EFSA Supporting Publications最新文献

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 the non-EU Acleris spp. that attack coniferous trees 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/acleris-conifers

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 non-EU Acleris spp. that attack deciduous trees and shrubs 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/acleris-deciduous-shrubs

The protocol provides a structured approach for evaluating emergency authorisations of insecticides and acaricides under Article 53 of EU Regulation 1107/2009. It aims to standardise the evaluation of emergency authorisations, prioritise sustainable alternative solutions and ensure compliance with overarching EU strategies. Flowcharts were developed to harmonise the evaluation and to provide a structured evaluation process. A key aspect of the protocol is its flexibility to accommodate various emergency situations. The protocol includes provisions for more comprehensive evaluation in cases involving products with a less favourable profile, while considering the availability of alternative chemical and non-chemical control methods. It underscores the importance of transitioning from emergency authorisation to regular authorisation processes. Additionally, the methodology includes recommendations for repeated authorisations and the establishment of spatial and temporal conditions and restrictions of use. A central focus of the protocol is on fostering sustainable, long-term solutions in case of repeated authorisation requests. By aligning with regulatory frameworks and integrating stakeholder feedback, the protocol aims to improve transparency and efficiency in addressing emergency situations that cannot be managed through other reasonable means.

This document should be used for reporting to EFSA samples analysed for chemicals. It provides guidance on how to use the Standard Sample Description (SSD2) data model for submission to the EU of analytical results of food and feed samples taken during control activities carried out to monitor residues of pesticides and veterinary medicinal products, contaminants, food additives, and food flavourings. This document does not replace – but complements and updates some aspects of – the general EFSA Guidance on Standard Sample Description (SSD2) and Guidance on Data Exchange (GDE2). It is meant to provide guidance on the specific technical and legislative requirements as well as clarity on data quality validation for chemical monitoring (ChemMon) data at national and EU levels.

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 2025.

This technical report provides guidance for reporting countries on how to submit their isolate-based quantitative antimicrobial resistance data, and data on the prevalence of zoonoses and microbiological agents and contaminants in food, food-borne outbreaks, animal populations and disease status. To collect these data, EFSA has created the Data Collection Framework (DCF) application. This report includes data dictionaries to guide the reporting of information derived from 2025 under Directive 2003/99/EC, Regulation (EU) 2017/625, Commission Implementing Regulation (EU) 2019/627 and Commission Implementing Decision (EU) 2020/1729. The objective is to explain in detail the individual data elements of the EFSA data models that are to be used for XML data submission through the DCF. In particular, it explains the data elements to be reported, including information about the data type, a reference to the list of permitted terms and any additional business rules or requirements that may apply.

This manual provides guidance for reporting antimicrobial resistance in food-producing animals and foodstuffs derived therefrom under the framework of Directive 2003/99/EC and Commission Implementing Decision (EU) 2020/1729. The objective is to harmonise and streamline Member States reporting to ensure that the antimicrobial resistance data collected are relevant and easy to analyse at the European Union level. Detailed guidelines are provided for reporting data and completing the free-text forms. This guidance typically applies to Salmonella spp., indicator commensal Escherichia coli, Campylobacter coli and Campylobacter jejuni, and the animal populations and food categories to be reported on. Guidance is also provided on indicator Enterococcus and meticillin-resistant Staphylococcus aureus. The manual notably includes specific guidance for reporting mandatory data on Salmonella spp. and commensal indicator E. coli producers of extended-spectrum beta-lactamases (ESBLs/AmpCs/carbapenemases) obtained from the harmonised routine monitoring, and ESBL-/AmpC-/carbapenemase-producing E. coli derived from specific monitoring. This manual is specifically aimed at guiding the reporting of information deriving from the year 2025.

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 amitinus, I. cembrae, I. duplicatus and I. sexdentatus 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-amitinus-cembrae-duplicatus-sexdentatus

This report describes a harmonised, stepwise methodology for the fit-for-purpose risk assessment of low-concern active substances (LCASs), developed in response to EFSA's call GP/EFSA/PLANTS/2023/04. LCASs include substances such as semiochemicals, botanicals, inorganics, peptides, and double-stranded RNA (dsRNA), which generally have lower risk profiles than conventional active substances. However, the current risk assessment framework – primarily designed for conventional substances – often lacks the flexibility required to appropriately address LCASs. The approach described here is based on problem formulation using generic pathways to harm. It offers a structured methodology aimed at harmonising case-by-case assessments based on the specific properties of individual LCASs. This approach supports both qualitative and quantitative assessments and covers hazards other than conventional toxicity, such as suffocation, desiccation and RNA interference. To apply this approach in practice, a problem formulation toolbox is provided, comprising three main elements:

1. Generic pathways to harm

2. Generic analysis plans, including the Analysis plan tool

3. Guidance on likelihood assessment

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 Dendroctonus micans 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/dendroctonus-micans