European Union Regulations Research Articles

Transnational networks of energy communities as counterpower in the European Union renewable energy transition framework

Abstract This article explores the communicative process by which transnational networks of energy communities (ECs) in Europe build counterpower vis-a-vis the European Union (EU) institutional framework, with the purpose of effectively contributing to the shaping and management of the EU policy and regulatory framework for renewable energy transition. Such a process consists in the identification of obstacles to effective participation, the facilitation of access to information on EU regulation and policy frameworks, and the production of technical knowledge that reframes how renewable energy transition is understood as a field of political intervention. The impact of EC networks, and other networks of related community-led initiatives, on the EU energy policy framework is still relatively small when compared to centralized, large-scale providers of energy. It is constrained by how differently EU regulatory and policy packages address ‘techno-energetic systems’ in energy transition, as well as disparities in the transposition of EU legislation by Member States. Still, EC networks are building counterpower by facilitating bottom-up information and skill sharing, focusing on facilitating access to information on EU regulation and policy frameworks, as well as producing knowledge that frames the obstacles to effective participation of ECs in policymaking. It expands the understanding of renewable energy transition as a field of policy intervention beyond merely instrumental logic, centred on regulation and policy support to technological innovation, by mainstreaming a substantive logic based on a comprehensive socioecological framing that embeds energy transition in a multidimensional understanding of territorial development and governance.

Recycled Aggregates Influence on the Mechanical Properties of Cement Lime-Based Mortars

The current framework for managing construction waste, guided by European Union regulations, calls for an integrated waste management system. However, the reuse of old plaster waste, particularly from deteriorated facades, remains underexplored. This study investigates the potential of repurposing old plaster waste as a substitute for aggregates and cement in mortars, with the aim of promoting environmental sustainability and resource efficiency. Three mortar mixes were analyzed: a control mix, a mix with 45% waste replacing aggregates, and a mix with 10% waste replacing cement. Results show that replacing 45% of aggregates with plaster waste led to a 30% reduction in flexural strength, while the 10% cement replacement increased flexural strength by 6%. Compressive strength dropped by 27% and 38% for cement and aggregate replacements, respectively. Despite these reductions, the waste replacement remained within acceptable limits for structural integrity. Further microscopic analysis revealed that the incomplete integration of portlandite particles from the waste contributed to non-uniform bonding and crystal formation, weakening the mortar’s structure. This research demonstrates the feasibility of reusing old plaster waste, offering a novel approach to reducing construction waste and promoting a circular economy. It contributes to filling the knowledge gap on the reuse of plaster mortars while aligning with sustainable construction goals.

Modelling the Effects of Forest use Change on Brownification of Finnish Rivers under Atmospheric Pressure.

Browning of surface waters due to increased terrestrial loading of dissolved organic matter (DOM) is observed across the Northern Hemisphere. The effects influence several ecosystem services from freshwater productivity to water purification. Brownification is often explained by changes in large-scale anthropogenic pressures and ecosystem functioning (acidification, climate change, and land cover changes). This study examined the effect of forest use changes on water browning in Finland, considering the effects of global pressures. Our goal was to find the ecosystems and geographic areas that are most sensitive to environmental pressures that increase the loading of DOM. We were also looking for land use strategies that decrease browning. We combined mathematical watershed modelling to scenarios of climate change, atmospheric deposition, and forest use change. Changes included scenarios of forest harvest and protection on forest, that were derived from European Union's regulation. The study area covered 20 watersheds from south to north of Finland. In northern Finland brownification continue. In southern Finland global influence (atmospheric deposition, climate change) seem to weaken, giving more space for local forest use change having an influence on brownification. Forest use change was more influential in river basins dominated by organic soils than in mineral soils. Extending forest protection decreased brownification especially in areas where the influence of atmospheric pressure is decreasing. When forest protection is planned to provide a carbon storage and sequestration potential and to favor biodiversity, it has favorable effect on surface water quality as well.

“ESG score” vs. “ESG rating”: a conceptual model for the sustainability assessment and self-assessment of European SMEs

This paper aims to contribute to the ongoing discourse regarding the distinctions and application of scoring and rating systems by presenting a conceptual model designed to assess and self-assess small and medium-sized enterprises (hereinafter also “SMEs”) on their sustainability transition. Indeed, SMEs operate in very different economic contexts and have simplified organizational and governance structures. These characteristics can be effectively captured through this conceptual model based on a customized questionnaire tailored to the specificities of SMEs. Following an analysis of existing literature and regulatory frameworks, a conceptual model is proposed that includes a questionnaire that, unlike commonly proposed industry questionnaires, is designed to generate an Environmental, Social and Governance (hereinafter also “ESG”) Score complemented by a forward-looking perspective. This model can be useful for SMEs, as it allows them to self-assess their strengths and weaknesses in the sustainability transition process, highlighting specific needs and suggesting actions to improve their sustainability transition. It also allows banks to make a more accurate assessment of the sustainability of their customers, facilitating the redefinition of green and social credit products according to the needs of SMEs. Additionally, it also supports supply chain leaders in ensuring a sustainable supply chain by facilitating the sustainability assessment of SMEs. This is so that everything complies with the new European Union (hereinafter also “EU”) regulations. Finally, the questionnaire is currently being tested at a local bank and has been proposed to SME suppliers in a specific supply chain. It will be possible to make changes to the questionnaire based on the feedback received during the administration phase.

Conceptual model for extending electric vehicle battery lifetime

To maximise the resource efficiency of electric vehicle lithium-ion batteries (LIBs), their lifetimes can be extended through cascading second- and third-life applications. Using expert input, this study establishes a conceptual model for understanding these applications’ state of health (SOH) thresholds and user requirements. Using a qualitative methodology, including focus group discussions with multistakeholder experts and policy analysis of the European battery regulatory landscape, we propose extending LIB use. Our model outlines potential second- and third-life applications aiming to maximise battery value retention. The findings highlight gaps in current European Union regulations that inadequately support battery-repurposing strategies. The conceptual model with an SOH threshold and key performance indicators serves as a foundation for researchers and industries to explore cascading battery applications, foster long-term resource efficiency and contribute to the circular economy by extending LIB lifespans through repurposing initiatives.

Reference, calibration and referral laboratories- a look at current European provisions and beyond.

European Union (EU) regulations on invitro diagnostics (IVD) and on serious cross-border threats to health provide for the establishment of European Reference Laboratories (EURLs) and their harmonization and cooperation with National Reference Laboratories (NRLs). While the EURLs under the IVD Regulation will be operational by 1 October 2024, the EURLs under the Regulation on serious cross-border threats to health will be operational by January 2025. Although NRLs may have been operating for a long time on the basis of national legislation, they should now cooperate with each other and with EURLs in a network of centers of excellence for the authorization and post-market surveillance of IVDs and for the epidemiological surveillance and control of communicable diseases. The term "reference laboratory" has long been used colloquially to refer to many kinds oflaboratories, regardless of their tasks, competencies, responsibilities and designation. A literature search and analysis confirmed this by showing that a considerable proportion of scientific publications in 2024 use the term "reference laboratory" inappropriately. In order to clarify the roles and functioning of EURLs and NRLs, we have evaluated the relevant current EU provisions and compared the findings with those of reference laboratories designated by other organizations, calibration (reference) laboratories and referral laboratories, which are simply referred to as "reference laboratories". With the forthcoming implementation of the EU regulations, at least the goals of providing safe and high-quality IVDs and adequate public health surveillance for communicable diseases appear to be achievable.

The removal of pollutants from synthetic bathroom greywater by coagulation-flocculation and filtration as a fit-for-purpose method

It has been demonstrated that treated bathroom greywater (TBGW) is a useful substitute for fresh water for non-potable applications in households. Reuse of TBGW for irrigation, toilet flushing, car washing etc. offers a good opportunity to save drinking water and meet the sustainable development goals (SDGs). In this study, synthetic bathroom greywater (SBGW) was compiled in a controlled manner and used as a substitute for bathroom GW. Detailed statistical analysis also was performed to confirm the similarity between real and synthetic BGWs. SBGW is suitable for testing efficiency of applied treatment methods. It was confirmed that coagulation–flocculation with iron(III) chloride and sand filtration was the most effective method of the tested 7 systems. The best and affordable treatment combination generates good-quality treated SBGW (TSBGW) (pH = 7.54 ± 0.29, TURB = 0.54 ± 0.49 NTU, BOD5 = 21 ± 10 mgL−1, COD = 32 ± 11 mgL−1, and TOC = 12.7 ± 6.7 mgL−1) for different non-potable purposes by complying with the regulated limit values for reuse. The elemental analysis of raw, TSBGW and tap water (TW) samples by MP-AES method provided further support for safe recycling. This study leads to the conclusion that the generation of TBGW by fit-for-purpose treatment can effectively meet the circular economy goals at household level. The recycling of GW is of limited importance in the European Union (EU) and legal regulations are not available in many countries. This study provides novel support for regulating the reuse of water in Eastern European countries.

Coupling UVC254 nm-LED/H2O2 and Fenton processes for disinfection and contaminants of emerging concern removal in continuous mode for wastewater reclamation in accordance with EU 2020/741

A novel strategy based on the sequential combination of UVC254 nm-LED/H2O2 and the Fenton process at neutral pH in continuous flow mode for wastewater reclamation has been assessed. The concentration of Escherichia coli (E. coli) reached water class A according to the European Union (EU) Regulation 2020/741 (≤10 CFU/100 mL) and a 87 ± 2 % of the contaminants of emerging concern (CECs) load was removed, complying with the new proposal regarding Urban Wastewater Treatment (Directive COM (2022) 541). To reach these results, initially the municipal wastewater secondary effluent was kept under UVC254 nm-LED/H2O2 process with a hydraulic residence time (HRT) of 5 min, a liquid depth of 5-cm and 1.8 mmol L−1 of H2O2. In the sequence, addition of Fe2+ to the outside of the UVC254 nm-LED reactor was added to acquire the desired concentration of 1.8 mmol L−1 Fe2+ (Fenton process). To obtain the same disinfection and CECs degradation by only UVC254 nm-LED/H2O2 process, 45 min-HRT were necessary. These results show that the coupled processes are the best strategy, given the reduction in HRT (from 45 to 5 min) and total cost (from 1.79 to 0.54 € m−3). In addition, new research on the application at pilot scale will encourage to evaluate the long-term toxicity of the reclaimed wastewater and to identify the main transformation products of the most abundant CECs.

Protection of Personal Data Processed in Artificial Intelligence Systems

The text undertakes an analysis of European Union regulations on the prevention of data protection breaches in AI systems, taking into account the provisions of the General Data Protection Regulation (GDPR) and the draft AI Act. Legal guarantees for the protection of personal data processed in AI systems are sought in the general principles of the GDPR (in particular the principles of lawfulness, transparency, data minimisation and confidentiality) and the regulations on liability for data breaches. The conclusions of the analysis indicate that the implementation of the solutions contained in the current and proposed regulations may be hampered by the autonomy of some AI systems.

Will the EU deforestation-free products regulation (EUDR) reduce tropical forest loss? Insights from three producer countries

The European Union regulation on deforestation-free products (EUDR) represents a policy innovation with important implications for the governance of global commodity chains. We discuss the risks and limitations of this policy derived from an ex-ante assessment of the robustness of its theory of change. For doing so, we use insights from the literature on zero-deforestation commitments and other private standards in value chains and from trade and deforestation patterns in three relevant producer countries (Brazil, Colombia and Indonesia). Despite the potentially positive symbolic effect in mobilizing a global agenda for combating deforestation, the EUDR faces several drawbacks and risks associated with three of its constitutive features: To be demand-oriented, having the value chain as the unit of intervention and holding a high degree of unilateralism. We conclude that to be effective in curbing tropical deforestation, the Regulation must be complemented with international cooperation aiming to strengthen national policies with a territorial approach, as well as social movements addressing the underlying causes of forest loss and human rights violations in the territories where it takes place.

Evaluation of an Enzyme-Linked Magnetic Electrochemical Assay for Hepatitis a Virus Detection in Drinking and Vegetable Processing Water

Globally, waterborne viral infections significantly threaten public health. While current European Union regulations stipulate that drinking water must be devoid of harmful pathogens, they do not specifically address the presence of enteric viruses in water used for irrigation or food production. Traditional virus detection methods rely on molecular biology assays, requiring specialized personnel and laboratory facilities. Here, we describe an electrochemical sandwich enzyme-linked immunomagnetic assay (ELIME) for the detection of the hepatitis A virus (HAV) in water matrices. This method employed screen-printed electrodes as the sensing platform and utilized commercially available pre-activated magnetic beads to provide a robust foundation for the immunological reaction. The ELIME assay demonstrated exceptional analytical performance in only 185 min achieving a detection limit of 0.5 genomic copies per milliliter (g.c./mL) and exhibiting good reproducibility with a relative standard deviation (RSD) of 7% in HAV-spiked drinking and processing water samples. Compared with the real-time RT-qPCR method described in ISO 15216-1, the ELIME assay demonstrated higher sensitivity, although the overall linearity of the method was moderate. These analytical attributes highlight the potential of the ELIME assay as a rapid and viable alternative for HAV detection in water used for agriculture and food processing.

European Union Regulation on Personal Data Protection in Medical Writing

The European General Data Protection Regulation 2016/679 (GDPR) aims to harmonize data protection laws across European Union (EU) Member States. The goal of GDPR is to ensure respect of the fundamental right to protection of the personal data and privacy, to enhance security measures, including information technology (IT) for data protection, and to render natural persons control over their personal data. Importantly, companies, institutions, freelancers (including medical writers) located outside the EU and handling personal data of natural persons living on the territory of the EU must comply with GDPR. Medical writers edit documents related to the activities in health sector that comprise personal data, specifically health data considered as sensitive data. Therefore, medical writing should put in place robust security measures and comply with the GDPR. This article is a clarification of the GDPR notions, principles, technical and organizational measures applied to the medical writing to guarantee protection of the personal data and respect of individual’s rights and freedoms.

LEGAL ANALYSIS OF EU ARTIFICIAL INTELLIGENCE ACT (2024): INSIGHTS FROM PERSONAL DATA GOVERNANCE AND HEALTH POLICY

Background: This study correlates the up-to-date ethical, functional and legal evaluations related to the management and governance of artificial intelligence (AI) under European Union (EU) law, particularly impacting the health data sector and medical standards as provided by the Artificial Intelligence Act within the Regulation adopted by the European Council in May 2024. The initial proposal for the management and governance of the AI sector was submitted in April 2021. Three years later, on 13 March 2024, the European Union Artificial Intelligence Act (EU AIA) was adopted by the European Parliament. Subsequently, on 21 May 2024, the Council adopted an innovative legislative framework that harmonises the standards and rules for AI regulation. This framework is set to take effect in May 2026, with the central objective of stimulating and motivating a fair, safe, legal single market that respects the principles of ethics and the fundamental rights of the human person. Methods: The current legal analysis focuses on the European Union’s new institutional governance involving a multistage approach to managing health data, ethical artificial intelligence, generative artificial intelligence and classification of types of AI by considering the degree of risk (e.g. artificial intelligence systems with limited risk and systems with high risk) and medical devices. It outlines the legal framework for AI regulation and governance in the EU by focusing on compliance with the previously adopted legislation in the Medical Devices Regulation (2017) and the In-Vitro Diagnostic Regulation (2017). The paper also examines the application of the newly adopted EU Artificial Intelligence Act in relation to national justice systems, previous EU regulations on medical devices and personal data protection regulation, and its correlation with the European Court of Human Rights jurisprudence. This opens up complex discussions related to judicial reform and access to justice. For this purpose, as a research objective, the legal analysis includes an innovative perspective following an integrative discussion on the latest legal reforms and regulations of the AI sector in Eastern Europe launched in 2024 with a special focus on the latest developments in the EU Candidate Countries namely Ukraine and the Republic of Moldova. Results and conclusions: The present research facilitates the exploration of the real benefits of managing innovative AI systems for medical data, research, and development, as well as within the medical technology industry.

Requirements for the content of harmful substances in market products of plastics and rubber. Part V. Vehicles and their equipment

This article continues the review of applicable regulations on the safety of products placed on the European Union (EU) market. Part V regarding the regulations on the control of hazardous substances in vehicles, including their components and equipment made of plastics and rubber, covers EU regulations and national acts adapting Polish law to EU legislation in this area.

Baby Foods: 9 Out of 62 Exceed the Reference Limits for Acrylamide.

Acrylamide (AA) is a contaminant resulting from the Maillard reaction and classified by the International Agency for Research on Cancer (IARC) as a probable carcinogen in Group 2A, with proven neurotoxic effects on humans. European Union (EU) Regulation No. 2017/2158 is currently in force, which establishes measures meant to reduce AA levels in food and sets reference values, but not legal limits, equal to 40 and 150 μg/kg AA in processed cereal-based foods intended for infants and young children and in biscuits and rusks, respectively. For this reason, sixty-two baby foods were analyzed using ultra-high performance liquid chromatography with diode array detector and quadrupole time-of-flight mass spectrometry (UHPLC-DAD-Q-TOF/MS) to check whether industries were complying with these values, even though AA control is not legally mandatory. In total, 14.5% of the samples exceeded the reference values; these were homogenized chicken products (211.84 ± 16.53, 154.32 ± 12.71, 194.88 ± 7.40 μg/kg), three biscuits (276.36 ± 0.03, 242.06 ± 0.78, 234.78 ± 4.53 μg/kg), a wheat semolina (46.07 ± 0.23 μg/kg), a homogenized product with plaice and potatoes (45.52 ± 0.28 μg/kg), and a children's snack with milk and cocoa (40.95 ± 0.32 μg/kg). Subsequently, the daily intake of AA was estimated, considering the worst-case scenario, as provided by the consumption of homogenized chicken products and biscuits. The results are associated with margins of exposure (MOEs) that are not concerning for neurotoxic effects but are alarming for the probable carcinogenic effects of AA.

Circular fertilisers combining dehydrated human urine and organic wastes can fulfil the macronutrient demand of 15 major crops

This study evaluated the potential for combining dehydrated human urine with one other form of organic waste to create circular fertilisers tailored to meet the macronutrient demand of 15 major crops cultivated globally. Through a reverse blending modelling approach, data on 359 different organic wastes were used to identify 38 fertiliser blends. Materials found to be particularly suitable as blending materials were various biochars and ashes, due to their low nitrogen and high phosphorus and/or potassium content, and byproduct concentrates, due to their high phosphorus content, since the nitrogen content of human urine is disproportionately higher than its phosphorus content. Several organic wastes were suitable for fertilising more than one crop. The macronutrient content of the simulated fertiliser blends was comparable to that of blended inorganic fertilisers, but only a few blends precisely matched the macronutrient demand of crops. Fertilising crops with some simulated fertilisers would potentially result in excess application of one or more macronutrients, and thus overfertilisation. For organic wastes with data available on their content of six or more heavy metals, it was found that the simulated fertilisers generally met European Union regulations on use of fertilisers of organic origin in agriculture. Overall, these findings suggest that fertiliser blends combining dehydrated human urine and organic wastes, both of which are widely available globally, could replace inorganic blended fertilisers in agriculture. Such recycling would help the global food system and water sector transition to circularity and promote better management of plant-essential nutrients in society.

Sustainability of Organic Fertilizers Use in Dryland Mediterranean Agriculture

Organic fertilization is a key issue in European Union (EU) regulations, particularly in the context of promoting a circular nutrient economy, maintaining soil quality, and sequestering carbon to face climate change. In a rainfed system in Northeastern Spain, an experiment was set up (split-plot design). It included five pre-sowing N fertilization treatments: control, mineral, pig slurry, and composted sewage sludge (two rates). The average N rates were 0, 30, 141, 176, and 351 kg N ha−1, respectively. They were combined with mineral N topdressings (0, 50, and 100 kg N ha−1). Three crops were grown: barley (nine years), wheat (three years), and rapeseed (one year). In the driest years (c. 350 mm rainfall), the yields averaged 2.5, 2.0, and 1.9 Mg ha−1, respectively. The maximum yields were for barley (6.5 Mg ha−1) and wheat (5.5 Mg ha−1). The avoidance of a significant increase in soil residual NO3−-N, plus the control of soil build up of available P, micronutrients, and Cd, defines the fertilization strategies. (i) With a previous spring drought season, no fertilization is needed in the following year, if devoted to winter cereals. (ii) In rainier seasons, pig slurry or composted sewage sludge (lowest rate) applied at sowing is sufficient; however, 50 kg of mineral-N ha−1 at the topdressing can be applied. The study found that pig slurry favors K, Mg, Cu, and Zn availability, while composted sewage sludge enhances Fe availability. Although it is possible to reduce N inputs from organic fertilizers, organic C build-up will be constrained.

Securing Privacy: Safeguarding Against Cyber Threats in the UAE and Morocco

This research evaluates the effectiveness of the current legal frameworks in the United Arab Emirates (UAE) and Morocco in organizing cybersecurity risks and safeguarding the privacy of individuals in the digital world. The research focuses on assessing the response of the legislation of these countries to the constantly evolving cybersecurity threats and determining its adequacy in ensuring the protection of the privacy of individuals while complying with European Union (EU) standards. The study explores different legal perspectives on protecting privacy rights by comparing the legislation from Morocco and the UAE with recent EU regulations. It recommended that effective control over electronic services be sought to mitigate illegal forms of privacy and personal data abuse. The legislative body of the UAE is urged to develop legislation on the right to information, taking cues from the legislative actions of Morocco. Furthermore, the Moroccan legislature emphasizes expanding the definition of personal data beyond the confines of sound and image.

Medium scale-up synthesis of nanomaghemite as an inhibitor of cadmium uptake in seedlings of Theobroma cacao L

The aim of this research was to show that the absorption of divalent cadmium ions (Cd2+) in Theobroma cacao L. seedlings can be controlled and adjusted by remediation with maghemite (γ-Fe2O3) nanoparticles (NPs), i.e., leading to the low tolerance limits established by the European Union (EU) in 2014 for Cd in products made from cocoa. The research had two stages; the first one involved the medium scale synthesis of 92 g of 15 nm γ-Fe2O3 NPs via room temperature chemical co-precipitation of ferrous salts and their characterizations using diverse physicochemical techniques. In the second stage, and for the first time, three doses of these γ-Fe2O3 NPs (1, 2, and 4 g) were applied to the substrate of cocoa seedlings of genotypes ICS 39, ICS 95, and CCN 51 for three months of exposure. A morphological analysis revealed non-significant toxic effects on the seedlings’ height, leaf area, and stem diameter among the genotypes and tested doses. The results of the atomic absorption analysis of the treatment with 4 g of γ-Fe2O3 NPs showed a concentration of 0.10 mg kg−1 of Cd2+, a limit lower than the control and the recommended value by the 2014 EU regulation. Thus, the transport and/or absorption of the Cd2+ toxic metal were significantly inhibited, since up to 74 % of Cd2+ uptake in the genotype ICS 95 was experimentally observed. Also, the environmental Fe-dynamics in the seedlings and soils demonstrated no transport of γ-Fe2O3 NPs to the seedlings. Thus, the study found that the Cd2+ adsorption in remediated soil using γ-Fe2O3 NPs involves three steps: electrostatic exchange, Fe-oxide adsorption, and substrate-γ-Fe2O3 NPs complexation and precipitation.

Screening and safety assessment of migrating substances released from biodegradable packaging materials into milk

Biodegradable polymeric packaging materials are being studied for their potential to replace traditional petroleum-based ones for food contact applications. However, potential safety concerns associated with the utilization of these biodegradable polymers have not been studied in detail. In this study, we conducted non-targeted screening and migration studies on two types of biodegradable milk packaging materials, which were composed of a mixture of polylactic acid (PLA), poly(butylene adipate-co-terephthalate) (PBAT), polybutylene succinate (PBS), and cellulose. In particular, we monitored the transfer of migrating substances from the packaging materials into a food simulant (50% ethanol) and into a real food (fat free and whole milk). A screening study identified seven compounds in the biodegradable packaging bags, including degradation products of antioxidants, lubricants, and plasticizers such as triethylene glycol, diethyl succinate, glycerin, 2,4-di-tert-butylphenol, and 13-docosenamide were identified. The migration studies indicated that the types and amounts of migrating substances transferred into the real food were appreciably lower than those transferred into the food simulant. Most of the detected migrating substances were below the levels established in the European Union regulations. However, the triethylene glycol levels (68-144 mg/kg) in the food simulant exceeded the limits (60 mg/kg) for one of the packaging materials tested. A safety assessment suggested that there is a low level of safety risk associated with one of the biodegradable packaging materials. This study provides important insights into the safety of biodegradable packaging materials that might be used in the food industry.