Commodity risk assessment of Tilia cordata and Tilia platyphyllos plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Tilia cordata and T. platyphyllos imported from the United Kingdom (UK) as: (a) bundles of budwood/graftwood; (b) 1- to 2-year-old whips, seedlings or transplants; (c) bundles of 1- to 2-year-old cell grown plants; (d) 1- to 7-year-old bare root single plants; and (e) up to 25-year-old single plants in pots, taking into account the available scientific information provided by the UK. A list of pests potentially associated with the commodities was compiled. The relevance of any pest was assessed based on evidence following defined criteria. None of the pests on the list fulfilled all relevant criteria and therefore none were selected for further evaluation. As a result, risk mitigation measures proposed in the technical dossier from the UK were listed, but not further evaluated.

Commodity risk assessment of Ligustrum ovalifolium and Ligustrum vulgare plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of the evergreen Ligustrum ovalifolium and the semi-evergreen Ligustrum vulgare imported from the United Kingdom (UK) as: (a) bare root plants and (b) plants in pots, taking into account the available scientific information, including the technical information provided by the UK. The category (a) 'bare root plants' includes bundles of 1- to 3-year-old bare root whips or transplants and single 1- to 7-year-old bare root plants. The category (b) 'plants in pots' includes bundles of 1- to 2-year-old cell grown plants (only L. vulgare) and 1- to 5-year-old plants in pots. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Bemisia tabaci and Scirtothrips dorsalis, and one pest not regulated in the EU, Diaprepes abbreviatus, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures proposed in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom considering the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with B. tabaci being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9915 and 10,000 per 10,000 bare root plants and plants in pots will be free from B. tabaci.

Commodity risk assessment of Corylus avellana plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Corylus avellana imported from the United Kingdom (UK) as: (a) bundles of 1- to 2-year old whips or transplants, (b) bundles of 1- to 2-year old cell grown plants, (c) 1- to 7-year old bare root single plants and (d) up to 15-year old single plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Phytophthora ramorum (non-EU isolates) and Thaumetopoea processionea fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with P. ramorum being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that between 9939 and 10,000 of the single plants in pots up to 15-year old will be free from P. ramorum (non-EU isolates).

Commodity risk assessment of Quercus petraea plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High-risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Quercus petraea imported from the UK as: (a) bundles of 1- to 2-year-old whips and seedlings, (b) 1- to 7-year-old bare root plants for planting and (c) less than 1- to 15-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Cronartium quercuum and Phytophthora ramorum (non-EU isolates), two protected zone quarantine pests, Cryphonectria parasitica and Thaumetopoea processionea, and four pests not regulated in the EU, Coniella castaneicola, Meloidogyne mali, Phytophthora kernoviae and Trinophylum cribratum, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures included in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with C. castaneicola being the pests most frequently expected on the imported plants. The Expert knowledge elicitation indicated with 95% certainty that between 9,711 and 10,000 per 10,000 less than 1- to 15-year-old plants in pots will be free from C. castaneicola.

Commodity risk assessment of Quercus robur plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High-risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Quercus robur imported from the UK as: (a) bundles of 1- to 2-year-old whips and seedlings, (b) 1- to 7-year-old bare root plants for planting and (c) less than 1- to 15-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Cronartium quercuum and Phytophthora ramorum (non-EU isolates), two protected zone quarantine pests, Cryphonectria parasitica and Thaumetopoea processionea and four pests not regulated in the EU, Coniella castaneicola, Meloidogyne mali, Phytophthora kernoviae and Trinophylum cribratum, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures included in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with C. castaneicola being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that between 9,711 and 10,000 per 10,000 less than 1- to 15-year-old plants in pots will be free from C. castaneicola.

Commodity risk assessment of Acer campestre plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Acer campestre imported from the UK as: (a) 1- to 7-year-old bare root plants for planting, (b) 1- to 15-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with Phytophthora ramorum being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that 9,757 or more 1- to 15-year-old plants in pots per 10,000 will be free from P. ramorum.

Commodity risk assessment of Acer pseudoplatanus plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Acer pseudoplatanus imported from the United Kingdom (UK) as: (a) 1- to 7-year-old bare root plants for planting, (b) 1- to 7-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For these pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For the selected pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Meloidogyne mali or M. fallax being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that 9,792 or more plants in pots per 10,000 will be free from Meloidogyne mali or M. fallax.

Commodity risk assessment of Acer palmatum plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Acer palmatum imported from the United Kingdom (UK) as: (a) 1- to 2-year-old bare root plants for planting and (b) 1- to 7-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For these pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For the selected pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Meloidogyne mali or M. fallax being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that 9,792 or more plants in pots per 10,000 will be free from Meloidogyne mali or M. fallax.

Commodity risk assessment of Acer platanoides plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Acer platanoides imported from the United Kingdom (UK) as: (a) 1- to 7-year-old bare root plants for planting, (b) 1- to 7-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Meloidogyne mali or M. fallax being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that 9,792 or more plants in pots per 10,000 will be free from Meloidogyne mali or M. fallax.

Commodity risk assessment of Fagus sylvatica plants from the UK.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Fagus sylvatica imported from the United Kingdom (UK) as: (a) 1- to 7-year-old bare root plants for planting, (b) < 1- to 15-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Phytophthora ramorum (non-EU isolates) and Thaumetopoea processionea, and two pests not regulated in the EU, Meloidogyne mali and Phytophthora kernoviae, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with M. mali being the pest most frequently expected on the imported plants. The expert knowledge elicitation (EKE) indicated with 95% certainty that between 9,793 and 10,000 plants in pots up to 15 years old per 10,000 will be free from M. mali.

On the use of antibiotics to control plant pathogenic bacteria: a genetic and genomic perspective.

Despite growing attention, antibiotics (such as streptomycin, oxytetracycline or kasugamycin) are still used worldwide for the control of major bacterial plant diseases. This raises concerns on their potential, yet unknown impact on antibiotic and multidrug resistances and the spread of their genetic determinants among bacterial pathogens. Antibiotic resistance genes (ARGs) have been identified in plant pathogenic bacteria (PPB), with streptomycin resistance genes being the most commonly reported. Therefore, the contribution of mobile genetic elements (MGEs) to their spread among PPB, as well as their ability to transfer to other bacteria, need to be further explored. The only well-documented example of ARGs vector in PPB, Tn5393 and its highly similar variants (carrying streptomycin resistance genes), is concerning because of its presence outside PPB, in Salmonella enterica and Klebsiella pneumoniae, two major human pathogens. Although its structure among PPB is still relatively simple, in human- and animal-associated bacteria, Tn5393 has evolved into complex associations with other MGEs and ARGs. This review sheds light on ARGs and MGEs associated with PPB, but also investigates the potential role of antibiotic use in resistance selection in plant-associated bacteria.

Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-024).

Following the submission of application EFSA-GMO-RX-024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.

Pest categorisation of Coniella granati.

The EFSA Plant Health Panel performed a pest categorisation of Coniella granati, a clearly defined fungus of the Order Diaporthales and the family Schizoparmaceae, described for the first time in 1876 as Phoma granatii and later named as Pilidiella granati. The pathogen mainly affects Punica granatum (pomegranate) and Rosa spp. (rose), causing fruit rot, shoot blight and cankers on crown and branches. The pathogen is present in North America, South America, as well as in Asia, Africa, Oceania and Eastern Europe and has also been reported in the EU (Greece, Hungary, Italy and Spain), where it is widespread in the major pomegranate growing areas. Coniella granati is not included in Commission Implementing Regulation (EU) 2019/2072 and there are no interceptions in the EU. This pest categorisation focused on those hosts for which the pathogen was detected and formally identified in natural conditions. Plants for planting, fresh fruits and as well as soil and other plant growing media are the main pathways for the further entry of the pathogen into the EU. Host availability and climate suitability factors occurring in parts of the EU are favourable for the further establishment of the pathogen. In the area of its present distribution, including Italy and Spain, the pathogen has a direct impact in pomegranate orchards as well as during post-harvest storage. Phytosanitary measures are available to prevent the further introduction and spread of the pathogen into the EU. Coniella granati does not satisfy the criteria that are within the remit of EFSA to assess for this species to be regarded as potential Union quarantine pest as it is present in several EU MSs.

Pest categorisation of Pantoea ananatis.

The EFSA Plant Health Panel performed a pest categorisation of Pantoea ananatis, a Gram-negative bacterium belonging to the Erwiniaceae family. P. ananatis is a well-defined taxonomic unit; nonetheless, its pathogenic nature is not well defined and non-pathogenic populations are known to occupy several, very different environmental niches as saprophytes, or as plant growth promoting bacteria or biocontrol agents. It is also described as a clinical pathogen causing bacteraemia and sepsis or as a member of the gut microbiota of several insects. P. ananatis is the causal agent of different diseases affecting numerous crops: in particular, centre rot of onion, bacterial leaf blight and grain discoloration of rice, leaf spot disease of maize and eucalyptus blight/dieback. A few insect species have been described as vectors of P. ananatis, among them, Frankliniella fusca and Diabrotica virgifera virgifera. This bacterium is present in several countries in Europe, Africa, Asia, North and South America, and Oceania from tropical and subtropical regions to temperate areas worldwide. P. ananatis has been reported from the EU territory, both as pathogen on rice and maize and as an environmental, non-pathogenic bacterium in rice marshes and poplar rhizosoil. It is not included in EU Commission Implementing Regulation 2019/2072. The pathogen can be detected on its host plants using direct isolation, or PCR-based methods. The main pathway for the entry of the pathogen into the EU territory is host plants for planting, including seeds. In the EU, there is a large availability of host plants, with onion, maize, rice and strawberry being the most important ones. Therefore, disease outbreaks are possible almost at any latitude, except in the most northern regions. P. ananatis is not expected to have frequent or consistent impact on crop production and is not expected to have any environmental impact. Phytosanitary measures are available to mitigate the further introduction and spread of the pathogen into the EU on some hosts. The pest does not satisfy the criteria, which are within the remit for EFSA to evaluate whether the pest meets the definition of a Union quarantine pest. P. ananatis is probably widely distributed in different ecosystems in the EU. It may impact some specific hosts such as onions while on other hosts such as rice it has been reported as a seed microbiota without causing any impact and can even be beneficial to plant growth. Hence, the pathogenic nature of P. ananatis is not fully established.

Assessment of genetically modified maize GA21 × T25 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-DE-2016-137).

Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post-market monitoring of food and feed is not considered necessary. The GMO Panel concludes that maize GA21 × T25 is as safe as its conventional counterpart and the non-GM reference varieties tested, with respect to potential effects on human and animal health and the environment.

Pest categorisation of cowpea mosaic virus.

The EFSA Panel on Plant Health conducted a pest categorisation of cowpea mosaic virus (CPMV) for the EU territory. The identity of CPMV, a member of the genus Comovirus (family Secoviridae), is established and detection and identification methods are available. The pathogen is not included in the Commission Implementing Regulation (EU) 2019/2072. It has been reported from the Americas, and several countries in Africa and Asia and it is not known to be present in the EU in natural conditions. CPMV is considered a major pathogen of cowpea on which it causes symptoms ranging from mild to severe mosaic, chlorosis and necrosis. The virus has been reported sporadically on some other cultivated species of the family Fabaceae, including soybean and some common bean varieties. CPMV is transmitted by cowpea seeds, with uncertainty on the transmission rate. There is uncertainty on seed transmission by other Fabaceae host species due to lack of information. CPMV is also transmitted by several beetle species, one of which, Diabrotica virgifera virgifera, is present in the EU. Seeds for sowing of cowpea are identified as the major entry pathway. The cultivated area and production of cowpea in the EU territory are mainly limited to local varieties cultivated at a small scale in Mediterranean EU Member States. Should the pest establish in the EU, an impact is expected on cowpea crops at local scale. There is high uncertainty on the potential impact that CPMV would cause on other natural hosts cultivated in the EU due to the lack of information from the areas of CPMV's current distribution. Despite the uncertainty concerning the potential impact on bean and soybean crops in the EU, CPMV satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest.

Pest categorisation of Lasiodiplodia pseudotheobromae.

The EFSA Plant Health Panel performed a pest categorisation of Lasiodiplodia pseudotheobromae, a clearly defined fungus of the family Botryosphaeriaceae, which was first described in 2008 as a cryptic species within the L. theobromae complex. The pathogen affects a wide range of woody perennial crops and ornamental plants causing root rot, damping-off, leaf spots, twig blight, cankers, stem-end rot, gummosis, branch dieback and pre- and post-harvest fruit rots. Lasiodiplodia pseudotheobromae is present in Africa, Asia, North and South America and Oceania and has also been reported from Spain with a restricted distribution. However, there is uncertainty on the status of the pathogen worldwide and in the EU because in the past, when molecular tools (particularly multigene phylogenetic analysis) were not available, the pathogen might have been misidentified as L. theobromae. Lasiodiplodia pseudotheobromae is not included in Commission Implementing Regulation (EU) 2019/2072 and there are no interceptions in the EU. Because of the very wide host range of the pathogen, this pest categorisation focused on those hosts for which there is robust evidence that the pathogen was formally identified by a combination of morphology, pathogenicity and multilocus sequence analysis. Plants for planting, including seeds, fresh fruits and bark and wood of host plants as well as soil and other plant-growing media are the main pathways for the further entry of the pathogen into the EU. Host availability and climate suitability factors occurring in parts of the EU are favourable for the further establishment of the pathogen. In the area of its present distribution, including Spain, the pathogen has a direct impact on cultivated hosts. multilocus measures are available to prevent the further introduction and spread of the pathogen into the EU. Lasiodiplodia pseudotheobromae satisfies the criteria that are within the remit of EFSA to assess for this species to be regarded as potential Union quarantine pest.

Pest categorisation of Xylella taiwanensis.

The EFSA Plant Health Panel performed a pest categorisation of Xylella taiwanensis, a Gram-negative bacterium belonging to the Xanthomonadaceae. The pathogen is a well-defined taxonomic entity, and it is the causal agent of the pear leaf scorch. X. taiwanensis is present in subtropical and temperate areas of the island of Taiwan, where it affects low chilling pear cultivars of the species Pyrus pyrifolia (Asian pear). No other plant species are reported to be affected by the pathogen. The pathogen is not known to be present in the EU territory and it is not included in the Commission Implementing Regulation (EU) 2019/2072. The main pathway for the entry of the pathogen into the EU territory is host plants for planting (except seeds); another possible pathway might be represented by putative insect vectors, though their identity remains unknown. The cultivated area of P. pyrifolia in the EU territory is very limited. Conversely, the genetically related P. communis is widely cultivated in most EU Member States and there is no information so far on the susceptibility of its several cultivars. Should the pest establish in the EU, economic impact is expected, provided that suitable insect vectors are present and P. communis is as susceptible to infection as P. pyrifolia. Phytosanitary measures are available to prevent the introduction and spread of the pathogen into the EU, since plants for planting from Taiwan is a closed pathway; nonetheless, putative vectors, if confirmed and identified, may represent an additional risk of the pathogen's introduction and spread. The lack of knowledge on whether X. taiwanensis can infect P. communis, the identity and presence of suitable vectors in the EU lead to key uncertainties on entry, establishment, spread and impact. X. taiwanensis satisfies the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest.

Assessment of genetically modified soybean MON 87701 × MON 89788 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-022).

Following the submission of application EFSA-GMO-RX-022 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in soybean MON 87701 × MON 89788 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-022 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701 × MON 89788.

Assessment of genetically modified soybean 40-3-2 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-023).

Following the submission of application EFSA-GMO-RX-023 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified soybean 40-3-2, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean 40-3-2 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-023 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean 40-3-2.