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DISCLAIMER
This working document has been prepared by DG ENV staff in order to facilitate the
discussion in the IAS Scientific Forum on a draft delegated act on risk assessments. It
has not yet been subject to an inter-service consultation nor revised by the Legal
Service.
ANNEX 1
Detailed description of the application of point (a) to (h) of Article 5(1) of Regulation
1143/2014
Elements to be
considered by the Risk
Assessments
Art 5(1)(a) - a description
of the species with its
taxonomic identity, its
history, and its natural
and potential range
Detailed description
(1) The description of the species should provide sufficient
information to ensure the risk assessment can be understood without
reference to additional documentation.
(2) The scope of the risk assessment should be very precisely
delineated, e.g. it should be clearly stated if it covers more than one
species, or if it includes hybrids (if so which ones) or if it excludes
some varieties, e.g. sterile varieties (if so which ones) Any such
choice must be properly justified.
While as a general rule a risk assessment should be developed for
one 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).
(3) The taxonomic identity of the species shall include the following
elements:
 the taxonomic family, order and class to which the species
belongs;
 the scientific name and author of the species, as well as a list
of the most common synonym names (a list of synonyms
needs to be developed to support the implementation of a
trade ban);
 a description of the most common varieties, breeds or
hybrids;
 information on the existence of other species that look very
similar:
o Other alien species with similar invasive
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characteristics, to be avoided as substitute species (in
this case preparing a risk assessment for more than
one species together may be considered)
o Other alien species without similar invasive
characteristics, potential substitute species
o Native species, potential misidentification and mistargeting
(4) The history of the species shall include following elements:
 a brief invasion history of the species, providing information
on countries invaded (in the EU and elsewhere if relevant),
with an indication of the timeline of first observations,
establishment and spread
(5) The natural and potential range of the species shall include the
following elements:
 an indication of the continent or part of a continent, climatic
zone or habitat where the species is naturally occurring and
potential natural changes of the natural range, in particular
under foreseeable climate change conditions
Art 5(1)(b) - a description
of its reproduction and
spread patterns and
dynamics including an
assessment of whether the
environmental conditions
necessary for its
reproduction and spread
exist
(1) Both descriptions of reproduction and spread patterns should
include elements of the species life history traits able to explain its
ability to establish and spread, including: reproductive or growth
strategy, dietary requirements, climatic requirements, specialist or
generalist characteristics, longevity.
(2) The description of the reproductive patterns and dynamics,
including availability of suitable environmental conditions in the EU
shall include the following elements:
 a list and description of the reproduction mechanisms of the
species in relation to the environmental conditions in the EU.
 an indication of the propagule pressure of each of those
reproduction mechanisms in relation to the environmental
conditions in the EU.
(3) The description of the spread patterns and dynamics, including
availability of suitable environmental conditions in the EU shall
include the following elements:
 a list and description of the spread mechanisms of the
species in relation to the environmental conditions in the EU.
 an indication of the speed of each of those spread
mechanisms in relation to the environmental conditions in
the EU.
Art 5(1)(c) - a description
of the potential pathways
of introduction and
spread of the species,
both intentional and
(1) For introduction as well as for spread, all relevant pathways
should be considered. The classification of pathways developed by
the Convention of Biological Diversity shall be used.
(2) The description of intentional pathways of introduction shall
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unintentional, including
where relevant the
commodities with which
the species is generally
associated
include the following elements:
 a list and description of pathways with an indication of their
importance and associated risks (e.g. the likelihood of
introduction in the EU, based on these pathways; likelihood
of survival, or reproduction, or increase during transport and
storage; ability and likelihood of transfer from the pathway
to a suitable habitat or host). Where possible give details
about the specific origins and end points of the pathways;
 an indication of the propagule pressure (e.g. estimated
volume or number of specimens, or frequency of passage
through pathway), including the likelihood of reinvasion
after eradication.
(3) The description of unintentional pathways of introduction shall
include the following elements:
 a list and description of pathways with an indication of their
importance and associated risks (e.g. the likelihood of
introduction in the EU, based on these pathways; likelihood
of survival, or reproduction, or increase during transport and
storage; likelihood of non-detection at entry point; ability
and likelihood of transfer from the pathway to a suitable
habitat or host). Where possible give details about the
specific origins and end points of the pathways;
 an indication of the propagule pressure (e.g. estimated
volume or number of specimens, or frequency of passage
through pathway), including the likelihood of reinvasion
after eradication.
(4) The description of commodities with which the introduction of
the species is generally associated shall include the following
elements:
 a list and description of commodities with an indication of
their importance and associated risks (e.g. likelihood of
commodity to be contaminated or to act as vector).
(5) The description of intentional pathways of spread shall include
the following elements:
 a list and description of pathways with an indication of their
importance and associated risks (e.g. the likelihood of spread
in the EU, based on these pathways; likelihood of survival,
or reproduction, or increase during transport and storage;
ability and likelihood of transfer from the pathway to a
suitable habitat or host). Where possible give details about
the specific origins and end points of the pathways.
 an indication of the propagule pressure (e.g. estimated
volume or number of specimens, or frequency of passage
through pathway), including the likelihood of reinvasion
after eradication.
(6) The description of unintentional pathways of spread shall include
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the following elements:
 a list and description of pathways with an indication of their
importance and associated risks (e.g. the likelihood of spread
in the EU, based on these pathways; likelihood of survival,
or reproduction, or increase during transport and storage;
ease of detection; ability and likelihood of transfer from the
pathway to a suitable habitat or host). Where possible give
detail about the specific origins and end points of the
pathways. Give an indication of the propagule pressure,
including the likelihood of reinvasion after eradication.
(7) The description of commodities with which the spread of the
species is generally associated shall include the following elements:
 a list and description of commodities with an indication of
their importance and associated risks(e.g. likelihood of
commodity to be contaminated or to act as vector).
Art 5(1)(d) - a thorough
assessment of the risk of
introduction,
establishment and spread
in relevant
biogeographical regions
in current conditions and
in foreseeable climate
change conditions
(1) Introduction and establishment may, for example, be evaluated
in terms of "likelihood", while spread may, for example, be
described in terms of “likelihood”, “rate” or “rapidity”.
(2) The thorough assessment of risks is not intended to provide a full
range of simulations on the basis of different climate change
scenarios, but to inform decision making. A description of likely
introduction within a medium timeframe scenario, with a clear
explanation of the assumptions made will be sufficient.
(3) The thorough assessment of the risk of introduction in current
conditions and foreseeable climate change conditions shall:
 provide insight in the risk of introduction into the Union;
 explain how foreseeable climate change conditions will
influence this risk.
(4) The thorough assessment of the risk of establishment in current
conditions and foreseeable climate change conditions shall:
 provide insight in the risk of establishment in (new areas in)
the Union;
 explain how foreseeable climate change conditions will
influence this risk.
(5) The thorough assessment of the risk of spread in current
conditions and foreseeable climate change conditions shall
 provide insight in the risk of spread into (new areas in) the
Union;
 explain how foreseeable climate change conditions will
influence this risk.
Art 5(1)(e) - a description
of the current distribution
(1) The current distribution in the Union or in neighbouring
countries shall include:
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of the species, including
whether the species is
already present in the
Union or in neighbouring
countries, and a
projection of its likely
future distribution
Art 5(1)(f) - a description
of the adverse impact on
biodiversity and related
ecosystem services,
including on native
species, protected sites,
endangered habitats, as
well as on human health,
safety, and the economy
including an assessment
of the potential future
impact having regard to
available scientific
knowledge


a list of biogeographic region(s) or marine subregion(s) in the
EU where the species is present and where it has established;
the current establishment status of the species in all Member
States and, where relevant, in neighbouring countries.
(2) The projection of its likely future distribution in the Union or in
neighbouring countries shall include:
 a list of biogeographic region(s) or marine subregion(s) in
the EU where the species could establish, in particular under
foreseeable climate change conditions
 a list of Member States and neighbouring countries where
the species could establish, in particular under foreseeable
climate change conditions
(1) The description of the impacts shall clearly differentiate between
known and potential future impacts. Known impacts shall be
described for the EU and for third countries, if relevant (e.g. with
similar eco-climatic conditions). Potential future impacts shall be
described for the EU only.
(2) The assessment of impacts may be quantitative or qualitative and
descriptive, and based on the best available data.
The magnitude of the impact shall be scored: the impact scoring
system used shall include a reference to the underlying publication.
(3) The description and assessment of known and potential future
impact on biodiversity and related ecosystem services, shall make
reference to:
 the different biogeographic regions where the species could
establish
 native species impacted, including red list species and
species listed in the Birds and Habitats Directives
 protected sites impacted, in particular Natura 2000
 endangered habitats impacted, in particular habitats listed in
the Habitats Directive, or red list habitats
 impacted chemical, physical or structural characteristics and
functioning of ecosystems
 ecosystem services impacted
 the ecological or environmental status of water bodies and
the marine environment
 diseases transmission and parasitism
(4) The description of known and potential future impact may add
information on:
 human health
 safety
 the economy
Art 5(1)(g) - an
(1) The assessment, in monetary or other terms, of the potential
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assessment of the
potential costs of damage
costs of damage on biodiversity and ecosystem services shall
describe those costs quantitatively and/or qualitatively depending on
what is available. An assessment of the above at EU scale might not
be possible, but qualitative data or different case studies from across
the EU or third countries may provide useful information to inform
decision making.
(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 is available.
An assessment of the above at EU scale might not be possible, but
qualitative data or different case studies from across the EU or third
countries may provide useful information to inform decision
making.
Art 5(1)(h) - a description
of the known uses for the
species and social and
economic benefits
deriving from those uses
(1) The description of known uses for the species shall include a list
and description of known uses in the EU and third countries, if
relevant.
(2) The description of social and economic benefits deriving from
those uses shall include a description of the environmental, social
and economic relevance of each of those uses, quantitatively and/or
qualitatively depending on what is available. A description of the
above at EU scale might not be possible, but qualitative data or
different case studies from across the EU, or third countries if
relevant, may provide useful information to inform decision making.
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