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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Pest categorisation of potato virus M (non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates)</title><author><name sortKey="Bragard, Claude" sort="Bragard, Claude" uniqKey="Bragard C" first="Claude" last="Bragard">Claude Bragard</name></author><author><name sortKey="Dehnen Chmutz, Katharina" sort="Dehnen Chmutz, Katharina" uniqKey="Dehnen Chmutz K" first="Katharina" last="Dehnen-Schmutz">Katharina Dehnen-Schmutz</name></author><author><name sortKey="Gonthier, Paolo" sort="Gonthier, Paolo" uniqKey="Gonthier P" first="Paolo" last="Gonthier">Paolo Gonthier</name></author><author><name sortKey="Jacques, Marie Gnes" sort="Jacques, Marie Gnes" uniqKey="Jacques M" first="Marie-Agnès" last="Jacques">Marie-Agnès Jacques</name></author><author><name sortKey="Jaques Miret, Josep Anton" sort="Jaques Miret, Josep Anton" uniqKey="Jaques Miret J" first="Josep Anton" last="Jaques Miret">Josep Anton Jaques Miret</name></author><author><name sortKey="Justesen, Annemarie Fejer" sort="Justesen, Annemarie Fejer" uniqKey="Justesen A" first="Annemarie Fejer" last="Justesen">Annemarie Fejer Justesen</name></author><author><name sortKey="Macleod, Alan" sort="Macleod, Alan" uniqKey="Macleod A" first="Alan" last="Macleod">Alan Macleod</name></author><author><name sortKey="Magnusson, Christer Sven" sort="Magnusson, Christer Sven" uniqKey="Magnusson C" first="Christer Sven" last="Magnusson">Christer Sven Magnusson</name></author><author><name sortKey="Milonas, Panagiotis" sort="Milonas, Panagiotis" uniqKey="Milonas P" first="Panagiotis" last="Milonas">Panagiotis Milonas</name></author><author><name sortKey="Navas Ortes, Juan A" sort="Navas Ortes, Juan A" uniqKey="Navas Ortes J" first="Juan A" last="Navas-Cortes">Juan A. Navas-Cortes</name></author><author><name sortKey="Parnell, Stephen" sort="Parnell, Stephen" uniqKey="Parnell S" first="Stephen" last="Parnell">Stephen Parnell</name></author><author><name sortKey="Potting, Roel" sort="Potting, Roel" uniqKey="Potting R" first="Roel" last="Potting">Roel Potting</name></author><author><name sortKey="Reignault, Philippe Lucien" sort="Reignault, Philippe Lucien" uniqKey="Reignault P" first="Philippe Lucien" last="Reignault">Philippe Lucien Reignault</name></author><author><name sortKey="Thulke, Hans Ermann" sort="Thulke, Hans Ermann" uniqKey="Thulke H" first="Hans-Hermann" last="Thulke">Hans-Hermann Thulke</name></author><author><name sortKey="Van Der Werf, Wopke" sort="Van Der Werf, Wopke" uniqKey="Van Der Werf W" first="Wopke" last="Van Der Werf">Wopke Van Der Werf</name></author><author><name sortKey="Vicent Civera, Antonio" sort="Vicent Civera, Antonio" uniqKey="Vicent Civera A" first="Antonio" last="Vicent Civera">Antonio Vicent Civera</name></author><author><name sortKey="Yuen, Jonathan" sort="Yuen, Jonathan" uniqKey="Yuen J" first="Jonathan" last="Yuen">Jonathan Yuen</name></author><author><name sortKey="Zappala, Lucia" sort="Zappala, Lucia" uniqKey="Zappala L" first="Lucia" last="Zappalà">Lucia Zappalà</name></author><author><name sortKey="Candresse, Thierry" sort="Candresse, Thierry" uniqKey="Candresse T" first="Thierry" last="Candresse">Thierry Candresse</name></author><author><name sortKey="Lacomme, Christophe" sort="Lacomme, Christophe" uniqKey="Lacomme C" first="Christophe" last="Lacomme">Christophe Lacomme</name></author><author><name sortKey="Bottex, Bernard" sort="Bottex, Bernard" uniqKey="Bottex B" first="Bernard" last="Bottex">Bernard Bottex</name></author><author><name sortKey="Oplaat, Carla" sort="Oplaat, Carla" uniqKey="Oplaat C" first="Carla" last="Oplaat">Carla Oplaat</name></author><author><name sortKey="Roenhorst, Annelien" sort="Roenhorst, Annelien" uniqKey="Roenhorst A" first="Annelien" last="Roenhorst">Annelien Roenhorst</name></author><author><name sortKey="Schenk, Martijn" sort="Schenk, Martijn" uniqKey="Schenk M" first="Martijn" last="Schenk">Martijn Schenk</name></author><author><name sortKey="Di Serio, Francesco" sort="Di Serio, Francesco" uniqKey="Di Serio F" first="Francesco" last="Di Serio">Francesco Di Serio</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">32626478</idno><idno type="pmc">7008812</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008812</idno><idno type="RBID">PMC:7008812</idno><idno type="doi">10.2903/j.efsa.2020.5854</idno><date when="2020">2020</date><idno type="wicri:Area/Pmc/Corpus">000721</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000721</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Pest categorisation of potato virus M (non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates)</title><author><name sortKey="Bragard, Claude" sort="Bragard, Claude" uniqKey="Bragard C" first="Claude" last="Bragard">Claude Bragard</name></author><author><name sortKey="Dehnen Chmutz, Katharina" sort="Dehnen Chmutz, Katharina" uniqKey="Dehnen Chmutz K" first="Katharina" last="Dehnen-Schmutz">Katharina Dehnen-Schmutz</name></author><author><name sortKey="Gonthier, Paolo" sort="Gonthier, Paolo" uniqKey="Gonthier P" first="Paolo" last="Gonthier">Paolo Gonthier</name></author><author><name sortKey="Jacques, Marie Gnes" sort="Jacques, Marie Gnes" uniqKey="Jacques M" first="Marie-Agnès" last="Jacques">Marie-Agnès Jacques</name></author><author><name sortKey="Jaques Miret, Josep Anton" sort="Jaques Miret, Josep Anton" uniqKey="Jaques Miret J" first="Josep Anton" last="Jaques Miret">Josep Anton Jaques Miret</name></author><author><name sortKey="Justesen, Annemarie Fejer" sort="Justesen, Annemarie Fejer" uniqKey="Justesen A" first="Annemarie Fejer" last="Justesen">Annemarie Fejer Justesen</name></author><author><name sortKey="Macleod, Alan" sort="Macleod, Alan" uniqKey="Macleod A" first="Alan" last="Macleod">Alan Macleod</name></author><author><name sortKey="Magnusson, Christer Sven" sort="Magnusson, Christer Sven" uniqKey="Magnusson C" first="Christer Sven" last="Magnusson">Christer Sven Magnusson</name></author><author><name sortKey="Milonas, Panagiotis" sort="Milonas, Panagiotis" uniqKey="Milonas P" first="Panagiotis" last="Milonas">Panagiotis Milonas</name></author><author><name sortKey="Navas Ortes, Juan A" sort="Navas Ortes, Juan A" uniqKey="Navas Ortes J" first="Juan A" last="Navas-Cortes">Juan A. Navas-Cortes</name></author><author><name sortKey="Parnell, Stephen" sort="Parnell, Stephen" uniqKey="Parnell S" first="Stephen" last="Parnell">Stephen Parnell</name></author><author><name sortKey="Potting, Roel" sort="Potting, Roel" uniqKey="Potting R" first="Roel" last="Potting">Roel Potting</name></author><author><name sortKey="Reignault, Philippe Lucien" sort="Reignault, Philippe Lucien" uniqKey="Reignault P" first="Philippe Lucien" last="Reignault">Philippe Lucien Reignault</name></author><author><name sortKey="Thulke, Hans Ermann" sort="Thulke, Hans Ermann" uniqKey="Thulke H" first="Hans-Hermann" last="Thulke">Hans-Hermann Thulke</name></author><author><name sortKey="Van Der Werf, Wopke" sort="Van Der Werf, Wopke" uniqKey="Van Der Werf W" first="Wopke" last="Van Der Werf">Wopke Van Der Werf</name></author><author><name sortKey="Vicent Civera, Antonio" sort="Vicent Civera, Antonio" uniqKey="Vicent Civera A" first="Antonio" last="Vicent Civera">Antonio Vicent Civera</name></author><author><name sortKey="Yuen, Jonathan" sort="Yuen, Jonathan" uniqKey="Yuen J" first="Jonathan" last="Yuen">Jonathan Yuen</name></author><author><name sortKey="Zappala, Lucia" sort="Zappala, Lucia" uniqKey="Zappala L" first="Lucia" last="Zappalà">Lucia Zappalà</name></author><author><name sortKey="Candresse, Thierry" sort="Candresse, Thierry" uniqKey="Candresse T" first="Thierry" last="Candresse">Thierry Candresse</name></author><author><name sortKey="Lacomme, Christophe" sort="Lacomme, Christophe" uniqKey="Lacomme C" first="Christophe" last="Lacomme">Christophe Lacomme</name></author><author><name sortKey="Bottex, Bernard" sort="Bottex, Bernard" uniqKey="Bottex B" first="Bernard" last="Bottex">Bernard Bottex</name></author><author><name sortKey="Oplaat, Carla" sort="Oplaat, Carla" uniqKey="Oplaat C" first="Carla" last="Oplaat">Carla Oplaat</name></author><author><name sortKey="Roenhorst, Annelien" sort="Roenhorst, Annelien" uniqKey="Roenhorst A" first="Annelien" last="Roenhorst">Annelien Roenhorst</name></author><author><name sortKey="Schenk, Martijn" sort="Schenk, Martijn" uniqKey="Schenk M" first="Martijn" last="Schenk">Martijn Schenk</name></author><author><name sortKey="Di Serio, Francesco" sort="Di Serio, Francesco" uniqKey="Di Serio F" first="Francesco" last="Di Serio">Francesco Di Serio</name></author></analytic><series><title level="j">EFSA Journal</title><idno type="eISSN">1831-4732</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Abstract</title><p>Following a request from the <styled-content style="fixed-case" toggle="no">EU</styled-content> Commission, the Panel on Plant Health has addressed the pest categorisation of non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of potato virus M (<styled-content style="fixed-case" toggle="no">PVM</styled-content>). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact compared to the current situation in the <styled-content style="fixed-case" toggle="no">EU</styled-content> and availability of control measures of non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content> has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content> are absent from the <styled-content style="fixed-case" toggle="no">EU</styled-content>, they do not meet one of the requirements to be regulated as a regulated non‐quarantine pest (<styled-content style="fixed-case" toggle="no">RNQP</styled-content>) (presence in the <styled-content style="fixed-case" toggle="no">EU</styled-content>); as a consequence, the Panel decided not to evaluate the other <styled-content style="fixed-case" toggle="no">RNQP</styled-content> criteria for these isolates. Populations of <styled-content style="fixed-case" toggle="no">PVM</styled-content> can be subdivided into two strains: the ordinary strain (<styled-content style="fixed-case" toggle="no">PVM</styled-content>‐O) is present in the <styled-content style="fixed-case" toggle="no">EU</styled-content>, while the divergent strain (<styled-content style="fixed-case" toggle="no">PVM</styled-content>‐D) is absent from the <styled-content style="fixed-case" toggle="no">EU</styled-content> or considered to have at most a limited distribution in the <styled-content style="fixed-case" toggle="no">EU</styled-content>. Non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content>‐O are not expected to have an additional impact in the <styled-content style="fixed-case" toggle="no">EU</styled-content> compared to <styled-content style="fixed-case" toggle="no">EU</styled-content> isolates and therefore do not meet the corresponding criterion to qualify as a potential Union quarantine pest. The Panel is unable to conclude on the potential impact of non‐<styled-content style="fixed-case" toggle="no">EU PVM</styled-content>‐D isolates in the <styled-content style="fixed-case" toggle="no">EU</styled-content> territory, but <styled-content style="fixed-case" toggle="no">PVM</styled-content>‐D isolates meet all the other criteria to qualify as a potential Union quarantine pest.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="King, Amq" uniqKey="King A">AMQ King</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">EFSA J</journal-id><journal-id journal-id-type="iso-abbrev">EFSA J</journal-id><journal-id journal-id-type="doi">10.1002/(ISSN)1831-4732</journal-id><journal-id journal-id-type="publisher-id">EFS2</journal-id><journal-title-group><journal-title>EFSA Journal</journal-title></journal-title-group><issn pub-type="epub">1831-4732</issn><publisher><publisher-name>John Wiley and Sons Inc.</publisher-name><publisher-loc>Hoboken</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">32626478</article-id><article-id pub-id-type="pmc">7008812</article-id><article-id pub-id-type="doi">10.2903/j.efsa.2020.5854</article-id><article-id pub-id-type="publisher-id">EFS25854</article-id><article-categories><subj-group subj-group-type="overline"><subject>Scientific Opinion</subject></subj-group><subj-group subj-group-type="heading"><subject>Scientific Opinion</subject></subj-group></article-categories><title-group><article-title>Pest categorisation of potato virus M (non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates)</article-title></title-group><contrib-group><contrib id="efs25854-cr-0001" contrib-type="author"><collab collab-type="authors">EFSA Panel on Plant Health (PLH)</collab></contrib><contrib id="efs25854-cr-0002" contrib-type="author"><name><surname>Bragard</surname><given-names>Claude</given-names></name></contrib><contrib id="efs25854-cr-0003" contrib-type="author"><name><surname>Dehnen‐Schmutz</surname><given-names>Katharina</given-names></name></contrib><contrib id="efs25854-cr-0004" contrib-type="author"><name><surname>Gonthier</surname><given-names>Paolo</given-names></name></contrib><contrib id="efs25854-cr-0005" contrib-type="author"><name><surname>Jacques</surname><given-names>Marie‐Agnès</given-names></name></contrib><contrib id="efs25854-cr-0006" contrib-type="author"><name><surname>Jaques Miret</surname><given-names>Josep Anton</given-names></name></contrib><contrib id="efs25854-cr-0007" contrib-type="author"><name><surname>Justesen</surname><given-names>Annemarie Fejer</given-names></name></contrib><contrib id="efs25854-cr-0008" contrib-type="author"><name><surname>MacLeod</surname><given-names>Alan</given-names></name></contrib><contrib id="efs25854-cr-0009" contrib-type="author"><name><surname>Magnusson</surname><given-names>Christer Sven</given-names></name></contrib><contrib id="efs25854-cr-0010" contrib-type="author"><name><surname>Milonas</surname><given-names>Panagiotis</given-names></name></contrib><contrib id="efs25854-cr-0011" contrib-type="author"><name><surname>Navas‐Cortes</surname><given-names>Juan A</given-names></name></contrib><contrib id="efs25854-cr-0012" contrib-type="author"><name><surname>Parnell</surname><given-names>Stephen</given-names></name></contrib><contrib id="efs25854-cr-0013" contrib-type="author"><name><surname>Potting</surname><given-names>Roel</given-names></name></contrib><contrib id="efs25854-cr-0014" contrib-type="author"><name><surname>Reignault</surname><given-names>Philippe Lucien</given-names></name></contrib><contrib id="efs25854-cr-0015" contrib-type="author"><name><surname>Thulke</surname><given-names>Hans‐Hermann</given-names></name></contrib><contrib id="efs25854-cr-0016" contrib-type="author"><name><surname>van der Werf</surname><given-names>Wopke</given-names></name></contrib><contrib id="efs25854-cr-0017" contrib-type="author"><name><surname>Vicent Civera</surname><given-names>Antonio</given-names></name></contrib><contrib id="efs25854-cr-0018" contrib-type="author"><name><surname>Yuen</surname><given-names>Jonathan</given-names></name></contrib><contrib id="efs25854-cr-0019" contrib-type="author"><name><surname>Zappalà</surname><given-names>Lucia</given-names></name></contrib><contrib id="efs25854-cr-0020" contrib-type="author"><name><surname>Candresse</surname><given-names>Thierry</given-names></name></contrib><contrib id="efs25854-cr-0021" contrib-type="author"><name><surname>Lacomme</surname><given-names>Christophe</given-names></name></contrib><contrib id="efs25854-cr-0022" contrib-type="author"><name><surname>Bottex</surname><given-names>Bernard</given-names></name></contrib><contrib id="efs25854-cr-0023" contrib-type="author"><name><surname>Oplaat</surname><given-names>Carla</given-names></name></contrib><contrib id="efs25854-cr-0024" contrib-type="author"><name><surname>Roenhorst</surname><given-names>Annelien</given-names></name></contrib><contrib id="efs25854-cr-0025" contrib-type="author"><name><surname>Schenk</surname><given-names>Martijn</given-names></name></contrib><contrib id="efs25854-cr-0026" contrib-type="author"><name><surname>Di Serio</surname><given-names>Francesco</given-names></name></contrib></contrib-group><pub-date pub-type="epub"><day>09</day><month>1</month><year>2020</year></pub-date><pub-date pub-type="collection"><month>1</month><year>2020</year></pub-date><volume>18</volume><issue>1</issue><issue-id pub-id-type="doi">10.1002/efs2.v18.1</issue-id><elocation-id>e05854</elocation-id><permissions><pmc-comment> © European Food Safety Authority </pmc-comment>
<copyright-statement content-type="article-copyright">© 2020 European Food Safety Authority. <italic>EFSA Journal</italic> published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.</copyright-statement><license license-type="creativeCommonsBy-nd"><license-p>This is an open access article under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nd/4.0/">http://creativecommons.org/licenses/by-nd/4.0/</ext-link> License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="file:EFS2-18-e05854.pdf"></self-uri><abstract id="efs25854-abs-0001"><title>Abstract</title><p>Following a request from the <styled-content style="fixed-case" toggle="no">EU</styled-content> Commission, the Panel on Plant Health has addressed the pest categorisation of non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of potato virus M (<styled-content style="fixed-case" toggle="no">PVM</styled-content>). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact compared to the current situation in the <styled-content style="fixed-case" toggle="no">EU</styled-content> and availability of control measures of non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content> has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content> are absent from the <styled-content style="fixed-case" toggle="no">EU</styled-content>, they do not meet one of the requirements to be regulated as a regulated non‐quarantine pest (<styled-content style="fixed-case" toggle="no">RNQP</styled-content>) (presence in the <styled-content style="fixed-case" toggle="no">EU</styled-content>); as a consequence, the Panel decided not to evaluate the other <styled-content style="fixed-case" toggle="no">RNQP</styled-content> criteria for these isolates. Populations of <styled-content style="fixed-case" toggle="no">PVM</styled-content> can be subdivided into two strains: the ordinary strain (<styled-content style="fixed-case" toggle="no">PVM</styled-content>‐O) is present in the <styled-content style="fixed-case" toggle="no">EU</styled-content>, while the divergent strain (<styled-content style="fixed-case" toggle="no">PVM</styled-content>‐D) is absent from the <styled-content style="fixed-case" toggle="no">EU</styled-content> or considered to have at most a limited distribution in the <styled-content style="fixed-case" toggle="no">EU</styled-content>. Non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolates of <styled-content style="fixed-case" toggle="no">PVM</styled-content>‐O are not expected to have an additional impact in the <styled-content style="fixed-case" toggle="no">EU</styled-content> compared to <styled-content style="fixed-case" toggle="no">EU</styled-content> isolates and therefore do not meet the corresponding criterion to qualify as a potential Union quarantine pest. The Panel is unable to conclude on the potential impact of non‐<styled-content style="fixed-case" toggle="no">EU PVM</styled-content>‐D isolates in the <styled-content style="fixed-case" toggle="no">EU</styled-content> territory, but <styled-content style="fixed-case" toggle="no">PVM</styled-content>‐D isolates meet all the other criteria to qualify as a potential Union quarantine pest.</p></abstract><kwd-group kwd-group-type="author-generated"><kwd id="efs25854-kwd-0001">European Union</kwd><kwd id="efs25854-kwd-0002">Non‐<styled-content style="fixed-case" toggle="no">EU</styled-content> isolate</kwd><kwd id="efs25854-kwd-0003">pest risk</kwd><kwd id="efs25854-kwd-0004">plant health</kwd><kwd id="efs25854-kwd-0005">plant pest</kwd><kwd id="efs25854-kwd-0006"><styled-content style="fixed-case" toggle="no">PVM</styled-content></kwd><kwd id="efs25854-kwd-0007">quarantine</kwd></kwd-group><counts><fig-count count="1"></fig-count><table-count count="9"></table-count><page-count count="33"></page-count><word-count count="15670"></word-count></counts><custom-meta-group><custom-meta><meta-name>source-schema-version-number</meta-name><meta-value>2.0</meta-value></custom-meta><custom-meta><meta-name>cover-date</meta-name><meta-value>January 2020</meta-value></custom-meta><custom-meta><meta-name>details-of-publishers-convertor</meta-name><meta-value>Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020</meta-value></custom-meta></custom-meta-group></article-meta><notes><p content-type="self-citation"><mixed-citation publication-type="self-citation" id="efs25854-cit-1001"><bold>Suggested citation: </bold><collab collab-type="authors">EFSA PLH Panel (EFSA Panel on Plant Health)</collab>, <string-name><surname>Bragard</surname><given-names>C</given-names></string-name>, <string-name><surname>Dehnen‐Schmutz</surname><given-names>K</given-names></string-name>, <string-name><surname>Gonthier</surname><given-names>P</given-names></string-name>, <string-name><surname>Jacques</surname><given-names>M‐A</given-names></string-name>, <string-name><surname>Jaques Miret</surname><given-names>JA</given-names></string-name>, <string-name><surname>Justesen</surname><given-names>AF</given-names></string-name>, <string-name><surname>MacLeod</surname><given-names>A</given-names></string-name>, <string-name><surname>Magnusson</surname><given-names>CS</given-names></string-name>, <string-name><surname>Milonas</surname><given-names>P</given-names></string-name>, <string-name><surname>Navas‐Cortes</surname><given-names>JA</given-names></string-name>, <string-name><surname>Parnell</surname><given-names>S</given-names></string-name>, <string-name><surname>Potting</surname><given-names>R</given-names></string-name>, <string-name><surname>Reignault</surname><given-names>PL</given-names></string-name>, <string-name><surname>Thulke</surname><given-names>H‐H</given-names></string-name>, <string-name><surname>van der Werf</surname><given-names>W</given-names></string-name>, <string-name><surname>Vicent Civera</surname><given-names>A</given-names></string-name>, <string-name><surname>Yuen</surname><given-names>J</given-names></string-name>, <string-name><surname>Zappalà</surname><given-names>L</given-names></string-name>, <string-name><surname>Candresse</surname><given-names>T</given-names></string-name>, <string-name><surname>Lacomme</surname><given-names>C</given-names></string-name>, <string-name><surname>Bottex</surname><given-names>B</given-names></string-name>, <string-name><surname>Oplaat</surname><given-names>C</given-names></string-name>, <string-name><surname>Roenhorst</surname><given-names>A</given-names></string-name>, <string-name><surname>Schenk</surname><given-names>M</given-names></string-name> and <string-name><surname>Di Serio</surname><given-names>F</given-names></string-name>, <year>2020</year><article-title>Scientific Opinion on the pest categorisation of potato virus M (non‐EU isolates)</article-title>. <source xml:lang="en">EFSA Journal</source> 2020;18(1):5854, 33 pp. <pub-id pub-id-type="doi">10.2903/j.efsa.2020.5854</pub-id></mixed-citation></p><fn-group id="efs25854-ntgp-0001"><fn id="efs25854-note-1001"><p><bold>Requestor:</bold> European Commission</p></fn><fn id="efs25854-note-1002"><p><bold>Question Number:</bold> EFSA‐Q‐2019‐00507</p></fn><fn id="efs25854-note-1003"><p><bold>Panel members:</bold> 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 Civera, Jonathan Yuen and Lucia Zappalà.</p></fn><fn id="efs25854-note-1004"><p><bold>Acknowledgments:</bold> This opinion was prepared in cooperation with the National Plant Protection Organization, Netherlands Food and Consumer Product Safety Authority under the tasking grant (GP/EFSA/ALPHA/2017/04).</p></fn><fn id="efs25854-note-1005"><p>Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder:</p></fn><fn id="efs25854-note-1006"><p>Figure 1: © CABI</p></fn><fn id="efs25854-note-1306"><p>Adopted: 26 September 2019</p></fn></fn-group></notes></front><body id="efs25854-body-0001"><sec id="efs25854-sec-0002"><label>1</label><title>Introduction</title><sec id="efs25854-sec-0003"><label>1.1</label><title>Background and Terms of Reference as provided by the requestor</title><sec id="efs25854-sec-0004"><label>1.1.1</label><title>Background</title><p>Council Directive 2000/29/EC<xref ref-type="fn" rid="efs25854-note-1007">1</xref> on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community establishes the present European Union plant health regime. The Directive lays down the phytosanitary provisions and the control checks to be carried out at the place of origin on plants and plant products destined for the Union or to be moved within the Union. In the Directive's 2000/29/EC annexes, the list of harmful organisms (pests) whose introduction into or spread within the Union is prohibited, is detailed together with specific requirements for import or internal movement.</p><p>Following the evaluation of the plant health regime, the new basic plant health law, Regulation (EU) 2016/2031<xref ref-type="fn" rid="efs25854-note-1008">2</xref> on protective measures against pests of plants, was adopted on 26 October 2016 and will apply from 14 December 2019 onwards, repealing Directive 2000/29/EC. In line with the principles of the above mentioned legislation and the follow‐up work of the secondary legislation for the listing of EU regulated pests, EFSA is requested to provide pest categorisations of the harmful organisms included in the annexes of Directive 2000/29/EC, in the cases where recent pest risk assessment/pest categorisation is not available.</p></sec><sec id="efs25854-sec-0005"><label>1.1.2</label><title>Terms of reference</title><p>EFSA is requested, pursuant to Article 22(5.b) and Article 29(1) of Regulation (EC) No 178/2002<xref ref-type="fn" rid="efs25854-note-1009">3</xref>, to provide scientific opinion in the field of plant health.</p><p>EFSA is requested to prepare and deliver a pest categorisation (step 1 analysis) for each of the regulated pests included in the appendices of the annex to this mandate. The methodology and template of pest categorisation have already been developed in past mandates for the organisms listed in Annex II Part A Section II of Directive 2000/29/EC. The same methodology and outcome is expected for this work as well.</p><p>The list of the harmful organisms included in the annex to this mandate comprises 133 harmful organisms or groups. A pest categorisation is expected for these 133 pests or groups and the delivery of the work would be stepwise at regular intervals through the year as detailed below. First priority covers the harmful organisms included in Appendix 1, comprising pests from Annex II Part A Section I and Annex II Part B of Directive 2000/29/EC. The delivery of all pest categorisations for the pests included in Appendix 1 is June 2018. The second priority is the pests included in Appendix 2, comprising the group of <italic>Cicadellidae</italic> (non‐EU) known to be vector of Pierce's disease (caused by <italic>Xylella fastidiosa</italic>), the group of <italic>Tephritidae</italic> (non‐EU), the group of potato viruses and virus‐like organisms, the group of viruses and virus‐like organisms of <italic>Cydonia</italic> Mill., <italic>Fragaria</italic> L., <italic>Malus</italic> Mill., <italic>Prunus</italic> L., <italic>Pyrus</italic> L., <italic>Ribes</italic> L., <italic>Rubus</italic> L. and <italic>Vitis</italic> L., and the group of <italic>Margarodes</italic> (non‐EU species). The delivery of all pest categorisations for the pests included in Appendix 2 is end 2019. The pests included in Appendix 3 cover pests of Annex I part A section I and all pest categorisations should be delivered by end 2020.</p><p>For the above mentioned groups, each covering a large number of pests, the pest categorisation will be performed for the group and not the individual harmful organisms listed under “such as” notation in the Annexes of the Directive 2000/29/EC. The criteria to be taken particularly under consideration for these cases, is the analysis of host pest combination, investigation of pathways, the damages occurring and the relevant impact.</p><p>Finally, as indicated in the text above, all references to ‘non‐European’ should be avoided and replaced by ‘non‐EU’ and refer to all territories with exception of the Union territories as defined in Article 1 point 3 of Regulation (EU) 2016/2031.</p><sec id="efs25854-sec-0006"><label>1.1.2.1</label><title>Terms of Reference: Appendix 1</title><p>List of harmful organisms for which pest categorisation is requested. The list below follows the annexes of Directive 2000/29/EC.</p><p><table-wrap id="nlm-table-wrap-1" xml:lang="en" orientation="portrait" position="anchor"><table frame="void" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><tbody><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IIAI</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Aleurocanthus</italic> spp.</td><td align="left" rowspan="1" colspan="1"><italic>Numonia pyrivorella</italic> (Matsumura)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Anthonomus bisignifer</italic> (Schenkling)</td><td align="left" rowspan="1" colspan="1"><italic>Oligonychus perditus</italic> Pritchard and Baker</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Anthonomus signatus</italic> (Say)</td><td align="left" rowspan="1" colspan="1"><italic>Pissodes</italic> spp. (non‐EU)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Aschistonyx eppoi</italic> Inouye</td><td align="left" rowspan="1" colspan="1"><italic>Scirtothrips aurantii</italic> Faure</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Carposina niponensis</italic> Walsingham</td><td align="left" rowspan="1" colspan="1"><italic>Scirtothrips</italic> citri (Moultex)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Enarmonia packardi</italic> (Zeller)</td><td align="left" rowspan="1" colspan="1"><italic>Scolytidae</italic> spp. (non‐EU)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Enarmonia prunivora</italic> Walsh</td><td align="left" rowspan="1" colspan="1"><italic>Scrobipalpopsis solanivora</italic> Povolny</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Grapholita inopinata</italic> Heinrich</td><td align="left" rowspan="1" colspan="1"><italic>Tachypterellus quadrigibbus</italic> Say</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Hishomonus phycitis</italic></td><td align="left" rowspan="1" colspan="1"><italic>Toxoptera citricida</italic> Kirk.</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Leucaspis japonica</italic> Ckll.</td><td align="left" rowspan="1" colspan="1"><italic>Unaspis citri</italic> Comstock</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Listronotus bonariensis</italic> (Kuschel)</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(b) Bacteria</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">Citrus variegated chlorosis</td><td align="left" rowspan="1" colspan="1"><italic>Xanthomonas campestris</italic> pv. <italic>oryzae</italic> (Ishiyama) Dye and pv. <italic>oryzicola</italic> (Fang. et al.) Dye</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Erwinia stewartii</italic> (Smith) Dye</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(c) Fungi</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Alternaria alternata</italic> (Fr.) Keissler (non‐EU pathogenic isolates)</td><td align="left" rowspan="1" colspan="1"><italic>Elsinoe</italic> spp. Bitanc. and Jenk. Mendes</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Anisogramma anomala</italic> (Peck) E. Müller</td><td align="left" rowspan="1" colspan="1"><italic>Fusarium oxysporum</italic> f. sp<italic>. albedinis</italic> (Kilian and Maire) Gordon</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Apiosporina morbosa</italic> (Schwein.) v. Arx</td><td align="left" rowspan="1" colspan="1"><italic>Guignardia piricola</italic> (Nosa) Yamamoto</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Ceratocystis virescens</italic> (Davidson) Moreau</td><td align="left" rowspan="1" colspan="1"><italic>Puccinia pittieriana</italic> Hennings</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Cercoseptoria pini‐densiflorae</italic> (Hori and Nambu) Deighton</td><td align="left" rowspan="1" colspan="1"><italic>Stegophora ulmea</italic> (Schweinitz: Fries) Sydow & Sydow</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Cercospora angolensis Carv. and Mendes</italic></td><td align="left" rowspan="1" colspan="1"><italic>Venturia nashicola</italic> Tanaka and Yamamoto</td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(d) Virus and virus‐like organisms</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">Beet curly top virus (non‐EU isolates)</td><td align="left" rowspan="1" colspan="1">Little cherry pathogen (non‐ EU isolates)</td></tr><tr><td align="left" rowspan="1" colspan="1">Black raspberry latent virus</td><td align="left" rowspan="1" colspan="1">Naturally spreading psorosis</td></tr><tr><td align="left" rowspan="1" colspan="1">Blight and blight‐like</td><td align="left" rowspan="1" colspan="1">Palm lethal yellowing mycoplasm</td></tr><tr><td align="left" rowspan="1" colspan="1">Cadang‐Cadang viroid</td><td align="left" rowspan="1" colspan="1">Satsuma dwarf virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Citrus tristeza virus (non‐EU isolates)</td><td align="left" rowspan="1" colspan="1">Tatter leaf virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Leprosis</td><td align="left" rowspan="1" colspan="1">Witches’ broom (MLO)</td></tr><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IIB</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insect mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Anthonomus grandis</italic> (Boh.)</td><td align="left" rowspan="1" colspan="1"><italic>Ips cembrae</italic> Heer</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Cephalcia lariciphila</italic> (Klug)</td><td align="left" rowspan="1" colspan="1"><italic>Ips duplicatus</italic> Sahlberg</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Dendroctonus micans</italic> Kugelan</td><td align="left" rowspan="1" colspan="1"><italic>Ips sexdentatus</italic> Börner</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Gilphinia hercyniae</italic> (Hartig)</td><td align="left" rowspan="1" colspan="1"><italic>Ips typographus</italic> Heer</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Gonipterus scutellatus</italic> Gyll.</td><td align="left" rowspan="1" colspan="1"><italic>Sternochetus mangiferae</italic> Fabricius</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Ips amitinus</italic> Eichhof</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(b) Bacteria</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Curtobacterium flaccumfaciens pv. flaccumfaciens</italic> (Hedges) Collins and Jones</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(c) Fungi</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Glomerella gossypii</italic> Edgerton</td><td align="left" rowspan="1" colspan="1"><italic>Hypoxylon mammatum</italic> (Wahl.) J. Miller</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Gremmeniella abietina</italic> (Lag.) Morelet</td><td align="left" rowspan="1" colspan="1"></td></tr></tbody></table></table-wrap></p></sec><sec id="efs25854-sec-0007"><label>1.1.2.2</label><title>Terms of Reference: Appendix 2</title><p>List of harmful organisms for which pest categorisation is requested per group. The list below follows the categorisation included in the annexes of Directive 2000/29/EC.<table-wrap id="nlm-table-wrap-2" xml:lang="en" orientation="portrait" position="anchor"><table frame="void" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><tbody><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IAI</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" colspan="2" rowspan="1">Group of Cicadellidae (non‐EU) known to be vector of Pierce's disease (caused by <italic>Xylella fastidiosa</italic>), such as:</td></tr><tr><td align="left" rowspan="1" colspan="1">1) <italic>Carneocephala fulgida</italic> Nottingham</td><td align="left" rowspan="1" colspan="1">3) <italic>Graphocephala atropunctata</italic> (Signoret)</td></tr><tr><td align="left" rowspan="1" colspan="1">2) <italic>Draeculacephala minerva</italic> Ball</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1">Group of Tephritidae (non‐EU) such as:</td></tr><tr><td align="left" rowspan="1" colspan="1">1) <italic>Anastrepha fraterculus</italic> (Wiedemann)</td><td align="left" rowspan="1" colspan="1">12) <italic>Pardalaspis cyanescens</italic> Bezzi</td></tr><tr><td align="left" rowspan="1" colspan="1">2) <italic>Anastrepha ludens</italic> (Loew)</td><td align="left" rowspan="1" colspan="1">13) <italic>Pardalaspis quinaria</italic> Bezzi</td></tr><tr><td align="left" rowspan="1" colspan="1">3) <italic>Anastrepha obliqua</italic> Macquart</td><td align="left" rowspan="1" colspan="1">14) <italic>Pterandrus rosa</italic> (Karsch)</td></tr><tr><td align="left" rowspan="1" colspan="1">4) <italic>Anastrepha suspensa</italic> (Loew)</td><td align="left" rowspan="1" colspan="1">15) <italic>Rhacochlaena japonica</italic> Ito</td></tr><tr><td align="left" rowspan="1" colspan="1">5) <italic>Dacus ciliatus</italic> Loew</td><td align="left" rowspan="1" colspan="1">16) <italic>Rhagoletis completa</italic> Cresson</td></tr><tr><td align="left" rowspan="1" colspan="1">6) <italic>Dacus curcurbitae</italic> Coquillet</td><td align="left" rowspan="1" colspan="1">17) <italic>Rhagoletis fausta</italic> (Osten‐Sacken)</td></tr><tr><td align="left" rowspan="1" colspan="1">7) <italic>Dacus dorsalis</italic> Hendel</td><td align="left" rowspan="1" colspan="1">18) <italic>Rhagoletis indifferens</italic> Curran</td></tr><tr><td align="left" rowspan="1" colspan="1">8) <italic>Dacus tryoni</italic> (Froggatt)</td><td align="left" rowspan="1" colspan="1">19) <italic>Rhagoletis mendax</italic> Curran</td></tr><tr><td align="left" rowspan="1" colspan="1">9) <italic>Dacus tsuneonis</italic> Miyake</td><td align="left" rowspan="1" colspan="1">20) <italic>Rhagoletis pomonella</italic> Walsh</td></tr><tr><td align="left" rowspan="1" colspan="1">10) <italic>Dacus zonatus</italic> Saund.</td><td align="left" rowspan="1" colspan="1">21) <italic>Rhagoletis suavis</italic> (Loew)</td></tr><tr><td align="left" rowspan="1" colspan="1">11) <italic>Epochra canadensis</italic> (Loew)</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(c) Viruses and virus‐like organisms</bold></td></tr><tr><td align="left" colspan="2" rowspan="1">Group of potato viruses and virus‐like organisms such as:</td></tr><tr><td align="left" rowspan="1" colspan="1">1) Andean potato latent virus</td><td align="left" rowspan="1" colspan="1">5) Potato virus T</td></tr><tr><td align="left" rowspan="1" colspan="1">2) Andean potato mottle virus</td><td align="left" rowspan="1" colspan="1">6) non‐EU isolates of potato viruses A, M, S, V, X and Y (including Yo, Yn and Yc) and Potato leafroll virus</td></tr><tr><td align="left" rowspan="1" colspan="1">3) Arracacha virus B, oca strain</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">4) Potato black ringspot virus</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1">Group of viruses and virus‐like organisms of <italic>Cydonia</italic> Mill., <italic>Fragaria</italic> L., <italic>Malus</italic> Mill., <italic>Prunus</italic> L., <italic>Pyrus</italic> L., <italic>Ribes</italic> L., <italic>Rubus</italic> L. and <italic>Vitis</italic> L., such as:</td></tr><tr><td align="left" rowspan="1" colspan="1">1) Blueberry leaf mottle virus</td><td align="left" rowspan="1" colspan="1">8) Peach yellows mycoplasm</td></tr><tr><td align="left" rowspan="1" colspan="1">2) Cherry rasp leaf virus (American)</td><td align="left" rowspan="1" colspan="1">9) Plum line pattern virus (American)</td></tr><tr><td align="left" rowspan="1" colspan="1">3) Peach mosaic virus (American)</td><td align="left" rowspan="1" colspan="1">10) Raspberry leaf curl virus (American)</td></tr><tr><td align="left" rowspan="1" colspan="1">4) Peach phony rickettsia</td><td align="left" rowspan="1" colspan="1">11) Strawberry witches’ broom mycoplasma</td></tr><tr><td align="left" rowspan="1" colspan="1">5) Peach rosette mosaic virus</td><td align="left" rowspan="1" colspan="1">12) Non‐EU viruses and virus‐like organisms of <italic>Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L</italic>. and <italic>Vitis L</italic>.</td></tr><tr><td align="left" rowspan="1" colspan="1">6) Peach rosette mycoplasm</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">7) Peach X‐disease mycoplasm</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IIAI</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" colspan="2" rowspan="1">Group of <italic>Margarodes</italic> (non‐EU species) such as:</td></tr><tr><td align="left" rowspan="1" colspan="1">1) <italic>Margarodes vitis</italic> (Phillipi)</td><td align="left" rowspan="1" colspan="1">3) <italic>Margarodes prieskaensis</italic> Jakubski</td></tr><tr><td align="left" rowspan="1" colspan="1">2) <italic>Margarodes vredendalensis</italic> de Klerk</td><td align="left" rowspan="1" colspan="1"></td></tr></tbody></table></table-wrap></p></sec><sec id="efs25854-sec-0008"><label>1.1.2.3</label><title>Terms of Reference: Appendix 3</title><p>List of harmful organisms for which pest categorisation is requested. The list below follows the annexes of Directive 2000/29/EC.<table-wrap id="nlm-table-wrap-3" xml:lang="en" orientation="portrait" position="anchor"><table frame="void" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><tbody><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IAI</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Acleris</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"><italic>Longidorus diadecturus</italic> Eveleigh and Allen</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Amauromyza maculosa</italic> (Malloch)</td><td align="left" rowspan="1" colspan="1"><italic>Monochamus</italic> spp. (non‐EU)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Anomala orientalis</italic> Waterhouse</td><td align="left" rowspan="1" colspan="1"><italic>Myndus crudus</italic> Van Duzee</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Arrhenodes minutus</italic> Drury</td><td align="left" rowspan="1" colspan="1"><italic>Nacobbus aberrans</italic> (Thorne) Thorne and Allen</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Choristoneura</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"><italic>Naupactus leucoloma</italic> Boheman</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Conotrachelus nenuphar</italic> (Herbst)</td><td align="left" rowspan="1" colspan="1"><italic>Premnotrypes</italic> spp. (non‐EU)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Dendrolimus sibiricus</italic> Tschetverikov</td><td align="left" rowspan="1" colspan="1"><italic>Pseudopityophthorus minutissimus</italic> (Zimmermann)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Diabrotica barberi</italic> Smith and Lawrence</td><td align="left" rowspan="1" colspan="1"><italic>Pseudopityophthorus pruinosus</italic> (Eichhoff)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Diabrotica undecimpunctata howardi</italic> Barber</td><td align="left" rowspan="1" colspan="1"><italic>Scaphoideus luteolus</italic> (Van Duzee)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Diabrotica undecimpunctata undecimpunctata</italic> Mannerheim</td><td align="left" rowspan="1" colspan="1"><italic>Spodoptera eridania</italic> (Cramer)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Diabrotica virgifera zeae</italic> Krysan & Smith</td><td align="left" rowspan="1" colspan="1"><italic>Spodoptera frugiperda</italic> (Smith)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Diaphorina citri</italic> Kuway</td><td align="left" rowspan="1" colspan="1"><italic>Spodoptera litura</italic> (Fabricus)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Heliothis zea</italic> (Boddie)</td><td align="left" rowspan="1" colspan="1"><italic>Thrips palmi</italic> Karny</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Hirschmanniella</italic> spp., other than <italic>Hirschmanniella gracilis</italic> (de Man) Luc and Goodey</td><td align="left" rowspan="1" colspan="1"><italic>Xiphinema americanum</italic> Cobb sensu lato (non‐EU populations)</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Liriomyza sativae</italic> Blanchard</td><td align="left" rowspan="1" colspan="1"><italic>Xiphinema californicum</italic> Lamberti and Bleve‐Zacheo</td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(b) Fung</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Ceratocystis fagacearum</italic> (Bretz) Hunt</td><td align="left" rowspan="1" colspan="1"><italic>Mycosphaerella larici‐leptolepis</italic> Ito et al.</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Chrysomyxa arctostaphyli</italic> Diete</td><td align="left" rowspan="1" colspan="1"><italic>Mycosphaerella populorum</italic> G. E. Thompson</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Cronartium</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"><italic>Phoma andina</italic> Turkensteen</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Endocronartium</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"><italic>Phyllosticta solitaria</italic> Ell. and Ev.</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Guignardia laricina</italic> (Saw.) Yamamoto and Ito</td><td align="left" rowspan="1" colspan="1"><italic>Septoria lycopersici</italic> Speg. var. <italic>malagutii</italic> Ciccarone and Boerema</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Gymnosporangium</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"><italic>Thecaphora solani</italic> Barrus</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Inonotus weirii</italic> (Murril) Kotlaba and Pouzar</td><td align="left" rowspan="1" colspan="1"><italic>Trechispora brinkmannii</italic> (Bresad.) Rogers</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Melampsora farlowii</italic> (Arthur) Davis</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(c) Viruses and virus‐like organisms</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">Tobacco ringspot virus</td><td align="left" rowspan="1" colspan="1">Pepper mild tigré virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Tomato ringspot virus</td><td align="left" rowspan="1" colspan="1">Squash leaf curl virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Bean golden mosaic virus</td><td align="left" rowspan="1" colspan="1">Euphorbia mosaic virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Cowpea mild mottle virus</td><td align="left" rowspan="1" colspan="1">Florida tomato virus</td></tr><tr><td align="left" rowspan="1" colspan="1">Lettuce infectious yellows virus</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(d) Parasitic plants</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Arceuthobium</italic> spp. (non‐EU)</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex IAII</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Meloidogyne fallax</italic> Karssen</td><td align="left" rowspan="1" colspan="1"><italic>Rhizoecus hibisci</italic> Kawai and Takagi</td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Popillia japonica</italic> Newman</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(b) Bacteria</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Clavibacter michiganensis</italic> (Smith) Davis et al. ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis et al.</td><td align="left" rowspan="1" colspan="1"><italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi et al.</td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(c) Fungi</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Melampsora medusae</italic> Thümen</td><td align="left" rowspan="1" colspan="1"><italic>Synchytrium endobioticum</italic> (Schilbersky) Percival</td></tr><tr><td align="left" colspan="2" rowspan="1"><underline underline-style="single"><italic toggle="yes"><bold>Annex I B</bold></italic></underline></td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(a) Insects, mites and nematodes, at all stages of their development</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><italic>Leptinotarsa decemlineata</italic> Say</td><td align="left" rowspan="1" colspan="1"><italic>Liriomyza bryoniae</italic> (Kaltenbach)</td></tr><tr><td align="left" colspan="2" rowspan="1"><bold>(b) Viruses and virus‐like organisms</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">Beet necrotic yellow vein virus</td><td align="left" rowspan="1" colspan="1"></td></tr></tbody></table></table-wrap></p></sec></sec></sec><sec id="efs25854-sec-0009"><label>1.2</label><title>Interpretation of the Terms of Reference</title><p>EFSA is asked to develop pest categorisations for non‐EU isolates of seven potato viruses, i.e. potato leaf roll virus and potato viruses A, M, S, V, X and Y (including Yo, Yn and Yc), which are defined by their geographical origin outside the EU. As such, isolates of these viruses occurring outside the EU territory are considered as non‐EU isolates. Accordingly, a virus isolate infecting a plant originating in a non‐EU country is considered to be a non‐EU isolate. All seven viruses are important pathogens of potato and, therefore, there is no uncertainty about the fact that non‐EU isolates have an impact on potato crops in absolute terms. However, EU isolates of these viruses already have an impact in the EU; consequently, the Panel decided to evaluate whether the non‐EU isolates would have an additional impact compared to the current situation, upon introduction and spread in the EU. This interpretation was agreed with the European Commission.</p><p>This scientific opinion presents the pest categorisation of non‐EU isolates of potato virus M (PVM). Non‐EU isolates of PVM are listed in the Appendices of the Terms of Reference (ToR) to be subject to pest categorisation to determine whether they fulfil the criteria of a quarantine pest for the area of the EU excluding Ceuta, Melilla and the outermost regions of Member States (MSs) referred to in Article 355(1) of the Treaty on the Functioning of the European Union (TFEU), other than Madeira and the Azores.</p><p>Because non‐EU isolates of PVM are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non‐quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates.</p><p>The new Plant Health Regulation (EU) 2016/2031<xref ref-type="fn" rid="efs25854-note-2004">4</xref>, on the protective measures against pests of plants, will be applying from December 2019. The regulatory status sections (Section <xref rid="efs25854-sec-0028" ref-type="sec">3.3</xref>) of the present opinion are still based on Council Directive 2000/29/EC, as the document was adopted in September 2019.</p></sec></sec><sec id="efs25854-sec-0010"><label>2</label><title>Data and methodologies</title><sec id="efs25854-sec-0011"><label>2.1</label><title>Data</title><sec id="efs25854-sec-0012"><label>2.1.1</label><title>Literature search</title><p>A literature search on PVM was conducted in the ISI Web of Science bibliographic database. The scientific name of the pest was used as search term. Relevant papers were reviewed with a focus on potential differences between isolates and strains. Further references and information were obtained from experts, as well as from citations in the reviewed papers and grey literature. The search was continued until no further information could be found or until the collected information was considered sufficient to perform the pest categorisation; consequently, the presented data is not necessarily exhaustive.</p></sec><sec id="efs25854-sec-0013"><label>2.1.2</label><title>Database search</title><p>Information on hosts, vectors and distribution at species level, was retrieved from CABI Crop Protection Compendium (CABI cpc) and relevant publications. Additional data on isolates distribution was obtained from the literature.</p><p>Data about the import of commodity types that could potentially provide a pathway for the pest to enter the EU and about the area of hosts grown in the EU were obtained from EUROSTAT (Statistical Office of the European Communities).</p><p>The Europhyt database was consulted to identify interceptions of non‐EU isolates of PVM. Europhyt is a web‐based network run by the Directorate General for Health and Food Safety (DG SANTÉ) of the European Commission and is a subproject of PHYSAN (Phyto‐Sanitary Controls) specifically concerned with plant health information. The Europhyt database manages notifications of interceptions of plants or plant products that do not comply with EU legislation, as well as notifications of plant pests detected in the territory of the MSs and the phytosanitary measures taken to eradicate or avoid their spread.</p></sec></sec><sec id="efs25854-sec-0014"><label>2.2</label><title>Methodologies</title><p>The Panel performed the pest categorisation for non‐EU isolates of PVM, following the guiding principles and steps presented in the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel, <xref rid="efs25854-bib-0008" ref-type="ref">2018</xref>) and in the International Standard for Phytosanitary Measures No 11 (FAO, <xref rid="efs25854-bib-0011" ref-type="ref">2013</xref>) and No 21 (FAO, <xref rid="efs25854-bib-0010" ref-type="ref">2004</xref>).</p><p>General information on PVM will be provided at species level. Further information will be added at the level of strains and/or non‐EU isolates when available and applicable.</p><p>This work was initiated following an evaluation of the EU plant health regime. Therefore, to facilitate the decision‐making process, in the conclusions of the pest categorisation, the Panel addresses explicitly each criterion for a Union quarantine pest and for a Union RNQP in accordance with Regulation (EU) 2016/2031 on protective measures against pests of plants, and includes additional information required in accordance with the specific terms of reference received by the European Commission. In addition, for each conclusion, the Panel provides a short description of its associated uncertainty.</p><p>Table <xref rid="efs25854-tbl-0001" ref-type="table">1</xref> presents the Regulation (EU) 2016/2031 pest categorisation criteria on which the Panel bases its conclusions. All relevant criteria have to be met for the pest to potentially qualify either as a quarantine pest or as a RNQP. If one of the criteria is not met, the pest will not qualify. A pest that does not qualify as a quarantine pest may still qualify as a RNQP that needs to be addressed in the opinion. For the pests regulated in the protected zones only, the scope of the categorisation is the territory of the protected zone; thus, the criteria refer to the protected zone instead of the EU territory.</p><p>It should be noted that the Panel's conclusions are formulated respecting its remit and particularly with regard to the principle of separation between risk assessment and risk management (EFSA founding regulation (EU) No 178/2002); therefore, instead of determining whether the pest is likely to have an unacceptable impact, the Panel will present a summary of the observed pest impacts. Economic impacts are expressed in terms of yield and quality losses and not in monetary terms, whereas addressing social impacts is outside the remit of the Panel.</p><table-wrap id="efs25854-tbl-0001" xml:lang="en" orientation="portrait" position="float"><label>Table 1</label><caption><p>Pest categorisation criteria under evaluation, as defined in Regulation (EU) 2016/2031 on protective measures against pests of plants (the number of the relevant sections of the pest categorisation is shown in brackets in the first column)</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Criterion of pest categorisation</th><th align="left" valign="top" rowspan="1" colspan="1">Criterion in Regulation (EU) 2016/2031 regarding Union quarantine pest</th><th align="left" valign="top" rowspan="1" colspan="1">Criterion in Regulation (EU) 2016/2031 regarding protected zone quarantine pest (articles 32–35)</th><th align="left" valign="top" rowspan="1" colspan="1">Criterion in Regulation (EU) 2016/2031 regarding Union regulated non‐quarantine pest</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">Identity of the pest (Section <xref rid="efs25854-sec-0017" ref-type="sec">3.1</xref>)</td><td align="left" rowspan="1" colspan="1">Is the identity of the pest established, or has it been shown to produce consistent symptoms and to be transmissible?</td><td align="left" rowspan="1" colspan="1">Is the identity of the pest established, or has it been shown to produce consistent symptoms and to be transmissible?</td><td align="left" rowspan="1" colspan="1">Is the identity of the pest established, or has it been shown to produce consistent symptoms and to be transmissible?</td></tr><tr><td align="left" rowspan="1" colspan="1">Absence/presence of the pest in the EU territory (Section <xref rid="efs25854-sec-0024" ref-type="sec">3.2</xref>)</td><td align="left" rowspan="1" colspan="1"><p>Is the pest present in the EU territory?</p><p>If present, is the pest widely distributed within the EU? Describe the pest distribution briefly!</p></td><td align="left" rowspan="1" colspan="1">Is the pest present in the EU territory? If not, it cannot be a protected zone quarantine organism</td><td align="left" rowspan="1" colspan="1">Is the pest present in the EU territory? If not, it cannot be a RNQP. (A regulated non‐quarantine pest must be present in the risk assessment area)</td></tr><tr><td align="left" rowspan="1" colspan="1">Regulatory status (Section <xref rid="efs25854-sec-0028" ref-type="sec">3.3</xref>)</td><td align="left" rowspan="1" colspan="1">If the pest is present in the EU but not widely distributed in the risk assessment area, it should be under official control or expected to be under official control in the near future</td><td align="left" rowspan="1" colspan="1"><p>The protected zone system aligns with the pest free area system under the International Plant Protection Convention (IPPC)</p><p>The pest satisfies the IPPC definition of a quarantine pest that is not present in the risk assessment area (i.e. protected zone)</p></td><td align="left" rowspan="1" colspan="1">Is the pest regulated as a quarantine pest? If currently regulated as a quarantine pest, are there grounds to consider its status could be revoked?</td></tr><tr><td align="left" rowspan="1" colspan="1">Pest potential for entry, establishment and spread in the EU territory (Section <xref rid="efs25854-sec-0032" ref-type="sec">3.3</xref>)</td><td align="left" rowspan="1" colspan="1">Is the pest able to enter into, become established in, and spread within, the EU territory? If yes, briefly list the pathways!</td><td align="left" rowspan="1" colspan="1"><p>Is the pest able to enter into, become established in, and spread within, the protected zone areas?</p><p>Is entry by natural spread from EU areas where the pest is present possible?</p></td><td align="left" rowspan="1" colspan="1"><p>Is spread mainly via specific plants for planting, rather than via natural spread or via movement of plant products or other objects?</p><p>Clearly state if plants for planting is the main pathway!</p></td></tr><tr><td align="left" rowspan="1" colspan="1">Potential for consequences in the EU territory (Section <xref rid="efs25854-sec-0042" ref-type="sec">3.4</xref>)</td><td align="left" rowspan="1" colspan="1">Would the pests’ introduction have an economic or environmental impact on the EU territory?</td><td align="left" rowspan="1" colspan="1">Would the pests’ introduction have an economic or environmental impact on the protected zone areas?</td><td align="left" rowspan="1" colspan="1">Does the presence of the pest on plants for planting have an economic impact as regards the intended use of those plants for planting?</td></tr><tr><td align="left" rowspan="1" colspan="1">Available measures (Section <xref rid="efs25854-sec-0044" ref-type="sec">3.5</xref>)</td><td align="left" rowspan="1" colspan="1">Are there measures available to prevent the entry into, establishment within or spread of the pest within the EU such that the risk becomes mitigated?</td><td align="left" rowspan="1" colspan="1"><p>Are there measures available to prevent the entry into, establishment within or spread of the pest within the protected zone areas such that the risk becomes mitigated?</p><p>Is it possible to eradicate the pest in a restricted area within 24 months (or a period longer than 24 months where the biology of the organism so justifies) after the presence of the pest was confirmed in the protected zone?</p></td><td align="left" rowspan="1" colspan="1">Are there measures available to prevent pest presence on plants for planting such that the risk becomes mitigated?</td></tr><tr><td align="left" rowspan="1" colspan="1">Conclusion of pest categorisation (Section <xref rid="efs25854-sec-0051" ref-type="sec">3.6</xref>)</td><td align="left" rowspan="1" colspan="1">A statement as to whether (1) all criteria assessed by EFSA above for consideration as a potential quarantine pest were met and (2) if not, which one(s) were not met</td><td align="left" rowspan="1" colspan="1">A statement as to whether (1) all criteria assessed by EFSA above for consideration as potential protected zone quarantine pest were met, and (2) if not, which one(s) were not met</td><td align="left" rowspan="1" colspan="1">A statement as to whether (1) all criteria assessed by EFSA above for consideration as a potential RNQP were met, and (2) if not, which one(s) were not met</td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap><p>The Panel will not indicate in its conclusions of the pest categorisation whether to continue the risk assessment process, but following the agreed two‐step approach, will continue only if requested by the risk managers. However, during the categorisation process, experts may identify key elements and knowledge gaps that could contribute significant uncertainty to a future assessment of risk. It would be useful to identify and highlight such gaps so that potential future requests can specifically target the major elements of uncertainty, perhaps suggesting specific scenarios to examine.</p></sec><sec id="efs25854-sec-0015"><label>2.3</label><title>Nomenclature</title><p>Virus nomenclature is reported using the latest release of the official classification by the International Committee on Taxonomy of Viruses (ICTV, Release 2018b.v1, <ext-link ext-link-type="uri" xlink:href="https://talk.ictvonline.org/taxonomy/">https://talk.ictvonline.org/taxonomy/</ext-link>). Virus names are not italicised throughout this opinion, corresponding to ICTV instructions.</p></sec></sec><sec id="efs25854-sec-0016"><label>3</label><title>Pest categorisation</title><sec id="efs25854-sec-0017"><label>3.1</label><title>Identity and biology of the pest</title><sec id="efs25854-sec-0018"><label>3.1.1</label><title>Identity and taxonomy</title><sec id="efs25854-sec-0019"><label>3.1.1.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0101" orientation="portrait"><p><italic>Is the identity of the pest established, or has it been shown to produce consistent symptoms and to be transmissible?</italic></p><p><bold>Yes.</bold> PVM is a well‐known virus and the definition of ‘non‐EU isolates’, as used in the present opinion has been clarified (see Section <xref rid="efs25854-sec-0009" ref-type="sec">1.2</xref>).</p></boxed-text></p><p>Potato virus M is a well‐characterised virus in the genus <italic>Carlavirus</italic>, family Betaflexiviridae (Adams et al., <xref rid="efs25854-bib-0001" ref-type="ref">2011</xref>). It has a single‐stranded positive‐sense RNA genome, and complete and/or partial genomic sequences are available for a number of isolates.</p></sec></sec><sec id="efs25854-sec-0020"><label>3.1.2</label><title>Biology of the pest</title><p>PVM is not known to be transmitted by pollen or true seeds (CABI cpc, <xref rid="efs25854-bib-0004" ref-type="ref">2019</xref>). It is transmitted by vegetative propagation (via tubers) and can be transmitted mechanically, e.g. by contaminated tools and wounds. In addition, some isolates are reported to be transmitted by aphids (Hemiptera: Aphididae) such as <italic>Aphis frangulae</italic> (Kaltenbach)<italic>, A. nasturtii</italic> (Kaltenbach), <italic>Macrosiphum euphorbiae</italic> (Thomas) and <italic>Myzus persicae</italic> (Sulzer) (Bode and Weidemann, <xref rid="efs25854-bib-0003" ref-type="ref">1971</xref>; Weidemann, <xref rid="efs25854-bib-0029" ref-type="ref">1986</xref>). However, for some isolates, aphid transmission failed or is reported as inefficient (Bode and Weidemann, <xref rid="efs25854-bib-0003" ref-type="ref">1971</xref>; Loebenstein et al., <xref rid="efs25854-bib-0020" ref-type="ref">2001</xref>). No further details on strain or isolate identity were provided in these reports and it is therefore not known whether the PVM‐O and PVM‐D strains differ in their aphid transmission properties.</p></sec><sec id="efs25854-sec-0021"><label>3.1.3</label><title>Intraspecific diversity</title><p>Viruses generally exist as quasispecies, which means that they accumulate as a cluster of closely related sequence variants in a single host (Andino and Domingo, <xref rid="efs25854-bib-0002" ref-type="ref">2015</xref>). This is likely due to competition among the genomic variants that are generated as a consequence of the error‐prone viral replication (higher in RNA than in DNA viruses) and the ensuing selection of the most fit variants in a given environment (Domingo et al., <xref rid="efs25854-bib-0007" ref-type="ref">2012</xref>). This genetic variability may have consequences on the virus’ biological properties (e.g. host range, transmissibility, and pathogenicity) as well as on the reliability of detection methods, especially when they target variable genomic regions.</p><p>This pest categorisation focuses on taxonomic levels below the species level, i.e. on isolates and strains, which are defined in this opinion as follows:
<list list-type="bullet" id="efs25854-list-0001"><list-item><p><bold>Isolate</bold>: virus population as present in a plant;</p></list-item><list-item><p><bold>Strain</bold>: group of isolates sharing biological, molecular, and/or serological properties (Garcıa‐Arenal et al., <xref rid="efs25854-bib-0014" ref-type="ref">2001</xref>).</p></list-item></list></p><p>ICTV does not address taxonomic levels below species level and, therefore, the names of strains are based on reports in literature. In the past, the term ‘strain’ has also often been used as a synonym for ‘isolate’. As a consequence of this inconsistent use of terminology, the literature is often unclear.</p><p>Two strains have been distinguished on the basis of their molecular properties, the ordinary strain (PVM‐O) and the divergent strain (PVM‐D) (Ge et al., <xref rid="efs25854-bib-0015" ref-type="ref">2012</xref>; Tabasinejad et al., <xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>; Mishchenko et al., <xref rid="efs25854-bib-0021" ref-type="ref">2018</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>). Unlike many other viruses, these two strains have recently been distinguished and there was no prior discrimination of these strains based on biological properties. There is evidence for the existence of genetic variation within these strains, in particular within PVM‐D (Cavileer et al., <xref rid="efs25854-bib-0005" ref-type="ref">1998</xref>; Xu et al., <xref rid="efs25854-bib-0030" ref-type="ref">2010</xref>; Tabasinejad et al., <xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>; Plchova et al., <xref rid="efs25854-bib-0024" ref-type="ref">2015</xref>; Su et al., <xref rid="efs25854-bib-0025" ref-type="ref">2017</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>).</p><p>In addition, two EU isolates (PVM‐Hu from Hungary (GQ923785) and PVM‐T20 from Slovakia (MH558035)) have been reported to group outside the PVM‐O and PVM‐D strains based on phylogenetic trees (Fox et al., <xref rid="efs25854-bib-0013" ref-type="ref">2009</xref>; Glasa et al., <xref rid="efs25854-bib-0016" ref-type="ref">2019</xref>). A BLASTn analysis shows that they are genetically similar one to each other. There is currently no evidence for the existence of isolates similar to PVM‐Hu and PVM‐T20 outside the EU. Should such isolates exist outside of the EU and be introduced, they would not be expected to have additional impact over that of the PVM‐Hu and PVM‐T20 isolates under the present situation. Therefore, these two isolates will not be considered further in this pest categorisation.</p><p>Table <xref rid="efs25854-tbl-0002" ref-type="table">2</xref> provides an overview of the non‐EU strains of PVM subject to this pest categorisation.</p><table-wrap id="efs25854-tbl-0002" xml:lang="en" orientation="portrait" position="float"><label>Table 2</label><caption><p>Overview of reported strains of PVM</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Strain</th><th align="left" valign="top" rowspan="1" colspan="1">Acronym</th><th align="left" valign="top" rowspan="1" colspan="1">Other information</th><th align="left" valign="top" rowspan="1" colspan="1">Key references</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">Divergent strain</td><td align="left" rowspan="1" colspan="1">PVM‐D</td><td align="left" rowspan="1" colspan="1">Including PVM‐ID from Idaho (USA) (Cavileer et al., <xref rid="efs25854-bib-0005" ref-type="ref">1998</xref>; Xu et al., <xref rid="efs25854-bib-0030" ref-type="ref">2010</xref>; Tabasinejad et al., <xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>) and PVM‐YN from Yunnan (China) (Su et al., <xref rid="efs25854-bib-0025" ref-type="ref">2017</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>)</td><td align="left" rowspan="1" colspan="1">Xu et al. (<xref rid="efs25854-bib-0030" ref-type="ref">2010</xref>), Tabasinejad et al. (<xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>)</td></tr><tr><td align="left" rowspan="1" colspan="1">Ordinary strain</td><td align="left" rowspan="1" colspan="1">PVM‐O</td><td align="left" rowspan="1" colspan="1">–</td><td align="left" rowspan="1" colspan="1">Xu et al. (<xref rid="efs25854-bib-0030" ref-type="ref">2010</xref>), Tabasinejad et al. (<xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>)</td></tr></tbody></table><table-wrap-foot id="efs25854-ntgp-0002"><fn id="efs25854-note-0755"><p>PVM: potato virus M.</p></fn></table-wrap-foot><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0022"><label>3.1.4</label><title>Detection and identification of the pest</title><sec id="efs25854-sec-0023"><label>3.1.4.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0201" orientation="portrait"><p><italic>Are detection and identification methods available for the pest?</italic></p><p><bold>Yes</bold>. Methods are available for detection and identification of PVM at the species level, and therefore for the identification of non‐EU isolates. Genomic data are available for the design of diagnostic tests at strain level.</p></boxed-text></p><p>As mentioned in the pest categorisation of non‐EU viruses and viroids of potato (EFSA PLH Panel, <xref rid="efs25854-bib-0988" ref-type="ref">2020</xref>), virus detection and identification are complicated by several recurrent uncertainties. ICTV lists species demarcation criteria, but it is not always clear whether these are met in diagnostic tests. Furthermore, in the absence or near absence of information on genetic variability, it is not possible to guarantee that a given test will detect all variants of a species. On the contrary, generic tests may detect closely related viruses in addition to the target species. This implies that the reliability of a test depends on its validation for the intended use. For initial screening, it is important to prevent false negative results, which means that the following performance characteristics are most relevant: analytical sensitivity, inclusivity of analytical specificity (coverage of the intraspecies variability) and selectivity (matrix effects). For identification, it is important to prevent false positives and, therefore, the possible occurrence of cross reactions should be determined, i.e. the exclusivity of the analytical specificity (the resolution should be sufficient to discriminate between related species).</p><p>PVM is a well‐known virus for which detection methods are available. Bioassays associated with enzyme‐linked immunosorbent assay (ELISA) are available for detection and identification of PVM, but do not allow reliable identification of strains. Real‐time polymerase chain reaction (RT‐PCR) detection tests are also available (Glasa et al., <xref rid="efs25854-bib-0016" ref-type="ref">2019</xref>).</p><p>Currently, no specific tests are available for the detection and identification PVM strains. However, genomic data are available (Plchova et al., <xref rid="efs25854-bib-0023" ref-type="ref">2009</xref>; Mishchenko et al., <xref rid="efs25854-bib-0021" ref-type="ref">2018</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>) that could be used to design of polymerase chain reaction (PCR) primers which would allow detection and identification at the strain level.</p></sec></sec></sec><sec id="efs25854-sec-0024"><label>3.2</label><title>Pest distribution</title><sec id="efs25854-sec-0025"><label>3.2.1</label><title>Pest distribution outside the EU</title><p>PVM occurs worldwide wherever potato is grown (Valkonen, <xref rid="efs25854-bib-0027" ref-type="ref">2007</xref>). Isolates of the PVM‐O strain are reported in Asia and Europe. In addition, Chaudhary et al. (<xref rid="efs25854-bib-0006" ref-type="ref">2019</xref>) recently reported a PVM‐O isolate from Africa. Isolates of the PVM‐D strain are reported in Asia and North America (Tabasinejad et al., <xref rid="efs25854-bib-0026" ref-type="ref">2014</xref>; Mishchenko et al., <xref rid="efs25854-bib-0021" ref-type="ref">2018</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>).</p><p>PVM has been reported in several South American countries (CABI cpc, <xref rid="efs25854-bib-0004" ref-type="ref">2019</xref>), but there is no information available about the strain(s) present.</p></sec><sec id="efs25854-sec-0026"><label>3.2.2</label><title>Pest distribution in the EU</title><sec id="efs25854-sec-0027"><label>3.2.2.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0301" orientation="portrait"><p><italic>Is the pest present in the EU territory? If present, is the pest widely distributed within the EU?</italic></p><p><bold>Yes.</bold> PVM‐O isolates are present in the EU.</p><p><bold>No.</bold> PVM‐D isolates are considered absent or present with limited distribution in the EU.</p></boxed-text></p><p>PVM‐O isolates are reported from several EU MSs, i.e. Czech Republic, Germany, Latvia, Poland and Slovakia (Plchova et al., <xref rid="efs25854-bib-0024" ref-type="ref">2015</xref>; Glasa et al., <xref rid="efs25854-bib-0016" ref-type="ref">2019</xref>; He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>).</p><p>A PVM‐D isolate, PVM‐VIRUBRA 4/009, was once reported in the Czech Republic (NCBI GenBank JN225461) (Plchova et al., <xref rid="efs25854-bib-0024" ref-type="ref">2015</xref>). This isolate was obtained from collection material in 1988. There are no recent reports of PVM‐D in the EU. Therefore, PVM‐D isolates are considered to have at most a limited distribution in the EU. However, this assessment is uncertain in the absence of specific surveys.</p></sec></sec></sec><sec id="efs25854-sec-0028"><label>3.3</label><title>Regulatory status</title><sec id="efs25854-sec-0029"><label>3.3.1</label><title>Council Directive 2000/29/EC</title><p>Non‐EU isolates of PVM are specifically listed in Council Directive 2000/29/EC and are regulated in Annex IAI (Table <xref rid="efs25854-tbl-0003" ref-type="table">3</xref>).</p><table-wrap id="efs25854-tbl-0003" xml:lang="en" orientation="portrait" position="float"><label>Table 3</label><caption><p>Non‐EU isolates of PVM in Council Directive 2000/29/EC</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Annex I, Part A</th><th align="left" valign="top" rowspan="1" colspan="1">Harmful organisms whose introduction into, and spread within, all member states shall be banned</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1"><bold>Section I</bold></td><td align="left" rowspan="1" colspan="1"><bold>Harmful organisms not known to occur in any part of the community and relevant for the entire community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>(d)</bold></td><td align="left" rowspan="1" colspan="1"><bold>Viruses and virus‐like organisms</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">2.</td><td align="left" rowspan="1" colspan="1"><p>Potato viruses and virus‐like organisms such as:</p><p>(g) non‐European isolates of potato viruses A, M, S, V, X and Y (including Y<sup>o</sup>, Y<sup>n</sup> and Y<sup>c</sup>) and Potato leafroll virus</p></td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0030"><label>3.3.2</label><title>Legislation addressing potato</title><p>Table <xref rid="efs25854-tbl-0004" ref-type="table">4</xref> reports on the articles in Council Directive 2000/29/EC which address potato or tuber‐forming species of <italic>Solanum</italic> L. PVM may also infect other hosts; references to the corresponding legislation is reported in Table <xref rid="efs25854-tbl-0005" ref-type="table">5</xref> (see Section <xref rid="efs25854-sec-0033" ref-type="sec">3.4.1</xref>).</p><table-wrap id="efs25854-tbl-0004" xml:lang="en" orientation="portrait" position="float"><label>Table 4</label><caption><p>Overview of the regulation in Annexes III, IV and V of Council Directive 2000/29/EC that applies to potato or tuber‐forming <italic>Solanum</italic> species</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" style="border-bottom:solid 1px #000000" valign="top" rowspan="1" colspan="1">Annex III, Part A</th><th align="left" colspan="2" style="border-bottom:solid 1px #000000" valign="top" rowspan="1">Plants, plant products and other objects the introduction of which shall be prohibited in all Member States</th></tr><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1"></th><th align="left" valign="top" rowspan="1" colspan="1">Description</th><th align="left" valign="top" rowspan="1" colspan="1">Country of origin</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">10.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., seed potatoes</td><td align="left" rowspan="1" colspan="1">Third countries other than Switzerland</td></tr><tr><td align="left" rowspan="1" colspan="1">11.</td><td align="left" rowspan="1" colspan="1">Plants of stolon‐ or tuber‐forming species of <italic>Solanum</italic> L. or their hybrids, intended for planting, other than those tubers of <italic>Solanum tuberosum</italic> L. as specified under Annex III A (10)</td><td align="left" rowspan="1" colspan="1">Third countries</td></tr><tr style="border-bottom:solid 1px #000000"><td align="left" rowspan="1" colspan="1">12.</td><td align="left" rowspan="1" colspan="1">Tubers of species of <italic>Solanum</italic> L., and their hybrids, other than those specified in points 10 and 11</td><td align="left" rowspan="1" colspan="1">Without prejudice to the special requirements applicable to the potato tubers listed in Annex IV, Part A Section I, third countries other than Algeria, Egypt, Israel, Libya, Morocco, Syria, Switzerland, Tunisia and Turkey, and other than European third countries which are either recognised as being free from <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>., in accordance with the procedure referred to in Article 18(2), or in which provisions recognised as equivalent to the Community provisions on combating <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>. in accordance with the procedure referred to in Article 18(2), have been complied with</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Annex IV, Part A</bold></td><td align="left" colspan="2" rowspan="1"><bold>Special requirements which shall be laid down by all member states for the introduction and movement of plants, plant products and other objects into and within all Member States</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Section I</bold></td><td align="left" colspan="2" rowspan="1"><bold>Plants, plant products and other objects originating outside the Community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1"><bold>Plants, plant products and other objects</bold></td><td align="left" rowspan="1" colspan="1"><bold>Special requirements</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">25.1</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., originating in countries where <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival is known to occur</td><td align="left" rowspan="1" colspan="1"><p>Without prejudice to the prohibitions applicable to the tubers listed in Annex III(A) (10), (11) and (12), official statement that:</p><p>(a) the tubers originate in areas known to be free from <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival (all races other than Race 1, the common European race), and no symptoms of <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival have been observed either at the place of production or in its immediate vicinity since the beginning of an adequate period;</p><p>or</p><p>(b) provisions recognised as equivalent to the Community provisions on combating <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival in accordance with the procedure referred to in Article 18(2) have been complied with, in the country of origin</p></td></tr><tr><td align="left" rowspan="1" colspan="1">25.2.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L.</td><td align="left" rowspan="1" colspan="1"><p>Without prejudice to the provisions listed in Annex (A) (10), (11) and (12) and Annex IV(A)(I) (25.1), official statement that:</p><p>(a) the tubers originate in countries known to be free from <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>.;</p><p>or</p><p>(b) provisions recognised as equivalent to the Community provisions on combating <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>. in accordance with the procedure referred to in Article 18(2), have been complied with, in the country of origin</p></td></tr><tr><td align="left" rowspan="1" colspan="1">25.3.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., other than early potatoes, originating in countries where Potato spindle tuber viroid is known to occur</td><td align="left" rowspan="1" colspan="1">Without prejudice to the provisions applicable to the tubers listed in Annex III(A) (10), (11) and (12) and Annex IV(A)(I) (25.1) and (25.2), suppression of the faculty of germination</td></tr><tr><td align="left" rowspan="1" colspan="1">25.4.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting</td><td align="left" rowspan="1" colspan="1">Without prejudice to the provisions applicable to the tubers listed in Annex III(A)(10), (11) and (12) and Annex IV(A)(I) (25.1), (25.2) and (25.3), official statement that the tubers originate from a field known to be free from <italic>Globodera rostochiensis</italic> (Wollenweber) Behrens and <italic>Globodera pallida</italic> (Stone) Behrensand(aa) either, the tubers originate in areas in which <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. is known not to occur;or(bb) in areas where <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. is known to occur, the tubers originate from a place of production found free from <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>., or considered to be free thereof, as a consequence of the implementation of an appropriate procedure aiming at eradicating <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. which shall be determined in accordance with the procedure referred to in Article 18(2)and(cc) either the tubers originate in areas where <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen are known not to occur; or(dd) in areas where <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen are known to occur,— either the tubers originate from a place of production which has been found free from <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations), and <italic>Meloidogyne fallax</italic> Karssen based on an annual survey of host crops by visual inspection of host plants at appropriate times and by visual inspection both externally and by cutting of tubers after harvest from potato crops grown at the place of production, or— the tubers after harvest have been randomly sampled and, either checked for the presence of symptoms after an appropriate method to induce symptoms, or laboratory tested, as well as inspected visually both externally and by cutting the tubers, at appropriate times and in all cases at the time of closing of the packages or containers before marketing according to the provisions on closing in Council Directive 66/403/EEC of 14 June 1996 on the marketing of seed potatoes (1) and no symptoms of <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen have been found</td></tr><tr><td align="left" rowspan="1" colspan="1">25.4.1.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., other than those intended for planting</td><td align="left" rowspan="1" colspan="1">Without prejudice to the provisions applicable to tubers listed in Annex III(A) (12) and Annex IV(A)(I) (25.1), (25.2) and (25.3), official statement that the tubers originate in areas in which <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. is not known to occur</td></tr><tr><td align="left" rowspan="1" colspan="1">25.4.2.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L.</td><td align="left" rowspan="1" colspan="1"><p>Without prejudice to the provisions applicable to tubers listed in Annex III(A) (10), (11) and (12) and Annex IV(A)(I) (25.1), (25.2), (25.3), (25.4) and (25.4.1), official statement that:</p><p>(a) the tubers originate in a country where <italic>Scrobipalpopsis solanivora</italic> Povolny is not known to occur; or</p><p>(b) the tubers originate in an area free from <italic>Scrobipalpopsis solanivora</italic> Povolny, established by the national plant protection organisation in accordance with relevant International Standards for Phytosanitary Measures.</p></td></tr><tr><td align="left" rowspan="1" colspan="1">25.5.</td><td align="left" rowspan="1" colspan="1">Plants of Solanaceae, intended for planting, other than seeds, originating in countries where Potato stolbur mycoplasm is known to occur</td><td align="left" rowspan="1" colspan="1">Without prejudice to the provisions applicable to tubers listed in Annex III(A) (10), (11), (12) and (13), and Annex IV(A)(I) (25.1), (25.2), (25.3) and (25.4), official statement that no symptoms of Potato stolbur mycoplasm have been observed on the plants at the place of production since the beginning of the last complete cycle of vegetation</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Section II</bold></td><td align="left" colspan="2" rowspan="1"><bold>Plants, plant products and other objects originating in the Community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1"><bold>Plants, plant products and other objects</bold></td><td align="left" rowspan="1" colspan="1"><bold>Special requirements</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">18.1.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting</td><td align="left" rowspan="1" colspan="1"><p>Official statement that:</p><p>(a) the Union provisions to combat <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival have been complied with;</p><p>and</p><p>(b) either the tubers originate in an area known to be free from <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>. or the Union provisions to combat <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>. have been complied with;</p><p>and</p><p>(d) (aa) either, the tubers originate in areas in which <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. is known not to occur; or</p><p>(bb) in areas where <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. is known to occur, the tubers originate from a place of production found free from <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>., or considered to be free thereof, as a consequence of the implementation of an appropriate procedure aiming at eradicating <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>.;</p><p>and</p><p>(e) either, the tubers originate in areas in which <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen are known not to occur, or in areas where <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen are known to occur:</p><p>— either, the tubers originate from a place of production which has been found free from <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen based on an annual survey of host crops by visual inspection of host plants at appropriate times and by visual inspection both externally and by cutting of tubers after harvest from potato crops grown at the place of production, or</p><p>— the tubers after harvest have been randomly sampled and, either checked for the presence of symptoms after an appropriate method to induce symptoms or laboratory tested, as well as inspected visually both externally and by cutting the tubers, at appropriate times and in all cases at the time of closing of the packages or containers before marketing according to the provisions on closing in Council Directive 66/403/EEC, and no symptoms of <italic>Meloidogyne chitwoodi</italic> Golden <italic>et al</italic>. (all populations) and <italic>Meloidogyne fallax</italic> Karssen have been found</p></td></tr><tr><td align="left" rowspan="1" colspan="1">18.1.1.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting, other than those to be planted in accordance with Article 4.4(b) of Council Directive 2007/33/EC</td><td align="left" rowspan="1" colspan="1">Without prejudice to the requirements applicable to the tubers of <italic>Solanum tuberosum</italic> L., intended for planting in Annex IV, Part A, Section II (18.1), official statement that the Union provisions to combat <italic>Globodera pallida</italic> (Stone) Behrens and <italic>Globodera rostochiensis</italic> (Wollenweber) Behrens are complied with</td></tr><tr><td align="left" rowspan="1" colspan="1">18.2</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting, other than tubers of those varieties officially accepted in one or more Member States pursuant to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (1)</td><td align="left" rowspan="1" colspan="1"><p>Without prejudice to the special requirements applicable to the tubers listed in Annex IV(A)(II) (18.1), official statement that the tubers:</p><p>— belong to advanced selections such a statement being indicated in an appropriate way on the document accompanying the relevant tubers,</p><p>— have been produced within the Community,</p><p>and</p><p>— have been derived in direct line from material which has been maintained under appropriate conditions and has been subjected within the Community to official quarantine testing in accordance with appropriate methods and has been found, in these tests, free from harmful organisms</p></td></tr><tr><td align="left" rowspan="1" colspan="1">18.3</td><td align="left" rowspan="1" colspan="1">Plants of stolon or tuber‐forming species of <italic>Solanum</italic> L., or their hybrids, intended for planting, other than those tubers of <italic>Solanum tuberosum</italic> L. specified in Annex IV(A)(II) (18.1) or (18.2), and other than culture maintenance material being stored in gene banks or genetic stock collections</td><td align="left" rowspan="1" colspan="1"><p>(a) The plants shall have been held under quarantine conditions and shall have been found free of any harmful organisms in quarantine testing;</p><p>(b) the quarantine testing referred to in (a) shall:</p><p>(aa) be supervised by the official plant protection organisation of the Member State concerned and executed by scientifically trained staff of that organisation or of any officially approved body;</p><p>(bb) be executed at a site provided with appropriate facilities sufficient to contain harmful organisms and maintain the material including indicator plants in such a way as to eliminate any risk of spreading harmful organisms;</p><p>(cc) be executed on each unit of the material;</p><p>– by visual examination at regular intervals during the full length of at least one vegetative cycle, having regard to the type of material and its stage of development during the testing programme, for symptoms caused by any harmful organisms,</p><p>– by testing, in accordance with appropriate methods to be submitted to the Committee referred to in Article 18:</p><p>– in the case of all potato material at least for:</p><p>– Andean potato latent virus,</p><p>– Arracacha virus B. oca strain,</p><p>– Potato black ringspot virus,</p><p>– Potato spindle tuber viroid,</p><p>– Potato virus T,</p><p>– Andean potato mottle virus,</p><p>– common potato viruses A, M, S, V, X and Y (including Yo, Yn and Yc) and Potato leaf roll virus,</p><p>– <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis et al.,</p><p>– <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi et al.,</p><p>– in the case of true seed potato of least for the viruses and viroid listed above;(dd) by appropriate testing on any other symptom observed in the visual examination in order to identify the harmful organisms having caused such symptoms;(c) any material, which has not been found free, under the testing specified under (b) from harmful organisms as specified under (b) shall be immediately destroyed or subjected to procedures which eliminate the harmful organism(s);(d) each organisation or research body holding this material shall inform their official Member State plant protection service of the material held.</p></td></tr><tr><td align="left" rowspan="1" colspan="1">18.3.1.</td><td align="left" rowspan="1" colspan="1">Seeds of <italic>Solanum tuberosum</italic> L., other than those specified in point 18.4.</td><td align="left" rowspan="1" colspan="1"><p>Official statement that:</p><p>The seeds derive from plants complying, as applicable, with the requirements set out in points 18.1., 18.1.1, 18.2 and 18.3;</p><p>and</p><p>(a) the seeds originate in areas known to be free from <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival, <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>., <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. and Potato spindle tuber viroid;</p><p>or</p><p>(b) the seeds comply with all of the following requirements:</p><p>(i) they have been produced in a site where, since the beginning of the last cycle of vegetation, no symptoms of disease caused by the harmful organisms referred to in point (a) have been observed;</p><p>(ii) they have been produced at a site where all of the following actions have been taken:separation of the site from other solanaceous plants and other host plants of Potato spindle tuber viroid;prevention of contact with staff and items, such as tools, machinery, vehicles, vessels and packaging material, from other sites producing solanaceous plants and other host plants of Potato spindle tuber viroid, or appropriate hygiene measures concerning staff or items from other sites producing solanaceous plants and other host plants of Potato spindle tuber viroid to prevent infection;only water free from all harmful organisms referred to in this point is used.</p></td></tr><tr><td align="left" rowspan="1" colspan="1">18.4</td><td align="left" rowspan="1" colspan="1">Plants of stolon, or tuber‐forming species of <italic>Solanum</italic> L., or their hybrids, intended for planting, being stored in gene banks or genetic stock collections</td><td align="left" rowspan="1" colspan="1">Each organisation or research body holding such material shall inform their official Member State plant protection service of the material held</td></tr><tr><td align="left" rowspan="1" colspan="1">18.5.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., other than those mentioned in Annex IV(A)(II)(18.1), (18.1.1), (18.2), (18.3) or (18.4)</td><td align="left" rowspan="1" colspan="1"><p>There shall be evidence by a registration number put on the packaging, or in the case of loose‐loaded potatoes transported in bulk, on the vehicle transporting the potatoes, that the potatoes have been grown by an officially registered producer, or originate from officially registered collective storage or dispatching centres located in the area of production, indicating that the tubers are free from <italic>Ralstonia solanacearum</italic> (Smith) Yabuuchi <italic>et al</italic>. and that</p><p>(a) the Union provisions to combat <italic>Synchytrium endobioticum</italic> (Schilbersky) Percival,</p><p>and</p><p>(b) where appropriate, the Union provisions to combat <italic>Clavibacter michiganensis</italic> ssp. <italic>sepedonicus</italic> (Spieckermann and Kotthoff) Davis <italic>et al</italic>.,</p><p>and</p><p>(c) the Union provisions to combat <italic>Globodera pallida</italic> (Stone) Behrens and <italic>Globodera rostochiensis</italic> (Wollenweber) Behrens are complied with</p></td></tr></tbody></table><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Annex IV, Part B</th><th align="left" colspan="3" valign="top" rowspan="1">Special requirements which shall be laid down by all member states for the introduction and movement of plants, plant products and other objects into and within certain protected zones</th></tr><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1"></th><th align="left" style="border-bottom:solid 1px #000000" valign="top" rowspan="1" colspan="1"><bold>Plants, plant products and other objects</bold></th><th align="left" valign="top" rowspan="1" colspan="1"><bold>Special requirements</bold></th><th align="left" valign="top" rowspan="1" colspan="1">Protected zone(s)</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">20.1.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting</td><td align="left" rowspan="1" colspan="1"><p>Without prejudice to the provisions applicable to the plants listed in Annex III(A) (10), (11), Annex IV(A)(I) (25.1), (25.2), (25.3), (25.4), (25.5), (25.6), Annex IV(A)(II) (18.1), (18.2), (18.3), (18.4), (18.6), official statement that the tubers:</p><p>(a) were grown in an area where Beet necrotic yellow vein virus (BNYVV) is known not to occur;</p><p>or</p><p>(b) were grown on land, or in growing media consisting of soil that is known to be free from BNYVV, or officially tested by appropriate methods and found free from BNYVV;</p><p>or</p><p>(c) have been washed free from soil.</p></td><td align="left" rowspan="1" colspan="1">F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)</td></tr><tr><td align="left" rowspan="1" colspan="1">20.2.</td><td align="left" rowspan="1" colspan="1">Tubers of <italic>Solanum tuberosum</italic> L., other than those mentioned in Annex IV(B) (20.1)</td><td align="left" rowspan="1" colspan="1"><p>(a) The consignment or lot shall not contain more than 1% by weight of soil,</p><p>or</p><p>(b) the tubers are intended for processing at premises with officially approved waste disposal facilities which ensures that there is no risk of spreading BNYVV.</p></td><td align="left" rowspan="1" colspan="1">F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Annex V</bold></td><td align="left" colspan="3" rowspan="1"><bold>Plants, plant products and other objects which must be subject to a plant health inspection (at the place of production if originating in the Community, before being moved within the Community<italic>—</italic>in the country of origin or the consignor country, if originating outside the Community) before being permitted to enter the Community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Part A</bold></td><td align="left" colspan="3" rowspan="1"><bold>Plants, plant products and other objects originating in the Community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Section I</bold></td><td align="left" colspan="3" rowspan="1"><bold>Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for the entire Community and which must be accompanied by a plant passport</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">1.3.</td><td align="left" colspan="3" rowspan="1">Plants of stolon‐ or tuber‐forming species of <italic>Solanum</italic> L. or their hybrids, intended for planting</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Section II</bold></td><td align="left" colspan="3" rowspan="1"><p><bold>Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for certain protected zones and which must be accompanied by a plant passport valid for the appropriate zone when introduced into or moved within that zone</bold></p><p>Without prejudice to the plants, plant products and other objects listed in Part I</p></td></tr><tr><td align="left" rowspan="1" colspan="1">1.5.</td><td align="left" colspan="3" rowspan="1">Tubers of <italic>Solanum tuberosum</italic> L., intended for planting.</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Part B</bold></td><td align="left" colspan="3" rowspan="1"><bold>Plants, plant products and other objects originating in territories, other than those territories referred to in Part A</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Section I</bold></td><td align="left" colspan="3" rowspan="1"><bold>Plants, plant products and other objects which are potential carriers of harmful organisms of relevance for the entire Community</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">4.</td><td align="left" colspan="3" rowspan="1">Tubers of <italic>Solanum tuberosum</italic> L.</td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0031"><label>3.3.3</label><title>Legislation addressing the organisms that vector PVM (Directive/2000/29/EC)</title><p>Some isolates of PVM (see Section <xref rid="efs25854-sec-0020" ref-type="sec">3.1.2</xref>) are reported to be transmitted by aphid vectors, which are not subject to specific regulation.</p></sec></sec><sec id="efs25854-sec-0032"><label>3.4</label><title>Entry, establishment and spread in the EU</title><sec id="efs25854-sec-0033"><label>3.4.1</label><title>Host range</title><p>Table <xref rid="efs25854-tbl-0005" ref-type="table">5</xref> provides information on reports of natural hosts (including potato) of PVM strains, including the associated uncertainties and regulation.</p><p>The following hosts have been reported as hosts without information of the strain(s) involved: <italic>Capsicum annuum</italic>,<italic> Capsicum frutescens</italic>,<italic> Datura metel</italic>,<italic> Fumaria officinalis</italic>,<italic> Galium aparine</italic> (CABI cpc, <xref rid="efs25854-bib-0004" ref-type="ref">2019</xref>), <italic>Solanum dulcamara</italic> (Perry and McLane, <xref rid="efs25854-bib-0022" ref-type="ref">2011</xref>), <italic>S. jasminoides</italic> (Verhoeven et al., <xref rid="efs25854-bib-0028" ref-type="ref">2006</xref>), <italic>Solanum nigrum</italic> (Chaudhary et al., <xref rid="efs25854-bib-0006" ref-type="ref">2019</xref>).</p><table-wrap id="efs25854-tbl-0005" xml:lang="en" orientation="portrait" position="float"><label>Table 5</label><caption><p>Natural hosts of PVM. Data regarding natural hosts was retrieved from the CABI cpc and literature up to 19 August 2019</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Strain</th><th align="left" valign="top" rowspan="1" colspan="1">Hosts<xref ref-type="fn" rid="efs25854-note-0075">a</xref></th><th align="left" valign="top" rowspan="1" colspan="1">Rationale and/or uncertainty</th><th align="left" valign="top" rowspan="1" colspan="1">Regulation<xref ref-type="fn" rid="efs25854-note-0007">b</xref></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">PVM‐D</td><td align="left" rowspan="1" colspan="1"><bold>Literature: </bold><italic>Solanum tuberosum</italic> (He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>)</td><td align="left" rowspan="1" colspan="1">Limited information. Additional natural hosts may exist</td><td align="left" rowspan="2" colspan="1"><p><italic><bold>Capsicum</bold></italic><bold>sp.:</bold> IVAI 16.6, 25.7, 36.3, IVAII 18.6.1, 18.7; VBI 1,3.</p><p><italic><bold>Nicotiana</bold></italic><bold>sp.:</bold> IVAI 25.7; IVAII 18.7.</p><p><italic><bold>Solanum</bold></italic><bold>sp.:</bold> IIIA 10,11,12; IVAI 25.1, 25.2, 25.3, 25.4, 25.4.1, 25.4.2, 25.5, 25.6, 25.7, 25.7.1, 25.7.2, 28.1, 36.2, 45.3, 48; IVAII 18.1, 18.1.1, 18.2, 18.3, 18.3.1, 18.4, 18.5, 18.6, 18.6.1, 18.7, 26.1, 27; IVBI 20.1, 20.2; VAI 1.3, 2.4; VAII 1.5; VBI 1, 3, 4.</p><p><italic><bold>Solanaceae</bold></italic>: IIIA 13</p></td></tr><tr><td align="left" rowspan="1" colspan="1">PVM‐O</td><td align="left" rowspan="1" colspan="1"><bold>Literature: </bold><italic>Nicotiana tabacum, Solanum lycopersicum, S. muricatum, S. tuberosum</italic> (He et al., <xref rid="efs25854-bib-0017" ref-type="ref">2019</xref>)</td><td align="left" rowspan="1" colspan="1">Limited information. Additional natural hosts may exist</td></tr></tbody></table><table-wrap-foot id="efs25854-ntgp-0003"><fn id="efs25854-note-0075"><label>a</label><p>Natural hosts including potato, i.e. <italic>Solanum tuberosum</italic> and tuber‐forming <italic>Solanum</italic> species.</p></fn><fn id="efs25854-note-0007"><label>b</label><p>Including regulation of hosts without information of the strain(s) involved.</p></fn></table-wrap-foot><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0034"><label>3.4.2</label><title>Entry</title><sec id="efs25854-sec-0035"><label>3.4.2.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0401" orientation="portrait"><p><italic>Is the pest able to enter into the EU territory? If yes, identify and list the pathways</italic>.</p><p><bold>Yes</bold>. Non‐EU isolates of PVM may enter the EU territory via plants for planting, i.e. seed potatoes (tubers) and/or microplants. Additional pathways include: ware potatoes (i.e. tubers intended for consumption or processing), plants for planting and fruits of other hosts, and viruliferous aphid vectors.</p></boxed-text></p><p>The following pathways can be considered for entry of non‐EU isolates of PVM into the EU: potato plants for planting (seed potatoes, microplants), ware potatoes (i.e. tubers intended for consumption or processing), plants for planting of other natural hosts, and viruliferous aphid vectors (see Table <xref rid="efs25854-tbl-0006" ref-type="table">6</xref> for the major pathways).</p><p>PVM is transmitted by vegetative propagation and therefore seed potatoes and more generally, plants for planting, are considered the most important pathway for entry. The potential pathways for entry of non‐EU isolates via seed potatoes of <italic>Solanum tuberosum</italic> and plants for planting of other tuber‐forming <italic>Solanum</italic> species and their hybrids is addressed by the current EU legislation (Table <xref rid="efs25854-tbl-0005" ref-type="table">5</xref>; (EU) 2000/29 Annex IIIA, 10 and 11), which includes that import is not allowed from third countries except Switzerland. Furthermore, import of seed potatoes from Canada into Greece, Spain, Italy, Cyprus, Malta and Portugal is allowed by a derogation (2011/778/EU, 2014/368/EU, document C (2014) 3878). PVM should be considered present in Switzerland (strain PVM‐O) and Canada (strain PVM‐D) and, by definition, the PVM isolates present in these countries are considered to be non‐EU isolates. Therefore, the pathway of plants for planting is considered partially regulated for both strains.</p><p>Entry of ware potatoes is addressed by the current EU legislation (table <xref rid="efs25854-tbl-0005" ref-type="table">5</xref>, Annex IIIA, 12). Import of ware potatoes is prohibited from third countries other than Algeria, Egypt, Israel, Libya, Morocco, Syria, Switzerland, Tunisia and Turkey, and from European non‐EU countries which are not free from <italic>Clavibacter michiganensis</italic> spp. <italic>sepedonicus</italic> or in which provisions on combating <italic>Clavibacter michiganensis</italic> spp. <italic>sepedonicus</italic> have not been complied with. The latter exemption currently applies to Serbia and Bosnia‐Herzegovina. PVM‐D is not known to be present in these countries subject to import derogations; therefore, the ware potatoes pathway is considered closed for non‐EU PVM‐D isolates. The ware potatoes pathway is considered partially regulated for non‐EU PVM‐O isolates because the virus is present in countries for which there is an import derogation (virus present in Asia and Europe). Note that as long as ware potatoes are used for the intended use (consumption or processing) the ability of non‐EU isolates of PVM to establish is very low. In addition, there are specific measures in place (Annex IV 25.3) for countries where potato spindle tuber viroid is known to occur (according to EPPO: Egypt, Israel and Turkey) aimed at mitigating the risk of establishment by suppression of the faculty of germination of ware potatoes, other than early potatoes, from these countries.</p><p>PVM has a limited number of natural hosts in addition to potato (see Section <xref rid="efs25854-sec-0033" ref-type="sec">3.4.1</xref>); these hosts are either regulated solanaceous species, or non‐regulated weed species (<italic>Galium aparine</italic>,<italic> Fumaria officinalis</italic>). There is no indication as to whether these non‐solanaceous species are hosts of PVM‐O and/or PVM‐D isolates, but no trade of plants for planting is expected for these species.</p><p>It is unclear whether some or all of the regulated solanaceous hosts can be infected by PVM‐D isolates (see Section <xref rid="efs25854-sec-0033" ref-type="sec">3.4.1</xref>). Although the import of plants for planting of solanaceous species is addressed by the legislation, it is possible to import such plants for planting from Mediterranean countries, some of them being subject to import derogations. As a consequence, the pathway of plants of planting of other hosts is considered as partially regulated for non‐EU PVM‐O and for non‐EU PVM‐D isolates. These evaluations are affected by uncertainties because there is no information about the strain(s) present in the countries subject to import derogations, and about the existence of non‐potato Solanaceous hosts of PVM‐D.</p><p>Viruliferous aphid vectors are a possible pathway of entry for non‐EU isolates of PVM (see Section <xref rid="efs25854-sec-0020" ref-type="sec">3.1.2</xref>). Since the relevant aphid species are not subject to specific regulation, this pathway is possibly open for non‐EU isolates of both strains of PVM. PVM is transmitted by aphids in a non‐persistent way, which implies that viruliferous aphids will lose the ability to transmit the virus within a short period. Therefore, this pathway is considered to be of minor importance and is not listed in Table <xref rid="efs25854-tbl-0006" ref-type="table">6</xref>.</p><p>Import of fruits can be an additional pathway for entry of non‐EU isolates of PVM. However, the lack of seed transmission (see Section <xref rid="efs25854-sec-0020" ref-type="sec">3.1.2</xref>) reduces the relevance of this potential pathway. Aphid vectors can probe the infected fruits and acquire the virus for later transmission. Fruits of <italic>Capsicum annuum</italic> can be imported from a range of countries where PVM isolates have been reported. Overall, this pathway is considered to be possibly open for non‐EU isolates of both strains of PVM. However, given the relatively unlikely series of events involved (aphids feeding on imported fruits followed by moving to susceptible plants) and the absence of seed transmission, this pathway is considered as minor and therefore not listed in Table <xref rid="efs25854-tbl-0006" ref-type="table">6</xref>.</p><table-wrap id="efs25854-tbl-0006" xml:lang="en" orientation="portrait" position="float"><label>Table 6</label><caption><p>Identified major pathways for potential entry of non‐EU isolates of PVM and the extent to which these pathways are addressed by current legislation</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Strain</th><th align="left" valign="top" rowspan="1" colspan="1">Potato plants for planting<xref ref-type="fn" rid="efs25854-note-0008">a</xref></th><th align="left" valign="top" rowspan="1" colspan="1">Ware potatoes<xref ref-type="fn" rid="efs25854-note-0008">a</xref></th><th align="left" valign="top" rowspan="1" colspan="1">Plants for planting of other hosts<xref ref-type="fn" rid="efs25854-note-0008">a</xref><sup>,</sup><xref ref-type="fn" rid="efs25854-note-0009">b</xref></th><th align="left" valign="top" rowspan="1" colspan="1">Uncertainties</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">PVM‐D</td><td align="left" rowspan="1" colspan="1">Pathway partially regulated: plants for planting of potato can be imported from Canada</td><td align="left" rowspan="1" colspan="1">Pathway considered closed: PVM‐D is not reported to be present in the countries subject to import derogations</td><td align="left" rowspan="1" colspan="1">Pathway partially regulated: PVM‐D isolates may have non‐potato solanaceous hosts and may be present in the countries subject to import derogations</td><td align="left" rowspan="1" colspan="1"><p>Geographic distribution</p><p>Existence of other natural hosts</p><p>Relevance of vectors</p></td></tr><tr><td align="left" rowspan="1" colspan="1">PVM‐O</td><td align="left" rowspan="1" colspan="1">Pathway partially regulated: plants for planting of potato can be imported from Switzerland</td><td align="left" rowspan="1" colspan="1">Pathway partially regulated: ware potatoes can be imported from a range of non‐EU European countries where PVM‐O is reported</td><td align="left" rowspan="1" colspan="1">Pathway partially regulated: plants for planting of solanaceous host species can be imported from Mediterranean countries</td><td align="left" rowspan="1" colspan="1"><p>Geographic distribution</p><p>Existence of other natural hosts</p><p>Relevance of vectors</p></td></tr></tbody></table><table-wrap-foot id="efs25854-ntgp-0004"><fn id="efs25854-note-0008"><label>a</label><p>‘<bold>Pathway open</bold>’: no regulation or ban that prevents this pathway, ‘<bold>Pathway closed</bold>’ (as opposed to ‘pathway open’): ban that prevents entry. ‘<bold>Pathway possibly open</bold>’: no direct evidence of the existence of the pathway (not closed by current legislation), but existence cannot be excluded based on comparisons with the biology of closely related viruses (in the same genus or family). ‘<bold>Pathway regulated</bold>’: regulations exist that limit the probability of entry along the pathway, but there is not a complete ban on imports. ‘<bold>Pathway partially regulated</bold>’: pathway consists of several sub‐pathways, some are open, while others are closed (e.g. regulation for some hosts, but not for others; a ban exists for some non‐EU MSs but not for all). ‘<bold>Not a pathway</bold>’: no evidence supporting the existence of the pathway.</p></fn><fn id="efs25854-note-0009"><label>b</label><p>Plants for planting, including seeds and pollen, of other hosts which are listed in Table <xref rid="efs25854-tbl-0005" ref-type="table">5</xref>.</p></fn></table-wrap-foot><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap><p>The Europhyt database does not report any interception of PVM by EU MSs between 1995 and 8 August 2019.</p></sec></sec><sec id="efs25854-sec-0036"><label>3.4.3</label><title>Establishment</title><sec id="efs25854-sec-0037"><label>3.4.3.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0601" orientation="portrait"><p><italic>Is the pest able to become established in the EU territory?</italic></p><p><bold>Yes</bold>. Non‐EU isolates of PVM are likely to become established in the EU territory, as EU isolates and the main hosts are already present in the EU.</p></boxed-text></p></sec><sec id="efs25854-sec-0038"><label>3.4.3.2</label><title>EU distribution of main host plants</title><p>Potato is widely grown in the EU, as reported in the pest categorisation of non‐EU viruses and viroids of potato (EFSA PLH Panel, <xref rid="efs25854-bib-0988" ref-type="ref">2020</xref>).</p></sec><sec id="efs25854-sec-0039"><label>3.4.3.3</label><title>Climatic conditions affecting establishment</title><p>Except for those conditions affecting survival of the host plants, no eco‐climatic constrains exist for the PVM isolates categorised here. Therefore, it is expected that these isolates are able to establish wherever their hosts may live. Potato is widely cultivated in the EU and therefore the Panel considers that climatic conditions will not impair the ability of the viruses addressed here to establish in the EU. However, it must be taken into consideration that virus impact, accumulation and distribution within natural hosts are dependent on environmental conditions. The same applies to expression of symptoms, vector populations and virus transmission being affected by climatic conditions.</p></sec></sec><sec id="efs25854-sec-0040"><label>3.4.4</label><title>Spread</title><sec id="efs25854-sec-0041"><label>3.4.4.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0701" orientation="portrait"><p><italic>Is the pest able to spread within the EU territory following establishment?</italic></p><p><bold>Yes.</bold> Non‐EU isolates of PVM can spread via plants for planting, by mechanical transmission, and in addition, some of them can be spread by aphid vectors.</p></boxed-text></p><p>Some non‐EU isolates of PVM can be transmitted by aphids (see Section <xref rid="efs25854-sec-0020" ref-type="sec">3.1.2</xref>), including <italic>Myzus persicae</italic> (Sulzer), which is widespread in and outside the EU (see Figure <xref rid="efs25854-fig-0001" ref-type="fig">1</xref>).</p><fig fig-type="Figure" xml:lang="en" id="efs25854-fig-0001" orientation="portrait" position="float"><label>Figure 1</label><caption><p>Global distribution map of <italic>Myzus persicae</italic> (Sulzer). Extracted from <styled-content style="fixed-case" toggle="no">CABI</styled-content> cpc on 8 August 2019</p></caption><graphic id="nlm-graphic-1" xlink:href="EFS2-18-e05854-g001"></graphic></fig></sec></sec></sec><sec id="efs25854-sec-0042"><label>3.5</label><title>Impacts</title><sec id="efs25854-sec-0043"><label>3.5.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0801" orientation="portrait"><p><italic>Would the pests’ introduction have an economic or environmental impact on the EU territory?</italic></p><p><bold>No.</bold> Non‐EU isolates of PVM‐O are not known to differ from PVM‐O isolates already present and no additional impact is therefore expected on the EU territory.</p><p><bold>Unable to conclude.</bold> The lack of information on possible differences in biological properties (host range, vector transmission, pathogenicity) does not allow the Panel to reach a conclusion on a potential additional impact of non‐EU isolates of PVM‐D on the EU territory.</p></boxed-text></p><p>As mentioned in the pest categorisation of non‐EU viruses and viroids of potato (EFSA PLH Panel, <xref rid="efs25854-bib-0988" ref-type="ref">2020</xref>), symptoms caused by viruses are influenced by different factors, such as the isolate of the virus, the host and variety, and environmental conditions. A causal relation between a virus and reported symptoms is not always clear, for example in the case of mixed infections. Mixed infections are especially common in vegetative‐propagated crops such as potato and the presence of additional viruses might increase or attenuate the observed symptoms. Therefore, reports on the symptomatology of individual viruses might not be conclusive, leading to uncertainties on the causal relation between a virus and the symptoms reported.</p><p>Infections of PVM are often symptomless, but are also reported to cause mottle, mosaic, leaf crinkling and rolling, and reduced growth (Jeffries, <xref rid="efs25854-bib-0018" ref-type="ref">1998</xref>; Loebenstein et al., <xref rid="efs25854-bib-0020" ref-type="ref">2001</xref>; CABI cpc, <xref rid="efs25854-bib-0004" ref-type="ref">2019</xref>). Severity is influenced by virus isolates and potato cultivar (Kowalska, <xref rid="efs25854-bib-0019" ref-type="ref">1978</xref>) and 15–45% yield reductions have been reported (Jeffries, <xref rid="efs25854-bib-0018" ref-type="ref">1998</xref>). PVM is considered to have an impact at the species level and various control measures have already been implemented (e.g. certification of plants for planting). No information could be found that describes the impact of PVM at the strain level.</p><p>PVM‐O isolates occur in the EU and there is no evidence for differences in molecular or biological properties between EU and non‐EU PVM‐O isolates. Therefore, non‐EU PVM‐O isolates are not expected to have an additional impact over the present situation, with uncertainties.</p><p>In the absence of information on the biology and, in particular, on biological differences with PVM isolates present in the EU, the Panel is unable to conclude whether non‐EU PVM‐D isolates would have an additional impact, should they be introduced into the EU.</p></sec></sec><sec id="efs25854-sec-0044"><label>3.6</label><title>Availability and limits of mitigation measures</title><sec id="efs25854-sec-0045"><label>3.6.1</label><p><boxed-text position="anchor" content-type="box" id="efs25854-blkfxd-0901" orientation="portrait"><p><italic>Are there measures available to prevent the entry into, establishment within or spread of the pest within the EU such that the risk becomes mitigated?</italic></p><p><bold>Yes</bold>. See Section <xref rid="efs25854-sec-0028" ref-type="sec">3.3</xref> for measures already implemented in the current legislation. Additional measures could be implemented to further regulate the identified pathways or to limit entry, establishment or spread of non‐EU isolates of PVM.</p></boxed-text></p></sec><sec id="efs25854-sec-0046"><label>3.6.2</label><title>Identification of additional measures</title><p>Phytosanitary measures are currently applied to potato and other hosts (see Sections <xref rid="efs25854-sec-0028" ref-type="sec">3.3</xref> and <xref rid="efs25854-sec-0033" ref-type="sec">3.4.1</xref>). Potential additional measures to mitigate the risk of entry of the isolates categorised in this opinion may include:
<list list-type="bullet" id="efs25854-list-0002"><list-item><p>Repel import derogations for potato plants for planting;</p></list-item><list-item><p>Set specific phytosanitary requirements addressing the isolates categorised in this opinion for imported seed potatoes and/or ware potatoes;</p></list-item><list-item><p>Extension of phytosanitary measures to specifically include hosts other than potato;</p></list-item><list-item><p>Banning import of non‐potato hosts plants for planting from countries where isolates other than PVM‐O isolates are present;</p></list-item><list-item><p>Extension of certification schemes and testing requirements to non‐Solanum natural hosts;</p></list-item><list-item><p>Extension of plant passport requirements to specifically include hosts other than stolon‐ and tuber‐forming <italic>Solanum</italic> species.</p></list-item></list></p><p>In addition, non‐EU isolates of PVM may enter in the EU through viruliferous aphids. Measures against aphids may include chemical treatment of consignments identified as potential entry pathways.</p><sec id="efs25854-sec-0047"><label>3.6.2.1</label><title>Additional control measures</title><p>Table <xref rid="efs25854-tbl-0007" ref-type="table">7</xref> reports on the potential additional control measures to reduce the likelihood of entry, establishment and/or spread of the categorised non‐EU isolates of PVM. The additional control measures are selected from a longer list reported in EFSA PLH Panel (<xref rid="efs25854-bib-0008" ref-type="ref">2018</xref>). Control measures are measures that have a direct effect on pest abundance.</p><table-wrap id="efs25854-tbl-0007" xml:lang="en" orientation="portrait" position="float"><label>Table 7</label><caption><p>Selected additional control measures to consider to reduce the likelihood of pest entry, establishment and/or spread of non‐EU isolates of PVM</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Information sheet <underline underline-style="single">(with hyperlink to information sheet if available)</underline></th><th align="left" valign="top" rowspan="1" colspan="1">Control measure summary</th><th align="left" valign="top" rowspan="1" colspan="1">Risk component</th><th align="left" valign="top" rowspan="1" colspan="1">Rationale</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1175887">http://doi.org/10.5281/zenodo.1175887</ext-link></td><td align="left" rowspan="1" colspan="1">Description of possible exclusion conditions that could be implemented to isolate the crop from pests and if applicable relevant vectors. E.g. a dedicated structure such as glass or plastic greenhouses</td><td align="left" rowspan="1" colspan="1">Spread</td><td align="left" rowspan="1" colspan="1">Growing plants in insect proof greenhouses may prevent infestation by viruliferous aphid vectors. This measure would not be applicable for potato, with the exception of early stages of seed potato production. Production of seed potatoes in areas with low aphid pressure (e.g. high altitude) would minimise the risk of infestation</td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1175910">http://doi.org/10.5281/zenodo.1175910</ext-link></td><td align="left" rowspan="1" colspan="1"><p>Use of chemical compounds that may be applied to plants or to plant products after harvest, during process or packaging operations and storage</p><p>The treatments addressed in this information sheet are: a) fumigation; b) spraying/dipping pesticides; c) surface disinfectants; d) process additives; e) protective compounds</p></td><td align="left" rowspan="1" colspan="1">Entry</td><td align="left" rowspan="1" colspan="1"><p>a), b) and c) could remove viruliferous aphid vectors</p><p>PVM is transmitted by aphids in a non‐persistent way, which implies that viruliferous aphids will lose the ability to transmit the virus within a short period Therefore, the additional effect on preventing entry is minimal</p></td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1175929">http://doi.org/10.5281/zenodo.1175929</ext-link></td><td align="left" rowspan="1" colspan="1">The physical and chemical cleaning and disinfection of facilities, tools, machinery, transport means, facilities and other accessories (e.g., boxes, pots, pallets, palox, supports, hand tools). The measures addressed in this information sheet are: washing, sweeping and fumigation</td><td align="left" rowspan="1" colspan="1">Spread</td><td align="left" rowspan="1" colspan="1">Cleaning tools may limit the spread via mechanical transmission. Cutting tubers was associated with PVM transmission</td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1181436">http://doi.org/10.5281/zenodo.1181436</ext-link></td><td align="left" rowspan="1" colspan="1">Rogueing is defined as the removal of infested plants and/or uninfested host plants in a delimited area, whereas pruning is defined as the removal of infested plant parts only, without affecting the viability of the plant</td><td align="left" rowspan="1" colspan="1">Establishment and spread</td><td align="left" rowspan="1" colspan="1">Rogueing of infested plants is efficient, in particular to prevent spread of PVM via contact. Pruning is not effective to remove a virus from infected plants</td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1181717">http://doi.org/10.5281/zenodo.1181717</ext-link></td><td align="left" rowspan="1" colspan="1"><p>Crop rotation, associations and density, weed/volunteer control are used to prevent problems related to pests and are usually applied in various combinations to make the habitat less favourable for pests</p><p>The measures deal with (1) allocation of crops to field (over time and space) (multi‐crop, diversity cropping) and (2) to control weeds and volunteers as hosts of pests/vectors</p></td><td align="left" rowspan="1" colspan="1">Spread and impact</td><td align="left" rowspan="1" colspan="1">Viruses are maintained by vegetative propagation and, therefore, control of volunteers is important. Control of weed hosts may be of relevance</td></tr><tr><td align="left" rowspan="1" colspan="1">Timing of planting and harvesting</td><td align="left" rowspan="1" colspan="1">The objective is to produce phenological asynchrony in pest/crop interactions by acting on or benefiting from specific cropping factors such as: cultivars, climatic conditions, timing of the sowing or planting, and level of maturity/age of the plant seasonal timing of planting and harvesting</td><td align="left" rowspan="1" colspan="1">Spread and impact</td><td align="left" rowspan="1" colspan="1">Relevant to prevent transmission by aphid vectors</td></tr><tr><td align="left" rowspan="1" colspan="1">Chemical treatments on crops including reproductive material</td><td align="left" rowspan="1" colspan="1">Chemical treatments on crops may prevent infestations by vectors and seed transmission</td><td align="left" rowspan="1" colspan="1">Spread and impact</td><td align="left" rowspan="1" colspan="1">Desiccation/removal of the foliage reduces the risk of transmission via aphid vectors and may prevent transport to the tubers of infected plants</td></tr><tr><td align="left" rowspan="1" colspan="1">Post‐entry quarantine and other restrictions of movement in the importing country</td><td align="left" rowspan="1" colspan="1"><p>This information sheet covers post‐entry quarantine of relevant commodities; temporal, spatial and end‐use restrictions in the importing country for import of relevant commodities; Prohibition of import of relevant commodities into the domestic country</p><p>Relevant commodities are plants, plant parts and other materials that may carry pests, either as infection, infestation, or contamination</p></td><td align="left" rowspan="1" colspan="1">Entry and spread</td><td align="left" rowspan="1" colspan="1">Identifying virus‐infected plants and banning their movement limit the risks of entry and spread in the EU</td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0048"><label>3.6.2.2</label><title>Additional supporting measures</title><p>Table <xref rid="efs25854-tbl-0008" ref-type="table">8</xref> reports on the possible additional supporting measures which are selected from the list reported in EFSA PLH Panel (2018). Supporting measures are organisational measures or procedures supporting the choice of appropriate risk reduction options that do not directly affect pest abundance.</p><table-wrap id="efs25854-tbl-0008" xml:lang="en" orientation="portrait" position="float"><label>Table 8</label><caption><p>Selected supporting measures in relation to currently unregulated hosts and pathways. Supporting measures are organisational measures or procedures supporting the choice of appropriate risk reduction options that do not directly affect pest abundance</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Information sheet title <underline underline-style="single">(with hyperlink to information sheet if available)</underline></th><th align="left" valign="top" rowspan="1" colspan="1">Supporting measure summary</th><th align="left" valign="top" rowspan="1" colspan="1">Risk component</th><th align="left" valign="top" rowspan="1" colspan="1">Comments</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1181430">http://doi.org/10.5281/zenodo.1181430</ext-link></td><td align="left" rowspan="1" colspan="1"><p>Inspection is defined as the official visual examination of plants, plant products or other regulated articles to determine if pests are present or to determine compliance with phytosanitary regulations (ISPM 5)</p><p>The effectiveness of sampling and subsequent inspection to detect pests may be enhanced by including trapping and luring techniques</p></td><td align="left" rowspan="1" colspan="1">Entry and spread</td><td align="left" rowspan="1" colspan="1"><p>Visual inspection may detect potentially infected material</p><p>Only applicable when visible symptoms on leaves and/or propagating tissues occur, which is dependent on the isolate, host/cultivar, and environmental conditions</p></td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1181213">http://doi.org/10.5281/zenodo.1181213</ext-link></td><td align="left" rowspan="1" colspan="1">Examination, other than visual, to determine if pests are present using official diagnostic protocols. Diagnostic protocols describe the minimum requirements for reliable diagnosis of regulated pests</td><td align="left" rowspan="1" colspan="1">Entry and spread</td><td align="left" rowspan="1" colspan="1">Laboratory testing may detect/identify non‐EU isolates of PVM on sampled material</td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1180845">http://doi.org/10.5281/zenodo.1180845</ext-link></td><td align="left" rowspan="1" colspan="1">Mandatory/voluntary certification/approval of premises is a process including a set of procedures and of actions implemented by producers, conditioners and traders contributing to ensure the phytosanitary compliance of consignments. It can be a part of a larger system maintained by a National Plant Protection Organization in order to guarantee the fulfilment of plant health requirements of plants and plant products intended for trade. Key property of certified or approved premises is the traceability of activities and tasks (and their components) inherent the pursued phytosanitary objective. Traceability aims to provide access to all trustful pieces of information that may help to prove the compliance of consignments with phytosanitary requirements of importing countries</td><td align="left" rowspan="1" colspan="1">Entry and spread</td><td align="left" rowspan="1" colspan="1">Certified and approved premises may guarantee the absence of the harmful viruses imported for research and/or breeding purposes</td></tr><tr><td align="left" rowspan="1" colspan="1"><ext-link ext-link-type="uri" xlink:href="http://doi.org/10.5281/zenodo.1180597">http://doi.org/10.5281/zenodo.1180597</ext-link></td><td align="left" rowspan="1" colspan="1">ISPM 5 defines a buffer zone as ‘an area surrounding or adjacent to an area officially delimited for phytosanitary purposes in order to minimize the probability of spread of the target pest into or out of the delimited area, and subject to phytosanitary or other control measures, if appropriate’ (ISPM 5). The objectives for delimiting a buffer zone can be to prevent spread from the outbreak area and to maintain a pest free production place, site or area</td><td align="left" rowspan="1" colspan="1">Spread</td><td align="left" rowspan="1" colspan="1">Buffer zones may contribute to reduce the spread of non‐EU isolates of PVM after entry in the EU</td></tr><tr><td align="left" rowspan="1" colspan="1">Phytosanitary certificate and plant passport</td><td align="left" rowspan="1" colspan="1"><p>An official paper document or its official electronic equivalent, consistent with the model certificates of the IPPC, attesting that a consignment meets phytosanitary import requirements (ISPM 5)</p><p>a) export certificate (import)</p><p>b) plant passport (EU internal trade)</p></td><td align="left" rowspan="1" colspan="1">Entry and spread</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">Certification of reproductive material (voluntary/official)</td><td align="left" rowspan="1" colspan="1">Certification of reproductive material when not already implemented would contribute to reduce the risk associated with spread</td><td align="left" rowspan="1" colspan="1">Spread</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">Surveillance</td><td align="left" rowspan="1" colspan="1">Official surveillance may contribute to early detection of non‐EU isolates of PVM, favouring immediate adoption of control measures if they come to establish</td><td align="left" rowspan="1" colspan="1">Spread</td><td align="left" rowspan="1" colspan="1"></td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0049"><label>3.6.2.3</label><title>Biological or technical factors limiting the effectiveness of measures to prevent the entry, establishment and spread of the pest</title><p><list list-type="bullet" id="efs25854-list-0003"><list-item><p>Symptomless infections for some of the non‐EU isolates of PVM in some hosts;</p></list-item><list-item><p>Uneven virus distribution or low concentrations limiting the reliability of the detection;</p></list-item><list-item><p>Absence of a validated diagnostic protocol allowing the typing of PVM strains.</p></list-item></list></p></sec></sec></sec><sec id="efs25854-sec-0050"><label>3.7</label><title>Uncertainty</title><p>The Panel identified the following knowledge gaps and uncertainties:</p><p><bold>Identity and biology</bold></p><p><list list-type="bullet" id="efs25854-list-0004"><list-item><p>Lack of information to support the assignment of isolates to PVM‐O or PVM‐D in reports without genomic data;</p></list-item><list-item><p>Limited biological data, in particular at strain level, i.e. on host range and aphid transmission, pathogenicity in potato;</p></list-item><list-item><p>Lack of information on whether identified biological differences are general features of PVM strains or apply only to a fraction of the isolates in a given strain;</p></list-item><list-item><p>Uncertainty on the existence of other non‐EU isolates of PVM that have not yet been identified and might have additional impact on the EU territory.</p></list-item></list></p><p><bold>Pest distribution</bold></p><p><list list-type="bullet" id="efs25854-list-0005"><list-item><p>Uncertainty on the geographical distribution and prevalence of the categorised strains of PVM because of the absence of systematic surveys.</p></list-item></list></p><p><bold>Regulatory status</bold></p><p><list list-type="bullet" id="efs25854-list-0006"><list-item><p>The concept of ‘non‐EU isolates’ leaves some room for interpretation, which may create confusion or difficulties when enforcing the legislation (see Section <xref rid="efs25854-sec-0009" ref-type="sec">1.2</xref>).</p></list-item></list></p><p><bold>Entry, establishment and spread in the EU (host range, entry, establishment, spread)</bold></p><p><list list-type="bullet" id="efs25854-list-0007"><list-item><p>Uncertainty on the host range of the categorised strains of PVM</p></list-item><list-item><p>Uncertainty on the ability and efficiency of aphid vectors to transmit non‐EU isolates of PVM</p></list-item><list-item><p>Uncertainty on the presence of PVM‐D in the Asian countries from which import of ware potatoes and plants for planting of other hosts is allowed.</p></list-item></list></p><p><bold>Impact</bold></p><p><list list-type="bullet" id="efs25854-list-0008"><list-item><p>Uncertainty on the magnitude of the impact of non‐EU isolates and whether this impact would exceed that of the isolates already present in the EU.</p></list-item></list></p></sec></sec><sec id="efs25854-sec-0051"><label>4</label><title>Conclusions</title><p>The information currently available on geographical distribution, biology, epidemiology, potential additional impact over the present situation, and potential entry pathways of non‐EU isolates of PVM has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. The conclusions of the Panel are summarised in Table <xref rid="efs25854-tbl-0009" ref-type="table">9</xref>.</p><p>With the exception of the criterion regarding the potential consequences in the EU territory for which the Panel is unable to conclude (see Section <xref rid="efs25854-sec-0042" ref-type="sec">3.4</xref>), non‐EU isolates of PVM‐D meet all the other criteria to qualify as a potential Union quarantine pest.</p><p>Non‐EU isolates of PVM‐O do not meet one of the criteria evaluated by EFSA to be regarded as a potential Union quarantine pest, since they are not expected to have an additional impact in the EU.</p><p>The Panel wishes to stress that these conclusions are associated with uncertainties because of limited information on distribution, biology and impact of PVM isolates at strain level. In particular, the magnitude of the potential additional impact over the present situation is generally unknown. Furthermore, other potentially harmful non‐EU isolates of PVM might exist that have not been discovered yet.</p><table-wrap id="efs25854-tbl-0009" xml:lang="en" orientation="portrait" position="float"><label>Table 9</label><caption><p>The Panel's conclusions on the pest categorisation criteria defined in Regulation (EU) 2016/2031 on protective measures against pests of plants (the number of the relevant sections of the pest categorisation is shown in brackets in the first column) for non‐EU isolates of PVM</p></caption><table frame="hsides" rules="groups"><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><col style="border-right:solid 1px #000000" span="1"></col><thead valign="top"><tr style="border-bottom:solid 1px #000000"><th align="left" valign="top" rowspan="1" colspan="1">Criterion of pest categorisation</th><th align="left" valign="top" rowspan="1" colspan="1">Panel's conclusions against criterion in Regulation (EU) 2016/2031 regarding Union quarantine pest</th><th align="left" valign="top" rowspan="1" colspan="1">Key uncertainties</th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">Identity of the pest (Section <xref rid="efs25854-sec-0017" ref-type="sec">3.1</xref>)</td><td align="left" rowspan="1" colspan="1"><p>The identity of PVM is well established</p><p>Methods are available for detection and identification of PVM at species level, but not the identification of strains. Genomic data are available for the design of diagnostic tests at the strain level</p></td><td align="left" rowspan="1" colspan="1">Uncharacterised PVM isolates may exist</td></tr><tr><td align="left" rowspan="1" colspan="1">Absence/presence of the pest in the EU territory (Section <xref rid="efs25854-sec-0024" ref-type="sec">3.2</xref>)</td><td align="left" rowspan="1" colspan="1"><p>PVM‐O isolates occur worldwide and are present in the EU</p><p>PVM‐D isolates are not reported in the EU, with the exception PVM‐VIRUBRA 4/009, which was reported once in the Czech Republic. Therefore PVM‐D isolates are considered to have at most a limited distribution in the EU</p></td><td align="left" rowspan="1" colspan="1">Unreported or more widespread presence of PVM‐D in the EU</td></tr><tr><td align="left" rowspan="1" colspan="1">Regulatory status (Section <xref rid="efs25854-sec-0028" ref-type="sec">3.3</xref>)</td><td align="left" rowspan="1" colspan="1">Non‐EU isolates of PVM are currently regulated in Annex IAI</td><td align="left" rowspan="1" colspan="1">Interpretation of the concept of ‘non‐EU isolate’</td></tr><tr><td align="left" rowspan="1" colspan="1">Pest potential for entry, establishment and spread in the EU territory (Section <xref rid="efs25854-sec-0032" ref-type="sec">3.3</xref>)</td><td align="left" rowspan="1" colspan="1"><p>Non‐EU isolates of PVM are able to enter into the EU</p><p>The pathway of plants for planting of potato is partially regulated for non‐EU isolates of both strains (plants for planting of potato can be imported from countries in which these strains are present.)</p><p>For ware potatoes the pathway is partially regulated for non‐EU isolates of PVM‐O (ware potatoes can be imported from countries in which these strains are present) The pathway is considered instead closed for non‐EU isolates of PVM‐D because PVM‐D is not reported in countries from which ware potatoes can be imported</p><p>For plants for planting of other hosts, the pathways are partially regulated for non‐EU isolates of PVM‐D and non‐EU isolates of PVM‐O (plants for planting of other solanaceous hosts can be imported from countries in which these strains are present)</p><p>The minor pathways of viruliferous aphids and import of fruits of hosts species are possibly open for non‐EU isolates of both strains</p><p>If non‐EU isolates of PVM were to enter the EU territory, they could become established and spread</p></td><td align="left" rowspan="1" colspan="1">For both strains, uncertainties on:
<list list-type="simple" id="efs25854-list-0009"><list-item><label>—</label><p> Geographical distribution</p></list-item><list-item><label>—</label><p> Existence of other natural hosts</p></list-item><list-item><label>—</label><p> Existence and/or relevance of vectors</p></list-item></list></td></tr><tr><td align="left" rowspan="1" colspan="1">Potential for consequences in the EU territory (Section <xref rid="efs25854-sec-0042" ref-type="sec">3.4</xref>)</td><td align="left" rowspan="1" colspan="1">There are no indications that non‐EU isolates of PVM‐O differ from PVM‐O isolates already present in the EU and no additional impact is therefore expected from non‐EU isolates of the PVM‐O strain.For non‐EU PVM‐D isolates, the Panel was unable to conclude on potential additional consequences in the EU territory due to limited information</td><td align="left" rowspan="1" colspan="1">Uncertainty on the magnitude of impact of non‐EU isolates</td></tr><tr><td align="left" rowspan="1" colspan="1">Available measures (Section <xref rid="efs25854-sec-0044" ref-type="sec">3.5</xref>)</td><td align="left" rowspan="1" colspan="1">Phytosanitary measures are available to reduce the likelihood of entry and spread of non‐EU isolates of PVM in the EU</td><td align="left" rowspan="1" colspan="1">No uncertainty</td></tr><tr><td align="left" rowspan="1" colspan="1">Conclusion on pest categorisation (Section <xref rid="efs25854-sec-0051" ref-type="sec">3.6</xref>)</td><td align="left" rowspan="1" colspan="1">Non‐EU isolates of PVM‐O do not meet one of the criteria evaluated by EFSA to be regarded as a potential Union quarantine pest, since they are not expected to have an additional impact in the EU.With the exception of the criterion regarding the potential consequences in the EU territory for which the Panel is unable to conclude (see Section <xref rid="efs25854-sec-0042" ref-type="sec">3.4</xref>), non‐EU PVM‐D isolates meet all the other criteria evaluated by EFSA to qualify as a potential Union quarantine pest</td><td align="left" rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">Aspects of assessment to focus on/scenarios to address in future if appropriate</td><td align="left" colspan="2" rowspan="1"><p>The main knowledge gaps or uncertainties identified concern:
<list list-type="simple" id="efs25854-list-0010"><list-item><label>—</label><p> Lack of information on the biology of the categorised strains (e.g. host range, vector transmission, pathogenicity)</p></list-item><list-item><label>—</label><p> Geographic distribution of PVM strains</p></list-item><list-item><label>—</label><p> Existence of other harmful non‐EU isolates</p></list-item><list-item><label>—</label><p> Possible unreported presence in the EU of PVM‐D isolates</p></list-item><list-item><label>—</label><p> Uncertainty on magnitude of impact of non‐EU isolates of PVM</p></list-item></list></p><p>Given the absence of information on possible biological differences between strains of PVM, the development of a full PRA is unlikely to allow to resolve the uncertainties attached to the present categorisation until more data become available</p></td></tr></tbody></table><permissions><copyright-holder>John Wiley & Sons, Ltd</copyright-holder></permissions></table-wrap></sec><sec id="efs25854-sec-0052"><title>Abbreviations</title><p><def-list list-type="simple"><def-item><term>CABI cpc</term><def><p>CABI Crop Protection Compendium</p></def></def-item><def-item><term>DG SANTÉ</term><def><p>Directorate General for Health and Food Safety</p></def></def-item><def-item><term>ELISA</term><def><p>enzyme‐linked immunosorbent assay</p></def></def-item><def-item><term>EPPO</term><def><p>European and Mediterranean Plant Protection Organization</p></def></def-item><def-item><term>FAO</term><def><p>Food and Agriculture Organization</p></def></def-item><def-item><term>ICTV</term><def><p>International Committee on Taxonomy of Viruses</p></def></def-item><def-item><term>IPPC</term><def><p>International Plant Protection Convention</p></def></def-item><def-item><term>ISPM</term><def><p>International Standards for Phytosanitary Measures</p></def></def-item><def-item><term>MS</term><def><p>Member State</p></def></def-item><def-item><term>PCR</term><def><p>polymerase chain reaction</p></def></def-item><def-item><term>PLH</term><def><p>EFSA Panel on Plant Health</p></def></def-item><def-item><term>PVM</term><def><p>potato virus M</p></def></def-item><def-item><term>RNQP</term><def><p>Regulated Non‐Quarantine Pest</p></def></def-item><def-item><term>RT‐PCR</term><def><p>real‐time polymerase chain reaction</p></def></def-item><def-item><term>TFEU</term><def><p>Treaty on the Functioning of the European Union</p></def></def-item><def-item><term>ToR</term><def><p>Terms of Reference</p></def></def-item></def-list></p></sec><sec id="efs25854-sec-0053"><title>Glossary</title><p><def-list list-type="simple"><def-item><term>Containment (of a pest)</term><def><p>Application of phytosanitary measures in and around an infested area to prevent spread of a pest (FAO, <xref rid="efs25854-bib-0009" ref-type="ref">1995</xref>, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Control (of a pest)</term><def><p>Suppression, containment or eradication of a pest population (FAO, <xref rid="efs25854-bib-0009" ref-type="ref">1995</xref>, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Entry (of a pest)</term><def><p>Movement of a pest into an area where it is not yet present, or present but not widely distributed and being officially controlled (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Eradication (of a pest)</term><def><p>Application of phytosanitary measures to eliminate a pest from an area (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Establishment (of a pest)</term><def><p>Perpetuation, for the foreseeable future, of a pest within an area after entry (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Impact (of a pest)</term><def><p>The impact of the pest on the crop output and quality and on the environment in the occupied spatial units</p></def></def-item><def-item><term>Introduction (of a pest)</term><def><p>The entry of a pest resulting in its establishment (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Isolate</term><def><p>Virus population as present in a plant</p></def></def-item><def-item><term>Measures</term><def><p>Control (of a pest) is defined in ISPM 5 (FAO <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>) as ‘Suppression, containment or eradication of a pest population’ (FAO, <xref rid="efs25854-bib-0009" ref-type="ref">1995</xref>). Control measures are measures that have a direct effect on pest abundance. Supporting measures are organisational measures or procedures supporting the choice of appropriate Risk Reduction Options that do not directly affect pest abundance</p></def></def-item><def-item><term>Pathway</term><def><p>Any means that allows the entry or spread of a pest (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Phytosanitary measures</term><def><p>Any legislation, regulation or official procedure having the purpose to prevent the introduction or spread of quarantine pests, or to limit the economic impact of regulated non‐quarantine pests (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Protected zones (PZ)</term><def><p>A Protected zone is an area recognised at EU level to be free from a harmful organism, which is established in one or more other parts of the Union</p></def></def-item><def-item><term>Quarantine pest</term><def><p>A pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Regulated non‐quarantine pest</term><def><p>A non‐quarantine pest whose presence in plants for planting affects the intended use of those plants with an economically unacceptable impact and which is therefore regulated within the territory of the importing contracting party (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Risk reduction option (RRO)</term><def><p>A measure acting on pest introduction and/or pest spread and/or the magnitude of the biological impact of the pest should the pest be present. A RRO may become a phytosanitary measure, action or procedure according to the decision of the risk manager</p></def></def-item><def-item><term>Spread (of a pest)</term><def><p>Expansion of the geographical distribution of a pest within an area (FAO, <xref rid="efs25854-bib-0012" ref-type="ref">2017</xref>)</p></def></def-item><def-item><term>Strain</term><def><p>Group of isolates sharing biological, molecular and/or serological properties</p></def></def-item></def-list></p></sec></body><back><fn-group id="efs25854-ntgp-0005"><title>Notes</title><fn id="efs25854-note-1007"><label>1</label><p>Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community. OJ L 169/1, 10.7.2000, p. 1–112.</p></fn><fn id="efs25854-note-1008"><label>2</label><p>Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants. OJ L 317, 23.11.2016, p. 4–104.</p></fn><fn id="efs25854-note-1009"><label>3</label><p>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, 1.2.2002, p. 1–24.</p></fn><fn id="efs25854-note-2004"><label>4</label><p>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. 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