Commodity risk assessment of Malus domestica plants from Ukraine
2021; Wiley; Volume: 19; Issue: 11 Linguagem: Inglês
10.2903/j.efsa.2021.6909
ISSN1831-4732
AutoresClaude Bragard, Katharina Dehnen‐Schmutz, Paolo Gonthier, Marie‐Agnès Jacques, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Panagiotis Milonas, Juan A Navas‐Cortés, Stephen Parnell, Roel Potting, Philippe Lucien Reignault, Hans‐Hermann Thulke, Wopke Van der Werf, Antonio Vicent Civera, Lucia Zappalà, Andrea Lucchi, Pedro Gómez, Gregor Urek, Umberto Bernardo, Giovanni Bubici, Anna Vittoria Carluccio, Michela Chiumenti, Francesco Di Serio, Elena Fanelli, Cristina Marzachì, Ciro Gardi, Olaf Mosbach‐Schulz, Eduardo de la Peña, Jonathan Yuen,
Tópico(s)Insect Pest Control Strategies
ResumoEFSA JournalVolume 19, Issue 11 e06909 Scientific OpinionOpen Access Commodity risk assessment of Malus domestica plants from Ukraine EFSA Panel on Plant Health (PLH), Corresponding Author EFSA Panel on Plant Health (PLH) alpha@efsa.europa.eu Correspondence:alpha@efsa.europa.euSearch for more papers by this authorClaude Bragard, Claude BragardSearch for more papers by this authorKatharina Dehnen-Schmutz, Katharina Dehnen-SchmutzSearch for more papers by this authorPaolo Gonthier, Paolo GonthierSearch for more papers by this authorMarie-Agnès Jacques, Marie-Agnès JacquesSearch for more papers by this authorJosep Anton Jaques Miret, Josep Anton Jaques MiretSearch for more papers by this authorAnnemarie Fejer Justesen, Annemarie Fejer JustesenSearch for more papers by this authorAlan MacLeod, Alan MacLeodSearch for more papers by this authorChrister Sven Magnusson, Christer Sven MagnussonSearch for more papers by this authorPanagiotis Milonas, Panagiotis MilonasSearch for more papers by this authorJuan A Navas-Cortes, Juan A Navas-CortesSearch for more papers by this authorStephen Parnell, Stephen ParnellSearch for more papers by this authorRoel Potting, Roel PottingSearch for more papers by this authorPhilippe Lucien Reignault, Philippe Lucien ReignaultSearch for more papers by this authorHans-Hermann Thulke, Hans-Hermann ThulkeSearch for more papers by this authorWopke Van der Werf, Wopke Van der WerfSearch for more papers by this authorAntonio Vicent Civera, Antonio Vicent CiveraSearch for more papers by this authorLucia Zappalà, Lucia ZappalàSearch for more papers by this authorAndrea Lucchi, Andrea LucchiSearch for more papers by this authorPedro Gómez, Pedro GómezSearch for more papers by this authorGregor Urek, Gregor UrekSearch for more papers by this authorUmberto Bernardo, Umberto BernardoSearch for more papers by this authorGiovanni Bubici, Giovanni BubiciSearch for more papers by this authorAnna Vittoria Carluccio, Anna Vittoria CarluccioSearch for more papers by this authorMichela Chiumenti, Michela ChiumentiSearch for more papers by this authorFrancesco Di Serio, Francesco Di SerioSearch for more papers by this authorElena Fanelli, Elena FanelliSearch for more papers by this authorCristina Marzachì, Cristina MarzachìSearch for more papers by this authorCiro Gardi, Ciro GardiSearch for more papers by this authorOlaf Mosbach-Schulz, Olaf Mosbach-SchulzSearch for more papers by this authorEduardo de la Peña, Eduardo de la PeñaSearch for more papers by this authorJonathan Yuen, Jonathan YuenSearch for more papers by this author EFSA Panel on Plant Health (PLH), Corresponding Author EFSA Panel on Plant Health (PLH) alpha@efsa.europa.eu Correspondence:alpha@efsa.europa.euSearch for more papers by this authorClaude Bragard, Claude BragardSearch for more papers by this authorKatharina Dehnen-Schmutz, Katharina Dehnen-SchmutzSearch for more papers by this authorPaolo Gonthier, Paolo GonthierSearch for more papers by this authorMarie-Agnès Jacques, Marie-Agnès JacquesSearch for more papers by this authorJosep Anton Jaques Miret, Josep Anton Jaques MiretSearch for more papers by this authorAnnemarie Fejer Justesen, Annemarie Fejer JustesenSearch for more papers by this authorAlan MacLeod, Alan MacLeodSearch for more papers by this authorChrister Sven Magnusson, Christer Sven MagnussonSearch for more papers by this authorPanagiotis Milonas, Panagiotis MilonasSearch for more papers by this authorJuan A Navas-Cortes, Juan A Navas-CortesSearch for more papers by this authorStephen Parnell, Stephen ParnellSearch for more papers by this authorRoel Potting, Roel PottingSearch for more papers by this authorPhilippe Lucien Reignault, Philippe Lucien ReignaultSearch for more papers by this authorHans-Hermann Thulke, Hans-Hermann ThulkeSearch for more papers by this authorWopke Van der Werf, Wopke Van der WerfSearch for more papers by this authorAntonio Vicent Civera, Antonio Vicent CiveraSearch for more papers by this authorLucia Zappalà, Lucia ZappalàSearch for more papers by this authorAndrea Lucchi, Andrea LucchiSearch for more papers by this authorPedro Gómez, Pedro GómezSearch for more papers by this authorGregor Urek, Gregor UrekSearch for more papers by this authorUmberto Bernardo, Umberto BernardoSearch for more papers by this authorGiovanni Bubici, Giovanni BubiciSearch for more papers by this authorAnna Vittoria Carluccio, Anna Vittoria CarluccioSearch for more papers by this authorMichela Chiumenti, Michela ChiumentiSearch for more papers by this authorFrancesco Di Serio, Francesco Di SerioSearch for more papers by this authorElena Fanelli, Elena FanelliSearch for more papers by this authorCristina Marzachì, Cristina MarzachìSearch for more papers by this authorCiro Gardi, Ciro GardiSearch for more papers by this authorOlaf Mosbach-Schulz, Olaf Mosbach-SchulzSearch for more papers by this authorEduardo de la Peña, Eduardo de la PeñaSearch for more papers by this authorJonathan Yuen, Jonathan YuenSearch for more papers by this author First published: 11 November 2021 https://doi.org/10.2903/j.efsa.2021.6909 Requestor: European Commission Question number: EFSA-Q-2020-00436 Panel members: Claude Bragard, Katharina Dehnen-Schmutz, Francesco Di Serio, Paolo Gonthier, Marie-Agnès Jacques, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Panagiotis Milonas, Juan A Navas-Cortes, Stephen Parnell, Roel Potting, Philippe L Reignault, Hans-Hermann Thulke, Wopke Van der Werf, Antonio Vicent, Jonathan Yuen and Lucia Zappalà. Declarations of interest: The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch. Acknowledgements: EFSA wishes to acknowledge the important contribution of Oresteia Sfyra. Amendment: An editorial correction was carried out. On page 40, in the table in section A.3.1. Georgia and Turkey were deleted in the row titled "Pest status in the EU countries". This correction does not materially affect the contents or outcome of this scientific output. To avoid confusion, the original version of the output has been removed from the EFSA Journal, but is available on request. Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder: Figure 2: © Wikimedia Commons, Ali Zifan (modified); Figure 3: © State Service of Ukraine on Food Safety and Consumer Protection (SSUFSCP). Adopted: 30 September 2021 Amended: 21 December 2021 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'). This Scientific Opinion covers plant health risks posed by 1- to 3-year-old dormant grafted plants and rootstocks of Malus domestica imported from Ukraine, taking into account the available scientific information, including the technical information provided by Ukraine. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two quarantine pests (Lopholeucaspis japonica and Tobacco ringspot virus), one protected zone quarantine pest (Erwinia amylovora) and one non-regulated pest (Eotetranychus prunicola) that fulfilled all relevant criteria were selected for further evaluation. For Erwinia amylovora, for which special requirements are specified in Commission Implementing Regulation (EU) 2019/2072, Annex X, item 9, the fulfilment of these requirements was evaluated. Based on the information provided in the dossier, the specific requirements for Erwinia amylovora were not met. For the three remaining selected pests, the risk mitigation measures proposed in the technical dossier from Ukraine were evaluated taking into account the possible limiting factors. For the selected pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Eotetranychus prunicola being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9,912 and 10,000 bundles (consisting of 50 plants each) per 10,000 would be free from Eotetranychus prunicola. 1 Introduction 1.1 Background and Terms of Reference as provided by European Commission 1.1.1 Background The new Plant Health Regulation (EU) 2016/203111 Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) 228/2013, (EU) 652/2014 and (EU) 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC. OJ L 317, 23.11.2016, pp. 4–104., on the protective measures against pests of plants, has been applied from December 2019. Provisions within the above Regulation are in place for the listing of 'high risk plants, plant products and other objects' (Article 42) on the basis of a preliminary assessment, and to be followed by a commodity risk assessment. A list of 'high risk plants, plant products and other objects' has been published in Regulation (EU) 2018/201922 Commission Implementing Regulation (EU) 2018/2019 of 18 December 2018 establishing a provisional list of high risk plants, plant products or other objects, within the meaning of Article 42 of Regulation (EU) 2016/2031 and a list of plants for which phytosanitary certificates are not required for introduction into the Union, within the meaning of Article 73 of that Regulation C/2018/8877. OJ L 323, 19.12.2018, pp. 10–15.. Scientific opinions are therefore needed to support the European Commission and the Member States in the work connected to Article 42 of Regulation (EU) 2016/2031, as stipulated in the terms of reference. 1.1.2 Terms of Reference In view of the above and in accordance with Article 29 of Regulation (EC) No. 178/200233 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, pp. 1–24., the Commission asks EFSA to provide scientific opinions in the field of plant health. In particular, EFSA is expected to prepare and deliver risk assessments for commodities listed in the relevant Implementing Act as "High risk plants, plant products and other\ objects". Article 42, paragraphs 4 and 5, establishes that a risk assessment is needed as a follow-up to evaluate whether the commodities will remain prohibited, removed from the list and additional measures will be applied or removed from the list without any additional measures. This task is expected to be on-going, with a regular flow of dossiers being sent by the applicant required for the risk assessment. Therefore, to facilitate the correct handling of the dossiers and the acquisition of the required data for the commodity risk assessment, a format for the submission of the required data for each dossier is needed. Furthermore, a standard methodology for the performance of "commodity risk assessment" based on the work already done by Member States and other international organizations needs to be set. In view of the above and in accordance with Article 29 of Regulation (EC) No. 178/2002, the Commission asks EFSA to provide scientific opinion in the field of plant health for M. domestica from Ukraine taking into account the available scientific information, including the technical dossier provided by the State Service of Ukraine on Food Safety and Consumer Protection (SSUFSCP). 1.2 Interpretation of the Terms of Reference The EFSA Panel on Plant Health (hereafter referred to as 'the Panel') was requested to conduct a commodity risk assessment of Malus domestica from Ukraine following the Guidance on commodity risk assessment for the evaluation of high-risk plant dossiers (EFSA PLH Panel, 2019a). The EU quarantine pests that are regulated as a group in the Commission Implementing Regulation (EU) 2019/2072 were considered and evaluated separately at species level. Annex II of Implementing Regulation (EU) 2019/2072 lists certain pests as non-European populations or isolates or species. These pests are regulated quarantine pests. Consequently, the respective European populations, or isolates, or species are non-regulated pests. Annex VII of the same Regulation, in certain cases (e.g. point 32), makes reference to the following countries that are excluded from the obligation to comply with specific import requirements for those non-European populations, or isolates, or species: Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Canary Islands, Faeroe Islands, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Montenegro, North Macedonia, Norway, Russia (only the following parts: Central Federal District (Tsentralny federalny okrug), Northwestern Federal District (SeveroZapadny federalny okrug), Southern Federal District (Yuzhny federalny okrug), North Caucasian Federal District (Severo-Kavkazsky federalny okrug) and Volga Federal District (Privolzhsky federalny okrug), San Marino, Serbia, Switzerland, Turkey, Ukraine and United Kingdom (except Northern Ireland1). Those countries are historically linked to the reference to 'non-European countries' existing in the previous legal framework, Directive 2000/29/EC. Consequently, for those countries, any pests identified, which are listed as non-European species in Annex II of Implementing Regulation (EU) 2019/2072 should be investigated as any other non-regulated pest. Pests listed as 'Regulated Non-Quarantine Pest' (RNQP)' in Annex IV of the Commission Implementing Regulation (EU) 2019/2072, and deregulated pests (i.e. pest which were listed as quarantine pests in the Council Directive 2000/29/EC and were deregulated by Commission Implementing Regulation (EU) 2019/2072) were not considered for further evaluation. In case a pest is at the same time regulated as an RNQP and as a protected zone quarantine pest; in this opinion, it should be evaluated as quarantine pest. In its evaluation, the Panel: Checked whether the information provided by the applicant (State Service of Ukraine on Food Safety and Consumer Protection - SSUFSCP) in the technical dossier (hereafter referred to as 'the Dossier') was sufficient to conduct a commodity risk assessment. When necessary, additional information was requested to the applicant. Selected the relevant union EU-regulated quarantine pests and protected zone quarantine pests (as specified in Commission Implementing Regulation (EU)44 Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019, OJ L 319, 10.12.2019, p. 1–279. , hereafter referred to as 'EU quarantine pests') and other relevant pests present in Ukraine and associated with the commodity. Assessed whether or not the applicant country implements specific measures for Union quarantine pests for which specific measures are in place for the import of the commodity from the specific country in the relevant legislative texts for emergency measures (https://ec.europa.eu/food/plant/plant_health_biosecurity/legislation/emergency_measures_en); the assessment was restricted to whether or not the applicant country applies those measures. The effectiveness of those measures was not assessed. Assessed whether the applicant country implements the special requirements specified in Annex VII (points 1–101) of the Commission Implementing Regulation (EU) 2019/2072 targeting Union quarantine pests for the commodity in question from the specific country. Assessed the effectiveness of the measures described in the dossier for those Union quarantine pests for which no specific measures are in place for the import of the commodity from the specific applicant country and other relevant pests present in applicant country and associated with the commodity. Risk management decisions are not within EFSA's remit. Therefore, the Panel provided a rating based on expert judgement regarding the likelihood of pest freedom for each relevant pest given the risk mitigation measures proposed by the SSUFSCP. 2 Data and methodologies 2.1 Data provided by the SSUFSCP The Panel considered all the data and information (hereafter called 'the Dossier') provided by SSUFSCP in February 2020, including the additional information provided by the SSUFSCP in January 2021 and in August 2021, after EFSA's request. The Dossier is managed by EFSA. The structure and overview of the Dossier is shown in Table 1. The number of the relevant section is indicated in the opinion when referring to a specific part of the Dossier. Table 1. Structure and overview of the Dossier Dossier section Overview of contents Filename 1.0 Technical dossier Malus d.docx 1.1 Pest list on Malus domestica Appendix Malus.docx 2.0 Additional information provided by the SSUFSCP on January 2021 UKR Malus.docx 3.0 Additional information provided by the SSUFSCP on August 2021 Annex 1.docx The data and supporting information provided by the SSUFSCP formed the basis of the commodity risk assessment. Table 2 shows the main data sources used by the SSUFSCP to compile the Dossier (details on literature searches can be found in the Dossier Section 1.1). Table 2. Database sources used in the literature searches by the SSUFSCP Acronym/short title Database name and service provider URL of database Justification for choosing database EPPO Name: EPPO Global Database Provider: European and Mediterranean Plant Protection Organization https://gd.eppo.int/ This database provides all pest-specific information that has been produced or collected by EPPO. Wikipedia https://en.wikipedia.org/wiki/Adoxophyes_oranahttps://en.wikipedia.org/wiki/Anarsia_lineatellahttps://en.wikipedia.org/wiki/Codling_moth General information on specific pests. Website of the Ministry of Agricultural Policy of Ukraine https://zakon.rada.gov.ua/go/z1300-06 List of regulated and quarantine pests (in Ukrainian). Website of the Government of Ukraine https://data.gov.ua/dataset/389ddb5a-ac73-44bb-9252-f899e4a97588 List of pesticides and agrochemicals approved for useState Register of Pesticides and Agrochemicals Permitted for Use in Ukraine in accordance with the requirements of the Resolution of the Cabinet of Ministers of Ukraine of November 21, 2007 No 1328 (in Ukrainian). 2.2 Literature searches performed by EFSA Literature searches in different databases were undertaken by EFSA to complete a list of pests potentially associated with M. domestica. The following searches were combined: (i) a general search to identify pests of M. domestica in different databases and (ii) a tailored search to identify whether these pests are present or not in Ukraine and the EU. The searches were run between 24 January 2021 and 22 April 2021. No language, date or document type restrictions were applied in the search strategy. The search strategy and search syntax were adapted to each of the databases listed in Table 3, according to the options and functionalities of the different databases and CABI keyword thesaurus. As for Web of Science, the literature search was performed using a specific, ad hoc established search string (see Appendix B). The string was run in 'All Databases' with no range limits for time or language filters. This is further explained in Section 2.3.2. Table 3. Databases used by EFSA for the compilation of the pest list associated with M. domestica Database Platform/Link Aphids on World Plants http://www.aphidsonworldsplants.info/C_HOSTS_AAIntro.htm CABI Crop Protection Compendium https://www.cabi.org/cpc/ Database of Insects and their Food Plants http://www.brc.ac.uk/dbif/hosts.aspx Database of the World's Lepidopteran Hostplants https://www.nhm.ac.uk/our-science/data/hostplants/search/index.dsml EPPO Global Database https://gd.eppo.int/ EUROPHYT https://webgate.ec.europa.eu/europhyt/ Leaf-miners http://www.leafmines.co.uk/html/plants.htm Nemaplex http://nemaplex.ucdavis.edu/Nemabase2010/PlantNematodeHostStatusDDQuery.aspx Plant Pest Information Network https://www.mpi.govt.nz/news-and-resources/resources/registers-and-lists/plant-pest-information-network/ Plant Viruses Online http://bio-mirror.im.ac.cn/mirrors/pvo/vide/famindex.htm Scalenet http://scalenet.info/associates/ Spider Mites Web https://www1.montpellier.inra.fr/CBGP/spmweb/advanced.php USDA ARS Fungal Database https://nt.ars-grin.gov/fungaldatabases/fungushost/fungushost.cfm Web of Science: All Databases (Web of Science Core Collection, CABI: CAB Abstracts, BIOSIS Citation Index, Chinese Science Citation Database, Current Contents Connect, Data Citation IndexFSTA, KCI-Korean Journal Database, Russian Science Citation Index, MEDLINESciELO Citation Index, Zoological Record) Web of Sciencehttps://www.webofknowledge.com World Agroforestry http://www.worldagroforestry.org/treedb2/speciesprofile.php?Spid=1749 GBIF https://www.gbif.org/ Fauna Europaea https://fauna-eu.org/ EFSA Pest Categorization of Non EU virus and viroids of Prunus L. https://www.efsa.europa.eu/it/efsajournal/pub/5735 EFSA List of Non-EU viruses and viroids of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.. https://www.efsa.europa.eu/it/efsajournal/pub/5501 Additional searches, limited to retrieve documents, were run when developing the opinion. The available scientific information, including previous EFSA opinions on the relevant pests and diseases (see pest data sheets in Appendix A) and the relevant literature and legislation (e.g. Regulation (EU) 2016/2031; Commission Implementing Regulations (EU) 2018/2019; (EU) 2018/2018 and (EU) 2019/2072), were taken into account. 2.3 Methodology When developing the opinion, the Panel followed the EFSA Guidance on commodity risk assessment for the evaluation of high-risk plant dossiers (EFSA PLH Panel, 2019a). In the first step, pests potentially associated with the commodity in the country of origin (EU-quarantine pests and other pests) that may require risk mitigation measures were identified. The EU non-quarantine pests not known to occur in the EU were selected based on evidence of their potential impact in the EU. After the first step, all the relevant pests that may need risk mitigation measures were identified. In the second step, the proposed risk mitigation measures for each relevant pest were evaluated in terms of efficacy or compliance with EU requirements as explained in Section 1.2. A conclusion on the likelihood of the commodity being free from each of the relevant pest was determined and uncertainties identified using expert judgements. Pest freedom was assessed by estimating the number of infested/infected bundles out of 10,000 exported bundles. Each bundle contains 50 pieces of M. domestica rootstocks. 2.3.1 Commodity data Based on the information provided by the Ukraine, the characteristics of the commodity were summarised. 2.3.2 Identification of pests potentially associated with the commodity To evaluate the pest risk associated with the importation of M. domestica from Ukraine, a pest list was compiled. The pest list is a compilation of all identified plant pests associated with M. domestica based on information provided in the Dossier Section 1.2 and on searches performed by the Panel. The search strategy and search syntax were adapted to each of the databases listed in Table 3, according to the options and functionalities of the different databases and CABI keyword thesaurus. The scientific names of the host plants (i.e. Malus domestica) were used when searching in the EPPO Global database and CABI Crop Protection Compendium. The same strategy was applied to the other databases excluding EUROPHYT and Web of Science. EUROHYT was consulted by searching for the interceptions associated with commodities imported from Ukraine, at species level, from 1995 to May 2020 and TRACES for interceptions from May 2020 to present. For the pests selected for further evaluation, a search in the EUROPHYT and/or TRACES was performed for the interceptions from the whole world, at species level. The search strategy used for Web of Science Databases was designed combining common names for pests and diseases, terms describing symptoms of plant diseases and the scientific and common names of the commodity. All the pests already retrieved using the other databases were removed from the search terms in order to be able to reduce the number of records to be screened. The established search string is detailed in Appendix B and was run on 12 April 2021. The titles and abstracts of the scientific papers retrieved were screened and the pests associated with M. domestica were included in the pest list. The pest list was eventually further compiled with other relevant information (e.g. EPPO code per pest, taxonomic information, categorisation, distribution) useful for the selection of the pests relevant for the purposes of this opinion. The compiled pest list (see Microsoft Excel® file in Appendix C) includes all identified pests that use M. domestica as host. The evaluation of the compiled pest list was done in two steps: first, the relevance of the EU-quarantine pests was evaluated (Section 4.1); second, the relevance of any other plant pest was evaluated (Section 4.2). 2.3.3 Listing and evaluation of risk mitigation measures All proposed risk mitigation measures were listed and evaluated. When evaluating the likelihood of pest freedom at origin, the following types of potential infection sources for M. domestica in nurseries were considered (see also Figure 1): pest entry from surrounding areas, pest entry with new plants/seeds, pest spread within the nursery. The risk mitigation measures adopted in the plant nurseries (as communicated by Ukraine) were evaluated with Expert Knowledge Elicitation (EKE) according to the Guidance on uncertainty analysis in scientific assessment (EFSA Scientific Committee, 2018). Figure 1Open in figure viewerPowerPoint Conceptual framework to assess likelihood that plants are exported free from relevant pests. Source: EFSA PLH Panel (2019b) Information on the biology, estimates of likelihood of entry of the pest to the nursery and spread within the nursery, and the effect of the measures on a specific pest were summarised in pest data sheets compiled for each pest selected for further evaluation (see Appendix A). 2.3.4 Expert Knowledge Elicitation To estimate the pest freedom of the commodity, an EKE was performed following EFSA guidance (Annex B.8 of EFSA Scientific Committee, 2018). The specific question for EKE was: 'Taking into account (i) the risk mitigation measures in place in the nurseries, and (ii) other relevant information, how many of 10,000 bundles of M. domestica rootstocks or grafted plants will be infested with the relevant pest when arriving in the EU?'. Bundle was used as unit for the EKE because of the possibility of pest movement/spread within the bundle. The EKE question was common to all pests for which the pest freedom of the commodity was estimated. The uncertainties associated with the EKE were taken into account and quantified in the probability distribution applying the semi-formal method described in section 3.5.2 of the EFSA-PLH Guidance on quantitative pest risk assessment (EFSA PLH Panel, 2018). Finally, the results were reported in terms of the likelihood of pest freedom. The lower 5% percentile of the uncertainty distribution reflects the opinion that pest freedom is with 95% certainty above this limit. 3 Commodity data 3.1 Description of the commodity The commodities to be imported are rootstocks and grafted plants of Malus domestica L. (common name: apple; family: Rosaceae). There are two rootstocks i.e. M9 and MM106 and these rootstocks are grafted with different cultivars i.e. Luna, Sirius, Rosella, Red Topaz, Allegro. Apple plants for export are produced by two growers i.e. Bakhmut Nursery, in the Bakhmut district, Donetsk region; and SE 'Holland Plant Ukraine', located in the Zakarpattia region (western Ukraine). Bakhmut nursery produces ungrafted rootstocks, while SE 'Holland Plant Ukraine' produces rootstocks and grafted plants with the aforementioned cultivars. The commodities for export (both roo
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