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Update of general guidelines for statistically sound and risk-based surveys of plant pests 更新统计上合理和基于风险的植物有害生物调查的一般准则
Pub Date : 2025-12-03 DOI: 10.2903/sp.efsa.2025.EN-9788
European Food Safety Authority (EFSA), Elena Lázaro, Stephen Parnell, Antonio Vicent Civera, Martijn Schenk, Jose Cortiñas Abrahantes, Juan Navas-Cortes, Hans-Hermann Thulke, Francesco Pecori, Joshua Koh, Jan Schans, Marc Aerts, Gabriele Zancanaro, Sybren Vos, Tomasz Kaluski

At the request of the European Commission, EFSA prepared the general guidelines for surveys of plant pests, describing the legal, international and scientific context in which the surveys are designed, the basic principles implemented for surveillance of quarantine pests and introducing the concepts needed for the design of statistically sound and risk-based surveys. Three types of specific surveys are addressed: detection surveys for substantiation of pest freedom, delimiting surveys to determine the boundaries of a potential infested zone, and monitoring surveys for prevalence estimation when measuring the effectiveness of eradication measures or for the confirmation of a low pest prevalence area. For each type of survey, the survey parameters are introduced and their interactions analysed showing the importance of the assumptions that are taken for each one of them: (i) the aims of the survey are defined as achieving a certain level of confidence of detecting a given pest prevalence (design prevalence), this reflects the trade-off between the acceptable level of the risk and availability of resources that determine the strength of the evidence to support the conclusion of the survey; (ii) the target population is described by its structure and size, including the risk factors; and (iii) the method sensitivity is defined as the combination of the sampling effectiveness and the diagnostic sensitivity for each inspection unit. EFSA's RiPEST and RiBESS+ tools1 are introduced for calculating the sample size using the survey parameters as input values for a statistically sound and risk-based survey design. The mathematical principles behind the tools are in line with the International Standards for Phytosanitary Measures. The survey design is flexible and can be tailored to each pest and specific situation in the Member States. Once the survey is implemented following this approach, the conclusions allow surveys to be compared across time and space, contributing to the harmonisation of surveillance activities across the EU Member States.

应欧洲联盟委员会的要求,欧洲食品安全局编写了植物有害生物调查的一般准则,描述了设计调查的法律、国际和科学背景,为监测检疫有害生物而实施的基本原则,并介绍了设计统计上合理和基于风险的调查所需的概念。研究了三种类型的具体调查:为证实无虫害而进行的检测调查,为确定潜在受虫害地区的边界而进行的划定调查,以及在衡量根除措施的有效性或为确认虫害低流行地区而进行的估计流行率的监测调查。对于每种类型的调查,都引入了调查参数,并分析了它们之间的相互作用,显示了对每种调查所采取的假设的重要性:(i)调查的目标被定义为在检测特定有害生物流行程度(设计流行程度)方面达到一定的置信度,这反映了可接受的风险水平与决定支持调查结论的证据强度的资源可用性之间的权衡;(ii)按其结构和规模描述目标人群,包括风险因素;(iii)方法灵敏度定义为每个检查单元的抽样有效性和诊断灵敏度的组合。介绍了EFSA的RiPEST和RiBESS+工具1,用于使用调查参数作为统计可靠和基于风险的调查设计的输入值来计算样本量。这些工具背后的数学原理符合《国际植物检疫措施标准》。调查设计是灵活的,可以根据会员国的每种有害生物和具体情况进行调整。一旦按照这种方法实施调查,得出的结论就可以跨时间和空间对调查进行比较,有助于协调欧盟成员国的监测活动。
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引用次数: 0
Guidelines for designing and optimising multi-pest surveys in citrus 柑橘多病虫害调查设计与优化导则
Pub Date : 2025-12-02 DOI: 10.2903/sp.efsa.2025.EN-9790
Pilar Vanaclocha, Elena Lázaro, Antonio Vicent, César Monzó

These guidelines for citrus crops surveys were prepared by EFSA at the request of the European Commission. Its aim is to guide the EU Member States in preparing crop-based surveys in citrus, while describing the context in which these surveys are designed. This contributes to the harmonization of surveillance activities across Member States. Target pests are quarantine pests for which citrus (Citrus spp. and related genera) are main hosts. These pests can be introduced into a crop from the environment or through the planting of infested/infected citrus trees. Surveys are needed to substantiate pest freedom in an area and/or in the citrus production chain. Pest-based surveys must be conducted in a scientifically and statistically sound manner. The guidelines describe how to define inspection units and which field detection, and laboratory methods can be used. After establishing the method sensitivity and defining a confidence level and design prevalence, RiPEST or RiBESS+ can be used to calculate the sample size for the target population. Surveys targeting multiple pests can be combined into a single crop-based survey, improving resource efficiency. This optimisation can be performed using the OptiPest tool, which requires data on sample size per pest and a time window for survey activities. The tool also allows the use of monthly capacity constraints. A case study on citrus crop surveys illustrates the optimisation procedure. Optimisation can be achieved by using the same field visit to carry out multiple survey activities, by conducting the same survey activity to investigate the presence of multiple pests, and/or by using the same laboratory sample to detect multiple pests. These guidelines address how the resulting survey program can be implemented by selecting survey sites and establishing field and laboratory procedures for detection an identification of the target pests.

这些柑橘作物调查指南是由欧洲食品安全局应欧洲委员会的要求编写的。其目的是指导欧盟成员国编制基于柑橘作物的调查,同时描述设计这些调查的背景。这有助于协调各会员国的监测活动。目标害虫是以柑橘(citrus spp.及相关属)为主要寄主的检疫性害虫。这些害虫可以从环境或通过种植受感染的柑橘树引入作物。需要进行调查,以证实在一个地区和/或柑橘生产链中无虫害。基于虫害的调查必须以科学和统计上合理的方式进行。该指南描述了如何定义检查单元以及可以使用哪些现场检测和实验室方法。在建立了方法灵敏度并定义了置信水平和设计流行度之后,可以使用RiPEST或RiBESS+来计算目标人群的样本量。针对多种有害生物的调查可以合并为单一的基于作物的调查,从而提高资源效率。这种优化可以使用OptiPest工具进行,该工具需要每种害虫的样本量数据和调查活动的时间窗口。该工具还允许使用每月容量限制。柑橘作物调查的一个案例研究说明了优化过程。通过使用相同的实地考察来开展多项调查活动,通过进行相同的调查活动来调查多种有害生物的存在,和/或通过使用相同的实验室样本来检测多种有害生物,可以实现优化。这些指导方针涉及如何通过选择调查地点和建立现场和实验室程序来实施调查计划,以检测和识别目标害虫。
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引用次数: 0
Pest survey card on Longidorus diadecturus 长臂猿有害生物调查卡
Pub Date : 2025-12-02 DOI: 10.2903/sp.efsa.2025.EN-9816
European Food Safety Authority (EFSA), Helena Romero, Eduardo de la Pena, Juan Antonio Diaz-Pendon, Cesar Petri, Fauve Maertens, Annemie Hoedekie, Jane Debode, Gregor Urek, Melanie Camilleri

This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M-2020-0114) at the request of the European Commission. The full pest survey card for Longidorus diadecturus is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/longidorus-diadecturus

本文件提供了应欧盟委员会要求在欧洲食品安全局植物有害生物监测任务(M-2020-0114)背景下编制的有害生物调查卡的结论。在欧洲食品安全局有害生物调查卡库的以下链接中,已经发布了完整的横角龙有害生物调查卡,并将在有新信息时进行更新:https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/longidorus-diadecturus
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引用次数: 0
Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for pethoxamid in light of confirmatory information on the endocrine disruption assessment 根据内分泌干扰评估的确认信息,与成员国、申请人和欧洲食品安全局就聚氰胺的农药风险评估进行磋商的结果
Pub Date : 2025-12-01 DOI: 10.2903/sp.efsa.2025.EN-9476
European Food Safety Authority (EFSA)

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory information requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory information and their use in the risk assessment for the active substance pethoxamid are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Austria and presents EFSA's scientific views and conclusions on the individual comments received.

欧盟委员会要求欧洲食品安全局(EFSA)根据指令91/414/EEC第6(1)条和法规(EC) No 1107/2009第6(f)条批准后要求的确认信息,就活性物质的风险评估提供科学援助。在此背景下,欧洲食品安全局对在与成员国、申请人和欧洲食品安全局就确认信息及其在活性物质聚乙氧胺风险评估中的使用进行的评论阶段提出的具体问题提出了科学观点。本报告总结了报告成员国奥地利组织的磋商过程的结果,并介绍了EFSA对收到的个人意见的科学观点和结论。
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引用次数: 0
Plant Health Newsletter on HORIZON SCANNING November 2025 地平线扫描植物健康通讯2025年11月
Pub Date : 2025-11-28 DOI: 10.2903/sp.efsa.2025.EN-9813
European Food Safety Authority (EFSA)
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引用次数: 0
Pest survey card on Ralstonia syzygii subsp. celebesensis 沙棘小蠊害虫调查卡。celebesensis
Pub Date : 2025-11-28 DOI: 10.2903/sp.efsa.2025.EN-9760
European Food Safety Authority (EFSA), Georgia D. Papadogiorgou, Eleftheria-Maria D. Bali, Niki K. Dionysopoulou, Georgios A. Kyritsis, Kostas D. Zarpas, Nikos T. Papadopoulos, Claude Bragard, Laura Carotti

This document provides the conclusions of the pest survey card that was prepared in the context of the EFSA mandate on plant pest surveillance (M-2020-0114) at the request of the European Commission. The full pest survey card for Ralstonia syzygii subsp. celebesensis is published and available online in the EFSA Pest Survey Card gallery at the following link and will be updated whenever new information becomes available: https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/ralstonia-syzygii-celebesensis

本文件提供了应欧盟委员会要求在欧洲食品安全局植物有害生物监测任务(M-2020-0114)背景下编制的有害生物调查卡的结论。沙氏拉斯顿菌亚种的完整虫害调查卡。celebesensis已发布,并可在欧洲食品安全局有害生物调查卡库中在线获取,链接如下,并将在有新信息时更新:https://efsa.europa.eu/plants/planthealth/monitoring/surveillance/ralstonia-syzygii-celebesensis
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引用次数: 0
Protocol of the systematic literature review on the vector status of potential vector species of selected vector-borne pathogens 对选定病媒传播病原体潜在病媒物种的病媒现状进行系统文献综述的方案
Pub Date : 2025-11-25 DOI: 10.2903/sp.efsa.2025.EN-9798
Francesca Dagostin, Marieta Braks, Cedric Marsboom, Valentina Tagliapietra, Andrei Daniel Mihalca, Annapaola Rizzoli, Wim Van Bortel

Vector-borne diseases (VBDs) pose significant risks to animal and human health, emphasizing the need for ongoing surveillance and mapping to support risk assessments. EFSA-Animal disease profiles were created to visualize the current understanding of main characteristic of important pathogens affecting animal health, including information on the potential vector status of several VBDs. This report updates a previous protocol for a review of the vector status of 36 selected pathogens (Massoels et al., 2023); and adds the protocol for review of the vector status of tick-borne encephalitis virus (TBEV) and Borrelia burgdorferi s.l. complex. Two systematic literature reviews are conducted, focusing on detection of pathogens in field-collected arthropods and vector competence under laboratory conditions. In addition, the protocol also addresses mechanical transmission of pathogens by arthropods, an often-underestimated route of disease spread. A narrative review will investigate arthropod species that may serve as mechanical vectors of six pathogens: Coxiella burnetii (Q fever), equine infectious anaemia virus (EIAV), lumpy skin disease virus (LSDV), Trypanosoma evansi (surra), Trypanosoma vivax, and Besnoitia besnoiti (bovine besnoitiosis). Evidence will be collated from experimental transmission studies, field detection, and epidemiological investigations, and classified by type and strength. The integrated results will assess the vector status of arthropod species on a global scale, providing an updated overview of species suspected or confirmed to play a role in disease transmission. A pathogen-vector matrix will be created to support future risk assessments, surveillance strategies, and control measures for vector-borne and mechanically transmitted infections in the EU and neighbouring regions. This work aims to enhance the understanding of vector-borne diseases and inform evidence-based decision-making to mitigate the risks associated with these pathogens. By combining biological and mechanical transmission data, this initiative will provide a comprehensive framework for managing vector-borne diseases and protecting animal and human health.

病媒传播疾病对动物和人类健康构成重大风险,强调需要进行持续监测和绘制地图,以支持风险评估。建立了欧洲食品安全局-动物疾病概况,以直观地了解目前对影响动物健康的重要病原体的主要特征,包括几种生物疫病潜在媒介状态的信息。本报告更新了先前审查36种选定病原体媒介状况的方案(Massoels等人,2023年);并增加了审查蜱传脑炎病毒(TBEV)和伯氏疏螺旋体(Borrelia burgdorferi s.l.复合体)媒介状况的方案。进行了两项系统的文献综述,重点是野外采集节肢动物的病原体检测和实验室条件下的媒介能力。此外,该议定书还涉及节肢动物病原体的机械传播,这是一种经常被低估的疾病传播途径。一篇叙述性综述将调查可能作为六种病原体机械载体的节肢动物物种:伯纳蒂克氏杆菌(Q热)、马传染性贫血病毒(EIAV)、结节性皮肤病病毒(LSDV)、伊文氏锥虫(surra)、间日锥虫和牛血吸虫病(牛血吸虫病)。将整理来自实验传播研究、现场检测和流行病学调查的证据,并按类型和强度分类。综合结果将在全球范围内评估节肢动物物种的病媒状况,提供怀疑或确认在疾病传播中起作用的物种的最新概况。将建立一个病原体-媒介矩阵,以支持未来在欧盟和邻近地区对媒介传播和机械传播感染进行风险评估、监测战略和控制措施。这项工作旨在加强对病媒传播疾病的了解,并为基于证据的决策提供信息,以减轻与这些病原体相关的风险。通过结合生物和机械传播数据,这一举措将为管理病媒传播疾病和保护动物和人类健康提供一个全面的框架。
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引用次数: 0
Protocol of the systematic literature review for the distribution of priority vector species within the VectorNet geographical area VectorNet地理区域内优先病媒物种分布的系统文献综述方案
Pub Date : 2025-11-25 DOI: 10.2903/sp.efsa.2025.EN-9799
Francesca Dagostin, Bulent Alten, Thomas Balenghien, Alessandra Della Torre, Vit Dvorak, Maria Goffredo, Kayleigh Hansford, Francis Schaffner, Annapaola Rizzoli, Valentina Tagliapietra, Marieta Braks, Cedric Marsboom, Wim Van Bortel

Within the context of VectorNet, the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) publish regularly updated vector distribution maps, which are informed by a comprehensive review of the literature, data from the VectorNet Entomological Network, and relevant reports. This protocol focuses on the systematic collection of data derived from peer-reviewed publications. The primary objective of this living systematic literature review (SLR) is to gather information regarding the presence, abundance, and seasonal patterns of targeted vector species, including mosquitoes, sand flies, biting midges, and ticks, within the geographical scope defined by VectorNet. Studies will be identified through searches in Web of Science™ and Medline/PubMed. Eligible studies will be screened and analysed for methodological rigor and relevance. The review will provide rigorous data that will be integrated in the VectorNet distribution maps.

在VectorNet的范围内,欧洲疾病预防和控制中心(ECDC)和欧洲食品安全局(EFSA)根据对文献的全面审查、来自VectorNet昆虫学网络的数据和相关报告,定期发布更新的病媒分布图。该方案侧重于系统收集来自同行评审出版物的数据。本活体系统文献综述(SLR)的主要目的是在VectorNet定义的地理范围内收集有关目标病媒物种(包括蚊子、沙蝇、蠓和蜱)的存在、丰度和季节模式的信息。研究将通过Web of Science™和Medline/PubMed进行搜索。合格的研究将被筛选和分析方法的严谨性和相关性。审查将提供严谨的数据,这些数据将被整合到VectorNet分布图中。
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引用次数: 0
Guidance for reporting the 2026 national control plans for veterinary medicinal product residues 2026年国家兽药残留控制计划报告指南
Pub Date : 2025-11-24 DOI: 10.2903/sp.efsa.2025.EN-9777
European Food Safety Authority (EFSA), Stefania Salvatore, Marta Vericat Ferrer, Valentina Bocca

This document should be used for the reporting of samples planned under the national control plans for residues of veterinary medicinal products to EFSA. It provides guidance on how to use the data model for submission to the EU of such data and related information.

本文件应用于向欧洲食品安全局报告根据国家兽药残留控制计划计划的样品。它就如何使用数据模型向欧盟提交此类数据和相关信息提供了指导。
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引用次数: 0
Update of the dietary exposure to sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228) with alternative maximum levels when used as food additives 二氧化硫(e220)、亚硫酸钠(e221)、亚硫酸氢钠(e222)、焦亚硫酸钠(e223)、焦亚硫酸钾(e224)、亚硫酸钙(e226)、亚硫酸氢钙(e227)和亚硫酸氢钾(e228)膳食暴露量的最新情况,以及作为食品添加剂时可选择的最高水平
Pub Date : 2025-11-19 DOI: 10.2903/sp.efsa.2025.EN-9754
European Food Safety Authority (EFSA), Zsuzsanna Horváth, Bruno Dujardin

In 2022, the EFSA Panel on Food Additives and Flavourings (FAF Panel) re-evaluated sulfur dioxide-sulfites (E 220-228). Due to the lack of biological and toxicological data, it was concluded that the existing toxicity database was insufficient to establish an Acceptable Daily Intake (ADI), leading to the withdrawal of the temporary group ADI. The Panel determined that the Margin of Exposure (MOE) for dietary exposure to these additives should be at least 80. The refined exposure scenario (Dataset D) showed MOEs below 80 for all groups, raising safety concerns. The European Commission therefore provided two sets of alternative maximum permitted levels (MPLs) and requested EFSA to update the exposure assessment for sulfur dioxide-sulfites (E 220-228), investigating the impact of possible changes in the authorizations and MPLs. The assessment was implemented for six scenarios: two regulatory maximum level scenarios (DS-MPL1 and DS-MPL2) and four refined non-brand loyal scenarios applying different assumptions to the reported use levels, and analytical data below MPLs (DSA1, DSA2, MDSD1, MDSD2). The highest exposure was found in toddlers in scenario DS-MPL1, with mean and P95 exposure estimates of 2.63 and 8.09 mg SO2 equivalents/kg bw per day. For refined scenarios of DSA1 and DSA2 (using use levels or analytical data in authorized food categories only), the highest mean and P95 estimates were 0.43 and 1.40 mg SO2 equivalents/kg bw per day in toddlers. The elderly showed the highest exposure in MDSD1 and MDSD2 (based on primarily analytical data, including carry-over and natural occurrence), with estimates up to P95 of 0.61 mg SO2 equivalents/kg bw per day. The main contributors were wine, beer, and meat preparations for adults and the elderly, fruit and vegetable juices and flavoured drinks for adolescents and children, and dried fruits and vegetables for infants and toddlers.

2022年,欧洲食品安全局食品添加剂和调味剂小组(FAF小组)重新评估了二氧化硫-亚硫酸盐(e220 -228)。由于缺乏生物学和毒理学数据,得出的结论是,现有的毒性数据库不足以建立可接受的每日摄入量(ADI),导致临时ADI组退出。专家组确定,这些添加剂的膳食暴露限度(MOE)应至少为80。经过改进的暴露情景(数据集D)显示,所有组的moe均低于80,这引起了人们对安全的担忧。因此,欧盟委员会提供了两套可选的最大允许水平(MPLs),并要求欧洲食品安全局更新二氧化硫-亚硫酸盐(e220 -228)的暴露评估,调查授权和MPLs可能变化的影响。评估针对六个场景进行:两个监管最高水平场景(DS-MPL1和DS-MPL2)和四个改进的非品牌忠诚度场景,对报告的使用水平采用不同的假设,以及低于MPLs的分析数据(DSA1, DSA2, MDSD1, MDSD2)。在情景DS-MPL1中,幼儿暴露量最高,平均暴露量和P95暴露量估计分别为每天2.63和8.09毫克二氧化硫当量/公斤体重。对于DSA1和DSA2的精细情景(仅使用授权食品类别的使用水平或分析数据),幼儿每天的最高平均和P95估计数分别为0.43和1.40 mg SO2当量/kg bw。老年人暴露在MDSD1和MDSD2中最高(主要基于分析数据,包括携带和自然发生),估计P95高达0.61 mg SO2当量/kg bw每天。主要来源是为成年人和老年人准备的葡萄酒、啤酒和肉类,为青少年和儿童准备的水果和蔬菜汁和调味饮料,以及为婴幼儿准备的干果和蔬菜。
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引用次数: 0
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