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 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 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.

Pest risk assessment of Leucinodes orbonalis for the European Union.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment of Leucinodes orbonalis (Lepidoptera: Crambidae), the eggplant fruit and shoot borer, for the EU. The assessment focused on potential pathways for entry, climatic conditions favouring establishment, spread and impact. Options for risk reduction are discussed but effectiveness was not quantified. L. orbonalis is a key pest of eggplant (aubergine/brinjal) in the Indian subcontinent and occurs throughout most of southern Asia with records mostly from India and Bangladesh. The main pathway of entry is fruit of solanaceous plants, primarily exotic varieties of eggplant, Solanum melongena and turkey berry, S. torvum. The trade in both commodities from Asia is small but nevertheless dwarfs the trade in other Solanum fruits from Asia (S. aethiopicum, S. anguivi, S. virginianum, S. aculeatissimum, S. undatum). Other Solanum fruits were therefore not further assessed as potential pathways. The trade in eggplant from Asia consists of special fruit types and caters mostly to niche markets in the EU, while most eggplant consumed in Europe is produced in southern European and northern African countries, where L. orbonalis does not occur. Using expert knowledge elicitation (EKE) and pathway modelling, the Panel estimated that approximately 3-670 infested fruit (90% certainty range, CR) of S. melongena or fruit bunches of S. torvum enter into regions of the EU that are suitable for L. orbonalis establishment each year. Based on CLIMEX modelling, and using two possible thresholds of ecoclimatic index (EI) to indicate uncertainty in establishment potential, climates favouring establishment occur mostly in southern Europe, where, based on human population, approximately 14% of the imported produce is distributed across NUTS2 regions where EI ≥ 30; or 23% of the produce is distributed where EI ≥ 15. Escape of adult moths occurs mostly from consumer waste. By analysing results of different scenarios for the proportion of S. melongena and S. torvum in the trade, and considering uncertainties in the climatic suitability of southern Europe, adult moth emergence in areas suitable for establishment is expected to vary between 84 individuals per year and one individual per 40 years (based on 90% CR in different scenarios). In the baseline scenario, 25% of the solanaceous fruit from Asia is S. torvum, 75% is S. melongena and EI ≥ 30 is required for establishment. After accounting for the chances of mating, host finding and establishment, the probability of a mated female establishing a founder population in the EU is less than 1 in 100,000 to about 1 event per 622 years (90% CR in baseline scenario). The waiting time until the first establishment is then 622 to more than 100,000 years (CR). If such a founder population were established, the moth is estimated to spread at a rate of 0.65-7.0 km per year after a lag phase of 5-92 years. The impact of the insect on the production of eggplant is estimated to be 0.67%-13% (CR) if growers take no specific action against the insect and 0.13%-1.9% if they do take targeted actions. Tomato (S. lycopersicum) and potato (S. tuberosum) are hosts of L. orbonalis, but the insect does not develop to maturity in tomato fruit, and it does not feed on potato tubers under field conditions; hence, damage to potato can only occur due to feeding on shoots. Tomato and potato are not preferred hosts; nevertheless, impact can occur if populations of L. orbonalis are high and preferred hosts are not available. The Panel did not assess this damage due to insufficient information.

Commodity risk assessment of plants of 12 selected Prunus species from Moldova.

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 defoliated 1- or 2-year old bare root plants for planting (grafted or not) of 12 Prunus species (Prunus armeniaca, P. avium, P. canescens, P. cerasifera, P. cerasus, P. davidiana, P. domestica, P. dulcis, P. fontanesiana, P. persica, P. salicina, P. tomentosa) imported from Moldova, taking into account the available scientific information, including the technical information provided by the applicant country. The evaluation identified three EU-quarantine pests, Erwinia amylovora (protected zone quarantine pest), Xiphinema rivesi non-EU populations and Xanthomonas arboricola pv. pruni (protected zone quarantine pest), which were selected for further evaluation, based on defined criteria, including their presence in the applicant country. It should be noted that there is uncertainty regarding whether all relevant pests have been identified due to a limited number of scientific publications and pest surveys in Moldova. For the three selected pests, the risk mitigation measures proposed in the technical dossier from Moldova 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 it, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Erwinia amylovora being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated, with 95% certainty, that between 9823 and 10,000 bundles (comprising 10-20 plants per bundle) out of 10,000 bundles would be free from E. amylovora.

Standard protocols for plant health scientific assessments.

In accordance with the EFSA Strategy 2027 outlining the need for fit-for-purpose protocols for EFSA generic scientific assessments, the EFSA Panel on Plant Health (PLH Panel) developed standard protocols to harmonise the problem formulation process and outputs for mandates addressing recurrent scientific questions. Three types of recurring EFSA plant health mandates require generic scientific assessments: (i) pest categorisation; (ii) commodity risk assessment for the purpose of derogation to provisions of the EU plant health law and (iii) quantitative pest risk assessment. The three standard protocols are tailored to the appropriate level of detail and build on the existing guidance documents laying out the methods for conducting risk assessment in the plant health domain. To develop a standard protocol for pest categorisation, the PLH Panel adapted the latest version of the standard template reporting the evidence needs and the assessment questions to conclude whether a pest fulfils the criteria for being considered a potential quarantine pest for the EU. To develop a standard protocol for commodity risk assessment, the PLH Panel adapted the procedure and standard templates used for commodity risk assessment of high risk plants. To develop a standard protocol for quantitative pest risk assessments (qPRA), the Panel reviewed the existing guidance document on qPRA and the qPRAs published by the PLH Panel. The hierarchy of assessment questions and sub-questions used were identified and extracted. Based on this, a hierarchically organised IT-tool was formulated as protocol for the planning and documentation of future qPRAs.

Commodity risk assessment of Prunus avium plants from United Kingdom.

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 Prunus avium possibly grafted on rootstocks of either P. avium, P. canescens, P. cerasus, P. pseudocerasus or their hybrids imported from the UK, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. Three quarantine pests Scirtothrips dorsalis, tobacco ringspot virus and tomato ringspot virus), one protected zone EU quarantine pest (Bemisia tabaci (European population), and three non- regulated pests (Colletotrichum aenigma, Eulecanium excrescens and Takahashia japonica) that fulfilled all relevant criteria were selected for further evaluation. The risk mitigation measures proposed in the technical Dossier from the UK were evaluated, taking into account the possible limiting factors. For these pests, 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 Colletotrichum aenigma being the pest most frequently expected on the imported potted plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9971 and 10,000 plants per 10,000 would be free from the above-mentioned fungus.

Commodity risk assessment of maple veneer sheets from Canada.

The European Commission requested the EFSA Panel on Plant Health to deliver a risk assessment on the likelihood of pest freedom from Union quarantine pests and pests subject to measures adopted pursuant to Article 30 of Regulation (EU) No 2016/2031 for the maple veneer sheets manufactured according to the process set out by Canada, with emphasis on the freedom from Davidsoniella virescens and Phytophthora ramorum (non-EU isolates). The assessment was conducted for veneer sheets of up to 0.7 mm and up to 6 mm thickness, taking into account the different phases in the veneer production in a systems approach. Some of those phases, taken alone, including the heat treatment of logs in a water bath, the cutting into thin veneer sheets and the final high heat drying of veneer sheets are expected to be effective against some of the pests, without uncertainties, making the system approach fully effective. The panel considers that no insects would survive cutting of logs into thin veneer sheets of 0.7 mm and that Xylella fastidiosa will not survive the temperatures in the water bath and final drying of veneers. The degree of pest freedom for the different groups of organisms is generally very high with slightly lower degree of pest freedom for veneer sheets of 6 mm thickness because of lower temperatures reached in the final drying of veneer sheets compared to thinner sheets. P. ramorum is not expected to survive the high heat drying of thin veneer sheets, but it may survive the lower temperatures inside thicker veneer sheets. The Expert Knowledge Elicitation (EKE) indicated, with 95% certainty, that between 9989 and 10,000 veneer sheets (thickness 6 mm) per 10,000 will be free from living P. ramorum. For D. virescens, the EKE indicated, with 95% certainty, that between 9984 and 10,000 veneer sheets (0.7 mm) per 10,000 and that between 9954 and 10,000 veneer sheets (6 mm) per 10,000 will be free from living inoculum. For other relevant groups of pests, the greatest likelihood of pest presence was observed for wood decay fungi. The EKE indicated, with 95% certainty, that between 9967 and 10,000 veneer sheets (0.7 mm) per 10,000 and that between 9911 and 10,000 veneer sheets (6 mm) per 10,000 will be free from living wood decay fungi.

Commodity risk assessment of Prunus spinosa plants from United Kingdom.

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 potted plants and bundles of bare-root plants or cell grown young plants or graftwood/budwood of Prunus spinosa imported from the United Kingdom, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. One quarantine pest, Scirtothrips dorsalis, one protected zone quarantine pest Bemisia tabaci (European population) and one non-regulated pest, the scale Eulecanium excrescens, that fulfilled all relevant criteria were selected for further evaluation. The risk mitigation measures proposed in the technical Dossier from the UK were evaluated, taking into account the possible limiting factors. For these pests, 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 E. excrescens being the pest most frequently expected on the imported potted plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9981 and 10,000 plants per 10,000 would be free from the above-mentioned scale.

Pest risk assessment of African Leucinodes species for the European Union.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment for the EU of African Leucinodes species (Lepidoptera: Crambidae), which are fruit and shoot borers, especially of eggplant type fruit. The assessment focused on (i) potential pathways for entry, (ii) distribution of infested imports within EU, (iii) climatic conditions favouring establishment, (iv) spread and (v) impact. Options for risk reduction are discussed, but their effectiveness was not quantified. Leucinodes spp. are widely distributed across sub-Saharan Africa but are little studied and they could be much more widespread in Africa than reported. Much African literature erroneously reports them as Leucinodes orbonalis which is restricted to Asia. The import of eggplant type fruit from sub-Saharan Africa consists of special fruit types and caters mostly to niche markets in the EU. The main pathway for entry is fruit of Solanum aethiopicum and exotic varieties of eggplant (S. melongena). CLIMEX modelling was used with two possible thresholds of ecoclimatic index (EI) to assess establishment potential. Climates favouring establishment occur mostly in southern Europe, where, based on human population, 14% of the imported produce is distributed across NUTS2 regions where EI ≥ 30; or where 23% of the produce is distributed where EI ≥ 15. Over the next 5 years, an annual median estimate of ~ 8600 fruits, originating from Africa, and infested with African Leucinodes spp. are expected to enter EU NUTS2 regions where EI ≥ 15 (90% CR ~ 570-52,700); this drops to ~ 5200 (90% CR ~ 350-32,100) in NUTS2 regions where EI ≥ 30. Escape of adult moths occurs mostly from consumer waste; considering uncertainties in pathway transfer, such as adult emergence, mate finding and survival of progeny, the annual median probability of a mated female establishing a founder population in NUTS regions where EI ≥ 15 was estimated to be 0.0078 (90% CR 0.00023-0.12125). This equates to a median estimate of one founder population ~ every 128 years (90% CR approximately one every 8-4280 years). Using an EI ≥ 30, the median number of founder populations establishing in the EU annually is 0.0048 (90% CR 0.0001-0.0739), equating to a median estimate of one founder population approximately every 210 years (90% CR approximately one every 14-7020 years). Under climate change for the period 2040-2059, the percent of infested produce going to suitable areas would be increased to 33% for EI ≥ 15 and to 21% for EI ≥ 30. Accordingly, the waiting time until the next founder population would be reduced to median estimates of 89 years for EI ≥ 15 (90% CR ~ 6-2980 years) and 139 years for EI ≥ 30 (90% CR 9-4655 years). If a founder population were to establish, it is estimated to spread at a rate of 0.65-7.0 km per year after a lag phase of 5-92 years. Leucinodes spp. are estimated to reduce eggplant yield by a median value of 4.5% (90% CR 0.67%-13%) if growers take no specific action, or 0.54% (90% CR between 0.13% and 1.9%) if they do take targeted action, matching previous estimates made during a risk assessment of L. orbonalis from Asia.

Risk assessment of Retithrips syriacus for the EU.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment for the EU of Retithrips syriacus (Mayet) (Thysanoptera: Thripidae), a polyphagous thrips, regarded as a tropical/subtropical pest occurring in several countries of Africa, South America, Asia and in the EU in Cyprus. The current risk assessment focused on potential pathways for entry, the climatic conditions allowing establishment, the expected spread capacity and the impact considering a time horizon of 10 years (2023-2032). The Panel identified the import of cut roses, persimmons, table grapes, as well as plants for planting of the genera Acalypha and Terminalia from third countries and those of Persea americana (avocado) from Israel as the most relevant entry pathways to consider. Over the next 10 years, an annual median estimate of 95 (90% Certainty Range, CR, ranging from 13 to 1832) potential R. syriacus founder populations per year are expected to successfully transfer to a suitable host in the EU NUTS2 regions where the climatic conditions are predicted as suitable for establishment; this value drops to a median of 4.6 founder populations per year (90% CR: 1 every 1.9 years - 85.6 per year) after considering the actual probability of establishment of a potential founder population. The estimated number of founder population per year is mostly driven by the import of cut roses and plants for planting. If such founder populations were to establish, R. syriacus is estimated to spread at a median rate of 0.05 km/year (90% CR 0.02-2.30 km/year) after a median lag phase of 1.1 years (90% CR 0.3-3.3 years). The overall impact on yield (expressed as % of the total agricultural production) directly attributable to R. syriacus when considering: (i) the main R. syriacus hosts in the EU, (ii) the areas of the EU where establishment is possible, (iii) the current agricultural practices and (iv) the evidence of impact from the countries where the pest is established for a long time, was estimated at 0.065% as the median value of the uncertainty distribution (90% CR 0.001%-0.571%). Options for risk reduction are discussed, but the effectiveness was not quantified.

Trace-back and trace-forward tools developed ad hoc and used during the STEC O104:H4 outbreak 2011 in Germany and generic concepts for future outbreak situations.

The Shiga toxin-producing Escherichia coli O104:H4 outbreak in Germany in 2011 required the development of appropriate tools in real-time for tracing suspicious foods along the supply chain, namely salad ingredients, sprouts, and seeds. Food commodities consumed at locations identified as most probable site of infection (outbreak clusters) were traced back in order to identify connections between different disease clusters via the supply chain of the foods. A newly developed relational database with integrated consistency and plausibility checks was used to collate these data for further analysis. Connections between suppliers, distributors, and producers were visualized in network graphs and geographic projections. Finally, this trace-back and trace-forward analysis led to the identification of sprouts produced by a horticultural farm in Lower Saxony as vehicle for the pathogen, and a specific lot of fenugreek seeds imported from Egypt as the most likely source of contamination. Network graphs have proven to be a powerful tool for summarizing and communicating complex trade relationships to various stake holders. The present article gives a detailed description of the newly developed tracing tools and recommendations for necessary requirements and improvements for future foodborne outbreak investigations.

Update of the risk assessment of mineral oil hydrocarbons in food.

Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species-specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague-Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound-upper bound (LB-UB) means and 95th percentiles of 0.085-0.126 and 0.157-0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB-UB mean and 95th percentile estimations of 0.003-0.031 and 0.011-0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.

Risk assessment of Citripestis sagittiferella for the EU.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a risk assessment of Citripestis sagittiferella (Lepidoptera: Pyralidae), the citrus pulp borer, an oligophagous pest reported from South-East Asia and restricted to Citrus spp. The entry risk assessment focused on the citrus fruit pathway. Two scenarios were considered: scenario A0 (current practice) and A2 (additional post-harvest cold treatment). Based on the outputs of the entry model obtained in scenario A0, the median number of founder populations in the EU citrus-growing area is estimated to be slightly less than 10 per year (90%-uncertainty interval between about one entry per 180 years and 1,300 entries per year). The risk of entry and the simulated numbers of founder populations are orders of magnitude lower for scenario A2 compared to scenario A0. The key uncertainties in the entry model include transfer, the cold treatment effectiveness, the disaggregation factor and sorting. The simulated numbers of established populations are only slightly lower than the numbers of founder populations. As the probability of establishment has little impact on the number of established populations, it is not a major source of uncertainty, despite the lack of data on the thermal biology of the pest. The median lag period between establishment and spread is estimated to be slightly more than 1 year (90%-uncertainty interval between about 2 months and 33 months). After the lag period, the median spread rate by natural means (flying) and due to transport of harvested citrus fruit from orchards to packinghouses is estimated at about 100 km/year (90%-uncertainty interval between about 40 and 500 km/year). The main sources of uncertainties affecting the spread rate include the extent to which environmental factors could hamper the build-up of the populations and the lack of data on the spread rate at the origin. The median impact of C. sagittiferella in the EU citrus-growing area is estimated at about 10% of infested fruits among the harvested citrus fruits (90%-uncertainty interval between about 2% and 25%). Uncertainties affecting the impact assessment include the susceptibility of different Citrus species and cultivars.

Efficacy of a postharvest treatment aiming at eradication of all developmental stages of Tecia solanivora in ware potatoes.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver a scientific opinion on the efficacy of a postharvest treatment aiming to eradicate all developmental stages of Guatemalan potato tuber moth Tecia solanivora (Lepidoptera: Gelechiidae) in ware potatoes. The Panel evaluated the scientific publication describing the elevated CO2 treatment, which was defined as: 10-day exposure to 30% CO2, 20% O2 and 50% N2 in controlled atmosphere at 17°C on the variety Negra Yema de Huevo (Papas Antiguas de Canarias, PDO potatoes, Solanum chaucha). In the scientific publication, the treatment was applied under semi-commercial and commercial conditions on artificially and field-infested tubers. The effect of the pest developmental stage on the treatment efficacy was investigated with artificial infestation of potato tubers with eggs, neonate and second instar larvae. Pupae and adults were placed in separate containers during the treatment. However, the third and fourth larval instars were not investigated. Further limitations were the sample size in the experiments, the mortality rate in the control group and the unknown level of infestation of the naturally infested potato tubers. It was not possible to evaluate the degree of pest freedom due to incomplete data on the conditions of production, i.e. the infestation level in the field. The Panel was able to conclude that although no surviving insects were observed in the performed experiments, the statistical evaluation of the presented results from the commercial trial indicate that it cannot be excluded that insects would survive the treatment. For example, based on the data provided the 95% confidence interval of the survival rate for eggs was: 0%-0.453%.

Risk assessment of N-nitrosamines in food.

EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines (N-NAs) in food. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N-NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. The lower confidence limit of the benchmark dose at 10% (BMDL10) was 10 µg/kg body weight (bw) per day, derived from the incidence of rat liver tumours (benign and malignant) induced by NDEA and used in a margin of exposure (MOE) approach. Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. 'Meat and meat products' is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. The CONTAM Panel concluded that the MOE for TCNAs at the P95 exposure is highly likely (98-100% certain) to be less than 10,000 for all age groups, which raises a health concern.

Assessment of the probability of introduction of Thaumatotibia leucotreta into the European Union with import of cut roses.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative pest risk assessment to assess whether the import of cut roses provides a pathway for the introduction of Thaumatotibia leucotreta (Lepidoptera: Tortricidae) into the EU. The assessment was limited to the entry and establishment steps. A pathway model was used to assess how many T. leucotreta individuals would survive and emerge as adults from commercial or household wastes in an EU NUTS2 region climatically suitable in a specific season. This pathway model for entry consisted of three components: a cut roses distribution model, a T. leucotreta developmental model and a waste model. Four scenarios of timing from initial disposal of the cut roses until waste treatment (3, 7, 14 and 28 days) were considered. The estimated median number of adults escaping per year from imported cut roses in all the climatically suitable NUTS2 regions of the EU varied from 49,867 (90% uncertainty between 5,298 and 234,393) up to 143,689 (90% uncertainty between 21,126 and 401,458) for the 3- and 28-day scenarios. Assuming that, on average, a successful mating will happen for every 435 escaping moths, the estimated median number of T. leucotreta mated females per year from imported cut roses in all the climatically suitable NUTS2 regions of the EU would vary from 115 (90% uncertainty between 12 and 538) up to 330 (90% uncertainty between 49 and 923) for the 3- and 28-day scenarios. Due to the extreme polyphagia of T. leucotreta, host availability will not be a limiting factor for establishment. Climatic suitability assessment, using a physiologically based demographic modelling approach, identified the coastline extending from the northwest of the Iberian Peninsula through the Mediterranean as area suitable for establishment of T. leucotreta. This assessment indicates that cut roses provide a pathway for the introduction of T. leucotreta into the EU.

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 ash logs from the US treated with sulfuryl fluoride to prevent the entry of the emerald ash borer Agrilus planipennis.

The European Commission submitted to the EFSA Panel on Plant Health a dossier by USDA proposing to use sulfuryl fluoride on ash log shipments to treat Agrilus planipennis for phytosanitary certification. After collecting additional evidence from USDA APHIS, external experts and literature, the Panel performed a quantitative assessment on the likelihood of pest freedom from A. planipennis, at the point of entry in the EU, of two different commodities fumigated with sulfuryl fluoride: (a) ash logs with bark; and (b) debarked ash logs. An expert judgement is given on the likelihood of pest freedom taking into consideration the measures acting on the pest, including uncertainties associated with the assessment. The likelihood of pest freedom from A. planipennis is lower for ash logs with bark compared with debarked ash logs. With 95% certainty, the Panel concludes that between 9,740 and 10,000 containers of ash logs with bark per 10,000 and between 9,989 and 10,000 containers of debarked ash logs per 10,000 will be free from A. planipennis, when fumigated with sulfuryl fluoride at the specific treatment regime proposed by the USDA APHIS.