not including external staff) from operational appropriations (former 'BA' lines) ||   ||   ||   ||   ||   ||   ||   ||   
 - Headquarters ||   ||   ||   ||   ||   ||   ||   ||   
 - Delegations ||   ||   ||   ||   ||   ||   ||   ||   
 07 01 05 03 - Other management expenditure for indirect research ||   ||   ||   ||   ||   ||   ||   ||   
 10 01 05 03 - Other management expenditure for direct research ||   ||   ||   ||   ||   ||   ||   ||   
 Other budget lines (specify where necessary) ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal – Outside Heading 5 ||   ||   ||   ||   ||   ||   ||   ||   
 GRAND TOTAL || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.08  || 0.56 for the first 7 years  
[1]               http://www.acceptance.ec.europa.eu/environment/nature/invasivealien/docs/ias_discussion_paper.pdf.
[2]               All studies are accessible from
http://ec.europa.eu/environment/nature/invasivealien/index_en.htm.
[3]               OJ ref 
[4]               OJ ref
[5]               OJ L 309, 13.12.1993, p. 1.
[6]               OJ L 38,
10.2.1982, p. 1.
[7]               OJ L 20, 26.1.2010, p. 7. 
[8]               OJ L 206, 22.7.1992, p. 7.
[9]               OJ L 164, 25.6.2008, p. 19.
[10]             OJ L 327, 22.12.2000, p. 1.
[11]             COM(2013) 260 final
[12]             COM(2013) 267 final
[13]             OJ L 106, 17.4.2001, p. 1.
[14]             OJ L 168, 28.6.2007, p.1.
[15]             OJ L 167, 27.6.2012, p. 1.
[16]             OJ L 309, 24.11.2009, p. 1.
[17]             OJ L 61,
3.3.1997, p. 1.
[18]             COM (2008)642 final.
[19]             OJ L 325, 9.12.2010, p. 4.
[20]             OJ L 204, 31.7.2012, p. 131.
[21]             OJ L
156, 25.6.2003, p. 17.
[22]             OJ L
55, 28.2.2011, p. 13.
[23]             OJ L
55, 28.2.2011, p. 13.
[24]             See points 19 and 24 of the Interinstitutional
Agreement for the period 2007-2013. 
[25]             The European Alien Species Information Network (EASIN)
aims at increasing access to data and information on alien species in Europe.
EASIN facilitates the exploration of existing alien species information from
distributed sources through a network of interoperable web services, following
internationally recognized standards and protocols. The project was initiated
in support of the implementation of the Biodiversity Strategy and the Marine
Strategy Framework Directive and it is available to the public since May 2012
[26]             ICT: Information and Communication Technologies