EU legislation for the registration of new bio-based products: Current challenges and barriers. A case study of products derived from municipal bio-waste for use in the agriculture and chemical industry sectors

KPIs as catalyst for energy-efficient building renovation under EU regulations

A framework for analysing spatial mobility in the green and digital transition: The MOBI-TWIN approach

Synthetic varroacides in honey bee colonies: A comprehensive monitoring program across the European Union

The implementation of Regulation (EU) No. 536/2014 (CTR) introduced a reformed clinical trial governance system in Italy, based on a single national ethics opinion, replacing the previous decentralized model. This transition has raised important questions regarding how sponsors orient their choice of Ethics Committees (ECs) within the new regulatory framework. The aim of this study is to evaluate geographical trends in sponsor-proposed ECs for clinical trials in Italy between January 2022 and January 2025, and to examine their association with therapeutic area, trial phase, and population characteristics. We conducted a retrospective three-year nationwide analysis based on data from the Italian Medicines Agency (AIFA) and the Clinical Trials Information System (CTIS). Adopting a longitudinal approach, descriptive and comparative evaluations were performed. A total of 1,462 Clinical Trials (CTs) were identified, of which 1,135 (77.8%) involved sponsor-proposed Ethics Committees (ECs), including both legacy ECs operating under Directive 2001/20/EC and Territorial Ethics Committees (TECs) active since June 2023. A marked geographical imbalance emerged in sponsor proposals: 60.2% targeted ECs located in Northern Italy, 26.4% in Central Italy, and 13.4% in Southern Italy and the Islands, with additional intra-regional disparities. Non-commercial sponsors often chose TECs within their own region (64.7%), frequently within the same institution. The results show a concentration of sponsor-proposed ECs in Northern Italy, together with marked intra-regional concentration patterns in regions hosting multiple ECs. The distribution of proposals also indicates that non-commercial sponsors frequently select TECs located within their own region and institution. In the most recent part of the observation period, a modest increase in proposals to Central TECs has been recorded. This nationwide analysis provides a descriptive overview of sponsor-driven EC selection in Italy under the CTR, identifying inter-regional and intra-regional imbalances. While some changes in sponsor behavior are observed in the latest data, continued monitoring over time is required. The observed patterns may be potentially influenced by contextual and organisational factors, as well as by additional variables not directly assessed in the analysis. Future studies incorporating these variables will be important to confirm whether the trends identified here persist over time and to better clarify the factors contributing to their distribution.

Amidst European integration and the global implementation of the Carbon Border Adjustment Mechanism (CBAM), Ukrainian industry faces the necessity of a radical transformation in environmental reporting. Traditional methods of monitoring pollutant concentrations are being superseded by integrated assessments of the product carbon footprint, necessitating the implementation of high-precision standards (EMAS, ISO 14064). The issue becomes particularly acute in the context of post-war reconstruction, which must be based on the principles of low-carbon development. The aim of the article is to develop the technical and methodological foundations for integrating international environmental standards into the management systems of Ukrainian industrial enterprises to ensure their competitiveness and environmental safety. The study employs methods of systems engineering analysis, mathematical modeling of energy and material balances according to ISO 14040/44, and satellite remote sensing methods for verifying environmental data under martial law conditions. A comparative analysis of the ISO 14001 architecture and the EMAS Regulation has been conducted. It was established that for successful export activities, Ukrainian enterprises must implement mandatory key performance indicators (KPIs) and public environmental statements. The mathematical algorithm for Life Cycle Assessment (LCA) has been detailed. Using a practical example of steel rolled products manufacturing, a methodology for calculating specific embedded emissions (CO2e) was demonstrated, allowing for the identification of "hotspots" within the technological cycle. The technical aspects of applying EU Regulation 2023/956 (CBAM) are substantiated. A model for calculating direct and indirect carbon loads has been developed, accounting for the specifics of the Ukrainian power grid and embedded emissions from precursors. The role of digital tools (the "EcoZagroza" platform, Sentinel satellites) as a basis for verifying environmental damage in conditions of limited physical access to objects has been determined. Conclusions and Practical Significance. A strategic "roadmap" for the implementation of Best Available Techniques (BAT) for enterprises in the Prydniprovya region is proposed. The research results can be utilized by environmental engineers and industrial managers to prepare for cross-border carbon regulation and to implement "green recovery" projects based on the "Build Back Better" principle.

Enhancing fibre-to-fibre recycling of mechanically recycled cotton through combed compact ring spinning.

The Ems Estuary faces existential challenges including flood risk, increasing turbidity, and biodiversity loss, all of which may intensify under future climate scenarios and require transboundary collaboration between the Netherlands and Germany. Addressing these challenges requires compliance with EU, national, and local regulations. Simultaneously each nation pursues socioeconomic benefits from the restoration through a holistic, system-based approach. This study synthesizes the key processes driving flood risk, hyper-turbidity, and salinization within the Ems Estuary. From this understanding the paper catalogues the planned and implemented pilot measures from both countries to advance their climate adaptation plans. Both nations share a common vision of leveraging the high turbidity of the estuary as an asset in climate adaption, e.g. for land raising, dyke reinforcement or habitat creation. Building on the pilot projects and shared visions, three transboundary upscaling strategies involving sediment management are proposed: (A) land elevation using dredged sediment; (B) multifunctional flood defences incorporating nature-based solutions; and (C) habitat creation and restoration to enhance ecological resilience. The Ems Estuary offers valuable insights for global transboundary estuarine management, illustrating how innovative sediment management and transboundary cooperation can be achieved to support climate adaptation and sustainable development. The study underscores the need for harmonized governance, standardized success metrics, and cross-border planning to enable effective upscaling.

This article addresses the issue of gender discrimination in the labor market, focusing on pay inequality. Although Poland has one of the lowest pay gaps for women compared to other European Union countries, if we look at the issue of gender inequality more broadly, through the prism of economic indicators, educational achievements, health and life expectancy, and political equality, we occupy a disadvantageous position in the ranking of EU member states. This article has two main goals. The primary goal of the text is to present the main assumptions of the EU regulation – the Gender Payment Gap, which is intended to reduce the pay gap between women and men in similar positions. The second goal of the article is to analyze statistical data relating to the problem of pay discrimination between women and men in the medium term (2012-2022), which provided the background for an overview of the Gender Payment Gap directive. Eurostat statistical data and data from the Global Gap Reports, which are prepared on behalf of the World Economic Forum, are presented.

In the European Union, animal products for human consumption are regulated as products of animal origin (POAO), while those not intended for human consumption are considered animal by-products (ABPs). Both POAO and ABP are subject to strict regulations to ensure animal and public health, and they are controlled through various EU directives and regulations. Consumer demand for plant-derived cosmetics, botanicals, and nutraceuticals has also increased sharply over the past decade. Ensuring the origin of ingredients, starting materials, and excipients used in these complex consumer products can be challenging, even when certified reference standards are available. Herein, we report a reliable approach for identifying the origin of cholesterol, a common ingredient in cosmetics and beauty products, using irm-13C NMR and IRMS to differentiate plant versus animal-derived cholesterol. Further, we show that we can also discriminate semi-synthetic cholesterol from plant and animal-derived varieties.

Despite the clinical success of CD19-directed CAR T-cell therapies, less than 50% of patients achieve long-term remission. Emerging evidence indicates that loss or reduced expression of CD19-due to mutations, deletions, alternative splicing-is a significant, underrecognized mechanism of treatment failure. Notably, CD19-negative subpopulations can be detected even prior to therapy, and patients with low CD19 expression consistently show poorer outcomes. Although current clinical guidelines do not mandate routine CD19 testing before treatment, this situation reflects both scientific and technical challenges. Importantly, patients with partial/ low CD19 expression may still benefit from therapy, complicating the definition of "target positivity." From a regulatory perspective, targeted therapies should ideally be used only when target expression is confirmed. This principle is difficult to implement, considering the scarcity of data and the difficulties of current diagnostic tools, risking both undertreatment and overtreatment. EU regulators have addressed the issue by introducing harmonized warnings in product information, but more is needed. We highlight this regulatory-clinical gap and advocate for improved diagnostic standards, better data integration, and dialogue among clinicians, developers, and regulators.

The identification of standing tree species, timber logs, and on-site assessment of their quality and value using images holds significant potential for forestry applications, including inventory management, traceability under EU regulations like the Deforestation Regulation, and market valuation amid growing demands for sustainable practices. This study addresses this by classifying images of timber logs by tree species and market value using the Orange data mining software, which leverages pre-trained convolutional neural networks (Inception v3 and SqueezeNet) to generate embeddings from a dataset of 5549 images collected at a real timber auction in Slovenia, followed by logistic regression image classification. Results show high accuracy for tree species classification (up to 92.6%), but substantially lower accuracy for market value classification (40%–55%), reflecting the greater complexity of value determination from visual features. These findings underscore the promise of deep learning for species identification while indicating the need for further methodological advancements to enhance value classification reliability, which offers the practical impact for operational forestry and bioeconomy value chains.

This research examines how varying degrees of globalization and digital transformation affect skill demand, socioeconomic inequality and convergence in the EU by 2030. The study employs a comprehensive scenario-mapping approach using state-of-the-art literature, existing econometric analyses conducted within the GI-NI project used as contextual inputs and expert insights. Four scenarios are developed based on potential trends in digital transformation (stagnation or acceleration) and globalization (further globalization or deglobalization). These scenarios highlight essential changes needed to improve skills and alleviate inequality. In all scenarios, the future labour market demands a rapidly evolving skill set, with persistent risks of skills mismatch across educational groups and a strong focus on digital, technical, analytical and communication skills. Three scenarios suggest worsening inequality, particularly affecting low-skilled workers, women and older individuals, while high-skilled workers adapt more quickly. The study shows that communication technology can drive between-region economic convergence, depending on the interaction with globalization and the pace of digital transformation. However, accelerated digital transformation with deglobalization poses divergence risks, as some EU regions may struggle to adapt quickly. The scenarios underscore the complex interplay between digital transformation and globalization, necessitating multifaceted policy responses to foster inclusive growth and mitigate the adverse effects on vulnerable populations.

The article examines the legal status of so-called “medicinal” or “pharmacy” cosmetics within the pharmaceutical assortment. Although Ukrainian legislation formally distinguishes between medicinal products and cosmetic products, consumers often perceive pharmacy cosmetics as having therapeutic properties. The study analyzes Ukrainian legislation, EU law – in particular Regulation (EC) No 1223/2009 on cosmetic products and Directive 2001/83/ EC on medicinal products – as well as German legislation and case law. The research is based on a combination of general scientific and special legal methods, including the formal-dogmatic method for the interpretation of statutory provisions; the comparative legal method for examining differences between Ukrainian, EU and German regulation; the hermeneutic method for clarifying legal definitions; the systemic-structural method for assessing regulatory mechanisms; the case-law analysis method for studying judicial practice of the Court of Justice of the European Union and German courts; and the logical-semantic method for analyzing legal terminology. The findings confirm that EU law establishes mutually exclusive categories of medicinal and cosmetic products, and that products claiming therapeutic effects must comply with pharmaceutical legislation. The widespread use of the term “medicinal cosmetics” lacks a proper legal basis and may mislead consumers, thereby requiring clearer regulatory enforcement and consumer protection measures. and contributes to the receipt of undue benefits by pharmaceutical institutions.

The term ‘superfoods’ refers to a rapidly expanding group of food products that have gained increasing global interest due to their high nutritional value and association with health-oriented dietary patterns. Many superfoods, particularly grains and seeds, are rich sources of essential minerals, plant protein, dietary fibre, and bioactive compounds, making them valuable components of gluten-free, vegetarian, and vegan diets. The aim of this study was to evaluate the elemental composition of selected superfood grains and seeds and to verify the reliability of manufacturers’ declarations. The analyses confirmed that the investigated samples possess a rich macro- and trace elemental composition, with pronounced differences among product groups. Based on median concentrations, pumpkin and hemp seeds were characterized by generally high levels of Mg, K, P, Fe, Mn, and Zn, whereas chia seeds exhibited notably elevated Ca content. In contrast, quinoa and amaranth showed comparatively lower elemental concentrations. Most of the results obtained for the analysed products are within the permissible deviation from the value declared on the packaging, as specified in the relevant EU regulations. The presence of potentially toxic elements, including Al, Pb, and Cd, was also detected. Cadmium accumulation was of particular concern in flax seeds, where all samples exceeded the limit of quantification and approached permissible levels. Principal component analysis revealed clear clustering patterns, indicating similarities between amaranth and quinoa, as well as between hemp and pumpkin seeds, while chia and flax seeds formed distinct groups. These results highlight both the nutritional potential of superfoods and the necessity for independent verification of their elemental composition.

This article analyzes the impact of artificial intelligence (AI) on copyright, highlightinghow AI-generated creations challenge traditional concepts of authorship and originality. It examines prior US court rulings that deny protection to works without human intervention and presents the advanced European regulation (EU Regulation No. 2024/1689), which establishes a risk-based legal framework. In contrast, Argentina lacks specific legislation, although projects are underway. The author proposes adapting the European model to ensure transparency, accountability, and compatibility between technological innovation and intellectual rights protection in the country.

Abstract This study examines the link between knowledge-intensive services (KIS) firms and higher education systems (HESs) across 24 EU countries. Using a novel dataset retrieved from Eurostat, ETER, Incites, and PATSTAT, our analysis proposes a new methodological approach in investigating the relationship between local HESs and the presence of KIS firms in EU NUTS-2 regions. We find that university spillovers—human capital, research, and third mission activities—enhance the number of KIS firms in a region, with larger and higher-quality institutions exerting a more significant effect. Furthermore, our findings highlight a positive correlation between the area of specialisation of universities and the industrial specialisation of a region. However, this result varies significantly across different KIS sectors, indicating the diverse nature of knowledge-intensive services. The findings may help policymakers understand the mechanisms attracting KIS firms and foster regional specialisation based on local knowledge.

Invasive alien species (IAS) represent one of the most significant threats to biodiversity in Romania and across the European Union. Despite the adoption of EU Regulation 1143/2014 on the prevention and management of the introduction and spread of IAS, its effective implementation at national level requires substantial institutional, scientific and operational capacity building. Here, we present a comprehensive national project, COMPLIAS Consolidarea Sistemului National de Management al Speciilor Alogene Invazive din Romania in Conformitate cu Cerintele UE / Strengthening the National Management System for Invasive Alien Species in Romania in Compliance with EU Requirements , SMIS 337191, funded under the Sustainable Development Programme (PDD/216, Priority 2, Specific Objective RSO 2.7) and implemented by the University of Bucharest in partnership with the Ministry of Environment, Waters and Forests of Romania. The project addresses all major obligations under EU Regulation 1143/2014 through seven interconnected work packages: (WP1) updating the regulatory and strategic framework, including the revision of the Invasive Alien Species Action Plan (IAS action plan); (WP2-WP4) comprehensive inventory and mapping of invasive alien species (plants, vertebrates and invertebrates) across Romania; (WP5) developing an early detection and border control system for IAS; (WP6) species distribution modelling, impact assessment and piloting eradication and control techniques for priority IAS; and (WP7) public awareness and stakeholder engagement campaigns. The project will also produce legally binding outputs, including a revised IAS action plan approved by Ministerial Order and mandatory country reports to the European Commission. This paper describes the project's objectives, methodological approach, expected outcomes and its contribution to the EU Biodiversity Strategy for 2030.

The world has been witnessing a growing and accelerating expansion in the use of artificial intelligence (AI) systems, as leading worldwide technology businesses compete to develop systems and software that can simulate the human mind, produce technological solutions, and accomplish activities that previously needed human mental effort. This has given rise to a host of new and unfamiliar legal challenges, including those connected to errors and ‘hallucinations’ that may produce inaccurate or misleading outputs. This paper examines the technical and practical risks associated with the use of AI, with a focus on the phenomenon of hallucinations that has recently become widely discussed, and its potential effects on users and third parties. This study adopts a comparative, analytical legal approach by analyzing the current legal framework to determine the extent to which the law protects the injured party, assessing the adequacy of existing civil-liability rules, and emphasizing the difficulties associated with proving fault and causation, as well as identifying the responsible party within the complex smart-transactions ecosystems. Accordingly, the objective of this paper is to determine how civil liability arising from the use of AI systems in numerous fields may be attributed, and to identify the future legal implications of such systems in light of the general rules of the UAE Civil Transactions Law and the substance of the EU regulation. Accordingly, the study presents a contemporary legal perspective on conventional culpability to safeguard the harmed person against AI faults and hallucinations. It concludes by proposing innovative legal mechanisms, such as strict (objective) liability, transparency obligations, and compulsory insurance, to compensate the injured party for ‘digital harm’ caused by AI technologies. The research indicates that legal responsibility and technical innovation must be balanced to safeguard the damaged party.

Etienne Gabriel Valk reviews A Datafied Mind. Untangling EU Regulation of Emotion Technology and Neurotechnology by Elisabeth Steindl