EFSA Supporting Publications最新文献

The European Observatory of Wildlife EOW, as part of the ENETWILD project, represents a collaborative network that has been operating since 2021 to develop and implement standardized protocols to obtain harmonized data on distribution and density of target mammal species. In so doing, the EOW aims at contributing to improving the quality of data that are available for wildlife management and risk assessment on a European scale. This report describes the activities carried out during the 2023 EOW campaign, which was joined by a total of 30 organizations who committed to collect data in 44 sites across 22 different countries. We present data on the distribution and density of three species – wild boar (Sus scrofa), European roe deer (Capreolus capreolus), and red fox (Vulpes vulpes) – obtained by implementing a camera trapping protocol and by fitting the random encounter model (REM) for density estimation. Camera-trap images were processed using the Agouti platform and some of its tools specifically designed for the management of camera trapping projects. This includes the use of photogrammetry to obtain parameters for the REM directly from the sequences of images. A total of 24 EOW sites were monitored in past years as well, providing multiannual density estimates and population trends and highlighting an improvement in the precision of the estimates, related to the improved study design and protocol implementation. We also describe the activities of the 2024 campaign, carried out as part of ENETWILD 2.0, where big efforts were made to expand the network, focusing on sites at risk of African Swine Fever, with wild boar/pig interactions and containing wetlands, as potential hubs for Avian Influenza. This effort resulted in the engagement of 40 participants monitoring 64 study sites (27 countries), including 28 study sites located either in infected areas or < 100km from the ASF frontline, and 25 sites with wetland habitats. Furthermore, in at least 20 sites pig farming is practised either intensively, extensively or as backyard farming. Finally, synergies were established with other international initiatives related to wildlife monitoring and disease prevention, with the aim of sharing experiences and sustaining a transnational data collection and harmonization.

The implementation of omics technologies and associated bioinformatics approaches hold significant promise for generating additional evidence for food and feed risk assessments thereby enhancing the European Food Safety Authority (EFSA) capacity to deliver scientific opinions and guidance documents in the future. To explore this possibility, EFSA launched a Call for the development of a roadmap to identify the main actions needed for a wider use of Omics in future risk assessments. To address this objective, this action roadmap outlines six project proposals. These proposals are based on a comprehensive mapping of the state-of-the-art omics and associated bioinformatics technologies in research, EFSA's activities as well as current and planned activities from other relevant regulatory bodies and organisations. The outlined recommendations also address some of the identified main knowledge gaps and highlight the added value that further investments in the different food & feed safety scientific domains could bring. In addition, the work in this roadmap addresses some key challenges and blockers that might hinder a wider integration of omics in risk assessment and leverages on the opportunities for cooperation with external stakeholders. Finally, this roadmap provides suggestions on how EFSA may more broadly and effectively engage with relevant stakeholders in the use of omics technologies and associated bioinformatics approaches in regulatory science.

In specific contract No 12 issued under the framework agreement OC/EFSA/AMU/2019/02, EFSA requested Open Analytics to implement a web application to do a risk assessment for honey bees, solitary bees and bumble bees. The software is developed in R and consists of a WEB-based tool composed by several modules providing data entry for active substances, uses, metabolites and the modelling of toxicity studies. The application is developed in a modular form such that new modules can be added when available, either by the developers of the application or by EFSA.

This report is the outcome of an EFSA procurement (OC/EFSA/GMO/2021/02 – LOT1) aiming at developing an in silico strategy to predict the toxicity of (novel) proteins. Up-to-date, commercially available tools predicting protein toxicity based on primary structures were evaluated for their accuracy and usability, using a curated dataset of annotated toxins and non-toxins from UniProt. ToxinPred2 and Toxify emerged as the top performers, showing both high accuracy and suitability for integration into an automated pipeline. Additional bioinformatics methods were explored, which provide sequence similarity-based information rather than direct predictions (BLAST, InterPro HMM profiles). By converting their outputs into features for machine learning models, a high prediction accuracy was achieved, though there is potential for improvement to reduce overfitting risks. An Artificial Intelligence (AI)-based consensus pipeline, integrating results from ToxinPred2, Toxify, and our machine learning models was developed. This consensus model reached a 95% accuracy rate in distinguishing toxins from non-toxins. Noteworthy, our BLAST-based machine learning model - although performance-wise comparable to BLAST - offers higher sensitivity and specificity across diverse queries than BLAST; it relies on database-based evolutionary relationships, which may significantly limit its applicability to novel or mutated toxins. Structure-based prediction methods are deemed impractical due to their resource intensity and reliance on accurate structural data; AI-driven structure prediction methods - like Rosetta and AlphaFold - are promising, however they are still under development and may not be suitable for the regulatory context yet. Recommendations are provided, including enhancement of the proposed consensus pipeline to create an independent open-source, user-friendly tool for evaluating the safety of (novel) proteins in food and feed; regular updates of the proposed databases and models; incorporation of 3D structures and in general validation of AI and machine learning models for regulatory uses.

In a context of global changes, a foresight study is helpful to look into the future, anticipate possible scenarios and take appropriate decisions to face emerging risks for food and feed safety. Considering that an increased use of the ocean is expected for the next decades, it is essential to explore its possible impact on the safety of food and feed from the oceans. A scoping study was carried out to analyse drivers of change that may impact/promote the future uses of the ocean and its resources. From bibliographic search, different ocean uses were identified: coastal and open-sea mining, marine aquaculture, sea transport and trade, energy production and related infrastructures, fisheries, ocean crops, saline farming, desalination, extraction of bioresources, marine protected areas and conservation of the ocean. Through the information gathered in the scoping study and the input of several experts, three key ocean uses were prioritised to proceed to a participatory foresight exercise: (i) coastal and open-sea mining; (ii) marine aquaculture; and (iii) sea transport and trade. The foresight exercise produced three possible scenarios for 2050 for each prioritised use of the ocean. On the basis of these scenarios, possible implications and potential emerging issues for the safety of food and feed from the oceans were identified and characterised through bibliographic data. This document also provides a description of the methodology followed in the scoping study and in the foresight exercise, and recommendations that could help EFSA to prepare to the challenges posed by the future exploitation of ocean resources.

The pressure global food systems exert on the environment has amplified over time, following the growth of the human population, changes in the food consumption patterns and intensification of the production systems. Without changes in food systems, an overpressure on agriculture and food production will be unavoidable, with inevitable consequences for the environment and human health. Animal-derived protein production like meat and milk is among the most important drivers of this impact. Under this context, the evaluation of the health and sustainability impacts of alternatives for animal-based food proteins are central aspects of this discussion. Health risk-benefit assessment (RBA) of foods estimates the overall human health impact following exposure to a particular food or food component, integrating risks and benefits in comparable measures. Methods that simultaneously consider the environmental impact of the food production systems were needed to perform a sustainable holistic assessment. “ALTERNATIVA | Alternative protein sources in the European diets – integrating health risk-benefit and sustainability” aimed to develop a holistic approach to assess the impact of alternative protein sources, integrating health and sustainability assessment. This project, considering five complementary work packages, developed activities to enhance the capacity-building among members of the consortium in applying methodologies related to the health RBA and sustainability impact assessment; to develop, in collaboration with different stakeholders, a protocol to integrate the assessment of the impact of foods/diets on health and on sustainability; to apply the derived framework to a case study, to validate it with a real case scenario, estimating the health and sustainability impacts of replacing red meat consumption by pulses in two different countries; and to disseminate and promote the established method of integrated health and sustainability assessment to other potential EU users. This external scientific report summarizes the main outputs and results obtained in the context of the ALTERNATIVA project.

This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application pursuant to Article 10 of Regulation (EU) 2015/2283 for a new authorisation or for the modification of an existing authorisation of a novel food for applications submitted to the European Commission as of 1 February 2025. The Transparency Regulation amended the General Food Law by introducing provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on novel foods, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA's scientific opinion. It also takes into account the updated Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283, which provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food.

Highly pathogenic avian influenza (HPAI) viruses pose a significant threat to both poultry and wild bird populations. Migratory wild birds play a key role in the intercontinental spread of avian influenza (AI), introducing the virus into poultry populations. In response to frequent AI outbreaks in Europe, the European Food Safety Authority (EFSA), at the request of the European Commission (EC), produces quarterly and annual epidemiological reports to monitor and analyse AI trends. A key component of this surveillance includes the integration of outbreak data from Member States and contributions from non-governmental ornithological organisations like the European Bird Census Council (EBCC) and the European Union for Bird Ringing (EURING) together in a predictive spatio-temporal risk assessment model. Previous data integration and modelling efforts led to the development of an early warning system for predicting HPAI outbreaks accessible through a publicly available online user interface: the Bird Flu Radar. This report presents an improvement of the system by expanding the species coverage and refining the existing base models behind the epidemiological model. Specifically, this report details the exploration to incorporate 12 additional wild bird species into the models, and the changes made to the base models predicting the distribution and movements of wild birds. We demonstrate the improvements respecting the existing base models while at the same time enhancing the effectiveness in predicting HPAI outbreaks and possibly mitigating negative effects in Europe by providing more accurate predictions to different stakeholders.