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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’

Transthyretin cardiac amyloidosis (ATTR-CA) leads to myocardial infiltration, affecting prognosis and survival. Diagnosing early-stage ATTR-CA remains challenging due to its subtle manifestations. This study investigates subclinical myocardial alterations in asymptomatic ATTR mutation carriers (ATTR-MC) using advanced cardiac magnetic resonance (CMR) techniques, including T1 mapping and myocardial strain analysis. A retrospective cohort of 60 subjects was analyzed, comprising 20 ATTR-CA patients, 20 asymptomatic ATTR-MC, and 20 controls. Standard CMR parameters were compared alongside myocardial strain analysis. Results indicated that despite preserved ejection fraction and myocardial morphology, ATTR-MC exhibited significantly impaired left ventricular global longitudinal strain (LV GLS), left atrial reservoir, conduit, and booster pump strain (LA RS, CS, and BPS) compared to controls. However, native T1 and extracellular volume (ECV) values remained within normal ranges, distinguishing early dysfunction from overt amyloid deposition seen in ATTR-CA. These findings suggest that myocardial strain analysis could serve as an early biomarker for subclinical ATTR-CA, offering a potential target for selecting patients who may benefit from early intervention. Implementing CMR-derived strain parameters in clinical practice may improve risk stratification and timely therapeutic decisions in ATTR-MC.

This scientific report provides an update of the Xylella spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with Xylella spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of Xylella spp. The current mandate covers the period 2021–2026. This report is related to the twelfth version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 July 2024 up to 31 December 2024 and recent Europhyt outbreak notifications. Informative data have been extracted from 41 selected publications. Fourteen new host plants were identified and added to the database. These plant species were naturally infected by X. fastidiosa, X. fastidiosa subsp. multiplex or X. fastidiosa subsp. fastidiosa in the United States, Italy, Portugal and Spain. No additional data were retrieved for X. taiwanensis and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to X. fastidiosa infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method (between sequencing and pure culture isolation (category A)), reaches now 463 plant species, 210 genera and 71 families. Such numbers rise to 727 plant species, 319 genera and 91 families if considered regardless of the detection methods applied (category E).

This scientific report provides an update of the Xylella spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with Xylella spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of Xylella spp. The current mandate covers the period 2021–2026. This report is related to the 11th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 January 2024 up to 30 June 2024, and recent Europhyt outbreak notifications. Informative data have been extracted from 27 selected publications. One new host plant (Quercus orocantabrica) was identified and added to the database. It was naturally infected by X. fastidiosa subsp. fastidiosa in Portugal. No additional data were retrieved for X. taiwanensis, and no additional multilocus sequence tipes (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to X. fastidiosa infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method (between sequencing and pure culture isolation (category A), reaches now 452 plant species, 204 genera and 70 families. Such numbers rise to 713 plant species, 312 genera and 89 families if considered regardless of the detection methods applied (category E).

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.

This scientific report provides an update of the Xylella spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with Xylella spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of Xylella spp. The current mandate covers the period 2021–2026. This report is related to the 13th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 January 2025 up to 30 June 2025, and recent Europhyt outbreak notifications. Informative data have been extracted from 45 selected publications. One new host plant (Carya carolinae‐septentrionalis) was identified and added to the database. It was naturally infected by X. fastidiosa subsp. multiplex in the United States. No additional data were retrieved for X. taiwanensis, and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to X. fastidiosa infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method (between sequencing and pure culture isolation (category A)), reaches now 464 plant species, 210 genera and 71 families. Such numbers rise to 728 plant species, 319 genera and 91 families if considered regardless of the detection methods applied (category E).

EFSA Strategy 2027 outlines the need for fit‐for‐purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ‘Draft framework for protocol development for EFSA's scientific assessments’ published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub‐questions is proposed: the ‘APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross‐cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub‐questions, including uncertainty analysis. Five possible approaches to answering individual (sub‐)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi‐formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and – not covered in this guidance – generating empirical evidence ex novo. The guidance is complemented by a standalone ‘template’ for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7349/full

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.

In agreement with Article 6(2) of the Regulation (EU) 2016/2031 on protective measures against pests of plants, the European Commission has been tasked by the Council and European Parliament to establish a list of Union quarantine pests which qualify as priority pests. The prioritisation is based on the severity of the economic, social and environmental impact that these pests can cause in the Union territory. The Commission's Joint Research Centre (JRC) is in charge of developing a methodology based on a multi‐criteria decision analysis and composite indicators. In this context, EFSA has provided technical and scientific data related to these pests, in particular: (i) the potential host range and distribution of each of these pests in the Union territory at the level of NUTS2 regions; (ii) parameters quantifying the potential consequences of these pests, e.g. crop losses in terms of yield and quality, rate of spread and time to detection. Expert knowledge elicitation methodology has been applied by EFSA in order to provide those parameters in a consistent and transparent manner.

EFSA was requested by the European Commission to produce a report on the susceptibility of olive varieties to the Apulian strain of Xylella fastidiosa (subsp. pauca strain CoDiRO, ST53). A systematic literature search identified 21 references providing results of primary research studies on olive plants infected (naturally or artificially) by ST53. From experimental infectivity studies and from surveys in olive orchards, converging lines of evidence indicate tolerance of the Leccino variety to ST53 infections, although no long‐term observations on yield are available yet. While the variety Leccino can become infected with the pathogen, it develops milder symptoms compared to those observed on susceptible varieties (e.g. Cellina di Nardò, Ogliarola salentina). Also, the size of the X. fastidiosa bacterial populations measured in Leccino‐infected plants is lower compared to susceptible olive varieties. Preliminary results show that tolerance or resistance traits can also be found in other olive varieties. New research is now in place in the EU to study the level of susceptibility of many olive varieties to ST53 infections, therefore more relevant results will become available in the coming years.