EFSA Supporting Publications最新文献

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.

The EFSA Animal Health and Welfare (AHAW) Network includes two subgroups: 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 beef cattle, including castration, disbudding, dehorning and tail docking, across different countries. Prior to the meeting, a questionnaire was distributed to the Network members to collect comprehensive data on these practices, including information on methods employed, age of the animals at which the procedures are performed, the individuals responsible for carrying the mutilation (including their qualification or training) and use of anaesthesia, sedation, and analgesia. Network members in the meeting discussed the questionnaire responses in depth, contributing with additional insights (e.g. on eventual measures adopted to reduce the need for mutilations) and clarifications. This exercise resulted in a comprehensive overview of current mutilation practices in beef cattle farming across the represented countries. The information included in this report will be considered for the risk assessment of the scientific opinion on the welfare of beef cattle on farm, expected to be delivered by the EFSA AHAW Panel in 2025.

Despite national and international efforts to prevent non-indigenous species’ introductions, the spread of transboundary plant pests has increased dramatically in recent years, and it seems inevitable that many more species will enter the EU in the future. Identifying plant pests’ entry points may offer some early insights to prevent new plant pest invasions and support the surveillance activities carried out in the EU territory. This document was prepared in the context of the EFSA grant GP/EFSA/ENCO/2020/02 and represents the final report of the “HoPPI: Hotspots for plant pests introduction” project. The main objectives of the project were to: i) make an inventory of the pests introduced in the EU in the last two decades; ii) identify hotspots of pests introduction in the EU; iii) identify and analyse the factors that determine their occurrence; iv) understand the role of world trade in affecting risk of introduction using network analysis; v) develop a tool for standardising the pathway model used for the entry step of the quantitative pest risk assessments carried out by EFSA. To meet Objective i, a dataset containing a comprehensive list of pests’ first introduction records in the EU between 1999 and 2019, was compiled. The final database includes 278 pest species introduced in the EU, as well as detailed information on the specific species, their origin, and the pathways through which they might have entered the EU. The identification of hotspots and factors in Objective ii and iii was performed using two different methodologies, Getis G* and a Bayesian hierarchical spatial model, that pinpointed specific regions within the EU that are particularly vulnerable to plant pest introductions, uncovering environmental, climatic, and anthropogenic factors contributing to the introduction of pests in specific regions. The application of network analysis in Objective iv sheds light on the intricate connections between international trade routes and the introduction of plant pests into the EU. The results highlight key pathways and trade networks that pose a higher risk of facilitating pest entry. In pursuit of Objective v, an R package named “qPRAentry” was developed.

Highly pathogenic avian influenza (HPAI) poses a significant threat to both poultry and wild birds. To help tackle this challenge, an early warning system for HPAI in wild birds based on spatio-temporal risk mapping, the Bird Flu Radar, has previously been developed by EFSA. This work focuses on the expansion of the existing model to assess the risk of introduction and establishment of HPAI in poultry. First, a literature review was conducted to identify the risk factors for virus introduction from wild birds into poultry farms and the availability of associated data in Europe. Second, a theoretical modelling framework was developed to assess, on a grid of 50 x 50 km cells, the relative weekly probability of HPAI introduction in at least one domestic poultry flock because of infectious wild birds. This probability was estimated as the combination of two probabilities: the probability of HPAI entry into the flock and the probability of HPAI establishment in the domestic poultry population. The model outcomes are computed for all farms together but also for twelve types of farms separately. Farm types were defined based on their production type and poultry species kept. Italy and France were used a case study to test the model performance over one year of data (February 2023 to March 2024), comparing model predictions with outbreaks reported as primary outbreaks in the European Union (EU) Animal Disease Information System (ADIS). For Italy, the model performances were good, with all the outbreaks being detected in areas within or close to high-risk spatio-temporal units. The results obtained for France were more mixed: several outbreaks were reported in high-risk areas, but some were missed, apparently due to the high influence of some key model parameters and geographical specificity. Indeed, all the outbreaks reported in Southwest France were not predicted by the proposed model. These first results are encouraging, but future work should focus on finding ways to adjust certain model parameters and to improve the assessment of model performance considering a longer time period and/or including more robust input data.

The safety of novel proteins is routinely evaluated in various regulated areas of the food and feed chain, including genetically modified (GM) crops and novel foods (NFs). This project aimed to map the food and feed products containing protein from the main GM crops, relevant food categories falling under the NF Regulation, and unconventional feed, together with their production processes and to discuss the effect of the mapped processes on the safety of the corresponding novel proteins. A scoping literature review (1,325 documents included), an open online survey and a stakeholder workshop were the basis to build up the mappings for products and processes, also including operational conditions for each processing step. In the case of crops, the information gathered also helped identify more than 40 products, and the corresponding production processes, not included in the OECD consensus documents for compositional considerations of GM crops. Moreover, a systematic literature review (154 documents included), carried out within the project, assisted in the identification of the available evidence on the impact of processing on protein safety. Overall, certain processes, such as thermal treatments, fermentation, or enzymatic hydrolysis, significantly enhanced protein digestibility across various food/feed matrices. Similarly, fermentation, ensiling, and extraction processes have been shown to improve nutritional properties in various products. The data collected seemed to indicate that heating can effectively reduce the activity of NEPs from GM crops and that heating and enzymatic hydrolysis can reduce IgE reactivity for certain proteins and operational conditions. However, exceptions to these trends were also reported in the literature, and in certain cases (e.g., impact on gut microbiota), the evidence gathered was insufficient to draw substantiated conclusions. This project also contributed to identify existing knowledge gaps and research needs towards regulatory risk assessment of food and feed products containing protein.

A cross-border outbreak of Salmonella Strathcona ST2559 is ongoing in the European Union/European Economic Area (EU/EEA) and the United Kingdom (UK). From 1 January 2023 to 5 November 2024, 232 confirmed cases of S. Strathcona ST2559 have been identified in 16 EU/EEA countries according to the European case definition: Austria (33), Croatia (3), Czechia (10), Denmark (9), Estonia (1), Germany (62), Finland (3), France (23), Ireland (1), Italy (67), Luxembourg (2), the Netherlands (2), Norway (3), Slovakia (5), Slovenia (2) and Sweden (6). Twenty-nine cases were also identified in the UK. Among the travel-associated cases, the most frequently visited country was Italy.

Tomatoes were identified as the vehicle of infection in several national epidemiological investigations undertaken in response to this multi-country outbreak. Whole genome sequencing cluster analyses suggest that the outbreak strain from multiple affected countries has a recent common origin.

The epidemiological, microbiological and traceability investigations in the 2023 Austrian outbreak and 2024 Italian outbreak confirmed that small tomatoes from the Sicily region of Italy were the vehicle of infection in these two outbreaks. The same conclusion was confirmed for a historical S. Strathcona ST2559 outbreak in Denmark in 2011.

Human and food sectors should continue to conduct investigations to verify whether small tomatoes from Sicily are the vehicle of infection in all EU countries that have reported or continue to report cases in this multi-country outbreak, as other foods could also be involved in the transmission. The environment's role in the contamination of the tomatoes should also be investigated, as the outbreak strain was also identified in a farm animal in the region. Investigations to identify the point of entry of S. Strathcona – including of irrigation water – should be conducted so the appropriate corrective measures are taken to stop the contamination from spreading and prevent possible new cases.

Wild boar density has been suggested to play a role in shaping African swine fever (ASF) transmission patterns. To provide quantitative estimates of the influence of wild boar density on ASF spread, a spatially-explicit detection-delay SIR mechanistic model of ASF transmission among density-explicit wild boar habitat was developed and parameterised to observed epidemic data in northern Italy from January 2022 through September 2023. Wild boar density estimates were generated by the ENETWILD consortium. Infectious periods, local prevalence at time of first detection, detection rates, and seasonal recovery rates were estimated directly from surveillance data. Eight models were constructed utilizing static and seasonal transmission rates along with linear relationships between habitat susceptibility/infectivity and wild boar density. Transmission rate, relative susceptibility, and relative infectivity were estimated by fitting each model to the observed epidemic using sequential Monte Carlo approximate Bayesian computation. The model that most closely fit the full data used a seasonal transmission rate but did not support a wild boar density effect on ASF spread across the entire study period. However, further analyses of the model outputs suggest that wild boar density likely played a role in shaping ASF transmission patterns during the second wave only (October 2022 – September 2023). This observation could be due to a lack of power in the first wave, lower surveillance rates in that period, or be from density estimates no longer reflecting the true wild boar density distributions upon the start of the second wave. These results demonstrate that wild boar density impacted ASF propagation in northern Italy. Further investigation by estimating parameters for individual epidemic waves could be beneficial to better characterise the wave-specific impact of wild boar density. The model developed here could be used in other contexts to evaluate if the influence of wild boar density is present across epidemic scenarios.

DNT guideline-based testing requires the assessment of neurologic, behavioural, and neuropathological endpoints. A review of the impact of DNT studies on regulatory actions revealed that the most common findings at the LOAEL were change in body weight, motor activity, auditory startle response, brain weight and brain morphometrics. An important issue in the interpretation of DNT study findings is that in many of these studies use exposures that impact systemic development as evidenced by decreased body weight and/or body weight gain, especially during the early postnatal period prior to weaning. Currently, there is no international consensus on what degree of growth reduction during early development causes alterations in DNT endpoints. This includes the controversial use of changes body weight adjusted brain weights in concluding that the brain weight changes represent an adverse finding. The current effort compiled brain and body weight changes from 173 publicly available DNT studies designed in line with DNT EPA or OECD test guidelines. This allowed a simple comparison of between a decrease in neonatal body weight and a decrease in brain weight. Results from this project clearly show that developmental exposure induced body weight decreases are not a reliable indicator of whether or not brain weight decreases. From the 173 retrieved studies, 70% showed decreased body weights in pups (122 studies), but only 50 of these studies (41%) reported concomitant decreased brain weights. In addition, there were three studies that reported brain weight decreases when body weight was not changed at any age. This suggests that while changes in body weight may be a confounding factor for some studies, it fails to be a reliable predictor of alteration in brain weight. Thus, use of the ratio of brain weight to body weight is not appropriate as a common approach to dismiss brain weight as a DNT effect. Clearly an international consensus on the interpretation of brain weight changes in DNT studies is needed that takes into account the data presented herein.

This report documents the outcomes of the EFSA procurement (OC/EFSA/NIF/2022/01) aimed at identifying in vitro toxicity testing approaches for (novel) proteins in the context of food and feed safety assessment. In the present report, we present an integrated testing strategy for the evaluation of toxicity of novel/toxic proteins. A text-mining approach was used to create a literature database of toxic outcomes associated with toxic proteins retrieved from the UniProt KB database using the search term “Toxin activity”. It was shown that toxic proteins are produced by a relatively limited phylogenetic subset, including, among others, bacteria, insects, serpents, molluscs, and fungi. Toxicological effects of these proteins are generally conserved within phylogenetic groups. Analysis of toxic effects from these proteins was performed using GO term analysis as well as a text-mining based approach. Relevant tests to address and quantify these toxicity effects were identified and evaluated for their applicability in an in vitro based toxicity testing strategy. A stepwise approach was developed. As a first step, an initial in silico prediction of toxicity is carried out (Step 1). This is followed by a battery of in vitro assays to address the primary mechanisms of toxicity associated with toxic proteins (Step 2). If concern arises in the Step 2 battery of tests, the use of relevant in vitro model systems to explore potential target organ toxicity are required (Step 3). Knowledge gaps have been identified and recommendations are provided in in vitro toxicity testing strategies, in particular for (novel) proteins. Some of these gaps involve the selection and integration of a standardized, relevant in vitro digestion step, reflective of passage through the digestive tract, within the testing strategy, as well as a thorough assessment of the suitability and applicability of in vitro tests and new approach methodologies for regulatory toxicity assessment of (novel) proteins. To accelerate the incorporation of NAMs in the assessment of protein safety, case studies and proof of concept projects are needed to demonstrate the utility and effectiveness of in vitro toxicity testing strategies in the safety assessment of (novel) proteins.