CELEX: 
Language: en
Date: 2017-11-27
Title: COMMISSION DELEGATED REGULATION (EU) …/... 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

EXPLANATORY MEMORANDUM
            
            
               1.CONTEXT OF THE DELEGATED ACT
            
            
               Regulation (EU) No 1143/2014 on invasive alien species (hereafter the IAS Regulation) sets out the framework to address the impact of invasive alien species on biodiversity and related ecosystem services and empowers the Commission to adopt, update and review a list of invasive alien species of Union concern. The Commission is assisted by a Committee consisting of Member States' representatives (hereafter the IAS Committee). 
            
            
               A precondition for considering the inclusion of a species on the list of invasive alien species of Union concern is the existence of a thorough risk assessment for that species backed by robust science addressing all the elements set out by Article 5(1) of the IAS Regulation.  
            
            
               Article 5(1) of the IAS Regulation sets out all the elements needed to produce a risk assessment capable of underpinning decision making. The IAS Regulation recognises that it may be useful to further specify those elements, including by providing a methodology to be applied in the risk assessment. Furthermore, scientific practices in the domain of risk assessments may evolve and such developments would need to be integrated in the practice of developing risk assessments for the purpose of the IAS Regulation. 
            
            
               Article 5(3) of the IAS Regulation empowers the Commission to adopt delegated acts to further specify the type of evidence acceptable regarding the capability of establishing and spreading of invasive alien species and provide a detailed description of the elements of risk assessments, including the methodology to be applied in the risk assessments, taking into account relevant national and international standards and the need to prioritise action against invasive alien species associated with, or that have the potential to cause, a significant adverse impact on biodiversity or related ecosystem services, as well as on human health or the economy, such adverse impact being considered as an aggravating factor. 
            
            
               The following considerations need to be taken into account. 
            
            
               A methodology is a system of methods used in a particular area of study or activity. This Delegated Regulation does not intend to develop a new risk assessment method, protocol or template, replacing existing and valid scientific exercises in this area. On the contrary, any method, protocol or template used to perform a risk assessment should be considered acceptable as a valid tool for the purpose of the IAS Regulation, provided that the common elements, as further specified by this Delegated Regulation, are properly addressed.
            
            
               Risk assessment and risk management should be clearly distinguished: a risk assessment is the evaluation of the probability of the introduction and spread of an organism and an assessment of its potential consequences, i.e. it evaluates the risks involved. Risk management instead is the evaluation and selection of options and measures to reduce or avoid such risks. Together, risk assessment and risk management, constitute the process known as risk analysis. Therefore, the risk assessment is considered, alongside the evaluation and selection of management options, a part of the tool that informs and enables the IAS Committee to perform its duties related to risk management.  
            
            
               As such, a risk assessment needs to be evidence based, rigorous and robust, and it should present facts and scientific evidence. It should thus be based on the best available information, if possible from peer reviewed scientific sources. If such scientific sources are lacking, or to complement those scientific sources, grey literature, expert opinions and other sources could also be used, if properly referenced and accompanied by an assessment of the uncertainty. This Delegated Regulation provides guidance on the development and the evaluation of risk assessments and sets the level of details and quality that a risk assessment should achieve. It aims at facilitating the work of the Commission, the Member States and the Scientific Forum, and at supporting the Commission and the IAS Committee in better decision making.
            
            
               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
            
            
               This Delegated Regulation has been developed on the basis of a number of studies and on the best available scientific literature. Furthermore, consultations were held with the Scientific Forum
                  1
               , the expert group established by the IAS Regulation with the mandate to provide scientific advice in relation to its implementation.
            
            
               The Scientific Forum is composed of experts and representatives from the scientific community, nominated by the Member States. This Forum had discussions to help prepare this Delegated Regulation in four meetings: on 4 April 2016 and 21 June 2016, discussion on the risk assessment methodology; on 6 October 2016 and 9 February 2017, discussion on a draft text of this Delegated Regulation.
            
            
               3.LEGAL ELEMENTS OF THE DELEGATED ACT
            
            
               As mentioned in the introductory section, Article 5(3) of the IAS Regulation provides the legal basis for the development of this Delegated Regulation. In particular, Article 5(3) empowers the Commission to: 1) further specify the type of evidence acceptable for the purposes of point (b) of Article 4(3) – i.e. capability of establishment and spread, 2) provide a detailed description of the application of points (a) to (h) of Article 5(1) and 3) set out the methodology to be applied when preparing a risk assessment, taking into account relevant national and international standards.
            
            
               This Delegated Regulation sets out to achieve these objectives: 
            
            
               Article 1 sets out the application of the common elements to be considered in a risk assessment; while Article 2 lays out a methodology, which sets out also the specification of the type of evidence that should underpin a risk assessment, including when the evidence relates to Article 4(3)(b) of the IAS Regulation. Finally, the Annex to this Regulation provides a detailed description of the application of points (a) to (h) of Article 5(1), the elements that need to be considered when preparing a risk assessment.
                     
            
            
               COMMISSION DELEGATED REGULATION (EU) …/...
            
            
               of XXX
            
         
         
            
               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
                  2
               , 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.  
            
            
               (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,
            
            
               
                     For the Commission
               
               
                     The President
                     […]
               
            
         
         
            
                  
                     (1)
                  
                        Published in the Register of Commission Expert Groups and Other Similar Entities, code number E03276
               
               
                  
                     (2)
                  
                        OJ L 317, 04.11.2014, p. 35. 
               
            
      
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                  This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the Commission.
               
            
            
            
               ANNEX
            
            
               Detailed description of the common elements
            
            
            
                     
                        The common elements 
                     
                  
                  
                     
                        Detailed description 
                     
                  
               
                     
                        Art 5(1)(a) - a description of the species with its taxonomic identity, its history, and its natural and potential range
                     
                  
                  
                     
                        (1) The description of the species shall provide sufficient information to ensure that the identity of the species can be understood without reference to additional documentation.
                     
                     
                     
                        (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 of its reproduction and spread patterns and dynamics including an assessment of whether the environmental conditions necessary for its reproduction and spread exist
                     
                     
                  
                  
                     
                        (1) The descriptions of reproduction and spread patterns shall include elements of the species life history and behavioural traits which can explain its ability to establish and spread, such as: reproduction or growth strategy, dispersal capacity, longevity, environmental and climatic requirements, specialist or generalist characteristics and other relevant available information.
                     
                     
                     
                        (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 of the potential pathways of introduction and spread of the species, both intentional and unintentional, including where relevant the commodities with which the species is generally associated
                     
                     
                  
                  
                     
                        (1) All relevant pathways for introduction as well as for spread shall be considered. The classification of pathways developed by the Convention on Biological Diversity
                           1
                         shall be used as a basis. 
                     
                     
                     
                        (2) The description of intentional 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 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 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 assessment of the risk of introduction, establishment and spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions
                     
                  
                  
                     
                        (1) The thorough assessment shall provide insights into the risks of a species' introduction into, establishment in and spread within relevant biogeographical regions in the risk assessment area, explaining how foreseeable climate change conditions will influence those risks. 
                     
                     
                     
                        (2) The thorough assessment of those risks does not 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 of the current distribution 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
                     
                  
                  
                     
                        (1) The description of the current 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 is present and where it has established;
                     
                     
                        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 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
                     
                  
                  
                     
                        (1) In the description, a distinction shall be made between the known impact and the potential future impact on biodiversity and related ecosystem services. The known impact shall be described for the risk assessment area, and for third countries if relevant (e.g. with similar eco-climatic conditions). The potential future impact shall be assessed only for the risk assessment area. 
                     
                     
                     
                        (2) The description of the known impact and the assessment of the potential future impact shall be based on the best available quantitative or qualitative 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
                           2
                         and species covered by Directive 2009/147/EC of the European Parliament and of the Council
                           3
                        ;
                     
                     
                        endangered 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 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 assessment of the potential costs of damage
                     
                  
                  
                     
                        (1) The assessment, in monetary or other terms, of the potential costs of damage on biodiversity and 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 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 Union and elsewhere, if relevant.
                     
                     
                     
                        (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. 
                     
                     
                  
               
         
         
            
                  
                     (1)
                  
                        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. 
               
               
                  
                     (2)
                  
                        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).
               
               
                  
                     (3)
                  
                        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).