Promoting Grid Flexibility Through Policy: Insights from EU Regulatory Frameworks

Endocrine-disrupting chemicals – pesticide regulatory issues from the EU perspective

The Global Relevance of the EU Single Market on Insurance After the Insurance Distribution Directive (IDD)

Background: This article explores the European Union's approaches to assessing energy security through a system of indicators in the dynamic conditions of geopolitical changes. It investigates the transformation of their role, from ignored warning signals to key tools for crisis management. The relevance of the study is driven by the need to evaluate the effectiveness of EU policy in response to Russia's energy blackmail and to identify new challenges following the bloc's rejection of its energy carriers. Methods: The research is based on an analysis of the EU's regulatory framework (the REPowerEU plan, relevant regulations), quantitative indicators from official sources (import dependency, diversification of suppliers, strategic reserves), and analytical reports from international institutions. A systemic approach is applied to assess the effectiveness of these indicators as preventive and operational tools in risk management. Results: It was found that until 2022, the indicators clearly signaled the EU's critical dependence on Russia, but these warnings were ignored due to a lack of political will. Following the invasion, the indicators became the foundation for setting measurable goals (demand reduction, storage filling), monitoring, and market stabilization, which helped overcome the acute phase of the crisis. At the same time, new systemic vulnerabilities were identified: dependence on the global LNG market, supply chains for critical raw materials for the "green" transition, and the growth of cyber threats. Conclusions: The role of energy security indicators in the EU has evolved from a passive warning to an active crisis management tool. Despite the demonstrated resilience, the Union's energy security remains dynamic and vulnerable. The existing monitoring system needs to be adapted to assess new geopolitical, technological, and raw material risks. Effective future management will require the development of new indicators that account for the complex nature of modern threats.

BackgroundThe European Union's Green Deal Industrial Plan (GDIP), introduced in 2023, aims to advance sustainability, energy independence, and carbon neutrality by 2050. Supported by the Net-Zero Industry Act (NZIA) and the Critical Raw Materials Act (CRMA), the GDIP seeks to boost clean technology manufacturing, particularly in sectors like electric vehicles (EVs), while ensuring a secure supply of critical raw materials. Additionally, the EU Battery Regulation 2023 establishes strict lifecycle management requirements to promote circularity in the battery sector. However, policy fragmentation, regulatory complexity, and stakeholder concerns pose challenges to achieving these objectives.MethodsThis study examines the coherence of the GDIP and its associated policies, assessing whether they form a unified framework or introduce contradictions that hinder progress. Through stakeholder analysis, the research explores perceptions of regulatory effectiveness, industrial competitiveness, and the role of workforce skills in facilitating the green transition.ResultsFindings indicate that while these policies share common objectives, they exhibit overlaps and inconsistencies that create barriers to investment and innovation. Stakeholders express concerns about regulatory clarity and feasibility, emphasizing the need for realistic targets, streamlined processes, and greater social acceptance of industrial projects. The research also highlights a critical skills gap in green technologies, underlining the necessity of workforce development initiatives to support the transition.ConclusionsFor the GDIP to achieve its full potential, EU policies must be better aligned, with clearer regulatory frameworks and stronger stakeholder engagement. Addressing the skills shortage, promoting industrial careers, and leveraging tools like the European battery passport will be crucial in fostering collaboration and ensuring successful implementation of the EU’s green industrial ambitions.

Use of biomass ash-based materials as soil fertilisers: Critical review of the existing regulatory framework

The energy transition is a complicated process that involves changing production and consumption habits, boosting the use of renewable energy sources, and reducing greenhouse gas emissions. This article examines the management of risks associated with this shift, focusing on investment, commercial, technological, regulatory, and environmental challenges. The paper proposes an effective way for dealing with new difficulties by assessing risks and the management techniques that accompany them. Furthermore, as a critical component of the energy revolution, the concept of Nearly Zero Energy Buildings (NZEB) is given, with a focus on the ambitions of INGV – Irpina Headquarters and the EU regulatory framework. Finally, the actions and methods employed to achieve the NZEB objectives are discussed, including the utilization of cutting-edge technologies and renewable energy sources. Furthermore, the concept of Nearly Zero Energy Buildings (NZEB) is introduced as an important component of the energy transition, with an emphasis on the European regulatory framework and the ambitions of the INGV – Irpina Headquarters. Finally, the interventions and techniques employed to achieve the NZEB targets are highlighted, such as the employment of advanced technologies and renewable energy resources. This study contributes significantly to understanding the processes and issues associated with the energy transition and the implementation of NZEB, hence boosting sustainability in the construction sector.

Regulation (EU) 2022/1925 on digital markets (Digital Markets Act) is one of the youngest, but already the most noteworthy documents that make up the EU regulatory framework in the area of competition protection in digital markets. It is part of the legal strategy for the digital transformation of the Union and aims in particular to prevent the abuse of market position by dominant digital platforms. The legal framework for the protection of competition in Serbia does not contain an equivalent regulation. The paper analyses the extent to which this EU Regulation on digital markets can serve as a model for possible reform of domestic regulations in the subject area, as well as whether there is a need for such a reform at all, given the level of development of digital markets in Serbia. Therefore, the subject of the research are the most important rules of the European act, the domestic legal regime of digital markets from the perspective of competition protection, and the possibilities of applying certain rules of the Regulation under the conditions of that regime. The research results in the view that the adoption of a similar regulation in Serbia would be premature, and that the introduction of certain solutions inspired by it into the analysed legal framework, when domestic digital markets are ripe for it, would be a more adequate way of improving it.

Purpose – This paper aims to introduce a method of performance-based procurement, based on the most economically advantageous tender (MEAT), for low-disturbance bridge construction projects in urban environment. Design/methodology/approach – The first part of this paper reviews the key performance indicators (KPIs) of low-disturbance construction and the procurement procedure based on the MEAT principles. The second part reflects on two actual bridge projects (the Rotebro bridge in Sweden and the Arno river bridge in Italy) as observatory case studies to analyse how clients and contractors can implement the KPIs in MEAT. Findings – The research findings demonstrate the possible inclusion of the KPIs of low-disturbance construction into the MEAT criteria. The MEAT principles can then be used in combination with either a traditional or an integrated procurement strategy. Research limitations/implications – The implementation of MEAT to achieve low-disturbance construction projects is considerably new and still requires an empirical validation. A further elaboration of the procurement strategy within the EU regulatory framework is strongly recommended in order to assure the broader impacts of sustainable construction. Practical implications – The findings and recommendations support the practical development and the use of MEAT in construction projects in the EU. Originality/value – This paper presents on-going investigation within the FP7 collaborative research project “PANTURA”, which addresses the actual research agenda of the European Commission on low-disturbance and urban-friendly civil infrastructure projects.

In 2023, three categories of therapeutic products obtained through the collection and subsequent engineering of hematopoietic cells exist and are valuable to patients treated for neoplastic diseases as well as a variety of nonneoplastic disorders: blood cell transfusions, stem and immune cell transplants, and cellular therapy medicinal products. The procurement and nature of various blood products and transfusion practices are described elsewhere in this handbook. In this chapter, we focus on hematopoietic cellular therapies as currently defined and managed in the FACT-JACIE International Standards for Hematopoietic Cellular Therapies (nowadays in version 8). Over the last two decades, major changes have occurred in the EU regulatory framework (as well as in other parts of the world, notably in the USA) that result in the coexistence of two categories of hematopoietic cellular therapies. Innovative and industry-manufactured somatic cell therapy or gene therapy medicinal products have entered the field at an accelerating pace since the last edition of this handbook. Some of them are distributed worldwide on a large scale, and a few of these medicinal products already complete or compete with traditional hematopoietic cell transplantation practices. We here update the description of organizational consequences of this historical transition for academic facilities and the new opportunities as well as challenges these advances are bringing to patients and healthcare practitioners, including strong needs for educational initiatives.

This study introduces a precise risk assessment approach for UAV-based emergency response at lakesides, utilising 5G connectivity and adhering to SORA 2.5 standards. The system facilitates BVLOS missions via real-time surveillance, AI-powered video analysis, and automated flight planning informed by fluctuating demographic and environmental data. UAVs are centrally administered using a Remote Operation Control Centre (ROCC), facilitating prompt intervention in both temperate and frigid weather situations. Field testing confirms its capacity for decreased response times and enhanced coordination within EU regulatory frameworks. As SORA 2.5 restricts BVLOS operations in populated areas, it does not account for dynamic environmental factors or the presence of controlled safety zones within these areas. This results in overly conservative restrictions that can hinder legitimate, safe UAV operations. Also, current SORA implementations largely rely on qualitative or class-based population risk models. To address this gap, the proposed methodology applies a quantitative, high-fidelity risk assessment using geospatial and real-time data layers like mobile network coverage, detailed population distribution, building structures, and weather forecasts. This enhances the precision of ground risk calculations, enables risk-informed decision-making, and supports regulatory compliance with improved operational flexibility. The proposed methodology aligns with the evaluation, demonstration, and submission phases proposed in recent updates, including tools like ZHAW’s SORA Tool v3.0.0.

Peer Review Report For: Stakeholder Perspectives on EU Regulatory Frameworks: Navigating Critical Raw Materials, Battery Innovation, and Recycling Challenges [version 1; peer review: 1 approved, 1 approved with reservations

The presence of industrial trans-fatty acids (iTFAs) in processed foods poses significant public health concerns, necessitating comprehensive regulatory frameworks. In this study, the current legal landscape governing iTFA in the European Union and Spain is analyzed, with a particular focus on regulatory effectiveness and implementation challenges. The research methodology combines a systematic review of existing regulations, including EU Regulation No. 1169/2011 and Spanish Law 17/2011, with the analysis of the scientific literature on iTFA health impacts. The results reveal significant regulatory gaps, particularly in enforcement mechanisms and iTFA detection methods. Key challenges are also identified in the present study, including inconsistent compliance monitoring, varying analytical methods for iTFA detection, and contradictions between EU and Spanish regulatory frameworks. Additionally, in this work, the need for harmonized approaches to ultra-processed food regulation is emphasized. Further, the conclusion is that despite the current regulations providing a foundation for iTFA control, it is compulsory to enhance the monitoring systems, and clearer regulatory guidelines are necessary. These would contribute valuable insights for policymakers, food industry stakeholders, and public health professionals working towards effective iTFA regulation.

The article investigates the role of digitalization and traceability in the logistics of biotechnological products amid growing global requirements for quality, safety, and transparency in supply chains. It emphasizes that biopharmaceuticals, vaccines, enzymes, and probiotics, due to their sensitivity to temperature and transport conditions, require strict compliance with Good Distribution Practice (GDP 2013/C 343/01) and the maintenance of a continuous cold chain. The study generalizes the provisions of EU and WHO regulatory frameworks (EU GDP, WHO TRS 1025) and current European initiatives such as the Digital Product Passport (DPP), which aim to ensure complete product traceability throughout the life cycle. The potential of Internet of Things (IoT), Radio Frequency Identification (RFID), and blockchain technologies for monitoring temperature, humidity, and location parameters, as well as for securing logistics data, is analyzed. The paper outlines the evolution of digital logistics standards from traditional quality control toward integrated digital ecosystems that record each product batch’s origin, storage, and distribution data. Based on a SWOT analysis, the authors identify the strengths of Ukraine’s biotechnological logistics sector (qualified specialists, certified hubs, experience in GDP implementation), weaknesses (fragmented digital systems, high technology costs, shortage of digital logistics experts), opportunities (EU harmonization, Horizon Europe programs, blockchain pilot projects), and threats (cybersecurity risks, infrastructure losses, regulatory gaps). The findings reveal that Ukraine’s logistics digitalization is in the early stages but demonstrates positive dynamics, supported by industry projects, national digital initiatives, and growing private-sector investment in smart logistics solutions. The article proposes strategic directions for the digital transformation of biotechnological logistics in Ukraine: the development of a unified national digital registry, pilot blockchain projects for vaccine traceability, and the establishment of smart logistics clusters that integrate business, academia, and regulators. Implementation of these approaches will enhance transparency, reliability, and sustainability of biotechnological supply chains and accelerate Ukraine’s integration into the European digital logistics ecosystem.

Podstawowym zadaniem Organu Europejskich Regulatorów Łączności Elektronicznej (Body of European Regulators in Electronic Communications — BEREC) jest doradzanie Komisji Europejskiej oraz organom regulacyjnym krajów członkowskich wchodzącym w jego skład, a po-nadto wspieranie Parlamentu Europejskiego i Rady w sprawach dotyczących stosowania unijnych ram regulacyjnych dotyczących łączności elektronicznej. Jego działalność pozwala zapewnić uczci-wą konkurencję i spójność regulacji na rynku wewnętrznym w dziedzinie łączności elektronicznej, z korzyścią dla europejskich konsumentów. Obecnie BEREC ma status niezależnego organu regula-cyjnego, skupiającego w swej strukturze decyzyjnej krajowe organy regulacyjne, czerpiąc w swojej działalności z ich wiedzy eksperckiej i doświadczeń regulacyjnych. Jakkolwiek regulacja w sektorze telekomunikacyjnym w dalszym ciągu leży w gestii krajowych organów regulacyjnych, ponieważ to one są najbliżej rynków, które mogą lepiej regulować. W artykule zostały omówione zasady organizacji oraz funkcjonowania Organu Europejskich Regulatorów Łączności Elektronicznej w kontekście zgodności przepisów regulujących jego dzia-łalność z zasadami dobrego zarządzania jako wartościami administracyjnymi i organizacyjnymi, które powinny determinować sposób korzystania przez instytucje unijne z uprawnień udzielonych im przez obywateli. W tekście zwrócono także uwagę na planowaną kompleksową reformę regu-lacji w sektorze łączności telekomunikacyjnej jako niezwykle ambitny projekt w ramach strategii Jednolitego Rynku Cyfrowego.

According to the European Commission’s “European Research Area Policy Agenda -- Overview of actions forthe period 2022-2024”, one of the actions foreseen within the Priority Area of “Deepening a truly functioning internal market for knowledge”, is the development of a legislative and regulatory framework fit for research, that would enable, among other things: access and reuse of publicly funded R&I results, including open access; access and reuse of publications and data for research purposes and; the seamless flow of research knowledge and data across the EU based on Article 179 TFEU and academic freedom. This paper examines the notions of Open Science (OS) and Open Access (OA), as well as the legal mechanism of the so-called Secondary Publication Right (SPR). It furthermore presents an overview of the measures undertaken by the Directorate-General for Research and Innovation in advancing access to knowledge and reflects on the fitness of the SPR mechanism to address the issues with existing barriers and challenges to the objectives set by the Commission.