EFSA Supporting Publications最新文献

The current report is the result of the recent EFSA-EBTC initiative to advance the use of automation tools in systematic reviews. The working group members identified the need for data exchange standards to facilitate transferring data between SR automation tools without loss or changes in data as a first priority. Closely related objectives identified were the concurrent development of data guidance and data content standards, and a strategy for governance of the resulting data standards, including their maintenance and regular updates. These conversations led up to the organization of workshops to initiate the development of data standards, as described in the current report. The EFSA-EBTC collaboration organized a four half-day workshop for an extensive group of stakeholders actively involved in the development or use of SR automation tools. The main objectives were 1) to generate a common understanding of the needs and hurdles for data standards in SR automation, 2) to collate viewpoints from all relevant stakeholders on how such standards may be developed, and 3) to kick-off the development process. Three preparatory workshops preceding the final workshop were organized to clarify the scope and objectives of the main workshop. This external scientific report contains the summary of the preparatory and main workshops, as well as the proposed strategy for the process of how these data standards could be developed. The recommended next steps for development focus on further refining the aims, analysis of the landscape, interoperability with existing standards, setting up the infrastructure (e.g., establishing a governance structure and working groups containing all essential stakeholders), and the process of actual data standard development, launching and monitoring adoption of the standards.

PERSAM is a software tool for predicting environmental concentrations of plant protection products (PPPs) in soil commissioned by EFSA. The PERSAM tool was first launched in 2013. In support of the EFSA guidance document for predicting environmental concentrations of PPPs in soil (2017), the PERSAM software tool was updated for calculating the predicted environmental concentration of PPPs in soil. The computerised tools will be released for use by applicants and risk assessors for the evaluation of PPPs and transformation products according to Parliament and Council Regulation (EC) 1107/2009. The software application assists the user in performing calculations using the analytical model, as described in the guidance document for predicting environmental concentrations of PPPs in soil (2017). More specifically, the software will be able to calculate: Tier-1 predicted environmental concentrations (PEC); Tier-2 95th-percentile PECs; and the selection of the grid cell including the scenario properties corresponding to the 95th-percentile PEC as needed for the scenario development at Tier 3A, and generation of a so-called transfer file that can be read by the numerical models described in the guidance document. PERSAM generates reports intended for regulatory submissions. Based on these reports authorities need to be able to check or reproduce the model results. This report describes the issues addressed and the solutions implemented in PERSAM 3.0.2 to 3.0.9.

A key step in the characterisation of bacterial strains used in the food and feed chain is the identification of antimicrobial resistance (AMR) genes in their genomes. The presence of acquired AMR genes influences important aspects of the risk assessment, such as the applicability of the qualified presumption of safety (QPS) approach, which can have a direct impact on the data requirements. Aiming to implement the EFSA approach to discriminate between ‘intrinsic’ and ‘acquired’ AMR genes, a bioinformatics pipeline was developed and applied to the species of the genus Bacillus that are most frequently subjects of applications for regulated products submitted to EFSA. The results are presented as a catalogue of genes indicating their abundance and distribution among complete and confirmed genomes publicly available for each species. The results of this work are aimed to support the evaluation of AMR genes in a consistent and harmonised way.

In specific contract No 19 issued under the framework agreement OC/EFSA/AMU/2019/02, EFSA requested Open Analytics to implement a web application running EFSA's Food Intake Enzyme Model (FEIM). It allows users from industries, applicants and risk assessors to autonomously run an exposure estimation to food enzyme intake. This estimation is done combining, for each specific food manufacturing process, the use level of the food enzyme with data from the EFSA comprehensive food consumption database and an ad-hoc database containing a list of relevant foods and technical conversion factors. Users can export results in Excel files or .html reports. The input tables can be re-uploaded for re-submitting calculations.

The European Food Safety Authority (EFSA) has a goal to efficiently conduct aggregate exposure assessments (AEAs) for chemicals using both exposure models and human biomonitoring (HBM) data by 2030. To achieve EFSA's vision, a roadmap for action for advancing aggregate exposure (AE) in the EU was developed. This roadmap was created by performing a series of engagement and data collection activities to map the currently available methods, data, and tools for assessing AE of chemicals, against the needs and priorities of EFSA. This allowed for the creation of a AEA framework, identification of data and knowledge gaps in our current capabilities, and identification of the challenges and blockers that would hinder efforts to fill the gaps. The roadmap identifies interdependent working areas (WAs) where additional research and development are required to achieve EFSA's goal. It also proposes future collaboration opportunities and recommends several project proposals to meet EFSA's goals. Eight proposal projects supported by SWOT analysis are presented for EFSA's consideration. The project proposals inform high-level recommendations for multi-annual and multi-partner projects. Recommendations to improve stakeholder engagement and communication of EFSA's work on AEA were gathered by surveying stakeholders on specific actions to improve EFSA's communication on AE, including webinars, virtual training, social media channels, and newsletters.

In the European Union, all chemical substances that are manufactured, imported or used in tonnages equal or higher than one tonne per year must be registered under the REACH regulation. This regulatory framework requires the collection and dissemination of detailed information on the properties, uses, and potential health and environmental impacts of chemicals. However, some of these chemicals may pose emerging risks in the food chain, necessitating the development of approaches to identify and assess such risks. The SCREENER project addressed this critical issue by analysing food items for the presence of chemicals that may pose unrecognised hazards.

Building on the findings from the previous REACH 1 and REACH 2 projects, which identified a suspect list of 212 chemicals, qualitative multi-residue high-resolution mass spectrometry (HRMS) methods have been developed.

Diverse food items such as wheat flour, kale, carrots, potatoes, peas, strawberries, oranges, meat, hen's eggs, and trout were pooled from 3 samples each, while cow's milk, and other fish types (salmon and herring) were pooled from 4 samples each to form a single sample. This pooling procedure resulted in 194 analytical samples, which were screened for the presence of the chemicals in the suspect list.

Additionally, non-target analysis (NTA) was performed on the same samples, focusing on detecting halogenated compounds. The aim was to detect substances potentially introduced into the food chain unintentionally through industrial and anthropogenic activities, which were previously unrecognised in the food chain.

In the final stage of the project, 15 chemicals were further prioritized for identification and quantitative analysis. Quantitative methods were developed and then applied to the same 194 samples, allowing for the identification and quantification of those chemicals. Subsequently, hazard characterization, exposure assessment, and risk characterisation were conducted. A preliminary characterization of the potential risk posed by the chemicals found in the samples during quantitative confirmatory analysis indicated no risk to human health in all but three cases where additional analysis on occurrence and detailed evaluation of the hazard can be considered as a possible follow-up action in the future.

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 Melampsora medusae f. sp. tremuloidis 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/melampsora-medusae-tremuloidis.

By using the latest available data, we provide estimates of wild boar (Sus scrofa) distribution and abundance pre-African Swine Fever (ASF) based on occurrence data in Europe. Secondly, as a basis for the calibration model output into densities, we used the predictions of relative abundance, and hunting yield-based model (hunted individuals per km²), at 2x2 km for wild boar (by ENETWILD Consortium) and local wild boar densities (individuals per km²) considered reliable and obtained in the framework of the European Observatory of Wildlife (EOW), as well as some from recent literature (2015 onwards). Hunting yield predictions were considered at different spatial scales namely 5, 10 and 15 km radii buffer around localities with density estimations. The calibration of hunting yield-based model into densities are a better fit for 15 km radius buffer and a significant relationship between model predictions of hunting yield and reliable density values at European level. This calibration of wild boar hunting yield-based model into densities will offer the possibility to predict density values of wild boar. This will be useful to incorporate into risk factor analyses for African Swine Fever at the selected spatial range. This is the first time that absolute density estimates have been made using these two approaches for Europe, which demonstrates the added value of the observatory approach (a number of study areas where reliable density values are obtained, such as from the EOW) to generate novel information of high value for epidemiological assessment. During an ASF outbreak hunting effort will change dramatically and will take a few years to return to similar pre-ASF levels, so post-ASF estimates of density would be limited to areas where ASF has been present for a while. However, there will be relatively limited effect on sighting data as these rely on a number of different actors, many of whom may be expected to return to normal activities relatively soon after ASF arrives. Thus, relative post-ASF wild boar density may be more reliable in the short term. These relative post-ASF densities were calculated but with the limited sighting data available at the chosen locations the uncertainty was high. We advocate for the developing this nework of wildlife monitoring across Europe, and in general, harmioized wildlife monitoring programs, ensuring standardisation and consistency in the data generated and collected, which is essential for assessing management and risks related not only to ASF but other wildlife diseases.

EFSA was asked by the European Commission to provide scientific assistance with respect to the EFSA scientific opinion on “Safety of Lemna minor and Lemna gibba whole plant material as a novel food (NF) pursuant to Regulation (EU) 2015/2283”, which was adopted in 2022. In that Scientific Opinion, the Panel concluded that the NF, considering its proposed uses and the content of manganese as compared to the content of manganese normally present in other leafy vegetables, may be of safety concern and, therefore, the safety of the NF could not be established. In the context of this mandate, EFSA was requested to evaluate whether the additional information provided by the applicant addresses the increase of manganese intake from the NF, which was considered substantial as compared to the background manganese dietary intake. The applicant provided new data showing that by reducing the manganese concentrations in the cultivation medium, the manganese content in Lemna gibba does not exceed the manganese content in spinach. EFSA emphasizes that the rest of the production process should not deviate from what was reported and assessed in the original NF opinion. Data assessed in 2022 along with data provided for the current assessment show that under the same cultivation conditions Lemna gibba and Lemna minor display similar manganese contents. EFSA acknowledges that the composition of the NF should adhere to the specification levels established in 2022. However, regarding manganese, given the contents observed following these latest production processes, EFSA considers that the maximum specification level for manganese in the NF should be set at 6 mg/kg fresh weight. Based on the additional data provided, EFSA concludes that the contents of manganese in the NF have been reduced to levels not exceeding those in other leafy vegetables.