EFSA Supporting Publications最新文献

This technical report aims at guiding the reporting of data on analytical test results, and related metadata, to EFSA in the context of the activities for the surveillance of avian influenza. The objective is to explain in detail the individual data elements that are included in the EFSA Standard Sample Description version 2 (SSD2) data model. The guidance is intended to support the reporting countries in data transmission using eXtensible Markup Language (XML) data file transfer through the Data Collection Framework (DCF) according to the protocol described in the EFSA Guidance on Data Exchange version 2 (GDE2). The data elements are explained, including information about data type, list of allowed terms and associated business rules. Instructions about how to report common sampling schemes are also provided to ensure harmonised reporting among countries.

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received in accordance with Article 23 of Regulation (EC) No 1107/2009 concerning basic substances. This evaluation was requested by way of a specific mandate from the European Commission following the submission of an application for approval of Quassia amara L. wood as a basic substance to be used in plant protection as an insecticide and repellent in pome fruit, stone fruit, hop and ornamentals. This report summarises the outcome of the public and targeted consultations with Member States and EFSA, and presents EFSA's scientific views on the individual comments received including the overall conclusions with the main findings on the application.

The present report describes the work performed in the EFSA-project ‘Data collection, update and further development of biologically-based models for humans and animal species to support transparency in food and feed safety’. Here, Focus is given to case studies for food and feed chemicals to predict kinetic parameters and profiles using generic and substance-specific physiologically-based kinetic (PBK) models for humans, including human subgroups, laboratory animal species, farm animals and a kinetic-dynamic model in salmon. For humans, five case studies were conducted to compare kinetic predictions using the human generic PBK 6-compartment COSMOS/TKPlatewith i) in vivo data from human clinical or biomonitoring studies, ii) substance-specific model predictions using molecules relevant to food safety. Another five case studies assessed the impact of physiological variability (including pregnancy, renal excretion, metabolism variability, or ontogeny) and their impact on biomarkers of exposure. Case studies on laboratory and farm animals focused on theophylline, caffeine, cannabinoids, alkaloids and mycotoxins using the generic 11/12 PBK compartment models integrated in EFSA's TKPlate to assess predicted and experimental parameters i.e. plasma concentrations, excretion via milk or eggs. Overall, predictions from the human generic and substance-specific PBK models for parameters of chronic exposure were similar and robust compared to the available experimental data. For test species and farm animals, model predictions from the generic TKPlate PBK models also performed well and were mostly within 2-fold compared to available experimental in vivo data. In addition, 3D molecular modelling case studies were also conducted to investigate transport of chemicals (ochratoxin A, perfluoroalkyls) and cytochrome P450 metabolism (ochratoxin A, safrole and other alkenylbenzenes) as a useful tool to generate metabolism information at the molecular level. Conclusions and recommendations for future work are formulated to further develop generic PBK models for parent compounds and metabolites and further guidance to use and parameterise these models in next generation risk assessment.

The main objectives of EFSA's activities on environmental scanning encompass: (i) the identification and analysis of emerging risks as well as more forward-looking signals, drivers and trends that could affect EFSA's work programme; (ii) developing and improving emerging risk identification methodologies and approaches; and (iii) communicating issues and risks that have been identified. The outcome of these activities equips EFSA to anticipate forthcoming challenges in the continuously evolving landscape of risk assessment. EFSA networks of knowledge that contribute to the emerging risks identification activity include the Emerging Risks Exchange Network (EREN), the Stakeholder Discussion Group on Emerging Risks (StaDG-ER), EFSA's scientific units, the Scientific Panels, the Scientific Committee and their working groups. The current technical report summarises the activities of all groups involved in the environmental scanning process, the issues identified in the course of 2023, and the collaborative activities. In total, 32 potential emerging issues were discussed in 2023 and five were concluded to be emerging risks. The potential issues were classified according to the hazard.

In 2023, EFSA has further implemented its environmental scanning and strategic options definition process with the development of the Emerging Risks Exchange Platform (ERAP), which is intended to centralise all emerging risks analysis activities. Acknowledging the breadth and variety of the scientific areas to be covered, EFSA has also put in place a collaborative network for preparedness that goes beyond just the European Union. Finally, special attention has been given to increasing the visibility of EFSA's environmental scanning work, making use of FoodSafeR's digital hub to disseminate EFSA's activities to a worldwide community of professionals dealing with preparedness, and with the creation of the biannual EFSA newsletter “Emerging Risks Update,” which provides valuable insights into EREN's and StaDG-ER's meetings and discussions, recent news and publications, upcoming events and activities related to environmental scanning.

New approach methodologies (NAMs) for developmental neurotoxicology are being developed and used to provide information on chemical hazard and risk for humans while limiting the use of animals. Recently OECD published an initial guidance document for use of the Developmental Neurotoxicity In Vitro Battery (DNT IVB), composed of in vitro assays that assess critical neurodevelopmental processes. To evaluate assay performance and develop new assays for inclusion in the DNT IVB, positive and negative control compounds with known actions neurodevelopmental processes are required. In contrast, to evaluate the ability of the battery of in vitro DNT assays to predict developmental neurotoxicity in vivo in mammals (and particularly in humans), a different set of positive and negative controls are required. These are DNT Reference Chemicals - chemicals with evidence for in vivo developmental neurotoxicity identified in studies of humans or experimental animals (positives), as well as chemicals with evidence that they do not result in developmental neurotoxicity in vivo (negatives). The OECD guidance proposed a draft list of approximately 100 chemicals for use as DNT Reference Chemicals. The importance of this common set of chemicals was to provide a basis for beginning the evaluation of the current DNT-IVB performance vs. the available in vivo DNT studies and determine the added value of possible new assays developed for inclusion in the DNT IVB. The purpose of the current report is to update Appendix A of OCED 337 (OECD, 2023) and provide a Recommended DNT Reference Chemical Test Set for use in in vitro DNT assay development and evaluation.

This report proposes a governance model for managing the activities involving ontologies at EFSA. It contains recommendations about (a) the scoping of the ontology development activities at EFSA (purpose and subject matter), (b) external and internal consistency and interoperability, (c) maintenance and evolution, (d) access policies, (e) IT considerations (aligned with Deliverable D4), (f) outsourcing strategy, (g) training needs related to ontologies. The proposed model is aligned with the existing governance activities of EFSA, such as Rebuild DF. The document is complemented with the adopted governance model of other ontologies.

Recent regulatory use of in vitro assays for developmental neurotoxicity have promulgated the development of initial OECD guidance for use of data from the developmental neurotoxicity in vitro battery (DNT IVB). One limitation in use of data from NAMs like the DNT IVB are the uncertainties of in vitro to predict in vivo effects. The lack of any curated database of in vivo DNT studies hampers such a comparison. The goal of the current effort was construction of a repository of all DNT studies defined as publicly available studies that followed DNT and/or reproductive guidelines containing a DNT cohort. The first specific aim was construction of a dataset that identified published studies and regulatory documents that mention completed, underway or planned DNT studies. This included documents which use read across as well agency waivers for DNT studies. The second aim identified those documents from Aim 1 that report the results of completed DNT studies. The third aim identified DNT studies that provide regulatory reviews with summary data. A total of 1648 documents were found from the overall search that had evidence of, 1) a completed, ongoing, or planned DNT study; 2) a read-across or planned read-across; or 3) a waiver. The 1648 documents included 324 DNT study citations. Final filtering of these data yielded a list of 153 DNT studies conducted on 144 chemicals and one stressor (diet restriction) for which there were both extensive data summaries and regulatory reviews. These results likely undercount the number of conducted studies due to the limited release of information from many regulatory agencies. In addition, the amount of information provided publicly available reviews ranges widely, from a one sentence summary to an extensive review with summaries of the methods, results and data interpretations. It is hoped that this paper will persuade regulatory agencies to release more DNT studies that provide comprehensive information. This will foster transparency and ensure public confidence in regulatory decisions. In addition, these results should provide data that promotes comparisons between in vitro and in vivo DNT methods.

Ontologies define the main concepts and relations of a domain and can play the role of common language between domain experts, software developers and computer systems, allowing for easier and more comprehensive data management. Ontologies can provide a structure and context for data, enabling better analysis and decision-making. Ontologies can be leveraged for improving various Machine Learning-based tasks (they can be used for improving the accuracy and consistency of training data, and we can combine ML-based predictions with ontology-based reasoning). Ontologies are key components for achieving semantic data integration. In the context of this deliverable, we have surveyed 40 ontologies and 7 other knowledge organization systems related to food safety and we have categorized them according to a set of appropriate criteria. Subsequently we analysed the 18 case studies, that could involve ontologies, and for each one we have described the possible use of ontologies and what would be the benefit. Finally the identified case studies have been evaluated with respect to a set of criteria regarding benefits, cost and maturity.

This document describes the steps that required for creating and maintaining an ontology; for exploiting an ontology in order to describe data from one or more data sources; and for developing services and applications that provide unified access and insightful analysis on the data. The document provides the state of the art of the various tools and software components that exist and can be used for carrying out various tasks of the overall process. The components are grouped based on their intended use and for each one of them a concise description, as well as other useful details (i.e. if they are open-source, their license, etc.), are provided. For each step or task, the involved software components are also described in a table presenting their details with respect to various dimensions (e.g. open-source, license, available online, key advantages, etc.), in order to enable their quick comparison. Moreover, successful examples of semantic data integration are presented, i.e., for cases where a top-level ontology is used for integrating data for the cultural and biodiversity domain, and services for large-scale semantic data integration (including hundreds of datasets from several domains). Furthermore, it provides the high-level architectural suggestions that can be used as a basis for the actual implementation of any ontology-based system; the described processes and tools can be exploited for the development of the ontology-based functionality. Finally, it offers the adaptations of the proposed architecture for the EFSA case studies, by providing details about their components and indicative pipelines and tools.

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.