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This Guidance describes a two‐phase approach for a fit‐for‐purpose method for the assessment of plant pest risk in the territory of the EU. Phase one consists of pest categorisation to determine whether the pest has the characteristics of a quarantine pest or those of a regulated non‐quarantine pest for the area of the EU. Phase two consists of pest risk assessment, which may be requested by the risk managers following the pest categorisation results. This Guidance provides a template for pest categorisation and describes in detail the use of modelling and expert knowledge elicitation to conduct a pest risk assessment. The Guidance provides support and a framework for assessors to provide quantitative estimates, together with associated uncertainties, regarding the entry, establishment, spread and impact of plant pests in the EU. The Guidance allows the effectiveness of risk reducing options (RROs) to be quantitatively assessed as an integral part of the assessment framework. A list of RROs is provided. A two‐tiered approach is proposed for the use of expert knowledge elicitation and modelling. Depending on data and resources available and the needs of risk managers, pest entry, establishment, spread and impact steps may be assessed directly, using weight of evidence and quantitative expert judgement (first tier), or they may be elaborated in substeps using quantitative models (second tier). An example of an application of the first tier approach is provided. Guidance is provided on how to derive models of appropriate complexity to conduct a second tier assessment. Each assessment is operationalised using Monte Carlo simulations that can compare scenarios for relevant factors, e.g. with or without RROs. This document provides guidance on how to compare scenarios to draw conclusions on the magnitude of pest risks and the effectiveness of RROs and on how to communicate assessment results. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1440/full ‘This guidance supersedes: a) the entire Guidance on a harmonised framework for pest risk assessment and the identification and evaluation of pest risk management options by EFSA. https://doi.org/10.2903/j.efsa.2010.1495; b) Sections 1.8 and 1.9 of Guidance on methodology for evaluation of the effectiveness of options for reducing the risk of introduction and spread of organisms harmful to plant health in the EU territory. https://doi.org/10.2903/j.efsa.2012.2755’

EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigating risk reduction options on sweetcorn, a principal host, reduces entry on that pathway 100‐fold. However, sweetcorn imports are a small proportion of all S. frugiperda host imports, several of which are already regulated and further regulation is estimated to reduce the median number entering over all pathways by approximately 10%. Low temperatures limit the area for establishment but small areas of Spain, Italy and Greece can provide climatic conditions suitable for establishment. If infested imported commodities are distributed across the EU in proportion to consumer population, a few hundreds to a few thousands of individuals would reach NUTS 2 regions within which suitable conditions for establishment exist. Although S. frugiperda is a known migrant, entry directly into the EU from extant populations in sub‐Saharan Africa is judged not feasible. However, if S. frugiperda were to establish in North Africa, in the range of thousands to over two million adults could seasonally migrate into the southern EU. Entry into suitable NUTS2 areas via migration will be greater than via commercial trade but is contingent on the establishment of S. frugiperda in North Africa. The likelihood of entry of the pest via natural dispersal could only be mitigated via control of the pest in Africa. If S. frugiperda were to arrive and become a pest of maize in the EU, Integrated Pest Management (IPM) or broad spectrum insecticides currently used against existing pests could be applied.

EFSA was asked to update the 2015 EFSA risk assessment on Xylella fastidiosa for the territory of the EU. In particular, EFSA was asked to focus on potential establishment, short‐ and long‐range spread, the length of the asymptomatic period, the impact of X. fastidiosa and an update on risk reduction options. EFSA was asked to take into account the different subspecies and Sequence Types of X. fastidiosa. This was attempted throughout the scientific opinion but several issues with data availability meant that this could only be partially achieved. Models for risk of establishment showed most of the EU territory may be potentially suitable for X. fastidiosa although southern EU is most at risk. Differences in estimated areas of potential establishment were evident among X. fastidiosa subspecies, particularly X. fastidiosa subsp. multiplex which demonstrated areas of potential establishment further north in the EU. The model of establishment could be used to develop targeted surveys by Member States. The asymptomatic period of X. fastidiosa varied significantly for different host and pathogen subspecies combinations, for example from a median of approximately 1 month in ornamental plants and up to 10 months in olive, for pauca. This variable and long asymptomatic period is a considerable limitation to successful detection and control, particularly where surveillance is based on visual inspection. Modelling suggested that local eradication (e.g. within orchards) is possible, providing sampling intensity is sufficient for early detection and effective control measures are implemented swiftly (e.g. within 30 days). Modelling of long‐range spread (e.g. regional scale) demonstrated the important role of long‐range dispersal and the need to better understand this. Reducing buffer zone width in both containment and eradication scenarios increased the area infected. Intensive surveillance for early detection, and consequent plant removal, of new outbreaks is crucial for both successful eradication and containment at the regional scale, in addition to effective vector control. The assessment of impacts indicated that almond and Citrus spp. were at lower impact on yield compared to olive. Although the lowest impact was estimated for grapevine, and the highest for olive, this was based on several assumptions including that the assessment considered only Philaenus spumarius as a vector. If other xylem‐feeding insects act as vectors the impact could be different. Since the Scientific Opinion published in 2015, there are still no risk reduction options that can remove the bacterium from the plant in open field conditions. Short‐ and long‐range spread modelling showed that an early detection and rapid application of phytosanitary measures, consisting among others of plant removal and vector control, are essential to prevent further spread of the pathogen to new areas. Further data collection will allow a reduction in uncertainty and facilitate more tailored and effective control given the intraspecific diversity of X. fastidiosa and wide host range.

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The EFSA Panel on Plant Health (PLHP) performed a pest categorisation of Spodoptera litura (Lepidoptera: Noctuidae) for the EU. S. litura is widely distributed across South and East Asia and Oceania. It is established in tropical and subtropical regions where there are no, or few, frost days each year. It can extend its range into cooler temperate regions during summer months. S. litura is highly polyphagous feeding on hosts within at least 40 botanical families, including economically important crops within Brassicaceae, Cucurbitaceae, Fabaceae, Malvaceae, Poaceae and Solanaceae. Larvae are primarily leaf feeders and can cause complete defoliation. At high population densities almost all plant parts are eaten. S. litura is a serious pest in the Asia‐Pacific region where it causes losses to many economically important cultivated field crops and crops such as eggplants, sweet peppers and tomatoes in protected cultivation. As a species that appears limited by winter temperatures, only a small area of the EU provides climatic conditions where establishment outdoors may be possible although cultivated and wild hosts are distributed across the EU. S. litura has been intercepted in the EU many times on ornamentals and leafy vegetables. Outbreaks have occurred in EU glasshouses and have been eradicated. Phytosanitary measures are available to inhibit entry. S. litura satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. S. litura does not meet the criteria of occurring in the EU, and plants for planting being the principal means of spread for it to be regarded as a potential Union regulated non‐quarantine pest.

Article 42 of the European Regulation (EU) 2016/2031, on the protective measures against pests of plants, introduces the concept of ‘high risk plants, plant products and other objects’ that are identified on the basis of a preliminary assessment to be followed by a commodity risk assessment. Following a request of the European Commission, this Guidance was developed to establish the methodology to be followed when performing a commodity risk assessment for high risk commodities (high risk plants, plant products and other objects). The commodity risk assessment performed by EFSA will be based on the information provided by the National Plant Protection Organisations of non‐EU countries requesting a lifting of import prohibition of a high risk commodity. Following international standards on pest risk analysis, this Guidance describes a two‐step approach for the assessment of pest risk associated with a specified commodity. In the first step, pests, associated with the commodity, that require risk mitigation measures are identified. In the second step, the overall efficacy of proposed risk reduction options for each pest is evaluated. A conclusion on the pest‐freedom status of the commodity is achieved. The method requires key uncertainties to be identified.

Plant diseases threaten both food security and the botanical diversity of natural ecosystems. Substantial research effort is focused on pathogen detection and control, with detailed risk management available for many plant diseases. Risk can be assessed using analytical techniques that account for disease pressure both spatially and temporally. We suggest that such technical assessments of disease risk may not provide an adequate guide to the strategies undertaken by growers and government to manage plant disease. Instead, risk-management strategies need to account more fully for intuitive and normative responses that act to balance conflicting interests between stakeholder organizations concerned with plant diseases within the managed and natural environments. Modes of effective engagement between policy makers and stakeholders are explored in the paper, together with an assessment of such engagement in two case studies of contemporary non-indigenous diseases in one food and in one non-food sector. Finally, a model is proposed for greater integration of stakeholders in policy decisions.

The EFSA Panel on Plant Health performed a group pest categorisation for the EU territory of non‐EU Scolytinae (Coleoptera: Curculionidae) on non‐coniferous hosts, which total 6495 known species. Most species attack apparently healthy, weakened or dead trees, either feeding on the phloem (‘bark beetles’ subgroup) or on fungi inoculated into the sapwood (‘ambrosia beetles’ subgroup). Smaller subgroups feed and reproduce in seeds and fruits, or in herbaceous plants. Some species are polygynous, the males initiate a gallery or a chamber on or in a new host and attract females. Others are monogamous, and the females initiate the new galleries. Many species respond to primary volatile attractants emitted by the hosts, and some produce aggregation pheromones that attract conspecifics of both sexes. The species attacking living hosts are often associated with fungi that contribute to weakening the host defences and provide nutrients to the insects. Some are inbreeding; the males in the offspring mate with their sisters and rarely leave their natal tree. The larvae of all species develop and pupate within their hosts. Based on catalogues and other published data, a database was constructed providing information on hosts, feeding and reproductive habits, geographic distribution and the Köppen–Geiger climate types in countries where species occur. The Scolytinae were screened to exclude species in the following categories: (i) 708 species attacking conifers; (ii) 127 species present in at least four EU Member States and (iii) 440 species occurring in areas with climatic conditions not occurring in the EU. Among the remaining 5220 species, 88 species known for their mobility, occupying at least two landmasses separated by geographical barriers and some of which had impact levels documented in literature, were extracted. They were grouped into four subcategories: (i) 12 species with high impact on plant health; (ii) 16 species with low or doubtful impact; (iii) 48 species with no impact; (iv) 12 species with no impact and which had never been recorded as ‘introduced’ in the consulted catalogues but occurring on at least two landmasses. All 88 species could enter the EU with wood or wood products, or with plants for planting, and could establish because host plants are available, and climate is suitable in parts of the EU. Control measures to inhibit introduction are available. There is considerable uncertainty regarding the potential impact of many species. Methods for the reliable identification of many species are lacking. For some species of non‐EU Scolytinae on non‐coniferous hosts, all criteria assessed by EFSA for consideration as potential quarantine pest are met. Nevertheless, the Panel was not able to develop a method to discriminate confidently between species that clearly meet the criteria for potential quarantine pest status and those that do not.

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.

This opinion updates the information included in the previous EFSA Scientific Opinion concerning the in planta control measures for Xylella fastidiosa, with a systematic review and critical analysis of the potential treatment solutions that have been published against this pest so far. The output of this opinion focuses on the application of chemical or biological treatments on living plants. In vitro studies, hot water treatments, use of resistant varieties and vector control are excluded from the review. The use of antibiotics is not considered due to the risk of antimicrobial resistance development. The use of weakly virulent or avirulent strains of X. fastidiosa is covered in this review, although this organism is an EU quarantine plant pest and its introduction in the EU territory is banned. Experiments were recently conducted to assess the effect of application of zinc, copper, and citric acid biocomplex, of N-acetylcysteine, and of 'diffusible signal factor' (and of its homologs). Their results showed that these control measures were sometimes able to reduce symptoms caused by X. fastidiosa. Recent experiments also showed that several species of endophytic microorganisms, some bacteriophages and inoculation of weakly virulent/avirulent strains of X. fastidiosa could offer some protection against the Pierce's disease. However, based on the reviewed results, the Panel concludes that, although several published experiments show some effects in reducing symptoms development, the tested control measures are not able to completely eliminate X. fastidiosa from diseased plants. The Panel confirms as previously stated that there is currently no control measure available to eliminate the bacteria from a diseased plant in open field conditions. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.