Pest categorisation of non‐EU viruses and viroids of Cydonia Mill., Malus Mill. and Pyrus L.

Abstract Following a request from the EU Commission, the Panel on Plant Health performed a pest categorisation of 17 viruses and viroids, herein called viruses, of Cydonia Mill., Malus Mill. and Pyrus L. determined as being either non‐EU or of undetermined standing in a previous EFSA opinion. These viruses belong to different genera and are heterogeneous in their biology. They can be detected by available methods and are efficiently transmitted by vegetative propagation techniques, with plants for planting representing a major long‐distance spread mechanism and, potentially, a major entry pathway. Depending on the viruses, additional pathway(s) can also be seed, pollen and/or vector transmission. Most of the viruses categorised here are known to infect only one of few related plant genera, but some of them have a wider host range, thus extending the possible entry pathways. Three viruses (apple necrotic mosaic virus, cherry rasp leaf virus, temperate fruit decay‐associated virus) and one viroid (apple fruit crinkle viroid) satisfy all the criteria to be considered as Union quarantine pests. Five viruses (apple green crinkle‐associated virus, blackberry chlorotic ringspot virus, eggplant mottled crinkle virus, tobacco ringspot virus and tomato ringspot virus) and one viroid (apple scar skin viroid), satisfy the criteria to be considered as Union quarantine pests with the possible exception of being absent from the EU territory or having a restricted presence and being under official control. The remaining six viruses (apple geminivirus, apple latent spherical virus, apple‐associated luteovirus, Pyrus pyrifolia cryptic virus, Pyrus pyrifolia partitivirus 2 and Tulare apple mosaic virus) and one viroid (apple hammerhead viroid) were not found to satisfy one or more of these criteria. The Panel highlights that for several viruses, especially those recently discovered, the categorisation is associated with high uncertainties mainly linked to the absence of data on biology and distribution. Since this opinion addresses specifically the non‐EU viruses, in general these viruses do not meet the criteria assessed by EFSA to qualify as a potential Union regulated non‐quarantine pests.


. Background
Council Directive 2000/29/EC 1 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.
Following the evaluation of the plant health regime, the new basic plant health law, Regulation (EU) 2016/2031 2 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 categorizations 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.

Terms of Reference
EFSA is requested, pursuant to Article 22(5.b) and Article 29(1) of Regulation (EC) No 178/2002 3 , to provide scientific opinion in the field of plant health.
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.
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 Cicadellidae (non-EU) known to be vector of Pierce's disease (caused by Xylella fastidiosa), the group of Tephritidae (non-EU), the group of potato viruses and virus-like organisms, the group of viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L. and the group of Margarodes (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 pests categorisations should be delivered by end 2020.
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.
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.

Interpretation of the Terms of Reference
Non-EU viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L. are pests listed in the Appendices to the Terms of Reference (ToR) to be subject to pest categorisation to determine whether they fulfil the criteria of quarantine pests or those of regulated non-quarantine pests 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.
The EFSA PLH Panel decided to address the pest categorisation of this large group of infectious agents in several steps, the first of which has been to list non-EU viruses and viroids (viruses and viroids, although different biological categories, are summarised together as 'viruses' in the rest of this opinion) of Cydonia, Fragaria, Malus, Prunus, Pyrus, Ribes, Rubus and Vitis (EFSA PLH Panel, 2019).
The process has been detailed in a recent Scientific Opinion (EFSA PLH Panel, 2019), in which it has also been clarified that In the process, three groups of viruses were distinguished: non-EU viruses, viruses with significant presence in EU (known to occur in several MSs, frequently reported in the EU, widespread in several MSs) or so far reported only from the EU, and viruses with undetermined standing for which available information did not readily allow to allocate to one or the other of the two above groups. A non-EU virus is defined by its geographical origin outside of the EU territory. As such, viruses not reported from the EU and occurring only outside of the EU territory are considered as non-EU viruses. Likewise, viruses occurring outside the EU and having only a limited presence in the EU (reported in only one or few MSs, with restricted distribution, outbreaks) are also considered as non-EU. This opinion provides the methodology and results for this classification which precedes but does not prejudice the actual pest categorisation linked with the present mandate. This means that the Panel will then perform pest categorisations for the non-EU viruses and for those with undetermined standing. The viruses with significant presence in the EU or so far reported only from the EU will be also listed, but they will be excluded from the current categorisation efforts. The Commission at any time may present a request to EFSA to categorise some or all the viruses excluded from the current EFSA categorisation. The same statements and definitions reported above also apply to the current opinion.
Due to the high number of the infectious agents to be categorised (a total of 101 viruses) and their heterogeneity in biology, host range and epidemiology, the EFSA PLH Panel established the need of finalising the pest categorisation in separate opinions by grouping non-EU viruses (a total of 87) and viruses with undetermined standing (14 viruses) according to the host crops. This strategy has the advantage of reducing the number of infectious agents to be considered in each opinion and appears more convenient for the stakeholders that will find grouped in a single opinion the categorisation of the non-EU viruses and those with undetermined standing infecting one or few specific crops. According to this decision, the current opinion covers the pest categorisation of the viruses and viroids of Cydonia, Malus and Pyrus that have been listed as non-EU viruses or as viruses with undetermined standing (13 and 4 viruses, respectively) in the previous EFSA scientific opinion (EFSA PLH Panel, 2019) (see Table 1).
Viruses of Fragaria, Prunus, Ribes, Rubus and Vitis will be addressed in other opinions. Virus-like diseases of unknown aetiology or diseases caused by phytoplasmas and other graft-transmissible bacteria are not addressed in this opinion.

Literature search
A literature search on viruses of Cydonia, Malus and Pyrus was conducted at the beginning of the categorisation in the ISI Web of Science bibliographic database, using the scientific name of the pest as search term. Relevant papers were reviewed and further references and information were obtained from experts, as well as from citations within the references and grey literature. When the collected information was considered sufficient to perform the virus categorisation, the literature search was not further extended; as a consequence, the data provided here for each virus are not necessarily exhaustive.

Database search
Pest information, on host(s) and distribution, was retrieved from the European and Mediterranean Plan Protection Organization Global Database (EPPO, 2018a) and relevant publications. When the information from these sources was limited, it has been integrated with data from CABI crop protection compendium (CABI, 2018; https://www.cabi.org/cpc/). The database Fauna Europaea (de Jong et al., 2014; https://fauna-eu.org) has been used to search for additional information on the distribution of vectors, especially when data were not available in EPPO and/or CABI. Data about the import of commodity types that could potentially provide a pathway for a 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).
The Europhyt database was consulted for pest-specific notifications on interceptions and outbreaks. Europhyt is a web-based network run by the Directorate General for Health and Food Safety (DG SANT E) 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.
Information on taxonomy of viruses and viroids was gathered from the Virus Taxonomy: 2018 Release (https://talk.ictvonline.org/taxonomy/), an updated official classification by the International Committee on Taxonomy of Viruses (ICTV). Information on the taxonomy of viruses not yet included in that ICTV classification was gathered from the primary literature source describing them. According to ICTV rules (https://talk.ictvonline.org/information/w/faq/386/how-to-write-a-virus-name), names of viruses are not italicised in the present opinion.

Methodologies
The Panel performed the pest categorisation for viruses of Cydonia, Malus and Pyrus, following guiding principles and steps presented in the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel, 2018b) and as defined in the International Standard for Phytosanitary Measures No 11 (FAO, 2013) and No 21 (FAO, 2004). 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 regulated nonquarantine pest 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. Table 2 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 regulated non-quarantine pest. 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 regulated non-quarantine pest 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.
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. 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 The protected zone system aligns with the pest free area system under the International Plant Protection Convention (IPPC) The pest satisfies the IPPC definition of a quarantine pest that is not present in the risk assessment area (e.g. protected zone) 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?
Pest potential for entry, establishment and spread in the EU territory (Section 3.4) Is the pest able to enter into, become established in, and spread within, the EU territory? If yes, briefly list the pathways! Is the pest able to enter into, become established in, and spread within, the protected zone areas?
Is entry by natural spread from EU areas where the pest is present possible? Is spread mainly via specific plants for planting, rather than via natural spread or via movement of plant products or other objects? Clearly state if plants for planting is the main pathway! 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.

3.
Pest categorisation 3.1. Identity and biology of the pests 3.1.1. Identity and taxonomy In Table 3, the information on the identity of the viruses categorised in the present opinion is reported. Eight viruses are included in the ICTV official classification scheme and therefore no uncertainty is associated to their identity. Nine viruses have not been yet officially classified, in general because they have been recently discovered. However, molecular and/or biological features of these viruses allowed proposing their tentative classification as novel species in either established or new genera, thus recognising them as infectious entities different from those previously reported. Therefore, also for viruses belonging to tentative species there is no uncertainty on their identity, although a limited uncertainty remains on their final taxonomic assignment. For two viruses (PpCV and 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?
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?
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?
Are there measures available to prevent pest presence on plants for planting such that the risk becomes mitigated?

Conclusion of pest categorisation (Section 4)
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 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 A statement as to whether (1) all criteria assessed by EFSA above for consideration as a potential regulated nonquarantine pest were met, and (2) if not, which one(s) were not met PpPV-2) recently discovered by next generation sequencing (NGS) (Osaki et al., 2017;Osaki and Sasaki, 2018), it is uncertain if they infect plants. These viruses have been proposed as new member species of the family Partitiviridae, which includes viruses infecting plants or fungi, but data confirming that the actual PpCV and PpPV-2 hosts are plants (and not plant-associated fungi) have not been provided.

Biology of the pests
All the viruses considered in the present pest categorisation are efficiently transmitted by vegetative propagation techniques. Some of them may possibly be mechanically transmitted by contaminated tools and/or injuries but this process is generally considered to be at best inefficient in woody hosts, such as Cydonia, Malus and Pyrus species. Some of these agents have additional natural transmission mechanisms as outlined in Table 4.  (Greber et al., 1992;Sdoodee and Teakle, 1993;Klose et al., 1996) Appleassociated luteovirus (AaLV)

No
Not known for AaLV, luteoviruses are very generally not reported as seed-transmitted (Mink, 1993) No Not known for AaLV, luteoviruses are very generally not reported as pollen-transmitted (Mink, 1993) Cannot be excluded Not known for AaLV, but luteoviruses are very generally transmitted by aphids (Gray and Gildow, 2003) VIRUS/ VIROID name

Cannot be excluded
Not known for EMCV (Allen, 1969), but some tombusviruses are known to be seed-transmitted (Rochon et al., 2012) No Not known for EMCV and tombusviruses are very generally not reported as pollen-transmitted Cannot be excluded Not known for EMCV, but transmission of other tombusviruses is known to be mediated by Olpidium sp. (Campbell, 1996;Singh et al., 2008) Pyrus pyrifolia cryptic virus (PpCV)

Intraspecific diversity
Viruses generally exist as quasi-species, which mean that they accumulate in a single host as a cluster of closely related sequence variants slightly differing from each other (Andino and Domingo, 2015). This is likely due to competition among the diverse genomic variants generated as a consequence of the error-prone viral replication system (higher in RNA than in DNA viruses) and the ensuing selection of the most fit variant distributions in a given environment (Domingo et al., 2012). This is also true for viroids (Di Serio et al., 2017a). This means that a certain level of intraspecific diversity is expected for all viruses. As an example, high intraspecific divergence has been observed in the X4 domain of the ToRSV RNA2 among different virus strains (Jafarpour and Sanfac ßon, 2009;Rivera et al., 2016); substantial sequence diversity has also been reported in six ApNMV Chinese isolates (Xing et al., 2018). This genetic variability may interfere with the efficiency of detection methods, especially when they are based on amplification of variable genomic viral sequences, thus generating uncertainties on the reliability and/or sensitivity of the viral detection for all existing viral variants. For example, it has been shown that sequence diversity observed in AGCaV may impair detection of some isolates by some specific primers (James et al., 2013).
For several viruses categorised in this opinion, information on their genetic variability is available, but studies showing a correlation between specific virus populations or variants and biological features (e.g. host range, transmissibility, pathogenicity) are rare, thus also contributing to increase the uncertainties on the possible consequences of intraspecific genetic variability on the virus biology. In the case of TRSV, several variants from different natural hosts have been reported (Stace-Smith, 1985). It is also known that the same ASSVd isolate may cause two different diseases (apple scar skin and dapple apple), depending on the inoculated cultivar (Desvignes et al., 1999), but whether specific viroid variants are actually selected in the infected hosts showing a specific disease in not known. Similarly, different sequence variants of AFCVd have been isolated from three different natural hosts (apple, hop and pomegranate), but whether they have different biological features remains unexplored.
All the above mentioned uncertainties are even more pronounced for viruses recently discovered by high-throughput sequencing (HTS), for which data on genomic diversity and biological features are almost completely lacking.

Detection and identification of the pest
For all the categorised viruses, molecular and/or serological detection methods are available. However, in the absence or near absence of information on the genetic variability of these agents, it is not possible to guarantee the specificity of the available detection methods and whether they can detect the majority of the strains of that particular virus. This is particularly true in the case of detection methods based on polymerase chain reaction (PCR) because one or a few mutations in the binding sites of primers may be sufficient to abolish amplification of a particular variant. For some of the categorised viruses, biological methods based on bioassays are also available. It must be also stressed that diagnostics in woody host plants is sometimes difficult because of the uneven virus distribution, low virus titres or presence of inhibitors in the extracts to be tested. In Table 5, the information on the availability of detection and identification methods for each categorised virus is summarised together with the associated uncertainty.

3.2.
Pest distribution 3.2.1. Pest distribution outside the EU The viruses of Cydonia, Malus and Pyrus categorised here have been reported mainly in Asia and North America. Their distribution outside the EU is reported in Table 6, which was prepared using data from the EPPO and/or CABI databases (Accessed from 7 September 2018 to 14 December 2018), and, when not available in these sources, from extensive literature searches. For some viruses, data from EPPO and CABI are not consistent; these cases have been highlighted by superscript numbers in Table 6. Available distribution maps are provided in Appendix A.

Tulare apple mosaic virus (TAMV)
Yes Sequence available on NCBI Uncertainty (absence of a proven protocol) (b) (a): For this recently described agent, a detection assay has been developed by the discovering laboratory. However, there is very limited information as to whether this assay allows the detection of a wide range of isolates of the agent. (b): Only one or very few isolates have ever been studied. The polyvalence of the reported assays is unknown.

Pest distribution in the EU
Only some of the viruses of Cydonia, Malus and Pyrus categorised here have been reported in the EU (Table 7), where they can be considered to have a restricted distribution. Given their restricted distribution, the Panel considers that these viruses fulfil the definition of non-EU viruses used in the present categorisation efforts.
In the case of ASSVd, that has been reported to be present in several MSs by CABI (Table 7), the quoted references are out dated (prior than the discovery of ASSVd as the agent of apple scar skin disease) and are doubtful because the viroid actual presence was not ascertained. The report of widespread presence of ASSVd in Greece (Kyriakopoulou et al., 2001) is also doubtful because it is based on detection methods lacking appropriate controls (possible cross-hybridisation of specific cRNA probe with other apscaviroids was not excluded) and the infecting ASSVd variants were not sequenced. However, the presence of ASSVd in Greece has been confirmed by appropriate approaches (Kaponi et al., 2012(Kaponi et al., , 2013. Overall, the Panel considers that ASSVd presence in several EU MSs is doubtful but that it should be considered present in Greece. In the case of TRSV and ToRSV, the viruses have been sporadically detected in some MSs, but the reports, generally old, have not been followed by extensive spread, thus suggesting that the virus remains restricted. Moreover, identification of these viruses has been followed by eradication efforts therefore TRSV and ToRSV detected in MS are generally under eradication or have been already eradicated (e.g. TRSV in Czech Republic and ToRSV in Italy in 2018, EPPO, 2018a,b; TRSV and ToRSV in the Netherlands, EPPO 2018b). In addition, some reports on presence of these viruses in EU MSs are likely incorrect or have been rectified by further publications (e.g. TRSV in Italy (Sorrentino et al., 2013) and ToRSV in France (EPPO, 2018a,b)). Taking this into account, the presence of TRSV and ToRSV in the EU MSs is considered rare and, in any case, restricted and under official control.
In the case of AGCaV, AHVd, BCRV and EMCV, the reports in the EU refer to findings in one or two MSs, generally in a few plants in restricted areas, and have not been followed by further notifications. Further outbreaks in the EU have never been reported for these viruses. Is the pest present in the EU territory? If present, is the pest widely distributed within the EU?
For the viruses not reported to occur in the EU, uncertainties on their possible presence derives from the lack of specific surveys and/or from their recent discovery.    Harmful organisms whose introduction into, and spread within, all Member States shall be banned Section I Harmful organisms not known to occur in any part of the community and relevant for the entire community  Plants, plant products and other objects the introduction of which shall be prohibited in certain protected zones

Description
Protected zone(s) 1 Without prejudice to the prohibitions applicable to the plants listed in Annex IIIA (9)  chips, sawdust and shavings, obtained in whole or part from these plants, wood packaging material, in the form of packing cases, boxes, crates, drums and similar packings, pallets, box pallets and other load boards, pallet collars, dunnage, whether or not actually in use in the transport of objects of all kinds, except dunnage supporting consignments of wood, which is constructed from wood of the same type and quality as the wood in the consignments and which meets the same Union phytosanitary requirements as the wood in the consignment, but including that which has not kept its natural round surface, originating in Canada and the USA Official statement that the wood: (a) originates in an area free from Saperda candida Fabricius, established by the national plant protection organisation in the country of origin, in accordance with the relevant International Standards for Phytosanitary Measures, which is mentioned on the certificates referred to in Article 13(1)(ii) under the rubric 'Additional declaration', or (b) has undergone an appropriate heat treatment to achieve a minimum temperature of 56°C for a minimum duration of 30 continuous minutes throughout the entire profile of the wood, which is to be indicated on the certificates referred to in Article 13(1)(ii), or (c) has undergone an appropriate ionising radiation to achieve a minimum absorbed dose of 1 kGy throughout the wood, to be indicated on the certificates referred to in Article 13(1)(ii).

7.5
Whether or not listed among the CN codes in Part B of Annex V, wood in the form of chips obtained in whole or part from Amelanchier Medik., Aronia Medik., Cotoneaster Medik., Crataegus L., Cydonia Mill., Malus Mill., Prunus L., Pyracantha M. Roem., Pyrus L. and Sorbus L., originating in Canada and the USA Official statement that the wood: (a) originates in an area established by the national plant protection organisation in the country of origin as being free from Saperda candida Fabricius in accordance with the relevant International Standards for Phytosanitary Measures, which is mentioned on the certificates referred to in Article 13(1)(ii) under the rubric 'Additional declaration', or (b) has been processed into pieces of not more than 2,5 cm thickness and width, or (c) has undergone an appropriate heat treatment to achieve a minimum temperature of 56°C for a minimum duration of 30 minutes throughout the entire profile of the chips, which is to be indicated on the certificates referred to in Article 13(1)(ii).
14.  (9) and (18), and Annex IV(A)(I) (15), (17) (9) and (18), Annex III(B)(1) and Annex IV(A)(I) (15), (17) and (19.2), official statement that: (a) the plants have been: either officially certified under a certification scheme requiring them to be derived in direct line from material which has been maintained under appropriate conditions and subjected to official testing for at least the relevant harmful organisms using appropriate indicatos or equivalent methods and has been found free, in these thests, from those harmful organisms, or derived in direct line from material which is maintained under appropriate conditions and subjected, within the last three complete cycles of vegetation, at least once, to official testing for at least the relevant harmful organisms using appropriate indicators or equivalent methods and has been found free, in these tests, from those harmful organisms; (b) no symptoms of diseases caused by the relevant harmful organisms have been observed on plants at the place of production, or on susceptible plants in its immediate vicinity, since the beginning of the last complete cycle of vegetation.

22.2
Plants of Malus Mill., intended for planting, other than seeds, originating in countries where apple proliferation mycoplasma is known to occur Without prejudice to the provisions applicable to the plants, listed in Annex III(A)(9) and (18), Annex III(B)(1) and Annex IV(A)(I)(15), (17), (19.2) and (22.1), official statement that (a) the plants originate in areas known to be free from apple proliferation mycoplasm; or (b) (aa) the plants, other than those raised from seeds, have been: either officially certified under a certification scheme requiring them to be derived in direct line from material which has been maintained under appropriate conditions and subjected to official testing for at least Apple proliferation mycoplasm using appropriate indicators or equivalent methods and has been found free, in these tests, from that harmful organism, or derived in direct line from material which is maintained under appropriate conditions and subjected, within the last six complete cycles of vegetation, at least once, to official testing for at least Apple proliferation mycoplasm using appropriate indicators or equivalent methods and has been found free, in these tests, from the harmful organism, (bb) no symptoms of diseases caused by Apple proliferation mycoplasm have been observed on plants at the place of production, or on susceptible plants in its immediative vicinity, since the beginning of the last complete three cycles of vegetation.

Plants with roots, planted or intended for planting, grown in the open air
Official statement that: (a) the place of production is known to be free from Clavibacter michiganensis ssp. sepedonicus (Spieckermann and Kotthoff) Davis et al. and Synchytrium endobioticum (Schilbersky) Percival, and (b) the plants originate from a field known to be free from Globodera pallida (Stone) Behrens and Globodera rostochiensis (Wollenweber) Behrens.

34.
Soil and growing medium, attached to or associated with plants, consisting in whole or in part of soil or solid organic substances such as parts of plants, humus including peat or bark or consisting in part of any solid inorganic substance, intended to sustain the vitality of the plants, originating in: -Turkey, -Belarus, Georgia, Moldova, Russia, Ukraine, non-European countries, other than Algeria, Egypt, Israel, Libya, Morocco, Tunisia Official statement that: (a) the growing medium, at the time of planting, was: either free from soil, and organic matter, or found free from insects and harmful nematodes and subjected to appropriate examination or heat treatment or fumigation to ensure that it was free from other harmful organisms, or subjected to appropriate heat treatment or fumigation to ensure freedom from harmful organisms, and (b) since planting: either appropriate measures have been taken to ensure that the growing medium has been maintained free from harmful organisms, or within two weeks prior to dispatch, the plants were shaken free from the medium leaving the minimum amount necessary to sustain vitality during transport, and, if replanted, the growing medium used for that purpose meets the requirements laid down in (a).  are clean (i.e. free from plant debris) and free from flowers and frutis, have been grown in nurseries, have been inspected at appropriate times and prior to export and found free from symptoms of harmful bacteria, viruses and virus-like organisms, and either found free from signs or symptoms of harmful nematodes, insects, mites and fungi, or have been subjected to appropriate treatment to eliminate such organisms.

6.
Wood within the meaning of the first subparagraph of Article 2(2), where it: (a) has been obtained in whole or part from one of the order, genera or species as described hereafter, except wood packaging material defined in Annex IV, Part A, Section I, Point 2: [. . .] -Amelanchier Medik., Aronia Medik., Cotoneaster Medik., Crataegus L., Cydonia Mill., Malus Mill., Prunus L., Pyracantha M. Roem., Pyrus L. and Sorbus L., including wood which has not kept its natural round surface, except sawdust or shavings, originating in Canada or the USA 7.
(a) Soil and growing medium as such, which consists in whole or in part of soil or solid organic substances such as parts of plants, humus including peat or bark, other than that composed entirely of peat. (b) Soil and growing medium, attached to or associated with plants, consisting in whole or in part of material specified in (a)  The natural host range of the viruses categorised in the present opinion varies from very restricted to extremely wide. For each one of these viruses, Table 10 integrates data from the previous Scientific Opinion (EFSA PLH Panel, 2019) with additional information on their natural hosts besides Cydonia, Malus and Pyrus spp. However, it must be considered that for all the viruses considered there is uncertainty about the possible existence of additional natural hosts that have not been reported so far. These uncertainties are of course even higher for recently discovered viruses. Eight non-EU viruses of Cydonia, Malus and Pyrus (AHVd, AGV, AGCaV, ALSV, ApNMV, AaLV, PpCV, PpPV-2) have not been reported to have additional natural hosts, although some of them are known to be able to infect some or many experimental herbaceous hosts (ALSV, AGV). The two viroids AFCVd and ASSVd and the viruses BCRV and EMCV naturally infect some additional hosts (Humulus lupulus and Diospyros kaki in the case of AFCVd; several Prunus spp. in the case of ASSVd; Rubus spp. and Rosa spp. in the case of BCRV; Solanum melongena, Pelargonium hortorum and Solanum capsicastrum in the case of EMCV). In contrast, a wide natural host range has been reported for CRLV, TRSV, ToRSV.

Entry
All the viruses of Cydonia, Malus and Pyrus categorised here can be transmitted by vegetative propagation material. Therefore, plants for planting of Cydonia, Malus and Pyrus must be considered as being potentially the most important entry pathway. Moreover, some of these viruses have additional natural hosts that also are vegetatively propagated (e.g. Humulus lupulus, Diospyros kaki, Prunus spp., Pelargonium spp., Rubus spp., Rosa spp.), thus providing additional entry pathways.
Some viruses of Cydonia, Malus and Pyrus categorised here can also be transmitted by seeds, and/or pollen, and/or vectors ( Table 4) that may also provide entry pathways. Information on seed, pollen and vector transmission are limited for some of the categorised viruses, especially for those recently discovered. Uncertainties on the transmission mechanisms for these viruses generate uncertainties also on the possible pathways to be considered. Major entry pathways for the viruses here categorised are summarised in Table 11.

Malus Pyrus Cydonia
Other hosts Although not specifically stated in the regulation, pollen for pollination is considered as dormant plants for planting (EFSA PLH Panel, 2013), thus import of pollen for pollination from Mediterranean countries, Australia, New Zealand, Canada and the continental states of the USA, without prejudice to other provisions, is also permitted, with the exception of E. amylovora Protected Zones (EFSA PLH Panel, 2013). However, as already stated in a previous EFSA opinion (EFSA PLH Panel, 2013): It should be stressed that the current legislation is complex and difficult to understand and that its interpretation when it comes to the specific case of pollen for pollination purposes is far from obvious.
Seeds from Cydonia, Malus and Pyrus are currently not regulated and can be imported without any restrictions. Seeds of some of the other hosts of the viruses categorised here are regulated.
Fruits of Cydonia, Malus and Pyrus imported from non-European countries must be accompanied by a phytosanitary certificate. This measure mostly targets the potential import of fruit flies in consignments and its relevance for the viruses categorised here is unclear. This situation is noteworthy for those agents that may be seed-transmitted, although fruit import is unlikely to represent a pathway of major relevance.
Although Annex IV AI, at point 19.2, requires 'official statement that no symptoms of diseases caused by the relevant harmful organisms' (e.g. non-European viruses and virus-like organisms) have been observed on the plants at the place of production since the beginning of last complete cycle of vegetation, this measure is considered to have limited impact in preventing import of infected plants of Cydonia, Malus and Pyrus intended for planting. This is because symptoms in the infected plants are often not obvious. Similarly, Annex IVAI point 22.1, applies to plants of Malus Mill. intended for planting, other than seeds, originating in countries where the relevant harmful organisms (e.g. CRLV and ToRSV) are known to occur on Malus Mill. and determines requirements for testing and certification. However, this measure does not apply to Cydonia and Pyrus, which may host other viruses categorised here. Similar requirements, without prejudice to other provisions (e.g. Annex I and III), are established in Annex IV with respect to plants of Prunus and Rubus intended for planting (Annex IVAI 23.2 and 23.3, respectively) for which certification excluding the presence of some viruses categorised here (CRLV and ToRSV) is requested. Also in this case, the needed certification and testing requirements for plants for planting is limited to only some of the viruses of Cydonia, Malus and Pyrus categorised here, thus closing only partially the related entry pathways. The Panel also notes that this legislation is complex, which may create interpretation problems, and that it does not completely eliminate the risk of introduction on the plant for planting pathway for at least some of the viruses categorised here.
Annex V (BI 1, 2 and BII 3, 4) establishes that plant for plantings, pollen and/or part of plants of several host species (Cydonia, Malus, Pyrus, Prunus, Rosa and Rubus) concerned must be accompanied by a valid phytosanitary certificate in order to be introduced in the EU. Although this measure may impair introduction of viruses explicitly mentioned in Annex IAI (TRSV, ToRSV, CRLV) it might not be as efficient for the other viruses categorised here, which are not explicitly mentioned, and are only covered by the general and possibly difficult to interpret term of Non-European viruses and virus-like organisms.
Annex VA lists all the potential hosts which must be checked and accompanied by a plant passport. This measure may impair the spread of viruses on Cydonia, Malus and Pyrus, and other species that are regulated in the EU (such as Prunus), but has no effect on the dissemination of viruses on nonregulated host plants.
Some viruses of Cydonia, Malus and Pyrus categorised here are transmitted by nematodes (CRLV, TRSV, ToRSV). Viruliferous nematodes entering the EU may introduce the associated viruses. The main entry pathways for nematodes are soil and growing media from areas where the nematodes occur. These pathways are closed by current legislation (Annex IIIA 14 of EU Directive 2000/29/EC). According to a previous EFSA pest categorisation of Xiphinema americanum sensu lato (EFSA PLH Panel, 2018a), only Soil and growing media attached to plants (hosts or non-host plants) from areas where the nematode occurs is a major entry pathway for nematodes vectoring viruses. This pathway is not closed as plants may be imported with soil or growing media attached to sustain their live. In the same opinion, soil and growing media attached to (agricultural) machinery, tools, packaging materials has been identified as an entry pathway, but it is not considered an important pathway (EFSA PLH Panel, 2018a).
In summary, the current legislation closes the plants for planting (and pollen) entry pathway for some of the viruses categorised here. While for other ones, this pathway is only partially regulated. In addition, for other natural hosts for some of these agents special requirements do not apply, leaving open potential entry pathways. Finally, the import of seeds of Cydonia, Malus and Pyrus or other hosts is generally not regulated and there are also weak points in the legislation addressing nematode vectors.
In the specific case of TAMV, this virus has only been found once and there is no evidence that it exists anymore in nature (AAB description of plant viruses nr. 42, http://www.dpvweb.net/dpv/showd pv.php?dpvno=42). The Panel therefore concludes that TAMV is highly unlikely to be able to enter in the EU. Table 11 summarises the major potential entry pathways that have been identified for the categorised viruses and the respective regulatory status. Interceptions of non-EU viruses of Cydonia, Malus and Pyrus were searched in Europhyt database on 18 September 2018 (EUROPHYT, 2018). Only 6 and 5 interceptions of TRSV and ToRSV were reported, respectively, mainly from ornamental hosts. They date back to more than 10 years ago (Table 12). No interception was registered in the case of ASSVd, ALSV, BCRV CRLV, EMCV and TAMV. No interception was reported regarding the apple fruit crinkle disease. AFCVd, AHVd, AGV, ApNMV, AaLV, PpCV, PpPV-2 and TFDaV are not listed in Europhyt. Pathway possibly open: the existence of the pathway, which is not closed by current legislation, is not supported by direct evidence regarding the biology of that virus. However, based on comparisons with the biology of closely related viruses (in the same genus or in the same family), the existence of the pathway cannot be excluded. Not a pathway: there is no evidence supporting the existence of the pathway. Pathway regulated: regulations exist that limit the probability of entry along the pathway, but there is not a complete ban on imports. Pathway partially regulated: the legislation does not cover all the possible paths (e.g. regulations exist for some hosts, but not for others; a ban exists for some non-EU MSs but not for all). (b): Import not banned from the listed country(ies). The analysis of entry pathways is affected by uncertainties coming from a) the transmission biology and host range of the agents and b) the geographical distribution of the agents. Based on the above data and considerations the entry pathways of the viruses here categorised have been considered as follows: • Entry pathway involving plants for planting of Cydonia, Malus and Pyrus, other than pollen and seeds: this pathway is closed for AFCVd, AGV, ALSV, ApNMV, AaLV, PpCV, PpPV-2, TFDaV and TAMV. It is partially regulated for ASSVd, AHVd, AGCaV, BCRV, CRLV, EMCV, TRSV, and ToRSV, mainly because the viruses are present in Countries from which import of dormant plants for planting is allowed. However, additional declaration for CRLV and ToRSV is explicitly requested by legislation in the phytosanitary certificate accompanying imported plants for planting, thus further reducing the risk of entry; • Entry pathway involving pollen of Cydonia, Malus and Pyrus: this pathway is partially regulated for BCRV, CRLV, TRSV and ToRSV. It is possibly open, with uncertainty on the biology of the agent, for AHVd. The pathway is closed for AaLV, ApNMV, PpCV and PpPV-2. For the other viruses, this is not considered a pathway, sometimes with uncertainty, because they are not reported to be pollen-transmitted; • Entry pathway involving seeds of Cydonia, Malus and Pyrus: this pathway is open for ALSV and BCRV. It is possibly open, with uncertainty on the biology of the agent, for ASSVd, AHVd, ApNMV, CRLV, EMCV, PpCV, PpPV-2, TRSV and ToRSV. For AFCVd, AGV, AGCaV and AaLV, this is not considered a pathway, sometimes with uncertainty, because they are not reported to be seed-transmitted; • Entry pathway involving other hosts. This pathways is considered: À partially regulated for AFCVd, ASSVd, BCRV, CRLV, EMCV, TRSV and ToRSV; À not to be a pathway for AHVd, AGV, AGCaV, ALSV, ApNMV, AaLV, PpCV and PpPV-2 (because they have a narrow natural host range); • Entry pathway involving viruliferous vectors: this pathway mainly refers to the nematodetransmitted viruses (CRLV, TRSV, ToRSV) and is considered partially regulated. The pathway is possibly open, with uncertainty linked to the biology of the agent, for AHVd, ASSVd, AGV, AaLV and EMCV.
Given the extreme uncertainties on the biology of TFDaV, it was not possible for the Panel to ascertain whether the entry pathways involving pollen or seeds of Cydonia, Malus and Pyrus and the pathway of viruliferous vectors might be open.
In the case of TAMV the entry pathways are considered closed because it has been found only once many years ago and there is no other evidence of its presence.

EU distribution of main host plants
Cydonia, Malus and Pyrus widely occur in EU as commercial crops as well as wild plants. Details on the area of pome fruit production in individual EU MSs are provided in Table 13.

Climatic conditions affecting establishment
Except for those affecting the hosts, no eco-climatic constraints for the viruses categorised here exist. Therefore, it is expected that these viruses are able to establish wherever their hosts may live. Cydonia, Malus and Pyrus are largely cultivated in the EU. The Panel therefore considers that climatic conditions will not impair the ability of viruses addressed here to establish in the EU. However, it must be taken into consideration that virus accumulation and distribution within natural hosts, especially in woody plants, are largely dependent on environmental conditions. The same applies to symptom expression and severity that may be affected by climatic conditions (e.g. temperature and light).

Spread
Long-distance spread of the viruses infecting Cydonia, Malus and Pyrus categorised here is mainly due to human activities (e.g. movement of plant for planting). Some of these viruses have also natural spread mediated by vectors that are mainly involved in short-distance movement of the pests. Yes, all of the categorised viruses can spread through the trade of plants for planting. Some of them are also spread by vectors and/or seeds and/or pollen

Vectors and their distribution in the EU (if applicable)
No vectors are known for many of the viruses categorised here (Table 4). For some of them (AFCVd, ASSVd, AGCaV, ApNMV, BCRV, PpCV, PpPV-2, TFDaV TAMV), the existence of vectors is not known and the biology of related agents would suggest an absence of vectors. In the case of AHVd, AGV, ALSV, AaLV, and EMCV, the existence of vector(s) appears possible (see below) but has not been proven (Table 4). Finally, in the case of CRLV, TRSV and ToRSV the existence of nematode vectors is demonstrated (EFSA PLH Panel, 2018a). In the specific case of TFDaV, the absence of any information or of closely related agents on which to base an assessment prevented the Panel to reach any conclusion on the possible existence of vector(s).
Nematode species X. americanum sensu stricto and Xiphinema americanum sensu lato (i.e. X. bricolense, X. californicum, X. inaequale, X. tarjanense) transmitting TRSV, ToRSV and/or CRLV have not been recorded in the EU. One (X. intermedium) has been reported in Portugal (Fauna Europea database), but without any reference to a specific publication. X. rivesi has been reported in six EU MSs (France, Germany, Italy, Portugal, Slovenia, Spain, Figure 1 (EFSA PLH Panel, 2018a)). Although under experimental condition the ability of EU populations of X. rivesi to transmit ToRSV and TRSV has been demonstrated, they have never been associated with the spread of the corresponding viral diseases under field condition in the EU (EFSA PLH Panel, 2018a).
For several viruses under categorisation there is uncertainty on the possible existence of vectors (Table 4) because vector-mediated (in the case of AHVd, AGV, AaLV, ALSV and EMCV) or vector-assisted (in the case of ApNMV, BCRV and TAMV) transmission has been reported for viruses of the same genus, but direct experimental evidence for the virus under categorisation is lacking. In any case, the identity of these possible vectors, if they exist, is not known, which precludes any analysis on their distribution. Transmission of ASSVd by Trialeurodes vaporariorum, which is widespread in the EU, has been reported only between herbaceous hosts in experimental trials (Walia et al., 2015), but whether this whitefly is able to transmit ASSVd to and between woody hosts in nature is unknown. 3.5.

Impacts
Many viruses categorised here cause symptoms in Cydonia, Malus and Pyrus, thus impacting fruit yield and/or quality. Some of them may also infect and cause severe diseases in other hosts. This situation concerns AFCVd, ASSVd, AGCaV, ApNMV, BCRV, CRLV, TFDaV, TRSV, ToRSV and TAMV (Table 14).
In the particular case of EMCV, no symptoms were reported in pear (Russo et al., 2002), but the virus is associated with symptoms in eggplant (Makkouk et al., 1981;Raj et al., 1988a;Rasoulpour and Izadpanah, 2008). On the other hand, the link between some of the other categorised agents and symptoms is at best tenuous. These are mostly true for recently discovered agents for which very little information is available and which were described from symptomless plants. However, uncertainties may exist on this aspect because for most of these viruses the susceptibility has not been tested on a range of cultivars of each host species nor has the potential for detrimental synergistic interactions with other viral agents been investigated.
No, for AGV, AHVd, ALSV, AaLV, PpCV, PpPV-2, since none of them has so far been associated clearly with symptomatic infection in apple, pear, quince or in other hosts.
RNQPs: Does the presence of the pest on plants for planting have an economic impact, as regards the intended use of those plants for planting? 4 Yes, for AFCVd, ASSVd, AGCaV, ApNMV, BCRV, CRLV, EMCV, TFDaV, TRSV, ToRSV and TAMV. Given the severity of the symptoms they may cause in apple, pear or quince (or eggplant in the case of EMCV), their presence in plants for planting would severely impact their intended use.
No, for AGV, AHVd, ALSV, AaLV, PpCV, PpPV-2. In the absence of a clear link to a symptomatology, it is unclear whether the presence of these agents in plants for planting would impact their intended use, except possibly under some specific situations.

Yes
AFCVd infecting apple causes fruit deformation with dappling and crinkling, the severity of which depend on the apple cultivar. AFCVd may also cause blister bark in some apple cultivars. Relevant losses were registered in Japan, where the disease is endemic, in the 1980s and 1990s. AFCVd caused losses also in hop in Akita prefecture (Japan). The association of AFCVd with symptoms in persimmon is unclear (Ito and Yoshida, 1998;Di Serio et al., 2017b) Yes  (Hadidi et al., 2017). This viroid is considered a major pathogens for apple in China and Japan

No
No symptom has been observed in inoculated apple seedlings (Serra et al., 2018). Since, AHVd has been reported from both non symptomatic and symptomatic trees (limb flattening, swelling and cracking, delignification, loss of apical dominance, and small and sparse foliage; Zhang et al., 2014;Messmer et al., 2017;Serra et al., 2018), uncertainties exist on the possibility that symptoms may be elicited in some specific cultivars and/or by specific viroid variants (Messmer et al., 2017) No Apple geminivirus (AGV)

No
No correlation of AGV with a specific apple disease was found in a the field survey (Liang et al., 2015). The virus has been reported in several apple cultivars, always without an association with symptoms

Yes
AGCaV has been associated with diseases in both apple and Cydonia trees. In apple, the fruit of susceptible cultivars show depressed areas, severe fruit malformation, cracking, brownish-red spots, swellings. Severe tree decline is associated with some virus isolates (James et al., 2013). In Cydonia, the virus is associated with symptoms consisting of poorly developed and malformed fruits that fall prematurely, fewer spurs bearing blossoms that appear frequently distorted, leaves smaller and paler than those from non-infected trees. Symptoms were observed in 30-40% of the trees in an infected orchard

Apple latent spherical virus (ALSV)
No ALSV does not induce any discernible symptoms in apple trees and in most of its experimental hosts (Koganezawa and Ito, 2011) No Apple necrotic mosaic virus (ApNMV)

Yes
ApNMV is closely associated with mosaic symptoms on leaves, supporting the involvement of this virus as the causal agent of a severe disease in apple (Noda et al., 2017) Yes Appleassociated luteovirus (AaLV)

No
No correlation of AaLV with a specific apple disease was found in a field survey (Shen et al., 2018). The virus has been reported in several apple cultivars, always without an association with symptoms

Yes
The association with a disease has not been confirmed for all the isolates and or blackberry varieties. Symptomatic blackberries infected by BCRV from Scotland showed line pattern and ringspot symptoms. However, American isolates did not cause symptoms when graft-transmitted to american germplasm blackberries (Poudel et al., 2011). BCRV pathogenicity may differ depending on the isolates or symptoms may develop only in plant mixed-infected also by another undetermined pathogen(s) (Martin et al., 2013) Yes

Yes
In infected apple trees, CRLV may cause severe fruit deformation and reduce the tree vigour and longevity; in peach and cherry it induces symptoms consisting of leaf enations, deformed leaves with depressions, reduction of fruit production and death of spurs and branches associated with stunting and decline in the most susceptible plants. Increased sensitivity to frost and fruit deformation has also reported in cherry (James, 2011). No uncertainty on the impact on the individual plant, however there are uncertainties on the efficiency of vector-mediated spread and overall impact under European condition (James, 2011) Yes

Yes
The virus causes growth reduction of apple and pear when inoculated in these hosts (Basso et al., 2015). Yes TRSV causes significant disease in soybeans (Glycine max), tobacco (Nicotiana tabacum), Vaccinium spp., especially V. corymbosum, and Cucurbitaceae. Infected grapevine develops symptoms of decline with shortened internodes, small and distorted leaves  and decreased berry yield (EPPO, 2001). Foliar symptoms (chlorotic spots, rings or areas surrounded by necrotic tissues may be induced in infected stone fruit trees (Martelli and Uyemoto, 2011). No uncertainty on the impact on the individual plant, however there are uncertainties on the efficiency of vector-mediated spread and overall impact under European condition.

Yes
ToRSV infecting grapevine induces stunted shoot growth, shortened internodes, leaf ringspot and mottling, reduced size of fruit clusters and abortion of many berries (Yang et al., 1986) as well as thickened, spongy phloem tissue with numerous necrotic pits. In Malus, ToRSV causes union necrosis, woody pitting and decline, with tree mortality of 90% and 40% for Red delicious and Spartan varieties, respectively (Sanfac ßon and Fuchs, 2011). The virus also causes symptoms in stone fruit trees consisting of stem pitting and decline (in peach and cherry), yellow bud mosaic (in peach and almond), brown line and decline (in plum) (Sanfac ßon and Fuchs, 2011). ToRSV is one of the most economically important virus diseases of red raspberry in North America (Stace-Smith and Converse, 1987), with some cultivars showing decline in vigour, stunting and significant fruit yield and quality reduction. Infected Rubus plants often die 4-5 years after infection (Pinkerton et al., 2008) • banning import of plants for planting (including pollen) from the countries where the viruses categorised here are reported, • extension of certification schemes and testing requirements to all natural hosts for the viruses categorised here, • extension of phytosanitary certificate requirements to specifically include hosts other than Cydonia, Malus and Pyrus for the viruses categorised here, • implementation of regulation for seeds of Cydonia, Malus, Pyrus and other hosts of seedtransmitted viruses categorised here.
Some of the viruses may also enter into the EU through viruliferous nematodes. In agreement with a recent EFSA scientific opinion (EFSA PLH Panel, 2018a) an additional measure could be the regulation of soil and growing media attached to imported plants.

Additional control measures
Additional control measures in Table 15 were selected from a longer list of possible control measures reported in EFSA PLH Panel (2018b). Additional control measures are organisational measures or procedures that directly affect pest abundance.

Additional supporting measures
Potential supporting measures are listed in Table 16. They were selected from a list of possible control measures reported in EFSA PLH Panel (2018b). Supporting measures are organisational measures or procedures supporting the choice of appropriate risk reduction options that do not directly affect pest abundance. • Latent infection status for some agents (AHVd, AGV, ALSV, AaLV, PpCV, PpPV-2, EMCV in pear); • Asymptomatic phase of virus infection renders visual detection unreliable; • Low concentration and uneven distribution in the woody hosts impairs reliable detection; • Limited reliability of molecular detection methods; • Absence of proven detection protocol for newly described agents; • Wide host range for some agents (CRLV, TRSV, ToRSV); • Difficulties to control vectors for soil-borne viruses (CRLV, TRSV, ToRSV, possibly also ALSV and EMCV); • Lack of information on potential vector(s) for some agents; • Difficulties to control pollen-mediated transmission for some agents (CRLV, TRSV, ToRSV).

Uncertainty
In the present opinion, viruses for which very different levels of information are available have been analyzed in parallel, including recently described agents for which very limited information is available. The main areas of uncertainty affecting the present categorisation efforts concern: • biological information on the categorised viruses, especially those described recently based on HTS data, is often very limited; • distribution, both in the EU and outside the EU, of the viruses categorised here, in particular but not only for the recently described ones; • volume of imported plants for planting, seeds and pollen of hosts; • host range of PpCV and PpPV-2 and whether they are plant-associated mycoviruses or true plant viruses; • interpretation of the legislation; • pathogenicity of some agents and, for others, the extent to which they would efficiently spread and have impact under conditions prevailing in the EU; • reliability of available detection methods, which is mainly due to i) the absence of information on the intraspecific variability of several agents (especially those recently reported, e.g. AHVd, AGV, AGCaV, ApNMV, AaLV, EMCV in pear, PpCV, PpPV-2, TFDaV) and ii) the lack of a proven detection protocol.
For each virus, the specific uncertainties identified during the categorisation process are reported in the conclusion tables below.

Conclusions
The Panel's conclusions on Pest categorisation of non-EU viruses and viroids of Cydonia, Malus and Pyrus are as follows: AFCVd, ApNMV, CRLV and TFDaV meet all the criteria evaluated by EFSA to qualify as Union quarantine pests. ASSVd, AGCaV, BCRV, EMCV, TRSV and ToRSV meet all the criteria evaluated by EFSA to qualify as Union quarantine pests with the possible exception of being absent from the EU territory or having a restricted presence and being under official control. AGV, AHVd, ALSV, AaLV, PpCV, PpPV-2 do not meet the criterion of having negative impact in the EU and therefore they do not meet all the criteria evaluated by EFSA to qualify as potential Union quarantine pests. TAMV does not meet the criterion of being able to enter in the EU.
All the viruses categorised in the current opinion do not meet the criteria evaluated by EFSA to qualify as potential RNQPs because they are non-EU viruses explicitly mentioned or considered as regulated in Annex IAI of Directive 2000/29/EC. The Panel wishes to stress that these conclusions are associated with particularly high uncertainty in the case of viruses discovered only recently and for which the information on distribution, biology and epidemiology are extremely scarce. A consequence of this situation is that for particular agents the results of the categorisation efforts presented here could be very significantly impacted by the development of novel information.   AFCVd is not known to be present in the EU AFCVd is not known to be present in the EU. Therefore, AFCVd does not meet this criterion to qualify as a potential Union RNQP Possible unreported presence in the EU

Regulatory status (Section 3.3)
AFCVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AFCVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AFCVd not explicitly named in Directive 2000/29/EC Pest potential for entry, establishment and spread in the EU territory (Section 3.4) AFCVd is able to enter in the EU. However, the Malus plants for planting pathway is closed by existing legislation so that entry is possible through trade of plants for planting of other hosts (hop and persimmon). If AFCVd were to enter the EU territory, it could become established and spread Phytosanitary measures are available to reduce the likelihood of entry into the EU (e.g., regulation (ban, request for certification) of plants for planting of hosts other than Malus (hop and persimmon)) Certification of planting material for susceptible hosts is, by far, the most efficient control method Importance of hosts other than Malus for AFCVd entry and spread

Conclusion on pest categorisation (Section 4)
AFCVd meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest AFCVd is a non-EU viroid (considered as regulated in Annex IAI of Directive 2000/29/ EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP  ASSVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' ASSVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' ASSVd not explicitly named in Directive 2000/29/EC Pest potential for entry, establishment and spread in the EU territory (Section 3.4) ASSVd is able to enter in the EU. The main pathway plants for planting of Malus, Pyrus and Prunus spp. is only partially closed by existing legislation. The seed pathway may be possibly open for the same host genera. If ASSVd were to further enter the EU territory, it could become established and spread.
Plants for planting constitute the main mean for ASSVd spread -possible existence of other host species -possible pollen or vectormediated transmission -importance of hosts other than Malus, Pyrus and Prunus for ASSVd dissemination and spread -efficiency of natural spread of ASSVd under EU conditions -significance of the seed pathway given the uncertainty on ASSVd seed transmission Potential for consequences in the EU territory (Section 3.5) Introduction and spread of ASSVd would have a negative impact on the EU apple and pear fruit industry Because of the negative impact of ASSVd on host species, it would have a negative impact on their intended use as plant for planting -magnitude of the impact of ASSVd under EU conditions -susceptibility to and impact of ASSVd on some apple and pear varieties grown in EU The main knowledge gaps or uncertainties identified concern: -existence of additional host species; -possible unreported presence in the EU; -regulatory status of AFCVd as it is not explicitly named in Directive 2000/29/EC; -possible presence of AFCVd in countries from which import of plant for planting of its hosts is permitted; -existence and efficiency of possible seed, pollen and vector transmission; -importance of hosts other than Malus for AFCVd dissemination and spread; -efficiency of natural spread and the magnitude of impact under EU conditions Phytosanitary measures are available to reduce the likelihood of entry into the EU (e.g., tightening of regulations (ban, request for certification, etc.) of plants for planting to cover imports from all countries where ASSVd is present, regulate seed import for susceptible species) Certification of planting material for susceptible hosts is, by far, the most efficient control method

Conclusion on pest categorisation (Section 4)
ASSVd meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest with the possible exception of the criterion of absence from the EU territory ASSVd is a non-EU viroid (considered as regulated in Annex IAI of Directive 2000/29/ EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge gaps or uncertainties identified concern: -geographical distribution and prevalence in the EU; -regulatory status of ASSVd as it is not explicitly named in Directive 2000/29; -possible additional host species; -possible pollen-or vector-mediated transmission; -importance of hosts other than Malus, Pyrus and Prunus for ASSVd dissemination and spread; -efficiency of natural spread of ASSVd under EU conditions; -significance of the seed pathway AHVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AHVd can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AHVd not explicitly named in Directive 2000/29/EC Pest potential for entry, establishment and spread in the EU territory (Section 3.4) AHVd is able to enter in the EU. The main pathway of plants for planting of Malus is only partially closed. If AHVd were to further enter the EU territory, it could become established and spread.
Plants for planting constitute the main means for spread for AHVd -possible seed, pollen or vector-mediated transmission -efficiency of natural spread of AHVd under EU conditions Potential for consequences in the EU territory (Section 3.5) Potential consequences are likely nil or very limited since no symptoms were observed in inoculated apple seedlings. Therefore AHVd does not meet this criterion to qualify as a Union quarantine pathogen The presence of AHVd on plants for planting is not expected to impact their intended use. Therefore, AHVd does not meet this criterion to qualify as a Union RNQP Possible pathogenicity of AHVd in some apple cultivars or under some specific conditions Available measures (Section 3.6) Phytosanitary measures are available to reduce the likelihood of entry into the EU (e.g. tightening of regulations (ban, request for certification) of plants for planting to cover imports from all countries where AHVd is present) Certification of planting material for susceptible hosts is, by far, the most efficient control method

Conclusion on pest categorisation (Section 4)
AHVd does not meet all the criteria evaluated by EFSA to be regarded as a Union quarantine pest. It is present in one EU MS and is not known to cause economic or environmental damage AHVd does not meet two of the criteria evaluated by EFSA to qualify as a potential Union RNQP: 1) it is not present in the EU and can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'; 2) it is not expected to impact the intended use of Cydonia, Malus and Pyrus plants for planting Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge gaps or uncertainties identified concern: -geographical distribution and prevalence in the EU; -regulatory status of AHVd as it is not explicitly named in Directive 2000/29; -existence of seed-, pollen-or vector-mediated transmission; -efficiency of natural spread of AHVd under EU conditions; -possible pathogenicity of AHVd in some apple cultivars or under some specific conditions. Given the very limited literature available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available  AGV is not known to be present in the EU AGV is not known to be present in the EU. Therefore, AGV does not meet this criterion to qualify as a potential Union RNQP Possible unreported presence of AGV in the EU

Regulatory status (Section 3.3)
AGV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AGV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' AGV not explicitly named in Directive 2000/29/EC Pest potential for entry, establishment and spread in the EU territory (Section 3.4) AGV may possibly enter in the EU. The main pathway Malus plants for planting is closed by existing legislation. Other potential pathways (seeds, other hosts) may possibly be open. If AGV were to enter the EU territory, it could become established and could spread.
Plants for planting constitute the main means for spread for AGV -possible existence of additional host species -possible presence of AGV in countries from which import of Malus spp. plants for planting is permitted -possible existence of seedand vector-mediated transmission -efficiency of natural AGV spread under EU conditions Potential for consequences in the EU territory (Section 3.5) Potential consequences are likely nil or very limited since no symptoms are known to be associated with AGV infection. Therefore, AGV does not meet this criterion to qualify as a Union quarantine pathogen The presence of AGV on plants for planting is not expected to impact their intended use. Therefore, AHVd does not meet this criterion to qualify as a Union RNQP AGV does not meet all the criteria evaluated by EFSA to be regarded as a Union quarantine pest. It is not known to cause economic or environmental damage AGV does not meet two of the criteria evaluated by EFSA to qualify as a potential Union RNQP: 1) it is not present in the EU and can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'; 2) it is not expected to impact the intended use of Cydonia, Malus and Pyrus plants for planting The main knowledge gaps or uncertainties identified concern: -possible existence of other host species; -regulatory status of AGV as it is not explicitly named in Directive 2000/29; -possible unreported presence in the EU -possible seed-, pollen-or vector-mediated transmission; -efficiency of natural spread of AGV under EU conditions; -pathogenicity of AGV in some apple cultivars or other hosts, under European conditions. Given the very limited information available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available AGCaV meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest, with the possible exception of the criterion of absence from the EU territory AGCaV is a non-EU virus (considered as regulated in Annex IAI of Directive 2000/ 29/EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge gaps or uncertainties identified concern: -possible existence of other host species; -geographical distribution and prevalence in the EU; -regulatory status of AGCaV as it is not explicitly named in Directive 2000/29; -susceptibility to and impact of AGCaV apple and quince varieties grown under EU conditions. Given the very limited literature available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available ALSV does not meet all the criteria evaluated by EFSA to be regarded as a Union quarantine pest. It is not known to cause economic or environmental damage ALSV does not meet two of the criteria evaluated by EFSA to qualify as a potential Union RNQP: 1) it is not present in the EU and can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'; 2) it is not expected to impact the intended use of Cydonia, Malus and Pyrus plants for planting Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge uncertainties identified concern: -possible existence of other host species; -geographic distribution; -regulatory status of ALSV as it is not explicitly named in Directive 2000/29; -possible pollen-or vector-mediated transmission; -efficiency of natural spread of ALSV under EU conditions; -potential impact of ALSV on apple varieties grown under EU conditions; -significance of the seed and pollen pathway given the absence of information on the volume of imported seeds and pollen of Malus spp. Given the very limited information available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available  The main knowledge gaps or uncertainties identified concern: -possible existence of other host species; -regulatory status of ApNMV as it is not explicitly named in Directive 2000/29; -possible presence in countries from which import of Malus spp. plants for planting is permitted; -existence and significance of seed-and pollen-transmission; -efficiency of natural spread of ApNMV under EU conditions; -susceptibility to and impact of ApNMV in some Malus cultivars grown under EU conditions. Given the very limited information available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available AaLV does not meet all the criteria evaluated by EFSA to be regarded as a Union quarantine pest. It is not known to cause economic or environmental damage AaLV does not meet two of the criteria evaluated by EFSA to qualify as a potential Union RNQP: 1) it is not present in the EU and can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'; 2) it is not expected to impact the intended use of Cydonia, Malus and Pyrus plants for planting Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge gaps or uncertainties identified concern: -possible existence of other host species; -regulatory status of AaLV as it is not explicitly named in Directive 2000/29; -possible presence of AaLV in countries from which import of Malus spp. plants for planting is permitted; -possible vector-mediated transmission; -efficiency of natural spread of AaLV under EU conditions; -pathogenicity of AaLV in some apple cultivars grown in the EU, in other hosts, or under some specific condition in the EU. Given the very limited available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available BCRV meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest with the possible exception of the criterion of absence from the EU territory BCRV is a non-EU virus (considered as regulated in Annex IAI of Directive 2000/29/ EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP The main knowledge gaps or uncertainties identified concern: -geographical distribution and prevalence in the EU; -regulatory status of BCRV as it is not explicitly named in Directive 2000/29; -existence of other host species; -possible presence in countries from which import of Malus plants for planting is permitted; -possible vector-mediated transmission; -significance of the seed and pollen pathway given the absence of information on the volume of imported seeds and pollen of Malus spp. and other hosts -efficiency of natural spread of BCRV under EU conditions; -magnitude of the impact of BCRV under EU conditions The main knowledge gaps or uncertainties identified concern: -possible seed-or pollen-mediated transmission mechanisms in woody hosts; -efficiency of natural spread of CRLV under EU conditions; -possible unreported presence in the EU; -magnitude of the impact of CRLV under EU conditions; -significance of the seed and pollen pathway given the absence of information on the volume of imported seeds and pollen of Malus spp. and other hosts EMCV meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest, with the possible exception of the criterion on absence from the EU territory EMCV is a non-EU virus (considered as regulated in Annex IAI of Directive 2000/29/ EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP Aspects of assessment to focus on/ scenarios to address in future if appropriate The main gaps or uncertainties identified concern: -possible existence of other host species; -regulatory status of EMCV as it is not explicitly named in Directive 2000/29; -possible presence in countries from which import of Pyrus plants for planting is permitted; -possible seed-or vector-mediated transmission; -efficiency of natural spread of EMCV under EU conditions; -magnitude of the impact of EMCV under EU conditions in its various hosts. The main knowledge gaps or uncertainties identified concern: -whether PpCV is a pear virus or a mycovirus associated with a pear colonising fungi; -regulatory status of PpCV as it is not explicitly named in Directive 2000/29/EC; -possible presence of PpCV in countries from which import of Pyrus spp. plants for planting is permitted; -possible seed-, pollen-or vector-mediated transmission; -efficiency of natural spread of PpCV under EU conditions. Given the very limited available information on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available PpPV-2 is not known to be present in the EU PpPV-2 is not known to be present in the EU. Therefore, PpPV-2 does not meet this criterion to qualify as a potential Union

Regulatory status (Section 3.3)
PpPV-2 can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' PpPV-2 can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' PpPV-2 does not meet all the criteria evaluated by EFSA to be regarded as a Union quarantine pest. It is not known to cause economic or environmental damage PpPV-2 does not meet two of the criteria evaluated by EFSA to qualify as a potential Union RNQP: 1) it is not present in the EU and can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'; 2) it is not expected to impact the intended use of Cydonia, Malus and Pyrus plants for planting Aspects of assessment to focus on/ scenarios to address in future if appropriate The main gaps or uncertainties identified concern: -whether PpPV-2 is a pear virus or a mycovirus associated with a pear colonising fungi; -regulatory status of PpCV as it is not explicitly named in Directive 2000/29/EC; -possible presence of PpPV-2 in countries from which import of Pyrus host plants for planting is permitted; -possible seed-, pollen-or vector-mediated transmission mechanisms; -efficiency of natural spread of PpPV-2 under EU conditions. Given the very limited available information on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available TFDaV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' TFDaV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' TFDaV meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest TFDaV is a non-EU virus (considered as regulated in Annex IAI of Directive 2000/29/ EC as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.'), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP Aspects of assessment to focus on/ scenarios to address in future if appropriate Due to the absence of close relatives on which to draw some hypotheses, the main gaps or uncertainties identified concern essentially all aspects of the biology of TFDaV, including: -possible seed-, pollen-or vector-mediated transmission mechanisms; -possible existence of other host species; -possible presence in countries from which import of Malus, Pyrus and Vitis plant for planting is permitted; -efficiency of natural spread of TFDaV under EU conditions; -magnitude of the impact of TFDaV under EU conditions; -regulatory status of TFDaV as it is not explicitly named in Directive 2000/29/EC. Given the very limited available on this very recently described virus, the development of a full PRA will not allow to resolve the uncertainties attached to the present categorisation until more data becomes available  The main knowledge gaps or uncertainties identified concern: -possible seed-or pollen-mediated transmission mechanisms in woody hosts, -efficiency of natural spread of TRSV under EU conditions; -magnitude of the impact of TRSV under EU conditions; -possible more significant presence in the EU; -significance of the seed and pollen pathway given the absence of information on the volume of the imported commodities for Malus or for other hosts from countries where TRSV is present ToRSV has been reported from several MSs but its presence is restricted and/or under eradication TRSV has been sporadically reported in the EU but its presence is restricted and/or under eradication Possible more significant presence in the EU

Regulatory status (Section 3.3)
ToRSV is currently regulated in Annex IAI TRSV is currently regulated in Annex IAI

No uncertainty
Pest potential for entry, establishment and spread in the EU territory (Section 3.4) ToRSV is able to enter in the EU. The Malus and Cydonia spp. plants for planting pathway is essentially closed by specific legislation targeting ToRSV. However, entry is possible on plants for planting of Cydonia and of other hosts, on seeds of herbaceous hosts and with viruliferous nematodes. If ToRSV were to further enter the EU territory, it could become established and spread Plants for planting, vectors, seeds and pollen constitute the main means for spread for ToRSV -possible seed or pollenmediated transmission mechanisms in woody hosts -efficiency of natural spread of ToRSV under EU conditions -origin and trade volumes of plants for planting of unregulated host species -significance of the seed and pollen pathway given the absence of information on the volume of imported seeds and pollen of Malus and Cydonia spp. and other host Potential for consequences in the EU territory (Section 3.5) Introduction and spread of ToRSV would have a negative impact on the EU pome fruit industry and on other crops Because of the negative impact of ToRSV on host species would have a negative impact on their intended use -magnitude of the impact of ToRSV under EU conditions ToRSV meets all the criteria evaluated by EFSA to qualify as a Union quarantine pest with the possible exception of the criterion on absence from the EU territory ToRSV is a non-EU virus (considered as regulated in Annex IAI of Directive 2000/29/ EC), and as such does not meet the EFSA criterion to qualify as a potential Union RNQP Aspects of assessment to focus on/ scenarios to address in future if appropriate The main knowledge gaps or uncertainties identified concern: -possible seed-or pollen-mediated transmission mechanisms in woody hosts; -efficiency of natural spread of ToRSV under EU conditions; -magnitude of the impact of ToRSV under EU conditions; -significance of the seed and pollen pathway given the absence of information on the volume of the imported commodities for Malus and Cydonia spp. or for other hosts from countries where ToRSV is present TAMV is not known to be present in the EU TAMV is not known to be present in the EU. Therefore, TAMV does not meet this criterion to qualify as a potential Union RNQP Possible unreported presence in the EU

Regulatory status (Section 3.3)
TAMV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' TAMV can be considered as regulated in Annex IAI as 'Non-European viruses and virus-like organisms of Cydonia Mill., Fragaria L., Malus Mill., Prunus L., Pyrus L., Ribes L., Rubus L. and Vitis L.' TAMV not explicitly named in Directive 2000/29/EC Pest potential for entry, establishment and spread in the EU territory (Section 3.4) Because it is no longer known to occur in nature, TAMV is most probably unable to enter in the EU Perpetuation, for the foreseeable future, of a pest within an area after entry (FAO, 2017) Impact (of a pest) The impact of the pest on the crop output and quality and on the environment in the occupied spatial units Introduction (of a pest) The entry of a pest resulting in its establishment (FAO, 2017) Measures Control (of a pest) is defined in ISPM 5 (FAO 2017) as 'Suppression, containment or eradication of a pest population' (FAO, 1995). 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. Pathway Any means that allows the entry or spread of a pest (FAO, 2017) Phytosanitary measures 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, 2017) Protected zones (PZ) 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. Quarantine pest 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, 2017) Regulated non-quarantine pest 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, 2017) Risk reduction option (RRO) 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 Spread (of a pest) Expansion of the geographical distribution of a pest within an area (FAO, 2017) Abbreviations