EFSA Supporting Publications最新文献

The main goal of this report is to assesses the performance of different quantile estimators with respect to estimating both non-extreme and extreme quantiles. An application within the field of exposure assessment is presented, also including the evaluation of different methods for usual intake estimation. The report also compares methods to calculate prediction intervals from historical control data (HCD). For quantile estimation, the standard sample quantiles were found to perform well for estimating non-extreme quantiles. In specific situations listed in the report, the semi-parametric method by Wei, Wang and Hutson is a good alternative. For estimating extreme quantiles, especially the methods based on the generalized extreme value distribution and the generalized Pareto distribution could be recommended as alternatives to the sample quantiles, which would typically require unrealistically high samples to perform well for extreme quantiles. With respect to usual intake and exposure estimation, in addition to the default observed individual mean (OIM) method that is currently applied at EFSA, alternative parametric methods are presented and their performance compared through simulations. It was seen that both the logistic-normal-normal or gamma hurdle model might provide valuable alternatives to the OIM, for which it has been observed that two-day consumption information might not always be sufficient to obtain reliable quantile estimates. For the prediction intervals from HCD, the default method at EFSA is based on mixed model theory. The performance of the default method depends on the ratio of between-to-within-study variability. When the ratio is larger than 1, good coverage was observed when at least 30 studies were included. When the ratio is smaller than 0.5, or when it is between 0.5 and 1, but less than 100 studies were considered, the bootstrap approach from Nagashima and colleagues was found to be a promising alternative. Further recommendations are provided in the report.

Extended-Spectrum β-Lactamases/AmpC β-Lactamases (ESBL/AmpC)-producing E. coli are increasing globally and represent a significant threat to public and animal health. These bacteria belong to the normal microbiota of humans and animals and are widespread in various environmental settings. Understanding their transmission dynamics through a One Health approach is crucial. This study aimed to investigate the transmission of ESBL/AmpC-producing E. coli among animals, food, the environment, and humans using phenotypic methods and Whole Genome Sequencing (WGS). The study included isolates collected and stored between 2014 and 2017, as well as those prospectively collected from 2018 to 2020. Human isolates were obtained from urine and blood cultures using standard methods and tested for antimicrobial susceptibility following EUCAST guidelines. Non-human isolates were cultured according to the EURL-AR protocols and susceptibility tested in line with Commission Implementing Decision 2013/652/EU. WGS was performed using the Illumina MiSeq platform and analysis done according to EURL-AR protocol. During the study period, 903 individuals were identified with ESBL/AmpC-producing E. coli. Every fourth isolate (n=226) was selected for WGS, of which 195 passed quality control. The prevalence of ESBL/AmpC-producing E. coli increased from 2.5% in 2014 to 5.4% in 2020, with the majority associated with ST-131 and CTX-M-type β-lactamase genes. A total of 154 non-human ESBL/AmpC-producing isolates were collected, comprising 14 from food, 108 from livestock, 12 from pets and 20 from the environment. Of these, 131 were successfully recovered and passed WGS quality control. These non-human isolates belonged to 55 different STs, each with low individual prevalence and up-regulated chromosomal AmpC was predominant. Generically related ESBL/AmpC-producing E. coli isolates were identified between animals and food sources, as well as between humans and environmental samples. However, no identical or related isolates were found between humans and animals or humans and food. Due to the low number of non-human ESBL/AmpC isolates, a formal risk assessment of resistance transfer from animals/food to humans could not be conducted.

Genotoxicity is one of the most important endpoints for human health. Several large databases of genotoxicity results are available for training the predictive systems. This has given rise to the generation of a large number of (Q)SAR models and Read-Across approaches. The main objectives of the contract OC/EFSA/SCER/2021/05 and its follow-up contract PO/EFSA/PREV/2025/02 were to update the existing EFSA genotoxicity database developed under the previous Contract GP/EFSA/PRAS/2014/01 through IUCLID application as well to migrate the existing data to IUCLID format. Chemical and genotoxicity information for pesticides active substances and their metabolites has been extracted from the EFSA draft/renewals assessment reports and entered into IUCLID according to the operational procedures developed under the project. In total, considering all IUCLID entries, the update includes 143 active substances and 279 metabolites. The final database, in IUCLID and excel format, is available inhttps://zenodo.org/communities/efsa-kj, and includes 389 active substances, 1058 metabolites, 6119 genotoxicity studies (26198 data points). In addition, under the new contract PO/EFSA/PREV/2025/02, 87 substances were added to this final database, in IUCLID format only. Availability of well-curated high-quality databases, covering a broader chemical space, is one of the key points to be addressed for the generation of more accurate and trustable results in risk assessment. In this context, this project is believed to provide firm ground for improving of confidence of (Q)SAR and Read-Across methods and provides an excellent example of good data management practices in respect of FAIR data principles, defined as Findability, Accessibility, Interoperability, and Reusability of data.

This technical report aims at guiding the reporting of data on analytical test results, and related metadata, to EFSA in the context of the activities for the surveillance of avian influenza. The objective is to explain in detail the individual data elements that are included in the EFSA Standard Sample Description version 2 (SSD2) data model. The guidance is intended to support the reporting countries in data transmission using eXtensible Markup Language (XML) data file transfer through the Data Collection Framework (DCF) according to the protocol described in the EFSA Guidance on Data Exchange version 2 (GDE2). The data elements are explained, including information about data type, list of allowed terms and associated business rules. Instructions about how to report common sampling schemes are also provided to ensure harmonised reporting among countries.

Whole Genome Sequencing (WGS) has become a cornerstone in microbiological investigations, particularly for food-borne outbreak detection and source attribution. In response to Commission Implementing Regulation (EU) 2025/179, the European Food Safety Authority (EFSA) developed guidelines for reporting WGS-based typing data through the EFSA WGS System. This platform, operational since July 2022, is part of the One Health WGS System developed by EFSA and the European Centre for Disease Prevention and Control (ECDC), enabling joint analysis of isolates from human, food, feed, animals, and related environments. Interoperability between EFSA and ECDC WGS systems relies on a query–response mechanism exchanging Core genome Multilocus Sequence Typing (cgMLST) profiles and essential metadata under strict visibility rules. These guidelines focus on the critical requirements and submission procedures that reporting countries must follow to ensure compliance with regulatory obligations and EFSA criteria when submitting data to EFSA. They define acceptance criteria for WGS data quality, metadata standards, and procedures for voluntary and mandatory data submissions. They also clarify roles and responsibilities of Country Officers, Data Providers, and Submitters, ensuring data integrity and confidentiality.

This technical report reflects the outcome of the 2024 mammalian toxicology experts’ meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. Development of harmonised approaches for testing and assessing pesticides for neurotoxicity potential and implementation of mechanistic information were agreed. General issues regarding the assessment of impurities and metabolites and the need to harmonise the extra uncertainty factors used for the derivation of health-based guidance values were discussed. Conclusions and further recommendations on these issues are reported.

There is no specific EU legislation dedicated to fish welfare during farming, transport, or killing; however, fish are covered under the general provisions of Council Directive 98/58/EC (protection of animals kept for farming purposes) and Regulations (EC) No 1/2005 (on the protection of animals during transport and related operations) and No 1099/2009 (on the protection of animals at the time of killing). Significant advancements in fish farming practices in recent years have introduced new welfare concerns. In this context, and to prepare for potential mandates on fish welfare, EFSA conducted an information-gathering exercise on fish farming during the 25th meeting of the EFSA Animal Health and Welfare (AHAW) Network aimed at mapping current fish farming systems in the EU. A pre-meeting survey was circulated to network representatives, and most responded. The aggregated results were discussed during the meeting, together with clarification questions and a poll. Not all major EU-farmed fish species are produced in every country. Some species are widely distributed, such as brown trout (Salmo trutta), carp (Cyprinus carpio), European eel (Anguilla anguilla), rainbow trout (Oncorhynchus mykiss) and salmon (Salmo salar). In contrast, species such as bluefin tuna (Thunnus thynnus) are only farmed in a few countries, while others are restricted to the Mediterranean areas, including seabass (Dicentrarchus labrax), and seabream (Sparus aurata). Common husbandry systems include Recirculating Aquaculture System, Flow-through System, freshwater ponds and net pens while almadraba traps and saltmarsh ponds are mainly used in Southern Europe. The links to all relevant national legislation or guidelines, as well as information on additional species and husbandry systems provided, were collected and are annexed to this report.

The Network of the National Contact Points for scientific support under Art 20 of Council Regulation (EC) 1099/2009 on the protection of the animals at the time of killing (scientific NCPs Network) includes nationally appointed representatives of Members States, including EFTA Countries. During the annual meeting in 2025, an exercise was performed to gather information from Network members on animal-based measures (ABMs) collected at slaughterhouses to monitor the level of welfare of Equidae in establishments. Prior to the meeting, Network members were requested to submit, via an online questionnaire, information on ABMs currently measured in ante- and post-mortem inspections of Equidae at the slaughterhouses in their countries, the availability of a database for the electronic recording of these ABMs, their feasibility, and any automated systems for their assessment. The questionnaire collected information on the species Equus caballus (horses), Equus asinus (donkeys) and their hybrids (mules and hinnies). During the meeting, a structured discussion was held on the information provided, and participants were also asked to vote and score the criteria for the provided ABMs. As a result of this exercise, an initial list of ABMs deemed useful to be collected in the slaughterhouses to retrospectively monitor the level of welfare of Equidae in establishments was produced, and related information was collected. The information included in this report will be used for the development of the relevant scientific opinion on the welfare of Equidae, expected to be adopted by end 2026.

These guidelines for surveys in potato crops have been prepared at the request of the European Commission. Its aim is to guide the EU Member States in preparing crop-based surveys in potato, while describing the context in which these surveys are designed. This contributes to the harmonization of surveillance activities across Member States. Surveys are needed to substantiate pest freedom in an area and/or in the potato production chain. Surveys must be conducted in a scientifically and statistically sound manner. The target pests covered by these guidelines are quarantine pests for which potato (Solanum tuberosum) is a main host. These pests can enter the crop from the environment or through the planting of infested seed potatoes. The guidelines describe how to define the inspection unit 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. 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. 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 monthly capacity constraints to be taken into account. The optimisation procedure is illustrated by a case study on potato crop surveys. These guidelines subsequently address how the resulting survey program can be implemented by selecting survey sites and establishing field and laboratory procedures for the detection and identification of the target pests.

This technical Report addresses a mandate from the European Commission according to Article 31 of Regulation (EC) No 178/2002 on existing processes put in place to remove recombinant DNA from fermentation products produced with genetically modified microorganisms (GMMs). Fifty applications representing products obtained by fermentation using GMMs and assessed under the Food Improvement Agents, Feed additives and Novel foods regulatory frameworks were selected. The purification steps applied in the selected applications were evaluated for their potential to remove/degrade residual DNA from the final products. Based on the data considered in this technical report, EFSA concluded that: there are steps in the manufacturing process that deliberately remove or degrade residual DNA from the products; other steps routinely used to remove impurities during purification processes can remove/degrade residual DNA however, their effectiveness is dependent on the processing conditions in which they are applied, size of DNA to be removed, their use in combination with other purification steps and/or the specific characteristics of the product produced. The analyses for the presence of residual DNA from the production strain submitted in the applications demonstrate that DNA from the production GMM is not detected when a combination of steps is used. However, a detailed description of the processing conditions used is often not provided in the applications. EFSA cannot determine a definitive list of purification steps or other processes and conditions that reliably remove the residual DNA from production GMMs in fermentation-derived products. This may not be feasible due to the varied nature of manufacturing processes and products under evaluation. However, based on the available data, it has been observed that at least one process to remove the biomass and one process to purify the product are necessary to remove residual DNA, each process including one or more steps.