Search Results (1,528)

Background/Objectives: Irritable Bowel Syndrome (IBS) is a widely prevalent chronic disorder of brain–gut interaction which represents a clinical challenge due to its complex underlying causes and the lack of a standardized treatment approach. This cross-sectional research collected real-world data (RWD) on the effectiveness, safety, and usage pattern of a natural substance-based medical device, Colilen IBS, indicated for the treatment of IBS. Methods: Surveys were conducted both in Italy and Germany with 6101 participants, including 4425 patients, 1014 pharmacists, and 662 physicians using a structured GxP web platform that allows voluntary participants to share their experiences with the device. The validated platform was designed to comply with post-market surveillance requirements of EU Regulation 2017/745. Statistical analyses included descriptive evaluations of responses to gauge overall effectiveness and safety of the device. Results: The effectiveness reported with the medical device was judged extreme or great by 79.2% of patients, with 89.2% of whom observed symptom improvement within one month. Both safety and tolerability were rated extreme or great by 90.7% of patients. Healthcare professionals reported a similar rate on the overall effectiveness, with 94.9% of pharmacists and 95.9% of physicians indicating it extreme or great. Similarly, the safety profile was corroborated by nearly all pharmacists (97.0%) and physicians (98.2%) reporting extreme or great satisfaction with both safety and tolerability of the medical device. Conclusions: This research provides RWD supporting the effectiveness and safety of the product for treating IBS. The strong coherence among patients, pharmacists, and physicians in positively rating the device’s performance suggests that this medical device represents a therapeutic option that effectively addresses patient needs while minimizing safety concerns. Continuous RWD collection is essential, as it offers insights into real-world practice and ensures ongoing confirmation of the product’s safety and effectiveness. Ultimately, this will advance IBS patient care by integrating real-world evidence into clinical management. Full article

Nowadays, biowaste valorization is a key point in the circular economy. Digestate and compost from organic waste treatment can be used as nutrient-rich fertilizers. In Europe, the use of biowaste-derived fertilizers is promoted by the European Fertilizer Regulation (EU) 2019/1009, which requires verification of their biological stability through regulated indices; however, it is not clear whether the proposed indices and threshold values indicate the same level of stability and what correlations there are between them. This study compared four biological stability indices, namely Oxygen Uptake Rate (OUR), Self-Heating (SH), Residual Biogas Potential (RBP), and Dynamic Respirometric Index (DRI), which were tested on 50 samples of compost and digestate. Overall, the results revealed that most of the compost and digestate samples were quite far from European standards. On the contrary, the RBP test seemed to be less stringent than the other indices, since a much larger number of samples was closer to or in compliance with the established threshold. Data analysis using Pearson’s coefficients showed a strong linear correlation between the indices. Nevertheless, the linear regression predictive model based on experimental data demonstrated that the indices could not represent the same level of stability, providing poor consistency and variability in the predicted values and established threshold. In particular, the DRI test appeared to be more severe than the other aerobic indices. This work could provide valuable support in improving evaluation criteria and promoting a sustainable use of compost and digestate as organic fertilizers from a circular economy perspective. Full article

Copper is a strategic raw material and an important component in electric motors, widely used across industries because of its excellent conductivity and recyclability. It plays an important role in the transformation from fossil fuel-based systems to green, electrified systems. However, substantial material losses continue throughout the lifecycle of electric motors, even with copper’s intrinsic capacity for circularity. Also, copper’s increasing demand, which is driven by the emergence of electric vehicles, industrial electrification, and renewable energy infrastructure, poses questions regarding its sustainable supply. The recovery of secondary copper sources from end-of-life (EoL) products is becoming more and more important in this context. However, it is still difficult to achieve circularity of copper, especially from industrial electric motors. This study investigates the challenges of closing the loop for copper during the lifecycle of motors in industrial applications. Based on an examination of EoL strategies, material flow insights, and practical investigation, the research pinpoints significant inefficiencies in the current processes. The widespread use of scraping as an approach of end-of-life management is one significant issue. Most of the electric motors are not built to separate their components, which makes both mechanical and manual disassembly difficult. The quality of recovered copper is thus compromised by the dominance of mixed metal shredding methods in the recycling step. This study highlights the need for systemic changes in addition to technical solutions to address copper circularity issues. It requires a focus on circularity in designing, giving disassembly and metal recovery a priority. This study focuses on circularity and its technological challenges in a value chain of copper. It not only identifies different processes such as supply chain disconnections and design constraints, but it also suggests workable solutions to close the copper flow loop in the electric motor sector. Copper quality and recovery is ultimately a problem involving design, technology, and cooperation, in addition to resources. This study supports the transition to a more sustainable and circular electric motor industry by offering a basis for directing such changes in industry practices and prospective EU regulations. Full article

The dimensions and the reduction capacity of Fe₃O₄ nanoparticles are considered to be the key parameters in achieving the successful, efficient removal of hexavalent chromium, aiming for drinking water purification. This research study focuses on the optimization of reaction parameters during the oxidative precipitation of FeSO₄ carried out in a microwave-heated plug-flow reactor, to realize the preparation of Fe₃O₄ nanoparticles with an increased reduction potential as reflected in the Fe²⁺/Fe³⁺ ratio by approximating the ideal value of 0.5. In particular, the coupling of synthesis with features that allow for control of the oxidation extent, and include the addition of a reducing agent, an increase in ageing temperature, and inhibition of aggregation, were tested as potential approaches to tune the reducing potential and overcome reported Cr(VI) capture efficiencies provided by Fe₃O₄ nanoparticles. The evaluation results showed that adding a reductant after nanoparticle formation inhibits spontaneoussurface oxidation, bringing an improvement in the Cr(VI) uptake capacity for a residual concentration equal to the new EU regulation limit, by around 40%, reaching a value of 2.15 mg/g. However, working at an ageing temperature of around 100 °C resulted in an even better performance with an uptake increase of 120% and a capacity value of 3.45 mg/g. Finally, adding nanoparticles in the form of a dispersion instead of a dried powder provides an extra 10% improvement as a consequence of limited aggregation. Full article

Methane emissions from underground coal mines are a significant source of greenhouse gases (GHGs) and a major safety concern. In highly methane-prone operations, a large proportion of emissions comes from low-content abandoned mine methane (LCAMM) accumulated in post-mining goafs, where concentrations usually stay below 30% CH₄. Building on the Research Fund for Coal and Steel (RFCS) REM project, this paper presents a cost–benefit analysis of a comprehensive scheme for capturing, transporting, and utilising LCAMM from post-mining goafs for electricity generation. The concept involves long-reach directional boreholes drilled behind isolation dams, a dedicated methane-reduced drainage system connected to a surface methane drainage station, and four 2 MWe gas engines designed to run on a 20–40% CH₄ mixture. Greenhouse gas performance is evaluated by comparing a “business-as-usual” scenario in which post-mining methane is combusted in gas engines to produce electricity without further GHG cost–benefit consideration. The results indicate that the project can achieve a positive net present value, highlighting the role of LCAMM utilisation for methane-intensive coal mines. The paper also explores the monetisation of non-emitted methane using the European Union Emissions Trading System (EU ETS), as well as social cost benchmarks and penalty levels consistent with the emerging EU Methane Emissions Regulation (EU MER). Full article

Objectives: This study explores the feasibility and value of integrating structured patient input into the PICOS (Population, Intervention, Comparator, Outcome, Study design) scoping process for Joint Clinical Assessments under the EU Health Technology Assessment Regulation. Methods: A modified Delphi panel, led by a steering committee composed of two clinicians, one patient expert, and one policy expert, engaged 12 individuals representing patient organizations across 12 European Member States to reach consensus on PICOS elements for CAR-T therapy in pediatric spinal muscular atrophy. Results: The Delphi process effectively facilitated PICOS consolidation and consensus among the 12 patient experts representing diverse EU contexts. Through 3 iterative rounds integrating quantitative rankings and qualitative feedback, the panel achieved strong agreement on key outcomes, intervention delivery, and study design elements, with population eligibility and comparator selection showing heterogeneity. Patient engagement was central: participants emphasized inclusive eligibility criteria, shared decision-making, and the inclusion of caregiver perspectives. The integration of qualitative insights allowed nuanced interpretation of dissent, distinguishing between genuine disagreement and framing effects, thereby enhancing transparency and scientific validity. Importantly, the process revealed patient priorities for outcomes, treatment burden, and evidence trade-offs, informing both PICOS refinement and future health technology assessment (HTA) strategies. This structured, participatory approach demonstrates the feasibility and value of incorporating patient voices systematically into early-stage EU HTA, fostering robust, credible, and context-sensitive consensus on complex rare-disease interventions. Conclusions: The study demonstrates the potential of consensus-building methodologies to enhance transparency, reduce heterogeneity, and support patient-centered evidence generation and decision-making in HTA. Full article

This paper introduces a mathematical model to assess the polluting impact of the decarbonization options for medium-sized High-Speed Crafts in the EU, and their consequences in terms of Market-Based Measure costs and Goal-Based Measure compliance under expected regulatory scenarios. This model is applied to a particular European High-Speed Craft operating in the Canary Islands. Considering slow steaming along with High Speed Craft’s retrofitting with alternative technologies for its electricity supply, we conclude that green H₂ fuel Cells provide the greatest environmental advantage by comparison with slow steaming alone, achieving a 6.96% improvement in emissions and savings under European Market-Based Measures of 39.76% by 2033. The expected regulative progression involves a 5.90% improvement in the Market-Based Measure costs’ convergence with the actual pollution impact of High-Speed Crafts. The findings warn about the pressing need to review the implementation of On-Shore Power Supply emissions into the Fuel EU fines, and about a concerning pull effect for the most polluting European High-Speed Crafts are moved towards the outermost regions of the EU due to their permanent exceptions from the application of the European Market-Based Measures. Full article

Water-saving agricultural irrigation systems depend heavily on the hydraulic stability of pressure-compensating (PC) emitters, whose performance is fundamentally shaped by internal flow-path geometry. This study analyzes six commercial PC emitters (E1–E6) operated under pressures of 0.8–2.0 bar to quantify how key geometric descriptors influence hydraulic parameters critical for efficient water use, including actual discharge (q_act), discharge coefficient (k), pressure exponent (x), emission uniformity (EU), and flow variability. All emitters had discharge deviations within ±7% of nominal values. Longer and more tortuous labyrinths enhanced compensation stability, while emitters with wider cross-sections and shorter paths produced higher throughput but weaker regulation efficiency. Linear mixed-effects modeling showed that effective flow area increased k, whereas normalized path length and tortuosity reduced both k and x. Predictive equations derived from geometric indicators closely matched measured values, with deviations below ±0.05 L/h for k and ±0.05 for x. These results establish a geometry-based hydraulic framework that supports emitter selection and design in water-saving agricultural irrigation, aligning with broader Agricultural Water–Land–Plant System Engineering objectives and contributing to more efficient and sustainable water-resource utilization. Full article

Background: The objective of this work was to support the implementation of the European Health Technology Assessment Regulation (EU HTAR) and optimize performance of the evolving EU HTA system. Therefore, an inclusive multi-stakeholder framework of key performance indicators (KPI) for success measurement was developed. Methods: A modified Delphi-procedure was applied as follows: (1) development of a generic KPI pool at the Fall Convention 2024 of the European Access Academy (EAA); (2) review of initial pool and identification of additional KPIs; (3) development of prioritized KPIs covering patient, clinician, Health Technology Developer (HTD), and System/Member State (MS) perspectives, and (4) consolidation of the stakeholder-centric KPIs after EAA’s Spring Convention 2025. Results: Steps 1 and 2 of the Delphi procedure revealed 14 generic KPI domains. Steps 3 and 4 resulted in four prioritized KPIs for patients (patient input; utilization of patient-centric outcome measures; time to access; equity); six for clinicians (population/intervention/comparator/outcomes (PICO); addressing uncertainty; clinician involvement; transparency; equity and time to access); four for HTDs (PICO; joint scientific consultation (JSC) process; joint clinical assessment (JCA) process; time to national decision making); five from a system/MS perspective (PICO; learning and training the health system; reducing duplication; equity and time to access). The scope of, e.g., the PICO-related KPI, differed between stakeholder groups. Also, several KPIs intentionally reached beyond the remit of EU HTA as they are also dependent on MS-specific factors including national health systems and budgets. Discussion and Conclusions: The KPI framework developed here presents a step towards the generation of systematic multi-stakeholder evidence to support a successful implementation of the EU HTAR. The relevance of the identified stakeholder-centric KPIs is confirmed by their alignment with the Health System Goals suggested in the context of “Performance measurement for health improvement” by the World Health Organisation. Implementation of the framework, i.e., measurement of KPIs, is envisioned to provide evidence to inform the 2028 revision of the EU HTAR. Full article

Under the requirements of the EU Nature Restoration Regulation, significant investment in the restoration of marine and coastal ecosystems will be necessary in EU Member States. A certain level of knowledge among the population will be required to ensure authorities have the required social license to pursue marine ecosystem restoration activities, and awareness raising campaigns will likely be a part of the body of actions taking place to support the delivery of the EU Nature Restoration Regulation. This survey assesses the baseline awareness, attitudes and support for marine and coastal restoration amongst the Irish adult population. Relatively low levels of awareness of both restoration initiatives and the regulation are documented, with approximately 15% of respondents aware of restoration activities and 19% aware of the regulation. While distance to the coast isn’t always strongly correlated with awareness and support, connection to the marine—represented by visiting the coast and being concerned about the marine environment—is strongly correlated with these metrics. The results indicate that information campaigns around marine and coastal restoration should attempt to highlight the benefits society receives from the marine and coastal environment and foster a sense of connection with it. Full article

The food supplement market has expanded rapidly in recent years, driven by demand for health, wellness, and healthy ageing; yet, the integrity of associated Health Claims (HC) remains uncertain. In the European Union (EU), food supplements are regulated under Directive 2002/46/EC, while HC use is governed by Regulation (EC) No. 1924/2006 (NHCR), which requires scientific substantiation evaluated by the European Food Safety Authority and subsequent authorisation by the European Commission/Member States. Despite this framework, concerns persist regarding unauthorised or non-compliant HC. This study examined the prevalence and compliance of HC on food supplement labels in the Republic of Ireland, comparing products sold in-store and online. A total of 192 food supplements were randomly selected across multiple categories, with HC compliance assessed against the EU Register of Nutrition and Health Claims and mandatory labelling requirements. In total, 2604 HC were identified, with multivitamins and botanicals as the most common categories reviewed. Although most HC referred to vitamins D and C and focused on immune function, only 80.7% of in-store claims and 75.6% of online claims were authorised, and only around one-third used the prescribed wording. Compliance was notably lower for botanicals, reflecting regulatory ambiguities around their use. These findings highlight persistent challenges in enforcing the NHCR, particularly for online sales and botanicals, and underscore the need for greater regulatory clarity and consumer protection. Full article

Hazelnut (Corylus avellana L.) is a major crop in the Caucasus region, but its safety is often threatened by Aspergillus flavus colonization and aflatoxin (AF) contamination. Although AFs are strictly regulated in the EU, the influence of post-harvest practices on fungal persistence and AF accumulation remains poorly defined. A three-year study was conducted to evaluate the effects of drying protocols, storage temperature, and conservation practices on fungal growth and AF occurrence in hazelnuts from three producing regions of Azerbaijan. Freshly harvested nuts were subjected to two drying regimes: good drying (sun-exposed, mixed, protected from rewetting) and bad drying (shaded, piled, rewetted). After drying, samples were stored at cold (8–10 °C) or room temperature (18–22 °C). Fungal prevalence was determined by CFU counts with morphological and qPCR identification of Aspergillus section Flavi. AFs were quantified by HPLC, and water activity (a_w) was monitored during storage. Drying emerged as the decisive factor: bad drying consistently resulted in markedly higher fungal loads for A. section Flavi, with mean counts up to 1.5 × 10² CFU/g, compared with 2.1 × 10¹ CFU/g under good drying, representing a 7-fold increase. In contrast, storage temperature and shell condition had negligible effects when nuts were properly dried. Aflatoxins were consistently below the 5 µg/kg EU limit for AFB₁ in traced and well-dried samples, whereas market samples occasionally exhibited AFB₁ concentrations >450 µg/kg. These findings highlight drying efficiency as the key determinant of fungal persistence and AF risk in hazelnut post-harvest management. Full article

Packaging plays a crucial role in product preservation and distribution but also constitutes a major source of environmental burden. In the beverage sector, where unit value is low, secondary and tertiary packaging significantly influence the environmental profile of the final product. This study quantifies the environmental trade-offs between conventional single-use and reusable packaging systems for aluminum cans, identifying the operational thresholds that justify a transition to circular models. A standardized Life Cycle Assessment (LCA) approach is applied to five packaging configurations: three current market scenarios and two alternative solutions based on reusable plastic crates (RPCs). System boundaries include production, distribution, end-of-life, and, where applicable, reverse logistics. A functional unit of one fully packaged 0.33 L aluminum can is adopted. Results reveal that while single-use cardboard solutions achieve favorable performance under certain impact categories, reusable systems outperform them when a sufficient number of reuse cycles is achieved and reverse logistics are efficiently managed. Sensitivity analyses highlight the critical influence of transport distances and reuse frequency on overall impacts, with performance deteriorating for reusable systems beyond 200 km or below 50 reuse cycles. These findings offer concrete, evidence-based guidance for supply-chain and logistics decision-makers to optimize packaging choices and distribution network design. The study also provides robust quantitative insights for policymakers and industry stakeholders by defining the precise operational conditions under which reusable systems deliver real environmental benefits. By presenting a comprehensive, system-level comparison of complete packaging systems, this research closes a critical gap in LCA studies and sets out a practical pathway for implementing circular, low-impact packaging strategies consistent with emerging EU regulations. Full article

This study examines the potential implications of the EU–Mercosur free trade agreement for the Polish horticultural sector, with particular emphasis on sustainability, trade competitiveness, and structural complementarities between the regions. Drawing on production, trade, and demographic data for the EU, Poland, and Mercosur countries, the analysis evaluates the alignment of horticultural supply and demand structures, the degree of intra-industry exchange, and the economic conditions shaping bilateral trade. The research applies the Grubel–Lloyd index and a Poisson Pseudo-Maximum Likelihood (PPML) gravity model to assess the determinants of Poland’s horticultural exports to Mercosur. The results indicate that trade remains predominantly inter-industry, reflecting substantial differences in agricultural specialisation and regulatory frameworks. At the same time, rising income levels in Mercosur, together with selected product-level complementarities, indicate emerging export opportunities for Poland. Poland’s trade with the Southern Common Market remains mainly as inter-industry, with the greatest export potential concentrated in high-value-added processed goods. Divergent sustainability standards, particularly in pesticide use, environmental regulation, and carbon-intensive transport, pose structural challenges that may affect the competitiveness and environmental footprint of expanded trade. Overall, the findings provide evidence that closer integration with Mercosur may support export diversification, but requires careful alignment with the EU’s sustainability objectives to ensure resilient and environmentally responsible development of the horticultural sector. Full article

Gas-insulated switchgear (GIS) offers multiple advantages compared to air-insulated switchgear (AIS); primarily, due to its more compact design and reduced maintenance requirements. In recent years, environmentally friendly replacement gases for SF₆ have become an important research topic, not least because EU regulation will ban the use of SF₆ in new equipment for its member states in the coming years. For detecting defects inside equipment, partial discharge (PD) measurements are an important and well-established method, including in acceptance tests (FAT and SAT) and online monitoring. An important question is whether the PD behavior of various defects analyzed in SF₆ differs in potential replacement gases. In this work, standard geometries in form of needle plane arrangements were used to analyze the PD inception behavior of natural origin gases (synthetic air, CO₂ and N_2,) in comparison to SF₆ at various application relevant pressures. PD was measured both by the conventional (IEC 60270 conform) and UHF technique, recording the phase resolved partial discharge patterns (PRPDs), as well as emitted UHF-pulses. The tip radius and the protrusion length of the needle electrode were varied in order to investigate the influence of the electric field distribution on the PD inception behavior. Results show positive pressure dependence, but also deviations from the linear growth of PDIV, intermittent discharge behavior in synthetic air for some conditions and high-current discharges in the N₂ in the setup used. Full article