EU Regulation Research Articles

Empowering Future Entrepreneurs: Developing an Online Entrepreneurial Mentoring Program Across Diverse EU Regions

The 2023 European Innovation Scoreboard reveals that there is an innovation asymmetry between different EU regions which is leading to an innovation gap. In particular southern and eastern EU countries showcase a lower level of innovation compared to their northern and western counterparts. Addressing this disparity, the ENTRPRENEDU project, funded by the European Union, pioneers a unique approach tailored for emerging and moderate innovation regions. This paper presents the development process of the curriculum for the ENTRPRENEDU online mentoring program, detailing the demand analysis, curriculum development, and implementation phases. This paper contributes to the discourse on entrepreneurial online education and mentoring program development by showcasing a tailored approach to curriculum design. The findings offer practical insights for educators, policymakers, and practitioners seeking to nurture entrepreneurship and innovation in diverse regional contexts.

A Robust Governance for the AI Act: AI Office, AI Board, Scientific Panel, and National Authorities

Abstract Regulation is nothing without enforcement. This particularly holds for the dynamic field of emerging technologies. Hence, this article has two ambitions. First, it explains how the EU’s new Artificial Intelligence Act (AIA) may be implemented and enforced by various institutional bodies, thus clarifying the governance framework of the AIA. Second, it proposes a normative governance model, providing recommendations to ensure uniform and coordinated execution of the AIA and the fulfillment of the legislation. The article explores how the AIA may be implemented by national and EU institutional bodies, encompassing longstanding bodies, such as the European Commission, and those newly established under the AIA, such as the AI Office. It investigates their roles across supranational and national levels, emphasising how EU regulations influence institutional structures and operations. These regulations may not only directly dictate the structural design of institutions but also indirectly request administrative capacities needed to enforce the AIA.

Europol cooperation in Hungarian law enforcement

Aim: The aim of the article is to present the practical aspects of Europol’s role in Hungarian law enforcement. Methodology: We have collected knowledge about the operation of Europol, its services and support of law enforcement by studying the available EU and Hungarian regulations, as well as performing the former management tasks of Europol Hungarian Liaison Bureau, and practical implementation of the tasks of the crime coordinator assisting domestic procedures. Findings: Europol’s law enforcement services provide Hungarian law enforcement agencies with opportunities that cannot be provided by other agencies. In addition to supporting specific investigations, the institutional system also provides IT, strategic and financial support to countries. Value: The study provides operational, practical insights into the possibilities of cooperation with Europol, which will allow the staff of the criminal and judicial authorities to have a deeper insight into the more effective detection and investigation, as well as answers on the individual services and their future, also interpreted in the context of the readers.

A TOPSIS analysis of regional competitiveness at European level

PurposeThe measurement of regional competitiveness is becoming essential for policymakers to address territorial disparities, while considering the issue of correlations among indicators. Therefore, the purpose of this paper is to measure regional competitiveness using the Technique for Order Preference by Similarity to the Ideal Solution (TOPSIS) by considering different distance measures and two levels of analysis to provide a comparative and comprehensive measurement of regional competitiveness in Europe.Design/methodology/approachThe authors apply TOPSIS based on three different distance measures (the Manhattan, the Euclidean and the Mahalanobis distance measures) to the regions of the EU Regional Competitiveness Index (RCI) 2019, which is taken as the frame of reference.FindingsThe authors replicate the RCI by using TOPSIS with a less preferred choice of distance measure, indicating TOPSIS as a valuable method for policymakers in the analysis of regional competitiveness. The authors argue in favour of the Mahalanobis distance measure as the best of the three, as it considers correlations among macro-economic indicators.Originality/valueThis study aims to make three contributions. Firstly, by replicating the RCI by means of TOPSIS with a less preferred choice of distance measure, the paper provides a benchmark for future research on regional competitiveness. Secondly, by suggesting the use of TOPSIS with the use of the Mahalanobis distance measure, the authors show how to measure regional competitiveness by taking into account correlations among pillars. Thirdly, the authors argue in favour of considering clusters of regions when measuring regional competitiveness.

373 Effect of Cu and Zn contents in growing finishing pig diets on animal performance and Cu and Zn content in manure, according to three manure management chains

Abstract Copper (Cu) and zinc (Zn) are essential nutrients for swine. However, as pigs have a low retention rate for these elements, more than 90% of ingested Cu and Zn are excreted, mainly in feces. After spreading manure, these trace elements could accumulate in the soil and potentially have negative environmental effects. Moreover, Cu and Zn are also limited natural resources that should be preserved. A better understanding of the behavior of these elements throughout the feed-animal-effluent-treatment continuum according to feed composition and manure management chain is thus required to propose alternative ways to reduce these environmental impacts. Three feeding strategies differing in their Cu and Zn contents were compared in 72 growing-finishing pigs raised in individual pens [from 24.3 ± 3.3 up to 110 ± 9.0 kg body weight (BW), one-half males; and one-half females] a first diet with Cu and Zn at maximum EU regulation levels (20 and 100 ppm of Cu and Zn, respectively; REG), a second diet without any Cu and Zn supplementation (5 ppm Cu, 30 ppm Zn; WS) and a third diet with Cu and Zn at an intermediary level (10 and 50 ppm of Cu and Zn; INT). Cu and Zn were supplemented as Cu2O (CoRouge, Animine) and ZnO (HiZox, Animine), respectively. Eighteen additional finishing pigs (6 per diet) were raised in digestibility cages for excreta collection over 10 d, and their feces were submitted to two types of manure treatment: anaerobic digestion (AD) and composting with straw. Over the entire experimental period, the dietary Cu and Zn content did not influence growth performance of pigs. The Cu and Zn concentrations of the feces decreased linearly (P < 0.001) with dietary content from 191 and 834 (REG) up to 63 and 359 (INT) and 40 and 213 (WS) mg Cu and Zn/kg dry matter (DM) respectively. After both manure treatments, the degradation of the organic matter resulted in a significant increase (twice as much) in Cu and Zn concentration per kg of DM. Feeding strategy appears to be the main lever to reduce the Cu and Zn content of effluents. However, in the context of the diversification of manure management strategies, it is also important to take into account the effect of the effluent collection and treatment chain (e.g., spreading of raw slurry, phase separation, anaerobic digestion, composting), which has also an impact on the behavior of Cu and Zn and consequently on the risk for the environment.

Cellulose-based nanostructured aerogels for leachate decontamination: Towards sustainable phosphorus recovery from sewage sludge ash

Recent EU data confirmed phosphorus as a critical raw material, with efficient recovery from sewage sludge ash presenting challenges, particularly due to the co-dissolution of heavy metals. This work investigated an innovative strategy for the removal of heavy metals from sewage sludge ash derived leachate by using sustainable cellulose nanosponges, synthetized by thermal cross-linking between branched polyethylenimine and 2,2,6,6-tetramethylpiperidin-1-yl)oxyl (TEMPO)-oxidized cellulose nanofibers.Lab-scale adsorption tests were conducted with varying sorbent amounts (1, 3 and 10 g/L) in absence or presence of citric acid (10 g/L) across pH values (1.8–10), to assess the removal of metals/metalloids (As, Cu, Cr, Ni, Zn, Fe, Al). P was subsequently precipitated from the decontaminated leachate by adding Ca(OH)2 till target pH.Results showed that cellulose nanosponges were able to adsorb considerable amounts of metallic ions, in particular Fe and Al, under strongly acidic conditions, reducing their percentage by 40% and 30%, respectively. Under optimized conditions (10 g/L of citric acid and 10 g/L of sorbent), the solid precipitate recovered at pH 8 from the decontaminated leachate was compliant with EU regulation 2019/1009 in terms of P2O5 and heavy metals content, suggesting its possible future use as raw material for inorganic fertilizers production.

Assuring reclaimed water quality using a multi-barrier treatment train according to the new EU non-potable water reuse regulation

In this study, we evaluated the ability of various pilot-scale treatment train combinations to meet the microbial requirements of the new European non-potable water reuse regulation 2020/741. The study utilized non-disinfected secondary effluent from the wastewater treatment plant in Schweinfurt, Germany, as feedwater for two pilot-scale treatment trains. The first, a reference treatment train (Train A), consisted of filtration and UV disinfection as specified for reclaimed water class A in the EU regulation. The second, an advanced treatment train (Train B), included ceramic ultrafiltration (UF), ozonation, biological activated carbon filtration (BAC), and final UV disinfection. Based on a Monte Carlo simulation for Train A, the EU requirements for pathogen removal were not met when an average UV dose of 400-600 J m−2 was applied. This shortcoming was likely due to a moderate transmittance range (50–65 %), resulting in decreased UV fluence. These findings suggest that operational conditions for disinfection should be more clearly specified to ensure consistent pathogen inactivation both during validation and regular operation. In contrast, treatment train B successfully met the requirements of the EU regulations by reducing pathogens to below the detection limit. The UF membrane demonstrated a positive effect on the overall log reduction values (LRVs) throughout the water reclamation system. It also enhanced the efficiency of downstream processes, such as ozonation and UV disinfection, by lowering total suspended solids and turbidity. However, even without the UF membrane, treatment train B was still able to meet the pathogenic EU requirements for non-potable reuse applications. Furthermore, the study observed that the inclusion of biologically activated carbon (BAC) filtration requires a final disinfection step (e.g., UV disinfection) to prevent the potential occurrence of heterotrophic bacteria that proliferate in the BAC filter. For process validation it is recommended to use at least two different virus surrogates (MS2 and PhiX174), rather than just one or total coliphage as required in the EU regulation.

The empirical evidence of digital trends in more disadvantaged European Union regions in terms of income and population density

AbstractRemote rural and postindustrial regions are much more vulnerable to population drain in comparison with industrialized centers and capitals, due to obvious reasons such as meager job opportunities, difficulties in accessing public services in education, healthcare and transport, housing, entertainment, lack of integration with other territories and, finally, less advanced levels of digitalization. This represents an open challenge for the European Union within the framework of its Cohesion Policy. This paper analyzes the impact of digital trends, represented by the percentage of the population with access to internet and broadband and the percentage of individuals who buy goods and internet services (percentages provided by Eurostat) in less populated EU NUTS2 regions with lower income, on the crude population growth rate composed of natural changes in population and migratory flows and on the unemployment rate by applying panel data analysis. It has been possible to confirm that digitalization has a positive impact on natural changes in population in EU regions with lower economic development. On the contrary, the unemployment rate does not affect natural changes in population, but it does have a negative impact on migratory flows. The findings show that digitalization may contribute to reversing negative demographic trends in more disadvantaged EU regions in terms of income and population density.

Optimization and Validation of a Cheaper, Safer, and More Sustainable Methodology for Aflatoxins Determination in Rich-Lipidic Matrices (Pistachio Nuts) Using Deep Eutectic Solvent Extraction and UHPLC-FLD Analysis.

Aflatoxins pose a major health concern and require strict monitoring in food products. Existing methods rely on hazardous organic solvents for extraction, prompting the development of a greener alternative. This study explores deep eutectic solvents (DESs) for aflatoxin extraction from pistachios, a valuable food product prone to aflatoxin contamination. The proposed method utilizes DES extraction followed by solid-phase extraction cleanup and ultrahigh-performance liquid chromatography coupled with fluorescence detector analysis. Recovery rates ranged from 85.5 to 99.1% for pistachios spiked with 1-8 ng/g aflatoxins, in compliance with EU regulations, with coefficients of variation less than 2.94%. The method demonstrates good sensitivity with limits of detection and quantification in the range of 0.02-0.22 ng/g and 0.05-0.72 ng/g, respectively. Greenness assessment using AGREEPrep and White Analytical Chemistry metrics confirms its environmental sustainability. This approach offers a promising, safer, and more eco-friendly alternative for aflatoxin extraction from complex food matrices like pistachios.

How sustainable is tuna aquaculture? A methodology to assess the sustainability of seafood production systems

IntroductionConsidering the need to feed the increasing world population, it is essential to ensure that food production systems are sustainable. Aquaculture has been identified as a potential crucial source of sustainable food with its significant potential for future growth, notably by the recent EU regulations aiming at boosting food security and sustainable food systems. In this context, it is important to reflect on how the aquaculture of carnivorous species, which are exhibiting the highest growth rates, stands in respect of environmental impacts and contribution to the overall food supply. In particular, tuna aquaculture has been largely criticized for its high environmental impacts and general low sustainability.MethodsHere, we present a methodology to assess the sustainability of seafood production systems, with a first analysis applied to Atlantic bluefin tuna (BFT) aquaculture, detailed for both BFT fattening and farming.ResultsResults suggest that the limited economic and social contributions of BFT aquaculture do not currently compensate its environmental impacts with an estimate of a 3.4-fold higher long-term social cost than the short-term economic gain.DiscussionHowever, it is also a species where the production cycle is not closed in commercial operation, and with a significant potential for further improvement as the control of the production process increases.

Development of an Innovative Pupillometer Able to Selectively Stimulate the Eye's Fundus Photoreceptor Cells.

Recent advancements in clinical research have identified the need to combine pupillometry with a selective stimulation of the eye's photoreceptor cell types to broaden retinal and neuroretinal health assessment opportunities. Our thorough analysis of the literature revealed the technological gaps that currently restrict and hinder the effective utilization of a method acknowledged to hold great potential. The available devices do not adequately stimulate the photoreceptor types with enough contrast and do not guarantee seamless device function integration, which would enable advanced data analysis. RetinaWISE is an advanced silencing pupillometry device that addresses these deficiencies. It combines a Maxwellian optical arrangement with advanced retinal stimulation, allowing for calibrated standard measurements to generate advanced and consistent results across multiple sites. The device holds a Class 1 CE marking under EU regulation 2017/745, thus facilitating clinical research progress.

The Carrier’s Defence to Liability for Delay under the Montreal Convention and EU Regulation 261/2004

This paper analyses the specific defence to liability for delay available to carriers, comparing its features under the Montreal Convention (MC99) and EU Regulation 261/2004 (Regulation 261). The relationship between these legal instruments has never been an easy one, whereas recent case law of the Court of Justice of the European Union on the socalled ‘extraordinary circumstances defence’ invites to explore similarities and differences between the international and the European approaches. The scope of application of the defence is clearer in Regulation 261 than in MC99. The former will only affect cancellations and delays – not cases of denied boarding, and its impact remains limited to the lump-sum compensation set out in Article 7 of Regulation 261. In turn, MC99 covers delays, but it is uncertain whether it also encompasses cancellations and situations of denied boarding – particularly when the passengers concerned are provided alternate transportation. Moreover, the defence laid down in MC99 applies to damage occasioned by delay, but the definition of ‘damage’ is left to domestic law. This situation gives rise to diverging decisions by national courts. Regarding the conceptualization of the defence, the wording of the relevant provisions might lead to think that both instruments share a regime of liability for presumed culpability. However, the extraordinary circumstances defence is much more complex. As a consequence, there is no alignment between MC99 and Regulation 261, although points of convergence are highlighted.

Regarding the establishment of the anti-burn «Fenix-MS» bed conformity with the requirements of quality and safety standards

The standards that anti-burn beds must meet are given. The design of the domestically produced anti-burn «Phoenix-MS» bed, which has improved design and technological indicators, is briefly described. The main test results of this bed, obtained in the process of independent conformity assessment, are presented. Their analysis showed that the product meets quality standards and ensures the safety of patients and medical personnel during its operation in medical institutions. It is noted that the manufacturer needs to carry out a more complete clinical evaluation of the product, taking into account the strengthening of this requirement in the new EU Regulation 2017/745 on medical devices.

Impact of Exchange Rate Regime Change on Bangladesh RMG Exports to the USA and the EU

Abstract Bangladesh adopted floating exchange rate system in May 2003. After that regime change, the country has faced a relatively higher volatility of nominal exchange rate than previous regime. Economic theories on volatility suggests that trade flow is adversely affected in response of fluctuation of the exchange rate. Bangladesh is the second largest readymade garments (RMG) exporter in the world and it is the main export product of the country. In this research, Difference in Difference (DID) model introduced by Card and Krueger (1994) is used for the yearly data of 1983 to 2022 to discern this impact of volatility on the RMG exports of Bangladesh. The result shows that RMG exports is negatively affected due to the exchange rate volatility and the estimated figure shows that on Bangladesh‘s average RMG exports has been lessened to the USA and EU regions by US$1.04 billion and 1.02 billion, respectively, owing to the volatility incurred by the regime change. Therefore, as volatility obviously has hindered RMG exports, the central bank of Bangladesh should stay alert to avoid high volatility of the nominal exchange rate to keep the RMG exports flow uninterrupted.

Air Passenger Rights Case Law Developments from 1 December 2023 to 15 June 2024

From 1 December 2023 to 15 June 2024, there have been several case developments in relation to air passenger rights. The first part of this article highlights recent decisions from the Court of Justice of the European Union that have shed light on the interpretation of EU Regulation No 261/2004, Package Travel Directive (EU) 2015/2302 and Council Directive 93/13/EEC of 5 April 1993 on Unfair Terms in Consumer Contracts.In the case Laudamotion GmbH v. flightright GmbH the Court stressed the standardized nature of compensation for a flight delay and held that for compensation claims under Regulation (EC) No 261/2004 due to a significant flight delay, passengers must adhere to the check-in requirements specified by the airline, even if they have already completed online check-in.In the case Eventmedia Soluciones SL v. Air Europa Líneas Aéreas SAU, the Court defined the rules governing the inclusion, in a contract of carriage, of a clause prohibiting the transfer of rights by passengers and the right of claim management companies to bring proceedings against airlines. In the case Cobult UG v. TAP Air Portugal SA (TAP), the Court clarified the rules applicable to passengers’ consent to the reimbursement of the cost of their ticket by a travel voucher rather than by a sum of money. In the case Touristic Aviation Services Limited (TAS) v. Flightright GmbH, the Court ruled that the shortage of staff at the airport responsible for baggage handling could be considered an extraordinary circumstance, provided the airline could demonstrate that they had taken all reasonable measures to prevent the delay.In the case QM v. Kiwi Tours GmbH, the Court held that to establish the existence of unavoidable and extraordinary circumstances significantly impacting the performance of a travel package, for the purpose of claiming a refund under Directive (EU) 2015/2302, only the situation prevailing on the date when the traveler terminated their travel contract should be considered. In the case Eventmedia Soluciones SL v. Air Europa Líneas Aéreas, the Court ruled on the fairness of clauses governing the assignment of rights by passengers to third parties under Directive 93/13/EEC on Unfair Terms in Consumer Contracts.

Prawne i praktyczne aspekty dotyczące przetwarzania danych osobowych w procesie rekrutacji

The subject of this article is to identify good practices, occurring risks and irregularities in the processing of personal data of job candidates as part of the employee recruitment process and to develop principles for verifying the correctness of the functioning of this process as a tool supporting the audit task. The recruitment process and the associated staff turnover is one of the key areas where the employer should ensure the organizational and legal security of the processed personal data, which undeniably affects its professionalism and the perception of external customers, such as job candidates. The uniformity of the legality of this process is influenced by both national labor laws and EU regulations. The key principles to ensure the compliance of processed data with the requirements of labor laws in the recruitment process are the principle of data minimization and storage limitation, as well as the processing of personal data of job candidates by persons only authorized by the employer, who have committed themselves to the principles of confidentiality and impartiality. The above is also related to the implementation of the controller’s information obligations to job candidates and their correlation with the actual processing of personal data by the controller and its authorized personnel.

Forma załatwienia sprawy administracyjnej a ochrona danych osobowych

The article is a synthesis of most important issues in the area of personal data protection in the context of administrative proceedings. Attention was paid to the specificity of the main forms of dealing with administrative matters, and in their context, to the legislator’s approach to the obligations of bodies in the implementation of the rights (settled in national and EU regulations) to which people are entitled. There are discussed laws which are connected with the topic of this article and included in the Administrative Procedure Code, the Personal Data Protection Act and the GDPR. The approach of doctrine, case law and obligations regarding the protection of personal data is presented here. Problems that may occur in the practice of applying the discussed standards were also highlighted, and as a result, threats to the implementation of the right to personal data protection in administrative proceedings.

Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment.

There has been rapid growth in the variety and number of real-world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose. Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia-Pacific regions. An online survey was designed and deployed to International Society for Pharmacoepidemiology members to understand current practice. Findings were summarized and used to inform key considerations and recommendations. Eleven RWD guidance documents were identified and mapped against 14 RWD assessment criteria. Variability was seen across these documents in guidance for these criteria. Between December 2022 and January 2023, 37 survey respondents reported having used RWD for post-marketing commitments (34, 92%) and/or background epidemiology (28, 76%). RWD were mostly identified through literature (33, 89%) and data landscaping (26, 70%); guidance documents referenced included: Food and Drug Administration (20, 54%), European Network for Centres for Pharmacoepidemiology and Pharmacovigilance (17, 46%), European Medical Agency (16, 43%), and Structured Process to Identify Fit-For-Purpose Data (11, 30%). Challenges for conducting feasibility assessments included RWD accessibility, ability to complete validation, and RWD provider responsiveness. Existing guidelines are used extensively by researchers, but key criteria for RWD identification and feasibility assessment are not reflected consistently and challenges remain. Recommendations have been made reflecting study findings.

The Evaluation of Climate Change Competitiveness via DEA Models and Shannon Entropy: EU Regions.

The purpose of this paper is to assess the efficiency of climate change competitiveness via a case study on EU regions by using the data envelopment analysis (DEA) model and Shannon entropy. First, on the same premise as similar composite indicators, we develop a DEA model to assess the relative performance of the regions in climate change competitiveness. Then, we extend our calculations with a DEA-like model and Shannon entropy to derive global estimates of a new competitiveness index by using common weights. Results show that the proposed DEA-Entropy model enables the construction of a regional climate change competitiveness index among all regions via a set of common weights. The proposed model's common weight structure demonstrates more discriminative power compared to the weights obtained through pure DEA or DEA-like methods. In order to validate the proposed DEA-Entropy model, it was applied to 120 EU regions. The results are meaningful for the regions to improve their competitiveness.

The EU Divorce Jurisdiction of Brussels IIB Regulation and Its Implementation in Austria

To accommodate the needs of its citizens in building relationships across borders, the EU has provided several regulations. Since its first establishment in 2000, the EU regulations on divorce and legal separation jurisdiction have been amended twice. There are some significant changes in this jurisdiction, from its original regulation in 2000 to its amendment version in 2003 up to the current version that was established in 2019. This paper tries to investigate the implementation of the current ruling EU instrument in Austria through three approaches by evaluating: 1) the infringement cases, 2) preliminary ruling proceedings, and 3) further official actions conducted by Austria. It can be concluded that Austria has never been accused of any infringements of the three regulations. The court judgments of the two proceedings of preliminary ruling submitted by Austrian courts concerning Brussels IIA Regulation are also in accordance with the regulated law of EC No 2201/2003. The establishment of an introductory decree on the summary and legal explanations of the Council Regulation EU No 1111/2019 by Austria is a very good practice that can be adopted by other EU member states. Therefore, this paper suggests that Austria has effectively implemented the 2019 EU instrument.