Guidance on the use of the benchmark dose approach in risk assessment.

The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.

List of non-EU viruses and viroids infecting potato (Solanum tuberosum) and other tuber-forming Solanum species.

The European Commission requested a pest categorisation of the non-EU viruses and viroids of potato (hereafter referred to as viruses). As a first step, a systematic literature and database search was carried out to identify the viruses reported to naturally infect Solanum tuberosum and other tuber-forming Solanum spp (hereafter referred to as potato). Based on the global distribution and on the prevalence inside the European Union (EU), the Panel identified 40 non-EU viruses known to occur only outside the EU or with only a limited presence in the EU (reported in only one or few Member States (MSs) and/or with restricted distribution, outbreaks). Twenty-seven viruses were identified as having a significant presence in the EU (known to occur in several MSs, frequently reported in the EU, widespread in several MSs) or reported only from the EU so far, and will be excluded from further categorisation in the frame of the present mandate. Five viruses remained with an undetermined standing because the available information did not allow their allocation to one of the above groups. The viruses considered non-EU and those with undetermined standing will be further categorised if not addressed by EFSA in previous scientific opinions. Seven viruses for which non-European isolates are specifically regulated in Annex I of directive 2000/29/EC will be categorised separately. The main knowledge gaps and uncertainties of this grouping concern the natural host status of potato, the taxonomy, and/or information on the geographical distribution and prevalence of some of the analysed viruses.

Pest categorisation of non-EU viruses and viroids of potato.

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of those viruses and viroids (hereafter referred to as viruses) of Solanum tuberosum and other tuber-forming Solanum spp. (hereafter referred to as potato) which are considered to be either non-EU or of undetermined standing based on a previous EFSA opinion. These viruses belong to different families and genera and either have an established identity or produce consistent symptoms. Plants for planting is the main pathway for entry for all categorised viruses as they can all be transmitted by vegetative propagation. Several categorised viruses have a relatively wide host range and/or are vector-transmitted, increasing the potential for entry. The information currently available on geographical distribution, biology, epidemiology, impact and potential entry pathways has been evaluated with regard to the criteria to qualify as potential Union quarantine pest or as Union regulated non-quarantine pest (RNQP). Since this opinion addresses specifically the non-EU potato viruses, in general these viruses do not meet the criteria assessed by EFSA to qualify as potential Union regulated non-quarantine pests. The following viruses meet the criteria to qualify as potential Union quarantine pest: APLV, APMMV, APMoV, ChiLCV, CYSDV, PAMV, PBRSV, PVH, PVP, PVT, PYDV, PYMV, PYV, PYVV, RCVMV, SALCV, SB26/29, ToCV, ToLCNDV, ToMHaV, ToMoTV, ToSRV and ToYVSV. With the exception of the criterion regarding the potential for consequences in the EU territory, for which the Panel is unable to conclude because of lack of information, AVB, CPSbV, PaLCrV, PapMV, PVB, PVU, SB41 and TVBMV meet all the other criteria to qualify as potential Union quarantine pest. PotLV and WPMV do not qualify as potential Union quarantine pest, since they are not reported to have any impact. For most of the categorised viruses, the conclusions of the Panel have inherent uncertainties, due to the lack of quantitative data on their impact and/or absence or limited availability of information on the biology, epidemiology and geographical distribution.

Pest categorisation of potato virus M (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus M (PVM). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact compared to the current situation in the EU and availability of control measures of non-EU isolates of PVM has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non-EU isolates of PVM are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. Populations of PVM can be subdivided into two strains: the ordinary strain (PVM-O) is present in the EU, while the divergent strain (PVM-D) is absent from the EU or considered to have at most a limited distribution in the EU. Non-EU isolates of PVM-O are not expected to have an additional impact in the EU compared to EU isolates and therefore do not meet the corresponding criterion to qualify as a potential Union quarantine pest. The Panel is unable to conclude on the potential impact of non-EU PVM-D isolates in the EU territory, but PVM-D isolates meet all the other criteria to qualify as a potential Union quarantine pest.

Pest categorisation of potato virus S (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus S (PVS). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact compared to the current situation in the EU, and availability of control measures of non-EU isolates of PVS has been evaluated with regard to the criteria to qualify as potential Union quarantine pest. Because non-EU isolates of PVS are absent from the EU, they do not meet one of the requirements to be regulated as an RNQP (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. Populations of PVS can be subdivided into two strains: the ordinary strain (PVS-O) with a worldwide distribution (including the EU), and the Andean strain (PVS-A) which is absent from the EU or considered to have at most a limited distribution in the EU. Two additional divergent isolates (PVS-A/PVS-O recombinants and PVS-arracacha) have also been categorised. Non-EU isolates of PVS-A are expected to have an additional impact as compared to the PVS isolates currently present in the EU, and therefore meet all the criteria to qualify as potential Union quarantine pests; the magnitude of the additional impact is, however, unknown. Non-EU isolates of PVS-A/PVS-O recombinants and of PVS-arracacha also meet these criteria, with the exception of the criterion regarding the potential additional consequences in the EU territory for which the Panel was unable to conclude. Non-EU PVS-O isolates are not expected to have an additional impact in the EU as compared to EU isolates and therefore do not meet the corresponding criterion.

Pest categorisation of potato virus A (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus A (PVA). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact over the current situation and availability of control measures of non-EU isolates of PVA has been evaluated with regard to the criteria to qualify as potential Union quarantine pest. Because non-EU isolates of PVA are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. This categorisation was performed considering two groups of isolates: those reported in Solanum betaceum (PVA-TamMV, not reported from the EU) and all other isolates (hereafter referred to as PVA, worldwide distribution). Non-EU isolates of PVA and of PVA-TamMV do not meet one of the criteria evaluated by EFSA to be regarded as a potential Union quarantine pest, since they are not expected to have an additional impact in the EU.

Pest categorisation of potato virus V (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus V (PVV). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact and availability of control measures of non-EU isolates of PVV has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non-EU isolates of PVV are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. This categorisation was performed considering two lineages, PVV-I (present in and outside the EU) and PVV-II (not reported in the EU), and isolate PVV-PA4 (unknown distribution). Non-EU isolates of PVV-I and PVV-PA4 do not meet one of the criteria evaluated by EFSA to be regarded as a potential Union quarantine pest, since they are not expected to have an additional impact in the EU. With the exception of the criterion regarding the potential consequences in the EU territory, for which the Panel is unable to conclude, non-EU isolates of PVV-II meet all the other criteria to qualify as a potential Union quarantine pest.

Pest categorisation of potato virus X (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus X (PVX). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact and availability of control measures of non-EU isolates of PVX has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non-EU isolates of PVX are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. On the basis of their ability to overcome potato resistance genes, PVX isolates can be divided into several pathotypes. PVX isolates that are not able to overcome resistance genes and PVX isolates that are able to overcome the Nb and/or Nx resistance genes are already present in the EU. Isolates able to overcome the Rx resistance gene have only been reported from South America. These Rx breaking isolates could potentially have an additional impact over the current situation in the EU and therefore meet all the criteria to qualify as a potential Union quarantine pest. All other non-EU isolates, should they be introduced, are not expected to have additional impact and therefore do not meet this criterion to qualify as a potential Union quarantine pest.

Pest categorisation of potato virus Y (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato virus Y (PVY). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways and potential additional impact of non-EU isolates of PVY, has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non-EU isolates of PVY are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. Populations of PVY can be subdivided into several strains and groups of isolates: strain C (PVY-C), strain N (PVY-N), strain O (PVY-O) and a wide range of recombinant isolates (PVY-recombinants) which have a worldwide distribution (including the EU). Two groups of isolates, i.e. the Brazilian (PVY-Br) and Chilean (PVY-Ch) isolates, are considered absent from the EU. Non-EU isolates of PVY-C, PVY-N, PVY-O and PVY-recombinants identified so far are not expected to have an additional impact in the EU compared to the PVY isolates already present and, therefore, do not meet the corresponding criterion to qualify as a potential Union quarantine pest. The Panel is unable to conclude on the potential additional impact of isolates of PVY-Br and PVY-Ch in the EU territory, but these isolates meet all the other criteria to qualify as potential Union quarantine pests.

Pest categorisation of potato leafroll virus (non-EU isolates).

Following a request from the EU Commission, the Panel on Plant Health has addressed the pest categorisation of non-EU isolates of potato leafroll virus (PLRV). The information currently available on geographical distribution, biology, epidemiology, potential entry pathways, potential additional impact and availability of control measures of non-EU isolates of PLRV has been evaluated with regard to the criteria to qualify as a potential Union quarantine pest. Because non-EU isolates of PLRV are absent from the EU, they do not meet one of the requirements to be regulated as a regulated non-quarantine pest (RNQP) (presence in the EU); as a consequence, the Panel decided not to evaluate the other RNQP criteria for these isolates. This categorisation was performed considering two groups of PLRV isolates: those associated with the tomato yellow top disease (PLRV-TYTV), not reported from the EU, and all other isolates (hereafter referred to as PLRV), with a worldwide distribution. Isolates of PLRV-TYTV could potentially have an additional impact over the current situation in the EU and therefore meet all the criteria to qualify as a potential Union quarantine pest. All other non-EU PLRV isolates, should they be introduced, are not expected to have additional impact and therefore do not meet this criterion to qualify as a potential Union quarantine pest.

Pest categorisation of tomato leaf curl New Delhi virus.

Following a request from the European Commission, the Panel on Plant Health performed a pest categorisation on tomato leaf curl New Delhi virus (ToLCNDV). ToLCNDV is a well-defined bipartite Begomovirus species, sometimes associated with satellite molecules. It is transmitted by Bemisia tabaci to a wide range of hosts. ToLCNDV is reported from Estonia, Greece, Italy, Portugal and Spain, with limited distribution. The prevalent strain (ToLCNDV-ES) in these countries is particularly adapted to cucurbits and is different from isolates reported outside the EU, which are better adapted to solanaceous crops and could therefore pose additional risk for EU agriculture. The virus is regulated under Commission Implementing Regulation (EU) 2019/2072. The main pathway of entry identified is plants for planting of susceptible hosts, even if entry could also occur via commodities carrying viruliferous B. tabaci and possibly by seeds. While establishment and local spread rely on B. tabaci, the virus can also be dispersed over long distances by movement of infected plants for planting. Establishment and spread are limited to regions with ecoclimatic conditions suitable for the establishment of vector populations (southern regions of Europe) or can occur as outbreaks wherever crops are grown under protected cultivation. The main uncertainties associated with this pest categorisation are the distribution and prevalence of ToLCNDV in the EU, the magnitude of the virus impact particularly on hosts different from Cucurbitaceae, and seed transmission. ToLCNDV meets all the criteria evaluated by EFSA to qualify as potential Union Quarantine Pest (QP); conversely, ToLCNDV does not meet the criterion of being widespread in the EU to qualify as a Regulated Non-Quarantine Pest (RNQP). Should new data show that ToLCNDV is widespread in the EU, the possibility would exist for non-EU isolates to qualify as QP, while ToLCNDV EU isolates (ToLCNDV-ES) could qualify as RNQP.

Pest categorisation of Phymatotrichopsis omnivora.

The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well-defined fungal species and reliable methods exist for its detection and identification. It is present in south-western USA, northern Mexico, Libya and Venezuela. The pest is not known to occur in the EU. P. omnivora has an extremely wide host range; quantitative impacts have been documented for Gossypium spp. (cotton), Medicago sativa (alfalfa), Malus domestica (apple), Prunus persica (peach) and Vitis vinifera (grapevine) as the major cultivated hosts. All major hosts and pathways of entry of the pest into the EU are currently regulated, except for soil and growing media attached or associated with plants originating in Libya. Host availability and climate and edaphic matching suggest that P. omnivora could establish in parts of the EU and further spread mainly by human-assisted means. The pest infects the roots causing wilting and death of its host plants. The introduction of the pest in the EU territory would potentially cause direct and indirect impacts at least to cotton, alfalfa, apple, peach and grapevine production. The main uncertainties concern the host range, the extrapolation to the EU of the climatic and edaphic conditions favouring the disease in some of the infested areas, the role of conidia in the epidemiology of the disease and the magnitude of potential impacts to the EU. P. omnivora meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering P. omnivora as a potential Union regulated non-quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Stagonosporopsis andigena.

The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well-defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The major cultivated host is Solanum tuberosum (potato); other tuber-forming Solanum species and wild solanaceous plants are also affected. All hosts and pathways of entry of the pest into the EU are currently regulated. Host availability and climate matching suggest that S. andigena could establish in parts of the EU and further spread mainly by human-assisted means. The pest affects leaves, stems and petioles of potato plants causing lesions and premature leaf drop but not the underground parts, including tubers. The disease causes yield reductions up to 80%, depending on the susceptibility of potato cultivars. Early application of fungicide sprays and cultivation of resistant potato cultivars are the most effective measures for disease management. The pest introduction in the EU would potentially cause impacts to potato production. The main uncertainties concern the host range, the maximum period the pest survives on host debris in soil, the maximum distance over which conidia of the pest could be dispersed by wind-blown rain, and the magnitude of potential impacts to the EU. S. andigena meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering S. andigena as a potential Union regulated non-quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Thecaphora solani.

The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solani is present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introduction into the EU is prohibited. The major host is Solanum tuberosum (potato), but various other tuber-forming Solanum species are also affected. The pest has also been reported on Solanum lycopersicum (tomato), and wild solanaceous plants are also affected. All the major hosts and pathways of entry are currently regulated. Host availability and climate matching suggest that T. solani could establish in parts of the EU and further spread by human-assisted means. The disease induces gall formation on potato tubers, stolons and underground stem parts, reducing yield and making tubers unmarketable. The pest introduction in the EU would potentially cause impacts to potato production. In the infested areas, the only available strategy to control the disease and prevent it from spreading is the application of quarantine and sanitation measures and the cultivation of resistant varieties. The main uncertainties concern the host range, the biology and epidemiology of the pest, and the potential of the pest to enter the EU through three unregulated minor pathways. T. solani meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering T. solani as a potential Union regulated non-quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Septoria malagutii.

The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well-defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into the EU is prohibited. The major cultivated host is Solanum tuberosum (potato), but other Solanum species including wild solanaceous plants are also affected. All hosts and pathways of entry of the pest into the EU are currently regulated. Host availability and climate matching suggest that S. malagutii could establish in parts of the EU and further spread mainly by human-assisted means. The pest affects leaves, stems and petioles of potato plants (but not the underground parts, including tubers) causing lesions, leaf necrosis and premature defoliation. In some infested areas, the disease has been reported to cause almost complete crop loss with favourable weather conditions and susceptible potato cultivars. The introduction of the pest into the EU would potentially cause impacts to potato production. The main uncertainties concern the host range, the maximum period the pest survives on host debris in soil, the maximum distance over which conidia of the pest could be dispersed by wind-driven rain and the magnitude of potential impacts to the EU. S. malagutii meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering S. malagutii as a potential Union regulated non-quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Phyllosticta solitaria.

The Panel on Plant Health performed a pest categorisation of Phyllosticta solitaria, the causal agent of blotch of apple, for the EU. The pest is a well-defined fungal species and methods are available for its detection and identification. P. solitaria is present in Canada and the continental states of the USA. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introduction into the EU is prohibited. The major cultivated host is Malus domestica (apple), but wild Malus and Crataegus species may also be affected. All hosts and major pathways of entry of the pest into the EU are currently regulated. The disease is favoured by warm, wet weather during the growing season. Host availability and climate matching suggest that P. solitaria could establish in parts of the EU and further spread mainly by human-assisted means. The pest causes premature defoliation, fruit cracking and rot, and twig and branch cankers. At the beginning of the 20th century, disease incidences of 70-90% on fruit of untreated susceptible apple cultivars had been reported and the disease was considered as a limiting factor in the commercial production of those cultivars. Nowadays, the disease is rare in commercial apple orchards, probably due to regular fungicide sprays against other diseases. The pest introduction in the EU would potentially cause impacts to apple production. The main uncertainties concern the host range, the maximum distance of conidial dispersal by wind-driven rain, and the magnitude of potential impacts to the EU. P. solitaria meets all the criteria assessed by EFSA for consideration as a potential Union quarantine pest. The criteria for considering P. solitaria as a potential Union regulated non-quarantine pest are not met, since the pest is not known to occur in the EU.

Pest categorisation of Fusarium oxysporum f. sp. albedinis.

The Panel on Plant Health performed a pest categorisation of the soil-borne fungus Fusarium oxysporum f. sp. albedinis, the causal agent of Fusarium wilt of date palm, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is listed in Annex IIAI of Directive 2000/29/EC and is not known to occur in the EU. Fusarium oxysporum f. sp. albedinis is present in Morocco, Algeria and Mauritania. Its major host is Phoenix dactylifera, which is the only Phoenix species known to be affected by the pest. Uncertainty exists about the host status of Lawsonia inermis, Medicago sativa and Trifolium spp. cultivated as intercrops in the infested areas and reported as being symptomless carriers of the pest. The pest could potentially enter the EU on host plants and soil/growing media originating in infested Third countries. The current pest distribution and climate matching suggest that the pest could establish and spread in the EU wherever the host is present. In the infested areas, the pest causes vascular wilt resulting in yield/quality losses and plant death. It is expected that pest introduction and spread in the EU could impact date production. The pest is expected to have high environmental consequences in the Elche area (Spain), which is a UNESCO World Heritage Site, as well as other EU areas where P. dactylifera is grown as an amenity tree. Current EU phytosanitary measures are not fully effective at mitigating the risk of introduction and spread of the pest in the EU. Fusarium oxysporum f. sp. albedinis meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. As the pest is not known to occur in the EU, this criterion to consider it as Union regulated non-quarantine pest is not met.

Pest categorisation of Apiosporina morbosa.

The Panel on Plant Health performed a pest categorisation of the fungus Apiosporina morbosa, the causal agent of black knot, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is listed in Annex IIAI of Directive 2000/29/EC and is not known to occur in the EU. Apiosporina morbosa is present in Alaska, Canada, Mexico and the continental states of the USA. The major hosts of A. morbosa are Prunus domestica and Prunus cerasus; the host status of other Prunus species and hybrids is uncertain because of contradictory reports or lack of information. The pest could potentially enter the EU on host plants for planting and plant parts originating in infested third countries. Wood of Prunus spp. is also a pathway of entry, but of minor importance. The current pest distribution and climate matching suggest that the pest could establish and spread in the EU wherever the hosts are grown. In the infested areas, the pest causes girdling of twigs and occasionally of larger branches, whereas trees with multiple infections loose vigour, bloom poorly, and become unproductive, stunted and susceptible to winter injury and infection by other pathogens. The presence of black knots makes trees unsuitable for timber production. It is expected that the pest introduction and spread in the EU would impact host production. Uncertainty exists on whether the agricultural practices and chemical control methods applied in the EU could prevent the establishment and spread of A. morbosa. A. morbosa meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. As the pest is not known to occur in the EU, this criterion to consider it as Union regulated non-quarantine pest is not met.

Pest categorisation of Colletotrichum gossypii.

The Panel on Plant Health performed a pest categorisation of Colletotrichum gossypii, the fungal agent of anthracnose and ramulosis diseases of cotton, for the EU. The identity of the pest is well established and reliable methods exist for its detection/identification. The pest is present in most of the cotton-growing areas worldwide, including Bulgaria and Romania in the EU. Colletotrichum gossypii is listed as Glomerella gossypii in Annex IIB of Directive 2000/29/EC and is not known to occur in Greece, which is a protected zone (PZ). The only hosts are Gossypium species, with G. hirsutum and G. barbadense being the most susceptible. The pest could potentially enter the PZ on cotton seeds originating in infested third countries or EU infested areas. Entry into PZ by natural means from EU infested areas is possible, although there is uncertainty on the maximum distance the pest can travel by wind or insects. Bolls and unginned cotton are minor pathways of entry. Pest distribution and climate matching suggest that the pest could establish and spread in cotton-producing areas of northern Greece. In the infested areas, the pest causes damping-off, leaf/boll spotting, boll rot, witches' broom symptoms and stunting resulting in yield and quality losses. It affects also the lint and seeds reducing fibres quality and seed germinability. It is expected that its introduction and spread in the EU PZ would impact cotton yield and quality. The agricultural practices and control methods currently applied in Greece would not prevent pest establishment and spread. Colletotrichum gossypii meets all the criteria assessed by EFSA for consideration as potential quarantine pest for the EU PZ of Greece. The criteria for considering C. gossypii as a potential Union regulated non-quarantine pest are also met since cotton seeds are the main means of spread.

Pest categorisation of Synchytrium endobioticum.

The Panel on Plant Health performed a pest categorisation of the fungus Synchytrium endobioticum, the causal agent of potato wart disease, for the European Union (EU). The identity of the pest is well established and reliable methods exist for its detection and identification. S. endobioticum is present in most continents. The pest is listed in Annex IAII of Directive 2000/29/EC and is present with a restricted and fragmentary distribution in the EU. The major host is Solanum tuberosum (potato), but in Mexico, the pest also affects wild Solanum spp. S. endobioticum could potentially enter the EU through multiple pathways associated with soil as substrate for non-host plants, contaminant or commodity. The presence of the pest in 16 EU Member States characterised by different climatic conditions suggests that it could establish in the rest of the EU. The disease induces the formation of warts on potato tubers, stolons and stem bases reducing plant growth and yield and making tubers unmarketable. Additional losses may occur during storage. The only available strategy to control the disease and prevent it from spreading is the application of strict phytosanitary measures and the cultivation of potato varieties resistant to the pathotype(s) present in the infested field(s). Specific phytosanitary measures exist (Council Directive 69/464/EEC) for the control of potato wart disease in the EU. The main uncertainties refer to the distribution and host range of the pest, and the importance of some pathways of entry. S. endobioticum meets all the criteria assessed by EFSA for consideration as potential Union quarantine pest. The criteria for considering S. endobioticum as a potential Union regulated non-quarantine pest are not met since, in addition to potato seed tubers, soil (as commodity, substrate or contaminant) and ware potato tubers are major means of spread.