EFSA Supporting Publications最新文献

This reporting manual provides guidance to European Union Member States for reporting on zoonoses and zoonotic agents in animals, food and feed under Directive 2003/99/EC, Regulation (EU) 2017/625, Commission Implementing Regulation (EU) 2019/627 and Commission Delegated Regulation (EU) 2018/772 and also on reporting other pathogenic microbiological agents or contaminants in food. The objective of this manual is to harmonise and streamline reporting by Member States to ensure that the data collected are relevant and comparable for analysis at the EU level. This manual covers all the zoonoses and zoonotic agents included under the current data collection system run by the European Food Safety Authority. Detailed instructions are provided for reporting data in tables and information in free-text forms. They cover the description of the sampling and monitoring schemes applied by the Member States, as well as the monitoring results. Special reference is made to data elements which enable trends to be identified and the analysis of sources of zoonotic agents at the EU level. This manual is specifically aimed at guiding the reporting of information derived from the year 2024.

This document provides guidance to applicants submitting applications on new nutrient sources 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 for a new authorisation of substances proposed as source of nutrients which may be added to food, including food supplements, foods for general population or foods for specific groups, pertaining to 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 a non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, and 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 new nutrient sources, 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.

In 2022, EFSA was mandated by the European Commission's Directorate-General for Health and Food Safety (M-2022-00070) to provide technical assistance on the list of Union quarantine pests qualifying as priority pests, as specified in Article 6(2) of Regulation (EU) 2016/2031 on protective measures against plant pests. As part of Task C, EFSA conducted comprehensive expert knowledge elicitations for 46 candidate priority pests, focusing on the lag period, rate of expansion and impact on production (yield and quality losses) and the environment. This report details the methodology for assessing these candidate priority pests for which the EFSA outputs and supporting datasets were delivered to the European Commission's Joint Research Centre, to feed the Impact Indicator for Priority Pest (I2P2) model and complete the pest prioritisation ranking exercise.

The EU Pollinator Hub is an open-source infrastructure that aims to standardise, collect, process, and visualise bee and pollinator-related data from any relevant source hold by stakeholders. The Hub features an online collective approach to sharing harmonised data pertinent to bee and pollinator health monitoring. It provides an online platform with three basic functionalities, allowing the creation and growth of an online community focused on bee and pollinator health data. First, the Hub allows such a community to standardise terminology or promote existing standards, connecting them with uploaded datasets, thanks to its “Vocabulary”. Second, it helps users comply with Open Data principles, ensuring data uploaded in the Hub is FAIR (Findable, Accessible, Interoperable, and Reusable). Finally, the Hub serves as a repository for data peer-reviewing, a pivotal process to verify the data quality, validity, and reusability of datasets made available by researchers, field practitioners, and institutional and industry stakeholders. The framework established by the EU Pollinator Hub allows datasets of varying nature, such as weather, landscape, and epidemiological data, to be analysed and processed together, providing a systems-based approach to improve data interoperability.

In June 2024, EFSA received two mandates from the European Commission (EC): (1) to review the Guidance Document on Terrestrial Ecotoxicology and (2) to develop guidance for assessing potential indirect effects on biodiversity through trophic interactions under agro-environmental conditions. Both mandates were issued pursuant to Article 29 of Regulation (EC) No 178/2002, in conjunction with Regulation (EC) No 1107/2009. In response to the request to develop an outline of the mandates' plan, with this document, EFSA clarifies timelines, as well as procedural and methodological aspects.

The workshop, co-organized by EFSA and the European Commission (DG SANTE) on 8-9 October 2024 in Brussels, was the first step in response to the mandates requesting EFSA to review the Guidance Document on Terrestrial Ecotoxicology and to develop a framework for assessing potential indirect effects on biodiversity through trophic interactions in agro-environmental conditions. The event featured three discussion rounds: Round 1 focused on identifying gaps in current practices, Round 2 provided deeper analysis of these gaps, and Round 3 examined data availability, feasibility, and potential methodologies for addressing the gaps identified in Rounds 1 and 2. The workshop's breakout sessions, central to the event, allowed participants to engage in in-depth discussions on five specialized topics: Exposure, Non-Target Arthropods, Non-Target Terrestrial Plants, in-soil organisms, and indirect effects. These sessions aimed to gather stakeholder input on the limitations of the current guidance, exchange knowledge on available data and test guidelines, and clarify expectations for the upcoming revision. Each group addressed specific aspects, such as exposure pathways, problem formulation, and effect assessment. The group on indirect effect, a topic currently lacking specific guidance, discussed what can be feasibly achieved in the course of the mandate timeframe. The plenary sessions, held at the end of each day, provided an opportunity for group rapporteurs to present the key findings from their breakout discussions, including identified gaps and suggestions for improvements. These presentations were followed by a Question & Answer session with the audience and reflections from EFSA on the discussions. The outcomes of the breakout sessions were enriching, offering valuable insights that will inform the revision of the guidance document, ensuring it reflects emerging needs and challenges in environmental protection.

Safeguarding global health is a moving target, with changes in climate and human activity raising new threats to public health, animal health and animal welfare. Decision support in the context of health management requires tools capable of making sense of large volumes of complex and multidisciplinary evidence. A One Health living risk assessment tool, L'ORA, was developed to assess the incursion risk for zoonotic and animal diseases using a One Health approach and allowing for automatic updates of the risk assessment. L'ORA estimates the incursion risk as the resultant of four steps: 1) Disease occurrence in source areas based on the distribution of diseases worldwide; 2) Rate of incursion based on the individuals or products moved from source areas to target areas and their probability of infection or contamination and contact with susceptible hosts in target areas; 3) Extent of disease spread in target areas, considering both domestic and wild host populations, vectors if the disease is vector-borne, and humans if the disease is zoonotic; and 4) Impact of the disease outbreak and concurrent control measures on public health, animal health and animal welfare, accounting for economic, societal, and environmental impacts. L'ORA is a decision support tool that was built as a generic tool comparing the relative risks of multiple diseases across multiple target areas. L'ORA monthly evaluates the incursion risk for each NUTS2 region in the European Union. Results can be used to identify areas of greater risk for each of the diseases to inform risk managers on where to focus attention and resources, and to inform, e.g., risk-based surveillance.

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 Euwallacea fornicatus sensu lato (s.l.), Fusarium ambrosium and F. euwallaceae surveys 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/euwallacea-fornicatus-fusarium-ambrosium-euwallaceae

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 Ips typographus 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/ips-typographus