Commission Delegated Regulation (EU) 2018/968 of 30 April 2018

supplementing Regulation (EU) No 1143/2014 of the European Parliament and of

the Council with regard to risk assessments in relation to invasive alien species

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1143/2014 of the European Parliament and of

the Council of 22 October 2014 on the prevention and management of the
introduction and spread of invasive alien species ( 1), and in particular Article 5(3)
thereof,

Whereas:

(1) The Commission has, in accordance with Article 4 of Regulation (EU) No

1143/2014, adopted a list of invasive alien species of Union concern (‘the Union list’),
which is to be updated regularly. A precondition for including new species on the
Union list is that a risk assessment as referred to in Article 5 of that Regulation (‘the
risk assessment’) has been carried out. Article 5(1) of Regulation (EU) No 1143/2014
sets out, in points (a) to (h), the common elements that are to be considered in the risk
assessment (‘the common elements’).

(2) Member States may, in accordance with Article 4(4) of Regulation (EU) No
1143/2014, submit requests for the inclusion of invasive alien species on the Union
list. Those requests are to be accompanied by the risk assessment. Several methods
and protocols to carry out the risk assessment are already in existence and are used
and respected within the scientific community in the area of biological invasions. The
value and scientific robustness of such methods and protocols should be recognised.
In the interest of efficiently using existing knowledge, any method or protocol which
includes the common elements should be accepted for the preparation of the risk
assessment. However, in order to ensure that all decisions on listing species are based
on risk assessments of similar high quality and robustness and to provide guidance to
the risk assessors on how the ensure that the common elements are appropriately
considered, it is necessary to set out a detailed description of the common elements, as
well as a methodology to be applied in the risk assessment to which the existing
methods and protocol should adhere.

(3) In order for the risk assessment to help underpin decision-making at the Union
level, it should be of relevance to the Union as a whole, excluding the outermost
regions (‘the risk assessment area’).

(4) In order for the risk assessment to provide a robust scientific basis and solid
evidence to underpin decision-making, all information in it, including in relation to
the ability of a species to establish and spread in the environment as per Article 4(3)
(b) of Regulation (EU) No 1143/2014, should be supported by the best available
scientific evidence. This aspect should be addressed in the methodology to be applied
in the risk assessment.
1
OJ L 317, 4.11.2014, p. 35.
(5) Invasive alien species are a serious environmental threat, but not every species is
equally well studied. In cases where a species is not present in the risk assessment
area or is only present in low numbers, there may be no knowledge or incomplete
knowledge about that species. By the time full knowledge is acquired, the species may
have already been introduced into or spread within the risk assessment area. Thus, the
risk assessment should be able to account for such lack of knowledge and information
and address the high degree of uncertainty as regards the consequences of an
introduction or spread of the relevant species.

(6) In order for the risk assessment to provide a sound basis to underpin decision-
making, it should be subject to rigorous quality control,

HAS ADOPTED THIS REGULATION:

Article 1

Application of the common elements

A detailed description of the application of the common elements laid down in points
(a) to (h) of Article 5(1) of Regulation (EU) No 1143/2014 (‘the common elements’)
is set out in the Annex to this Regulation.

Article 2

Methodology to be applied in the risk assessment

1. The risk assessment shall include the common elements, as specified in the Annex
to this Regulation, and shall comply with the methodology set out in this Article. The
risk assessment may be based on any protocol or method, provided that all
requirements set out in this Regulation and in Regulation (EU) No 1143/2014 are
fulfilled.

2. The risk assessment shall cover the territory of the Union, excluding the outermost
regions (‘the risk assessment area’).

3. The risk assessment shall be based on the most reliable scientific information
available, including the most recent results of international research, supported by
references to peer reviewed scientific publications. In cases where there are no peer
reviewed scientific publications or where the information provided by such
publications is insufficient, or to supplement the information collected, the scientific
evidence may also include other publications, expert opinions, information collected
by Member States’ authorities, official notifications and information from databases,
including information collected through citizen science. All sources shall be
acknowledged and referenced.

4. The method or protocol used shall allow for completion of the risk assessment to
take place even where there is no information about a certain species or when the
information about a species is insufficient. Where there is such a lack of information,
the risk assessment shall state that fact explicitly so that no question in the risk
assessment is left unanswered.

5. Each answer provided in the risk assessment shall include an assessment of the
level of uncertainty or confidence attached to that answer, reflecting the possibility
that information needed for the answer is not available or is insufficient or the fact
that the available evidence is conflicting. The assessment of the level of uncertainty or
confidence attached to an answer shall be based on a documented method or protocol.
The risk assessment shall include a reference to that documented method or protocol.

6. The risk assessment shall include a summary of its different components, as well as
an overall conclusion, in a clear and consistent form.

7. A quality control process shall be an integral part of the risk assessment and shall
include at least a review of the risk assessment by two peer reviewers. The risk
assessment shall include a description of the quality control process.

8. The author(s) of the risk assessment and the peer reviewers shall be independent
and have relevant scientific expertise.

9. The author(s) of the risk assessment and the peer reviewers shall not be affiliated to
the same institution.

Article 3

Entry into force

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

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

Done at Brussels, 30 April 2018.

For the Commission

The President

Jean-Claude JUNCKER
 ANNEX

Detailed description of the common elements

The common elements Detailed description

Art 5(1)(a) — a description (1) The description of the species shall provide
of the species with its sufficient information to ensure that the identity of the
taxonomic identity, its species can be understood without reference to
history, and its natural and additional documentation.
potential range
(2) The scope of the risk assessment shall be clearly
delineated. While, as a general rule, one risk
assessment should be developed for each single
species, there may be cases where it may be justified to
develop one risk assessment covering more than one
species (e.g. species belonging to the same genus with
comparable or identical features and impact). It shall be
clearly stated if the risk assessment covers more than
one species, or if it excludes or only includes certain
subspecies, lower taxa, hybrids, varieties or breeds (and
if so, which subspecies, lower taxa, hybrids, varieties or
breeds). Any such choice must be properly justified.

(3) The description of the taxonomic identity of the

species shall include all of the following elements:

— the taxonomic family, order and class to which the

species belongs,

— the current scientific name of the species and author

of that name,

— a list of the most common synonyms of the current

scientific name,

— names used in commerce,

— a list of the most common subspecies, lower taxa,

hybrids, varieties or breeds,

— information on the existence of other species that

look very similar:

— other alien species with similar invasive

characteristics, to be avoided as substitute species (in
this case preparing a risk assessment for more than one
species together may be considered, cf. point (2);
 — other alien species without similar invasive
characteristics, that could be used as potential substitute
species;

— native species, to avoid potential misidentification

and mis-targeting.

(4) The description of the history of the species shall

include the invasion history of the species, including
information on countries invaded (in the risk
assessment area and elsewhere, if relevant) and an
indication of the timeline of the first observations,
establishment and spread.

(5) The description of the natural and potential range of

the species shall include an indication of the continent
or part of a continent, climatic zone and habitat where
the species is naturally occurring. If applicable, it
should be indicated whether the species could naturally
spread into the risk assessment area.

Art 5(1)(b) — a description (1) The descriptions of reproduction and spread

of its reproduction and patterns shall include elements of the species life
spread patterns and history and behavioural traits, which can explain its
dynamics including an ability to establish and spread, such as reproduction or
assessment of whether the growth strategy, dispersal capacity, longevity,
environmental conditions environmental and climatic requirements, specialist or
necessary for its generalist characteristics and other relevant available
reproduction and spread information.
exist
(2) The description of the reproduction patterns and
dynamics shall include all of the following elements:

— a list and description of the reproduction

mechanisms of the species,

— an assessment of whether suitable environmental

conditions for the species’ reproduction exist in the risk
assessment area,

— an indication of the propagule pressure of the

species (e.g. number of gametes, seeds, eggs or
propagules, number of reproductive cycles per year) for
each of those reproduction mechanisms in relation to
the environmental conditions in the risk assessment
area.

(3) The description of the spread patterns and dynamics

 shall include all of the following elements:

— a list and description of the spread mechanisms of

the species,

— an assessment of whether suitable environmental

conditions for the species’ spread exist in the risk
assessment area,

— an indication of the rate of each of those spread

mechanisms in relation to the environmental conditions
in the risk assessment area.

Art 5(1)(c) — a description (1) All relevant pathways for introduction as well as for
of the potential pathways of spread shall be considered. The classification of
introduction and spread of pathways developed by the Convention on Biological
the species, both intentional Diversity (2) shall be used as a basis.
and unintentional,
including where relevant (2) The description of intentional pathways of
the commodities with which introduction shall include all of the following elements:
the species is generally
associated — a list and description of pathways with an indication
of their importance and associated risks (e.g. the
likelihood of introduction into the risk assessment area,
based on those pathways; the likelihood of survival,
reproduction or increase during transport and storage;
the ability and likelihood of transfer from those
pathways to a suitable habitat or host), including, where
possible, details about the specific origins and end
points of the pathways,

— an indication of the propagule pressure (e.g. the

estimated volume or number of specimens, or the
frequency of passage through those pathways),
including the likelihood of reinvasion after eradication.

(3) The description of unintentional pathways of

introduction shall include all of the following elements:

— a list and description of pathways with an indication

of their importance and associated risks (e.g. the
likelihood of introduction into the risk assessment area,
based on those pathways; the likelihood of survival,
reproduction or increase during transport and storage;
the likelihood of non-detection at the entry point; the
ability and likelihood of transfer from those pathways

2
UNEP/CBD/SBSTTA/18/9/Add.1. — References to the classification of pathways developed by the
Convention on Biological Diversity shall be construed as references to the latest amended version of
that classification.
to a suitable habitat or host), including, where possible,
details about the specific origins and end points of the
pathways,

— an indication of the propagule pressure (e.g. the

estimated volume or number of specimens, or the
frequency of passage through those pathways),
including the likelihood of reinvasion after eradication.

(4) The description of commodities with which the

introduction of the species is generally associated shall
include a list and description of commodities with an
indication of associated risks (e.g. the volume of trade
flow; the likelihood of the commodity being
contaminated or acting as a vector).

(5) The description of intentional pathways of spread

shall include all of the following elements:

— a list and description of pathways with an indication

of their importance and associated risks (e.g. the
likelihood of spread within the risk assessment area,
based on those pathways; the likelihood of survival,
reproduction or increase during transport and storage;
the ability and likelihood of transfer from those
pathways to a suitable habitat or host), including, where
possible, details about the specific origins and end
points of the pathways,

— an indication of the propagule pressure (e.g. the

estimated volume or number of specimens, or the
frequency of passage through those pathways),
including the likelihood of reinvasion after eradication.

(6) The description of unintentional pathways of spread

shall include all of the following elements:

— a list and description of pathways with an indication

of their importance and associated risks (e.g. the
likelihood of spread within the risk assessment area,
based on those pathways; the likelihood of survival,
reproduction or increase during transport and storage;
the ease of detection; the ability and likelihood of
transfer from those pathways to a suitable habitat or
host), including, where possible, details about the
specific origins and end points of the pathways,

— an indication of the propagule pressure (e.g. the

estimated volume or number of specimens, or the
 frequency of passage through those pathways),
including the likelihood of reinvasion after eradication.

(7) The description of commodities with which the

spread of the species is generally associated shall
include a list and description of commodities with an
indication of associated risks (e.g. the volume of trade;
the likelihood of a commodity being contaminated or
acting as vector).

Art 5(1)(d) — a thorough (1) The thorough assessment shall provide insights into
assessment of the risk of the risks of a species’ introduction into, establishment
introduction, establishment in and spread within relevant biogeographical regions
and spread in relevant in the risk assessment area, explaining how foreseeable
biogeographical regions in climate change conditions will influence those risks.
current conditions and in
foreseeable climate change (2) The thorough assessment of those risks does not
conditions have to include a full range of simulations on the basis
of different climate change scenarios, as long as an
assessment of likely introduction, establishment and
spread within a medium timeframe scenario (e.g. 30-50
years) with a clear explanation of the assumptions is
provided.

(3) The risks referred to in point (1) may, for example,

be described in terms of ‘likelihood’ or ‘rate’.

Art 5(1)(e) — a description (1) The description of the current distribution in the
of the current distribution risk assessment area or in neighbouring countries shall
of the species, including include all of the following elements:
whether the species is
already present in the — a list of biogeographic region(s) or marine
Union or in neighbouring subregion(s) in the risk assessment area, where the
countries, and a projection species is present and where it has established,
of its likely future
distribution — the current establishment status of the species in
each Member State and, where relevant, in
neighbouring countries.

(2) The projection of the likely future distribution in the

risk assessment area or in neighbouring countries shall
include all of the following elements:

— a list of biogeographic region(s) or marine

subregion(s) in the risk assessment area, where the
species could establish, in particular under foreseeable
climate change conditions,
 — a list of Member States and, where relevant,
neighbouring countries where the species could
establish, in particular under foreseeable climate
change conditions.

Art 5(1)(f) — a description (1) In the description, a distinction shall be made

of the adverse impact on between the known impact and the potential future
biodiversity and related impact on biodiversity and related ecosystem services.
ecosystem services, The known impact shall be described for the risk
including on native species, assessment area, and for third countries if relevant (e.g.
protected sites, endangered with similar eco-climatic conditions). The potential
habitats, as well as on future impact shall be assessed only for the risk
human health, safety, and assessment area.
the economy including an
assessment of the potential (2) The description of the known impact and the
future impact having assessment of the potential future impact shall be based
regard to available on the best available quantitative or qualitative
scientific knowledge evidence. The magnitude of the impact shall be scored
or otherwise classified. The impact scoring or
classification system used shall include a reference to
the underlying publication.

(3) The description of the known impact and the

assessment of the potential future impact on
biodiversity shall make reference to all of the following
elements:

— the different biogeographic regions or marine sub-

regions where the species could establish,

— native species impacted, including red list species

and species listed in the annexes of Council Directive
92/43/EEC (3) and species covered by Directive
2009/147/EC of the European Parliament and of the
Council (4),

— habitats impacted, including red list habitats and

habitats listed in the annexes of Directive 92/43/EEC,

— protected sites impacted,

— impacted chemical, physical or structural

characteristics and functioning of ecosystems,

— impacted ecological status of aquatic ecosystems or

3
Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild
fauna and flora (OJ L 206, 22.7.1992, p. 7).
4
Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the
conservation of wild birds (OJ L 20, 26.1.2010, p. 7).
 impacted environmental status of marine waters.

(4) The description of the known impact and the

assessment of the potential future impact on related
ecosystem services shall make reference to all of the
following elements:

— provisioning services,

— regulating services,

— cultural services.

(5) The description of the known impact and the

assessment of potential future impact on human health,
safety and the economy, shall, if relevant, include
information on:

— illnesses, allergies or other affections to humans that

may derive directly or indirectly from a species,

— damages provoked directly or indirectly by a species

with consequences for the safety of people, property or
infrastructure,

— direct or indirect disruption of, or other

consequences for, an economic or social activity due to
the presence of a species.

Art 5(1)(g) — an (1) The assessment, in monetary or other terms, of the

assessment of the potential potential costs of damage on biodiversity and
costs of damage ecosystem services shall describe those costs
quantitatively and/or qualitatively depending on what
information is available. If the information available is
not sufficient to assess the costs for the entire risk
assessment area, qualitative data or different case
studies from across the Union or third countries shall
be used, if available.

(2) The assessment of the potential costs of damage on

human health, safety, and the economy shall describe
those costs quantitatively and/or qualitatively
depending on what information is available. If the
information available is not sufficient to assess the
costs for the entire risk assessment area, qualitative data
or different case studies from across the Union or third
countries shall be used, if available.

Art 5(1)(h) — a description (1) The description of known uses for the species shall
of the known uses for the include a list and description of known uses in the
species and social and Union and elsewhere, if relevant.
economic benefits deriving
from those uses (2) The description of social and economic benefits
deriving from the known uses for the species shall
include a description of the environmental, social and
economic relevance of each of those uses and an
indication of associated beneficiaries, quantitatively
and/or qualitatively depending on what information is
available. If the information available is not sufficient
to provide a description of those benefits for the entire
risk assessment area, qualitative data or different case
studies from across the Union or third countries shall
be used, if available.