European Commission Research Articles

The content and associated health risk assessment of toxic elements, micro-, and macrominerals in common carp, Wels catfish, and silver carp from the Danube River in Serbia.

Three fish species (common carp, Wels catfish, and silver carp) were collected from three locations along the Danube River in Serbia, and fish meat was analyzed for the content of toxic elements, micro- and macrominerals. Silver carp had the highest lead (Pb), arsenic (As), and cadmium (Cd) content, while Wels catfish had the highest level of mercury (Hg). Moreover, metal pollution index (MPI) ranged from 0.1096 to 0.275 and among the fish, the silver carp had the highest MPI (from 0.21 to 0.28), indicating that it could be reliable bioindicator of river pollution. Maximum determined levels of As (0.1968mg/kg of w.w.), Hg (0.175mg/kg of w.w.), and Pb (0.0315mg/kg of w.w.) did not exceed values prescribed by the European Commission Regulation, Codex Alimentarius Commission, Food and Agriculture Organization (FAO), and national regulations, but Cd in silver carp was at levels higher than prescribed (0.0808mg/kg of w.w.). Furthermore, our study's results showed that the target hazard quotient (THQ) of each analyzed element and hazard index (HI) were < 1, indicating that consumers would not be exposed to adverse health effects after consuming these fish species from the Danube River. Regarding target cancer risk (TR), for Pb this was below 10-6, which was regarded as negligible, while TRs for As and Cr were between 10-4 and 10-6, which was regarded as acceptable. Moreover, since the studied fish had low values of health risk indexes, it could be concluded that fish meat did not pose a significant risk to human health.

Guidelines International Network: Principles for Use of Artificial Intelligence in the Health Guideline Enterprise.

Artificial intelligence (AI) has been defined by the High-Level Expert Group on AI of the European Commission as "systems that display intelligent behaviour by analysing their environment and taking actions-with some degree of autonomy-to achieve specific goals." Artificial intelligence has the potential to support guideline planning, development and adaptation, reporting, implementation, impact evaluation, certification, and appraisal of recommendations, which we will refer to as "guideline enterprise." Considering this potential, as well as the lack of guidance for the use of AI in guidelines, the Guidelines International Network (GIN) proposes a set of principles for the development and use of AI tools or processes to support the health guideline enterprise. A GIN working group on AI developed these principles, informed by the results of a scoping review and practical examples, through iterative discussion. Eight principles were identified to adhere to when using AI in the guideline context: transparency, preplanning, additionality, credibility, ethics, accountability, compliance, and evaluation. These complementary principles are described in a comprehensive way, but they do not provide detailed instructions on how to use specific AI tools. Although these principles are expected to apply across different contexts and stages of the guideline enterprise, details on their implementation have some degree of flexibility. Guideline development groups choosing to use AI will be able to adequately implement the principles if they ensure aspects such as structured reporting on the use of AI tools, involvement of experts in AI, and allocation of funding for the adequate use of AI tools. The GIN principles may support guideline developers in the responsible and transparent use of AI to ensure trustworthy guidelines.

The Derivation of Acute and Chronic Environmental Quality Standards for Nickel in European Surface Waters: A Demonstrable need to follow scientific evidence.

Environmental Quality Standards (EQS) derived under the European Water Framework Directive are legally binding and enshrined in individual European Member State Country national legislation. These EQS are derived following well-established guidance documents. In 2013, EQS for nickel were derived for freshwaters to be protective against long and short-term exposures, at 4 and 34 µg L-1, respectively. The value for long-term exposures uses chronic ecotoxicity data and accounts for bioavailability, whereas the short-term value uses acute data and does not account for bioavailability. In 2022, the European Commission revised these values as part of the on-going legislative process. Despite an increase in available data for both chronic and acute ecotoxicity endpoints, the update and development of chronic and acute Biotic Ligand Models (BLMs) published in peer-reviewed literature, and the accessibility of vastly more monitoring data (used in the European EQS derivation), the values for the nickel EQS were reduced by increasing the assessment factors, to account for increases in apparent uncertainties. The Commission's 2022 derivation failed to consider additional chronic data for more than 20 species as well as the updated and new acute and chronic BLMs. As a result, the derived nickel EQS is limited in its applicability and relevance to European freshwater ecosystems, as illustrated in practice by the observation that monitoring sites can comply with the chronic EQS but fail the acute EQS. Here, we provide an explanation as to why this has occurred and detail what it means for the risk assessment of nickel in European Member State freshwaters. Finally, we outline a path forward, that should be relevant for any risk-based and evidence-driven regulatory framework and acknowledging that political decisions are part of the process, but that these should be separate and after scientific aspects are undertaken.

Unravelling the Southern Neighbourhood Dynamics of the European Research Area: Dynamics of the European Research Area: Tailored Positive External Differentiation and SegmentationTailored Positive External Differentiation and Segmentation

This article explains how the European Commission steers the incorporation of entities from specific geographic areas and specialising in specific thematic domains into international research-intense projects through detailed guidance elaborated in the documentation of open calls for project applications. This hoop-test guided process tracing study aims to better understand what factors come into play in the formation and facilitation of the engagement of the European Southern Neighbourhood-based entities in the European Research Area through projects funded by the European Union’s Framework Programmes. This category-driven, qualitatively-oriented text analysis is based on the coding of various policy-relevant geographic reference points to clarify the exact contextual background that played a decisive role in including entities from Morocco and Tunisia in project consortiums.

Self-reported preferences for seasonal daylight saving time meet fundamentals of human physiology: Correlations in the 2018 public consultation by the European Commission

ABSTRACT We analyze the results to question 2 (individual preferences for cancelling or keeping the current clock regulations) from the 2018 Public Consultation on summertime arrangements (DST) conducted by the European Commission. We reveal correlations in the shares of population for cancelling the regulations and the winter sunrise time (SRW) [R 2 = 0.177; p = 0.03; N = 25] and the onset of human activity [R 2 = 0.677; p = 5 × 10−5; N = 17]. The results are in line with the rationale behind the regulations in the range of latitude 35 to 63: larger values of SRW (larger latitude) brought larger shares against the regulations; and earlier onset of human activity relative to SRW brought larger shares against the regulations. The shares for cancelling the regulation did not show correlations with time offset (position in time zone), thus challenging the current view within the circadian community.

Digital Product Passport Design Supporting the Circular Economy Based on the Asset Administration Shell

This paper investigates the design of a digital product passport (DPP) model based on the asset administration shell (AAS) framework to support the circular economy while ensuring cross-industry applicability. In a circular economy, resources are continuously reused, fostering more sustainable manufacturing. The European Commission’s initiatives target this issue, with the DPP playing a critical role in sharing product sustainability information, such as product composition and repairability, throughout its lifecycle. However, a widely applicable DPP approach has yet to be established. This study consolidates existing standards, and scientific literature to develop a data model that aligns with circular economy principles. Using the AAS framework initially developed by the Plattform Industrie 4.0, we mapped the data requirements to submodel templates and addressed gaps in the data needed for real-life implementation. The results demonstrate that the proposed DPP data model is specific enough for practical use cases, such as the upcoming EU battery passport, while remaining flexible enough for application across various industries. The AAS framework’s adaptability and comprehensive data exchange capabilities make it a suitable foundation for developing DPPs that support the transition to a circular economy.

Vliv judikatury Evropského soudu pro lidská práva na harmonizaci trestního řízení v Evropě

The European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) is a standard-setting instrument for questions related to criminal procedure. Several ECHR provisions refer to the principle of fair trial, personal freedom, non-retroactivity, the right to appeal in criminal matters, and the right not to be tried or punished twice. With respect to the practice of human rights protection in Europe, jurisprudence developed by the European Court of Human Rights (ECourtHR) has crucial impact on the current understanding of those procedural standards. The importance of Strasbourg case-law for the development of common European rules is unquestionable. The practice of national criminal courts as well as national legal doctrine has been heavily influenced by judgments of the ECourtHR. The systematization of case-law concerning criminal procedure is today considered to be an import task of European and national criminal law experts. In this article several factors limiting the impact of Strasbourg case-law on the harmonization of criminal procedure law have been pointed out. The heterogeneity of 47 different European legal orders and the flexible way of implementation of ECourtHR judgments complicates the development of precise rules which are foreseeable to lawyers in European countries. The case overload crisis of the ECourtHR which has been deepening in the past years also may significantly weaken the mechanism and its impact on harmonization. In general, criminal procedure rules formulated by the ECourtHR are mostly regarded as minimum standards. Since the adoption of the Amsterdam Treaty there have been discussions and projects concerning the harmonization of criminal procedure within the European Union. A proposal for a framework decision on certain procedural rights in criminal proceedings throughout the European Union has been presented by the European Commission in 2004. The future of the proposal is uncertain as several EU member states oppose the idea of a legally binding instrument on criminal procedure rights. In any case, a new EU instrument of harmonization has to respect the standards already set out by the ECourtHR.

Bonos verdes para financiar la inversión socialmente responsable: un análisis bibliométrico

Sustainable finance has grown in importance in recent years due to its close relationship with sustainable development and the estimated large investment needs. After a long period of near-zero interest rates, we have witnessed a change in the scenario in the last two years, so it is important to know how this may affect the transition to a sustainable economy. To approach this object of study and contextualize it, a bibliometric analysis is carried out, using the Web of Science database, on: sustainable finance, Socially Responsible Investment and green bonds. The evolution of publications, the most active countries, the most relevant institutions and authors, the most researched topics, the most cited articles and the relationship of these three areas with the Sustainable Development Goals have been analyzed, in order to try to detect trends, omissions and research opportunities. The analysis reveals that sustainable finance is highly associated with climate aspects and green bonds, that the performance of green bond portfolios and other sustainable financial assets is a widely researched issue, and that the European Union is very active in knowledge generation, also having a long history in this object of study, supported by both the regulatory and institutional framework, and driven by the European Green Deal presented by the European Commission in 2019 and the Action Plan against Climate Change of the European Central Bank in 2021.

Certified reference materials for GMO analysis-more than 25 years of GMO CRM production at EC JRC.

Certified reference materials (CRMs) play a crucial role in ensuring the quality of analytical measurements. Particularly, the EU labelling legislation on genetically modified organisms (GMOs) in food and feed products explicitly requires CRMs for its implementation. The CRMs are used to calibrate and control the quantitative real-time polymerase chain reaction (qPCR) method and support official control laboratories, such as National Reference Laboratories (NRLs), in maintaining their ISO/IEC 17025 accreditation. The Joint Research Centre of the European Commission (EC JRC) is specialized in the production of reference materials and has been producing GMO CRMs since 1998. Together with a validated event-specific qPCR method, these GMO CRMs form the EU reference system for the quantification of EU-authorized GMO events in food and feed products and ensure a common GMO labelling threshold. This article gives a retrospective view on the more than 25 years of GMO CRM production at JRC. It describes requirements for GMO CRMs in view of an EU market authorization under (EC) No. 1829/2003. The evolution and major improvements of the production of GMO CRMs at JRC are summarized as well as the current understanding of theEU's GMO reference system for GMO quantification and its impact on commutability. It provides insights into GMO CRM sales and their worldwide distribution. This information may be useful for policymakers and researchers in understanding the current EU GMO measurement landscape and to anticipate possible future demands related to GMO events based on new genomic techniques (NGTs).

Intra-Community VAT Fraud: Is It Really a 50 Billion Euro Problem?

In this article, the authors investigate whether intra-Community VAT fraud remains a EUR 50 billion problem in the European Union today. The authors argue that the methods used for estimating the intra-Community VAT fraud gap are flawed and seem structurally too high, and that the intra-Community VAT fraud gap should show a decline, rather than the constant EUR 50-60 billion it is often assumed to be. In the meantime, these “fixed” figures still drive policy changes. In recent years, the European Commission and the Member States have indeed implemented several measures to fight intra-Community VAT fraud. However, not all measures specifically target intra-Community VAT fraud. The authors argue that some new VAT measures lack substantiation and advocate for deeper analysis of the potential impact of specific measures on specific groups of taxable persons in order to better justify new VAT policies.

P0008 A multi-omics approach across multiple chronic inflammatory diseases identifies a distinct type-1-interferon endotype of Inflammatory Bowel Disease

Abstract Background IBD shares many clinical and immunological features with other chronic inflammatory diseases (CIDs) like rheumatoid arthritis (RA) and psoriasis (Pso). Extraintestinal manifestations, particularly in the joints and skin, often overlap with these CIDs. We hypothesize that a systems medicine approach involving omics-driven phenotyping of multiple CIDs can yield a novel, therapy-relevant molecular taxonomy of disease. In this study, we aim to identify IBD-specific molecular signatures and those shared with other CIDs, as well as novel endotypes of IBD. Methods We recruited a cross-sectional cohort of 650 patients with CIDs (CD, UC, RA, Pso, psoriatic arthritis [PsA], and systemic lupus erythematosus [SLE]) along with 202 healthy controls (HC) at the University Hospital Kiel. Active or inactive disease was defined by clinical activity scores (i.e., CD: CDAI &amp;lt;150; UC: partial Mayo ≤2). Blood samples were collected and subjected to RNA sequencing and methylation profiling. Detailed clinical phenotypes and 5 years-follow-up data were obtained by chart review. We conducted differential gene expression and methylation analyses comparing each CID with HCs to identify shared molecular signatures. Core (activity-independent) signatures were defined by the overlap of differential expression in both active vs. HC and inactive disease vs. HC. Biclustering methods (UnPaSt) were used to uncover distinct patient endotypes based on expression profiles. Results IBD shared the most differential signatures with RA, indicating common pathways in their pathogenesis. Core signatures upregulated across all CIDs correlated with DNA methylation changes, reflecting the molecular mechanism of chronicity, and were enriched in pathways related to cytokine signaling, neutrophil chemotaxis, and humoral immune response. While methylation signatures in enhancer regions were shared among most CIDs, disease-specific methylation was mainly located in CpG islands. One disease-overarching subgroup of 71 patients with active disease, identified by biclustering, exhibited upregulation of interleukin-27 and type-1 interferon signaling, including 16 out of 121 active IBD patients with a skewed sex ratio toward females and higher rates of therapy escalations within 5 years (Log-rank test: p=0.0089). Conclusion Our study highlights shared and disease-specific immune dysregulation pathways contributing to the pathogenesis of IBD and other CIDs. We show the clear presence of core signatures of disease regardless of disease activity, which could represent insights into actionable targets for causative treatments and better disease control of CIDs. With our approach, we identified a distinct molecular endotype of IBD with worse prognosis, warranting further validation studies. References This project has received funding from the DFG Cluster of Excellence 2167 "Precision medicine in chronic inflammation", the BMBF (e:Med Network iTREAT 01ZX2202A), the European Union/Horizon2020 (SYSCID, No 733100) and the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 831434 (3TR) and No 853995 (ImmUniverse).The JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. The content provided in this publication reflects the author's views only. Neither the Innovative Medicines Initiative (IMI JU) nor the European Commission are responsible for any use that may be made of the information it contains.

Aspects of Convergence in the EU’s Renewed Strategic “Vision” of the European Administrative Space

The set of “overarching principles” and shared values of member states, known as the “European Administrative Space”, from various documents of the European Commission and SIGMA, was revised in 2023 to adjust and upgrade the existing framework to the most recent practices and guidelines established by the OECD, the EU, and other international organizations. The present article explores this renewed vision of the consolidation of the European Administrative Space and the instruments that the European Union, especially the European Commission, will use to expand cooperation and offer support to Member States in planning and adapting their public administrations’ reforms for the current and future needs of their societies.

P0918 Identification of a serum proteomics signature linked with anti-TNF therapy response outcomes in Inflammatory Bowel Disease

Abstract Background While treatment options for active disease in IBD become diverse, the choice of therapies is mostly based on patient characteristics, disease course and severity but restrained by economic rationales. To maximize treatment effectiveness, predictive biomarkers are needed to guide therapies either ex ante or at the earliest possible time point after therapy initiation. Previously, we identified dynamic blood-based RNA and DNA methylation signatures that are linked with therapy response to anti-TNF in IBD1. Here, we aim to identify serum proteome biomarkers associated with therapeutic outcomes in IBD patients receiving anti-TNF treatment. Methods 31 ulcerative colitis (UC) and 27 Crohn’s disease (CD) patients with active clinical and endoscopic disease were recruited and followed at baseline (W0) and at weeks 2 (W2), 6 (W6), and 14 (W14) after initiating infliximab therapy. The clinical endpoint of interest was defined as a combination of clinical remission (partial Mayo ≤ 2/CDAI &amp;lt; 150) and endoscopic response (reduction in endoscopic Mayo ≥ 1/SES-CD ≥ 50%) at W14. Serum was collected at each time point and subjected to proximity extension assays (Olink® Explore 3072 panel) to screen for 2,944 proteins. Linear mixed models (LMM) were applied to identify differentially expressed proteins (DEPs) between endpoint achievers/non-achievers over time. Additionally, post-analysis of DEPs was performed using cv.glmnet with least absolute shrinkage and selection operator (LASSO) regression to identify candidate predictive marker sets. Results A total of 229 DEPs were identified over time between UC responders and non-responders: 8 at W0, 22 at W2, 181 at W6, and 78 at W14. In CD patients, 23 DEPs were identified: 9 at W0, 7 at W2, 13 at W6, and 13 at W14. These DEPs were disease-specific and linked to Gene Ontology (GO) terms related to inflammatory response and cell differentiation. Using LMM and machine learning, we identified 5 baseline proteins in UC and 6 in CD patients that differentiated combined endpoint achievers from non-achievers (AUROC: UC: 0.958, CD: 0.800). Additionally, we identified dynamic changes from W0 to W2 in 7 proteins associated with immune regulation in UC patients (1 in CD), which were linked to therapeutic outcomes at W14. Conclusion Detecting specific ex ante biomarkers or early dynamic molecular signatures are critical for precision medicine in IBD. Our data suggest that serum proteomics profiling enables the differentiation of patients who will attain therapeutic success under anti-TNF therapy from those who will not. This study warrants further investigations in larger, independent datasets to confirm the potential clinical utility of the proteomics signature. References (1) Mishra N, et al. Longitudinal multi-omics analysis identifies early blood-based predictors of anti-TNF therapy response in inflammatory bowel disease. Genome Med. 2022 Sep 24;14(1):110. doi: 10.1186/s13073-022-01112-z. PMID: 36153599; PMCID: PMC9509553. This project has received funding from the DFG Cluster of Excellence 2167 "Precision medicine in chronic inflammation", the BMBF (e:Med Network iTREAT 01ZX2202A, and GUIDE-IBD 031L0188A), and the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 831434 (3TR) and No 853995 (ImmUniverse).The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The content provided in this publication reflects the author’s views only. Neither the Innovative Medicines Initiative (IMI JU) nor the European Commission are responsible for any use that may be made of the information it contains.

P0565 Spatial Metabolic Profiles in Ulcerative colitis patients determine response to therapy

Abstract Background Ulcerative Colitis (UC) is an heterogenous debilitating disease without a cure. The step-up therapy approach aims at controlling and alleviating intestinal inflammation by achieving and maintaining clinical and endoscopic remission. However, the rate of primary non-response or loss of response to therapies is still high. Predictive markers that accurately guide decisions about the best therapeutic choice are an unmet need. This study aims to determine the intestinal metabolic profiles of UC patients and explore differences in response groups of given treatments, thus helping a better patient stratification. Methods Mucosal biopsies collected from active UC patients (N=26) at week 0 and 14 after treatment (vedolizumab, tofacitinib and filgotinib) were sectioned at 10 µm thickness. Patients were classified as non-responders (NR), responders (R) and super responders (SR) based on both endoscopic and partial Mayo scores. Sections were processed by matrix-assisted laser desorption/ionization (MALDI) coupled with Orbitrap Exploris™ 120 Mass Spectrometer. Raw spectral data was processed with MSConverter and MSIpixel for metabolite quantification and annotation. Comprehensive statistical analyses including quantitative metabolite distributions, Moran’s I spatial correlations and pathway enrichment analysis were performed via an in-house developed computational pipeline. Results Spatial metabolomic analysis revealed different metabolite patterns between R and NR across all drugs. Notably, all non-responders exhibited a dysregulated lipid metabolism. In the Vedolizumab group, a fragmented pattern distribution of metabolites was found in NR characterized by an increase of canavalmine, N1-acetylspermidine and heptanenitrile at week 0, whereas SR showed a significant tissue reorganization environment, with increased number of metabolites such as LysoPA, LysoPE and 5alpha-Cholesta-7,24dien-3beta-ol, involved in anti-inflammatory pathways, as well as glutathione and purine metabolism. Additionally, SR showed histamine- and IgE-related pathways supporting cellular regeneration. Conclusion Overall, these data depicted the alteration of mucosal lipid metabolism as a hallmark of non-response to therapies, and evidenced that the effectiveness of a specific treatment in UC is impacted by the initial mucosal metabolic state conditioned by diet and medications. The validation of these results in a larger sample size will aid the prediction of therapy response. References ImmUniverse project: this project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 853995. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The content provided in this abstract reflects only the author's view and neither the IMI JU nor the European Commission are responsible for any use that may be made of the information it contains.

P0455 An eosinophilic endotype of ulcerative colitis is linked with a more complicated disease phenotype

Abstract Background The course, extent, and therapeutic response in ulcerative colitis (UC) are highly heterogeneous. The spatial and immunological variability of chronic inflammation in UC may explain the inconsistent responses to advanced therapies. Eosinophils are found in both inflamed and non-inflamed tissue at varying numbers, though their exact role in UC pathophysiology and clinical significance is still unclear, despite being part of the Geboes score criteria. We therefore aimed to systematically assess the clinical characteristics of UC patients with tissue eosinophilia as reported by pathology, hypothesizing that this group represents a molecularly distinct sub-entity of UC. Methods We screened all pathology reports from endoscopies performed on IBD patients at the University Hospital Schleswig-Holstein (UKSH, Kiel), between 2010 and 2022. Of 10,552 reports, we identified 179 cases with confirmed UC diagnosis, informed consent, and sufficient clinical and follow-up data. Clinical data extracted from electronic medical records included baseline demographics, histo-endoscopic disease activity, routine blood markers, and 24-month follow-up for UC-related hospitalization, surgery, and therapy escalation (with advanced therapies or systemic steroids). A molecular cross-sectional UC cohort (n=587) recruited at UKSH during the same period served as the control group. Early disease was defined as a disease duration of less than 24 months with no prior advanced therapies. Results Patients with tissue eosinophilia were younger (median age: 36 vs. 42 years, p=0.0095), had a lower BMI (25.20 vs. 33.90 kg/m², p&amp;lt;0.0001), higher blood eosinophil counts (0.20 vs. 0.09 /nL, p=0.0003), elevated CRP levels (3.88 vs. 2.47 mg/L, p=0.0342), and higher Endoscopic Mayo Scores (2 vs. 1, p=0.0003) compared to controls. However, the Nancy Histology Index (2 vs. 2, p&amp;gt;0.05) as well as the sex ratio (male sex: 56.42% vs. 57.99%; p&amp;gt;0.05) was similar between the groups. Within 24 months of follow-up, the tissue eosinophilia group had a higher likelihood of disease-related hospitalization (Log-rank test: p=0.0029) and UC-related surgery (p=0.0223). When stratified by disease phase, these findings were significant only in patients in the late disease phase (hospitalization: p=0.0345; surgery: p=0.0012). Conclusion Tissue eosinophilia in patients in the later stage of their disease is associated with worse long-term outcomes, such as UC-related hospitalization and surgery within 2 years. These findings hint towards the existence of a type-2 immunity-associated endotype of UC. Further studies on eosinophil count and their activation states are needed to define functional signatures of this novel group of patients that might benefit from therapies targeting type-2-cytokines. References This project has received funding from the DFG Cluster of Excellence 2167 “Precision medicine in chronic inflammation”, the BMBF (e:Med Network iTREAT 01ZX2202A), EKFS (2022_EKMS.23), the PATHWAYS Global Innovation Grant program (Sanofi &amp; Regeneron), and the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 831434 (3TR) and No 853995 (ImmUniverse).The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The content provided in this publication reflects the author’s views only. Neither the Innovative Medicines Initiative (IMI JU) nor the European Commission are responsible for any use that may be made of the information it contains.

Mycotoxins in Cheese: Assessing Risks, Fungal Contaminants, and Control Strategies for Food Safety

According to the scientific information reviewed, cheese is highly susceptible to contamination by mycotoxin-producing fungi, primarily species from the genera Aspergillus (A. niger, A. flavus) and Penicillium (P. commune, P. solitum, P. palitans, and P. crustosum). Studies on various types of cheese made from cow’s milk report an average concentration of Aflatoxin M1 (AFM1) at 13,000 ng kg−1, which is alarming since the regulatory limits for AFM1 in cheese range from 250 to 500 ng kg−1. For instance, limits set by Codex Alimentarius, the European Commission (EC), Turkey, and Iran are 250 ng kg−1. In the Netherlands, the limit is 200 ng kg−1, and in Italy, it is 450 ng kg−1. However, the concentration of mycotoxins frequently exceeds these regulatory limits, including critical mycotoxins such as ochratoxin A, citrinin, and cyclopiazonic acid, which pose significant global health concerns. Therefore, this study aims to review the mycobiota responsible for producing key mycotoxins in cheese and to assess the influence of physicochemical factors on fungal growth and mycotoxin production. By incorporating control strategies such as hygiene practices, pasteurization, and the use of preservatives, this study seeks to improve methodologies in the cheese production chain and mitigate contamination by fungi and mycotoxins.

DOP120 Low-intensity Pulsed Ultrasound Modulates Metabolite Release Reflecting the Inflammatory Status of Colonic Mucosa

Abstract Background Recently, we investigated Low-Intensity Pulsed Ultrasound (LIPUS) as a non-invasive and safe method to identify circulating biomarkers that reflect the colonic mucosal status in experimental colitis models. Here, we evaluate the capability of LIPUS to reveal a wide spectrum of tissue-derived proteins and metabolites as potential biomarkers of colitis. Methods Acute colitis was induced in 10 female C57B6N mice by ad-libitum administration of 2,5% dextran sodium sulfate (DSS) for 7 days. Colon-focused LIPUS stimulation (38 kHz, 150 mW/cm2, 20% duty cycle, 3 minutes) was applied at day 7 of colitic and healthy mice. Blood samples were collected 2 hours post-LIPUS exposure and plasma was analyzed by Olink® proteomics and LC-MS untargeted metabolomics. STRING database and Metabolite Enrichment Analysis Set (MSEA) were used for comprehensive pathway evaluation of proteins and metabolites. Results As expected, DSS-treated murine plasma displayed altered proteomic and metabolomic profiles compared to healthy controls at baseline, with a significant exacerbation of IL-6, IL-17A and TNF-family inflammatory mediators, tryptophan intermediates and microbial metabolites. LIPUS did not alter the cytokine profile observed before stimulation. However, microbiota-associated compounds involved in tryptophan, glutamate and riboflavin pathways, as well as phospatidylcholine (PE) family members, such as Lyso-PE, were significantly enhanced in the blood of colitic mice after LIPUS stimulation, conceiving the inflammatory status of the intestinal mucosa. Conversely, LIPUS stimulation in healthy mice upregulated circulating factors (Tnni3, Dlk1, lgmn and Kitlg) which are expressed by intestinal epithelial cells and that play a role in the epithelial-immune cell crosstalk. Nucleoside precursors of the pyrimidine metabolism and galacturonate involved in the vitamin C synthesis, which are potentially involved in intestinal mucosa homeostasis, were also significantly increased after LIPUS stimulation in healthy mice plasma. Conclusion LIPUS differentially enhances the release of specific metabolites based on the inflammatory status of the colonic mucosa. Thus, uninflamed LIPUS-stimulated intestinal mucosa releases proteins indicative of mucosal health, whilst injured intestinal mucosa readily discharges metabolites associated with the inflammatory process. This suggests the potential utility of LIPUS as a non-invasive diagnostic tool for gut inflammation assessment, improving diagnostic accuracy and efficiency in patients with colonic disorders. Further research is needed to validate these findings in humans for clinical parameter correlation. References ImmUniverse project: this project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 853995. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The content provided in this abstract reflects only the author's view and neither the IMI JU nor the European Commission are responsible for any use that may be made of the information it contains.

STRATEGIC NOISE MAP FOR BELGRADE NIKOLA TESLA AIRPORT

Environmental noise management is a critical aspect of public health policy, particularly within the European Union, which established Directive 2002/49/EC to standardize noise assessment and mitigation efforts across member states. Serbia has integrated the Directive's provisions through its Law on Environmental Noise Protection and accompanying by-laws. This paper presents the strategic noise mapping process for Belgrade Nikola Tesla Airport, Serbia's largest international airport, marking a significant milestone as it is the first time a strategic noise map is being developed for a major airport in Serbia. The legal framework, methodology, and results of this mapping process are discussed in detail. Utilizing the CNOSSOS-EU:2015 method and the Aviation Environmental Design Tool (AEDT) for acoustic calculations, the study defines the affected areas, noise indicators, and population exposure based on 2023 air traffic data. The results indicate that the Lden noise levels exceeding 55 dB impacted 24,223 residents, while the Lnight noise levels exceeding 50 dB affected 7,493 residents. The analysis also includes the estimated number of dwellings, schools, hospitals, and people affected by different noise levels, providing necessary data for developing action plans aimed at mitigating noise pollution. Additionally, the study examines the potential health impacts, including population annoyance and sleep disturbance, using dose-effect relationships as defined by the European Commission. The results underline the importance of ongoing noise monitoring and the need for timely revisions of strategic noise maps and action plans to ensure compliance with both national and EU regulations. This research contributes to the broader effort of environmental noise management, offering insights into the methodologies and challenges of strategic noise mapping for airports in Serbia.

Public knowledge, attitudes, and practices regarding antibiotics use and resistance in Montenegro.

A drug consumption monitoring revealed that Montenegro is one of the major consumers of antimicrobial drugs in Europe. The aim of this study is to obtain the first data on the knowledge, attitudes, and practices of the general population in Montenegro regarding antibiotics use. This cross-sectional study was designed according to the methodology of Eurobarometer survey on antimicrobial resistance, created by the European Commission. The standardized questionnaire was conducted in Podgorica, in October-November 2022. A total of 532 participants completed the questionnaire. More than a half of responders (60.9%) have received antibiotics within the last 12 months and among them 33.4% was missing a medical prescription, nor the antibiotic was administered by a medical practitioner. The rest of the responders mostly had some antibiotics left over from a previous course (13.0%), had taken it from a pharmacy (11.4%), or elsewhere without a prescription. The most frequent reasons for antimicrobial therapy were "cold" (22.5%), "sore throat" (21.0%), "cough" (19.4%), and "COVID-19" (coronavirus disease 2019) (17.9%). Throat swab, blood test, urine test, or other test that could identify the cause of the illness preceded antimicrobial therapy in 46.3% participants. Only one-half of the participants were convinced that antibiotics are ineffective in viral infection treatment. This study is the first report on public knowledge, attitudes and practices regarding antibiotics use and resistance in Montenegro and it highlights the need for the knowledge improvement among general population, better regulations for antibiotics procurement and a campaign regarding appropriate antibiotics use among youth.

Spatial identification of regions exposed to multi-hazards at the pan-European level

Abstract. The European Commission Disaster Risk Management Knowledge Centre (DRMKC) has developed and hosts a web platform, the Risk Data Hub (RDH), designed to facilitate access to and sharing of curated, EU-wide risk data, tools, and methodologies, ultimately supporting disaster risk management (DRM) initiatives. Based on the RDH data, we propose a methodology for the identification of regions with multi-hazard exposure at the pan-European level (EU27+UK). This methodology aims to support disaster risk management (DRM) decision-making processes at both national and subnational levels in the EU. By employing a meta-analysis approach and aggregating the hotspots of exposure to single hazards, we provide an objective, statistically robust assessment of the European multi-hazard landscape at the finest spatial subdivision level, local administrative units (LAUs). Our results suggest that 21.4 % of European LAUs are exposed to multiple natural hazards, affecting around 87 million people (18.8 % of the European population). Furthermore, nearly half this population is exposed to more than three hazards. We find that beyond population density, the income level (i.e. high, medium, low) is the primary driver that influences risk status at the local level, within both rural and urban areas. On average, we find higher multi-hazard exposure for people living in high-income urban areas or low-income rural areas. We further validate our results by comparing them with empirical data on fatalities and disaster events, revealing a relatively high correlation between statistically significant multi-hazard hotspots and fatalities (r=0.59). By providing a detailed assessment of multi-hazard exposure at the pan-European scale, this study contributes to a better integration of multi-hazard risks in European disaster risk management plans.