EFSA Supporting Publications最新文献

This document should be used for reporting to EFSA samples planned under the national control plans for residues of veterinary medicinal product. It provides guidance on how to use the data model for submission to the EU of such data and related information.

In 2024, the European Food Safety Authority (EFSA) organised two crisis preparedness sessions. The internal crisis workshop focused on EFSA's preparedness to respond under the Serious Cross-Border Threats to Health (SCBTH) Regulation (EU) 2022/2371 and especially the requirement for a Joint Risk Assessment (JRA) with other EU agencies. EFSA's crisis training contractor, Instinctif Partners, developed the internal workshop for EFSA's Senior Management Team to increase awareness of the implications, roles and responsibilities in a JRA, as well as identifying required amendments for EFSA's internal crisis response procedures and the draft Interagency Working Arrangement under article 20 of the SCBTH Regulation. The workshop was mainly discussion-based, with a series of exercises focusing on identifying areas for process amendment, following three context-setting presentations. The external crisis exercise was co-developed by the Food Safety Authority of Ireland (FSAI), EFSA and Instinctif Partners to rehearse a multi-agency, multi-Member State response under the SCBTH regulation. Lasting 2.5-days, the preparedness training event comprised an overview of the Regulation on SCBTH, a role-played, 1.5-day simulation exercise and a half-day debrief session. The event was held in person at the Convention Centre, Dublin, and also involved multiple participants joining online. In addition to rehearsing the development of a multi-agency JRA in response to a SCBTH, the training also aimed to clarify Member States’ interaction during such a response. The objectives of both events were achieved, based on recorded outcomes and feedback provided by participants in evaluation surveys. This Annual Report summarises the external crisis exercise and provides a detailed overview of the development, running, and outcomes of the internal workshop, along with the participants’ feedback.

OECD Good Laboratory Practice (GLP) principles were developed by governments as a regulatory control mechanism to ensure that safety studies would be of acceptable quality and integrity. EU Directives 2004/09/EC and 2004/10/EC incorporate the OECD GLP principles into the EU regulatory framework, requiring that studies submitted for the assessment and authorization adhere to the principles of GLP. In its role as European risk assessor authority, EFSA launched a project to strengthen the methodology for verifying GLP studies for all regulated product areas under its remit, with three main objectives: to establish verification methodology and tools through a fit for purpose GLP verification checklist, to test the methodology by applying it to substantial amount of studies across different regulatory areas and different study types and to develop a hands-on training program for GLP assessors and scientific units/risk assessors for the use and understanding of the created GLP checklist. Following these objectives, the study evaluation had two levels of assessment: identification of GLP observations and assessing scientific reliability of studies where GLP observations were made. Around 1,000 studies were investigated to examine the developed methodology. The GLP verification checklist proved to be fit for purpose for verifying GLP studies. Hands-on training was made available on the EU academy platform (https://academy.europa.eu/).

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 Nemorimyza maculosa 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/nemorimyza-maculosa

A catalogue of toxicity endpoints was developed for a consistent collection of toxicological information. The toxicity endpoints of relevance for cumulative risk assessment were organised in a table for each target organ/tissue/system (cumulative assessment group (CAG) at level 1) including information on specific toxicological effect(s) (CAG at level 2), indicators that reflect the relevance for the CAG at level 2, and descriptions/interpretations that allow an understanding of the CAG at level 2. A data model for the collection of toxicity endpoints was developed to ensure the possibility of integration of the collected data to the EFSA OpenFoodTox database, in order to extend it to non-critical endpoints. The collection of toxicity endpoints and grouping of active substances were performed for a total of 328 active substances and 165 of their metabolites. The data model was filled in for all the OpenFoodTox columns as far as possible and essential information which could not be entered in the OpenFoodTox columns were noted in the ‘Remark column’. In total, 29 CAGs at level 1 have been evaluated for inclusion of specific toxicological effects (CAGs at level 2), whereas four CAG1 targets (gastrointestinal tract, immune system, lungs and skin) were not evaluated as the effects observed in these CAG1 targets were not considered relevant for CAGs at level 2. A number of toxicological effects considered adverse and of relevance for human risk assessment, but generally not relevant for CAGs at level 2, include mortality, clinical signs of toxicity, changes in bodyweight and body weight gain, changes in food consumption and water consumption, changes in clinical biochemistry and urinalysis parameters and changes in organ weights without histopathological changes. © National Food Institute, Technical University of Denmark, 2024

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 Fusarium oxysporum f. sp. albedinis 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/fusarium-oxysporum-albedinis

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 chrysanthemum stem necrosis virus 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/chrysanthemum-stem-necrosis-virus.

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 potato viruses and phytoplasmas regulated as Union quarantine pests 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/potato-viruses-phytoplasmas

The European Food Safety Authority (EFSA) collaborated with the Food Safety Authority of Ireland (FSAI) to plan and run a simulation exercise to rehearse a multi-agency, multi-Member State response under Regulation (EU) 2022/2371 on Serious Cross Border Threats to Health (SCBTH). Engaging with EFSA's training contractor, Instinctif Partners, EFSA and FSAI co-developed a 2.5-day preparedness training event, comprising an overview of the Regulation on SCBTH, a role-played, 1.5-day simulation exercise and a half-day debrief session. The event, which was held in person at the Convention Centre, Dublin, also involved multiple participants joining online. In addition to rehearsing the development of a multi-agency joint risk assessment (JRA) in response to a SCBTH, the training also aimed to clarify Member State interaction during such a response. The debrief session elicited much discussion and a number of actions were identified as next steps. This debrief session, alongside the identified actions and participants’ responses to the post-event evaluation survey, demonstrate that the training achieved its objectives. There were fifty-one participants in the training event representing four units of European Commission Directorate General on Health and Food Safety (DG SANTE), five EU Agencies and five Member States. Eight facilitators from Instinctif Partners, FSAI and EFSA ensured the smooth and efficient running of the event. This report documents the development, content, conclusions and recommendations of the training event, as well as the participants’ evaluation of it.

The EFSA Animal Health and Welfare (AHAW) Network Animal Welfare includes two sub-groups: the subgroup specialised on Animal Welfare (AW) and the subgroup of the scientific National Contact Points (NCPs) for scientific support established under Art 20 of Council Regulation (EC) 1099/2009. In March 2024, during the annual meeting of the EFSA Network subgroups, EFSA conducted an information-gathering exercise on mutilation practices in turkeys, both breeders and turkeys kept for meat production, focusing on beak trimming, toe trimming de-toeing, and de-snooding, across different countries. Prior to the meeting, a questionnaire was distributed to the Network members to gather comprehensive data on these practices, including the methods employed, the age at which the mutilations are performed, the individuals responsible for performing them, and the use of analgesia or anaesthesia. The questionnaire also explored measures in place to reduce the need for these mutilations and any alternative strategies being implemented. During the meeting, participants engaged in a structured discussion, elaborating on questionnaire responses and providing additional insights and clarifications. This exercise resulted in a comprehensive overview of current mutilation practices in turkey farming across the represented countries. The information included in this report will support the risk assessment of the scientific opinion on the welfare of turkeys on farm, expected to be delivered by the EFSA AHAW Panel in 2025.