European Regulation Research Articles

Battery Waste Management in Europe: Black Mass Hazardousness and Recycling Strategies in the Light of an Evolving Competitive Regulation

The increasing significance of batteries in the 21st century and the challenges posed by the anticipated surge in end-of-life batteries, particularly within the European context, are examined in this study. Forecasts predict a notable escalation in battery waste, necessitating a focus on the recycling of black mass (BM)—a complex and hazardous byproduct of the battery recycling process. Employing systematic analysis, this research investigates the hazardous nature of BM derived from various battery types. The study underscores the urgent need for definitive legislative classification of BM’s hazardous properties (HPs), in accordance with European regulations. This comprehensive examination of BM’s HPs contributes significantly to the understanding of BM recycling complexities, proving essential for industry stakeholders and guiding future developments in this field. Additionally, the study explores innovative technologies and strategies that could improve recycling efficiency and reduce associated risks. A pivotal finding of this investigation is the inherently hazardous nature of BM, leading to the recommendation that BM should be classified at a minimum under the “HP3—Flammable” category. This discovery underscores the critical need for stringent management protocols and robust regulatory frameworks to address the burgeoning challenge of battery waste in Europe.

Special Issue “Sustainable Control Strategies of Plant Pathogens in Horticulture”

European Regulation No [...]

Use of three-dimensional printing technology for supporting the hip reconstruction surgery in paediatric patients

The use of three-dimensional (3D) printed patient-specific anatomical models is nowadays a viable strategy for improving surgical outcome in medicine. In adult surgery, 3D printing technology is commonly studied, but its use in paediatric surgery is still under development. This work presents the implementation of 3D printing technology in Orthopaedic department of the paediatric hospital “Santobono-Pausilipon” in Naples by fabricating 3D printed anatomical models of paediatric patients. The 3D printed models fabricated were used for the training of the surgical team during the preoperative planning and for carrying out a surgical simulation. The anatomical models are designed in compliance with the current European Medical Devices regulation and following the already existing guidelines in literature. The impact of the 3D printed anatomical models used, a total of seven printed anatomical models based on four patients, is then evaluated throughout a questionnaire proposed to the surgical team, composed by eight paediatric orthopaedic surgeons. Surgeons answered to a total of ten questions, six scale-based questions and four free-text questions. Results obtained from the questionnaires highlighted how 3D printed anatomical models can lead to a better understating of the treated pathologies, carrying relevant improvements in both the surgical team training and the surgical outcome.

Two-Wheeled Urban Vehicles—A Review of Emissions Test Regulations and Literature

Two-wheeled vehicles, due to their population, constitute a significant share of road vehicles in Europe. Therefore, this article presents an overview and analysis of the applicable legal regulations regarding two-wheeled vehicle engines in terms of toxic exhaust emission tests. For the correct interpretation of emission standards, the authors of this work made the necessary analysis of the categorization of two-wheeled vehicles based on Polish law and the criteria of European regulations. The presented analysis concerns not only the current regulations, but also their development trends over the years. These considerations are supplemented with a literature review, which includes the problems of the ecology, energy consumption and construction of the considered group of vehicles. The work presented in this article also concerns the assessment of the conditions for conducting tests on objects belonging to category L in laboratory conditions on chassis dynamometers. On this basis, considerations were made to evaluate the currently applicable WMTC (World Motorcycle Test Cycle) test by comparing it with the actual operation of two-wheeled vehicles. This resulted in the formulation of conclusions regarding the need to introduce procedures for testing pollutant emissions in road conditions in the approval process.

Fundamentals, Operation and Global Prospects for the Development of Biogas Plants—A Review

As the global demand for renewable energy continues to rise, biogas production has emerged as a promising solution for sustainable energy generation. This review article presents the advantages of biogas technologies (mainly agricultural, based on waste of animal and plant origin) and extensively discusses the main principles of biogas production in the anaerobic digestion (AD). In this respect, the main parameters of the process, which require monitoring and decisive for its efficiency are described, therefore: temperature, pH value, retention time and organic loading rate (OLR). The principles of substrate selection are also discussed and the necessity and advantages of the use of organic waste according to the model of a circular economy and the concept of sustainable development, are indicated. It is emphasized that according to the new European regulations, the crops classified as food cannot be considered energy crops. The part on biogas production is summarised with an explanation of the necessity to treat and purify biogas. Biogas purification is important from the point of view of the efficiency of its conversion into electricity. A special place in this paper is devoted to the design, construction, functioning and operation of biogas plants, based on both scientific and practical aspects. In conclusion of this chapter, the economic aspects and profitability of operating biogas plants are discussed. Cost and benefit analyses are the major tool used for the systematic evaluation of the financial costs and potential benefits associated with the operation of biogas plants. The important fact is that the return on investment can be achieved within a few years, provided the activities are well-planned and executed. In addition to the fundamental issues of the operation of biogas plants, this article presents the global situation regarding the development of biogas plants, discussing in detail the specific needs and limitations on different continents. It is a interesting and extensive part of this article. The global agricultural biogas market is at very different levels of development. Most such installations are located in Asia and Europe. China has the highest number of biogas plants, with more than 100,000 biogas plants, followed by Germany with over 10,000 plants. In addition to the 100,000 biogas plants, China also has a large number of household biogas units, which gives a total of approx. 40 million operating units. The article concludes with a discussion of opportunities and barriers to the development of biogas plants, pointing to: financial issues, access to feedstock, political regulations, public awareness and the geopolitical situation. The most frequently cited reasons for investment failure include economic problems, lack of professional knowledge.

Case reports of tropane alkaloid contamination in spinach from Italy and its potential implications for consumer health

This study reports cases of intoxication that occurred in various regions of Italy in October 2022. These incidents were linked to the consumption of leafy vegetables contaminated with tropane alkaloids (TAs), likely due to suspected cross-contamination with toxic plants from the Datura genus. Although official controls were unable to identify the specific weed responsible for the contamination, chemical analysis of the remaining spinach and spinach-based foods consumed by the affected patients revealed concentrations of atropine and scopolamine up to 4642 μg/kg and 8158 μg/kg, respectively. While European regulations currently lack maximum limits for TAs in leafy vegetables, the concentrations detected in 4 out of 5 samples exceeded the maximum limits currently established for cereal-based foods, infant cereal-based foods, and herbal infusions.To assess the acute dietary exposure to atropine and scopolamine, estimated daily intakes of the Italian population were calculated using the TA concentrations measured in spinach samples or assuming the presence of 1 % of the weight of one Datura stramonium leaf in a 500 g spinach pouch. Both exposure scenarios resulted in concerning exposure levels, far exceeding the acute reference dose of 0.016 μg/kg bw by 2–1200 times. Toddlers exhibited the highest mean and 95th percentile acute dietary exposures compared to adults and the elderly. These findings emphasize the necessity of intensifying monitoring efforts and enacting regulatory measures to minimize exposure to TAs from dietary sources that are less commonly associated with contamination, especially for mitigating potential health risks for vulnerable population groups.

Public Administration Functions in the Developing Hydrogen Market

Abstract The purpose of this article is to present the functions of public administration in the developing hydrogen market from the perspective of current European Union and national legal regulations. Considerations in this regard are preceded by justification for the necessity of adopting a law for the use of hydrogen in the energy system in view of the threats resulting from the energy and climate crisis.

Changes in the European Union definition for endocrine disruptors: how many molecules remain a cause for concern? The example of crop protection products used in agriculture in France in the six last decades.

The endocrine-disrupting effects of phytopharmaceutical active substances (PAS) on human health are a public health concern. The CIPATOX-PE database, created in 2018, listed the PAS authorized in France between 1961 and 2014 presenting endocrine-disrupting effects for humans according to data from official international organizations. Since the creation of CIPATOX-PE, European regulations have changed, and new initiatives identifying substances with endocrine-disrupting effects have been implemented and new PAS have been licensed. The study aimed to update the CIPATOX-PE database by considering new 2018 European endocrine-disrupting effect identification criteria as well as the new PAS authorized on the market in France since 2015. The endocrine-disrupting effect assessment of PAS from five international governmental and non-governmental initiatives was reviewed, and levels of evidence were retained by these initiatives for eighteen endocrine target organs. The synthesis of the identified endocrine-disrupting effects allowed to assign an endocrine-disrupting effect level of concern for 241 PAS among 980 authorized in France between 1961 and 2021. Thus, according to the updated CIPATOX-PE data, 44 PAS (18.3%) had an endocrine-disrupting effect classified as "high concern," 133 PAS (55.2%) "concern," and 64 PAS (26.6%) "unknown effect" in the current state of knowledge. In the study, 42 PAS with an endocrine-disrupting effect of "high concern" are similarly classified in CIPATOX-PE-2018 and 2021, and 2 new PAS were identified as having an endocrine-disrupting effect of "high concern" in the update, and both were previously classified with an endocrine-disrupting effect of "concern" in CIPATOX-PE-2018. Finally, a PAS was identified as having an endocrine-disrupting effect of "high concern" in CIPATOX-PE-2018 but is now classified as a PAS not investigated for endocrine-disrupting effects in CIPATOX-PE-2021. The endocrine target organs associated with the largest number of PAS with an endocrine-disrupting effect of "high concern" is the reproductive system with 31 PAS. This is followed by the thyroid with 25 PAS and the hypothalamic-pituitary axis (excluding the gonadotropic axis) with 5 PAS. The proposed endocrine-disrupting effect indicator, which is not a regulatory classification, can be used as an epidemiological tool for occupational risks and surveillance.

The future of organic certification: potential impacts of the inclusion of Participatory Guarantee Systems in the European organic regulation

Third-party certification (TPC) is the standard approach to quality assurance for organic production, but its administrative burden and cost make it difficult for smallholders to access it. Internal Control Systems (ICS) and Participatory Guarantee Systems (PGS) are possible alternative approaches because they are more accessible and less costly. Regulation (EU) 2018/848 on organic production allows ICS for small farmers. However, PGS are not included, despite being promoted by the International Federation of Organic Agriculture Movements (IFOAM) and officially recognised by several countries worldwide. This study aims to evaluate the possible future inclusion of PGS at the European level. Twenty-eight experts participated in a Delphi exercise, and both optimistic and pessimistic views were agreed upon amongst them. In the pessimistic view, bureaucratic excess and standardisation requirements needed in the process of PGS institutionalisation could emerge, resulting in even more rigid practices compared to the current ones. In the optimistic view, recognising PGS as a legitimate approach to guarantee the quality of organic products could foster the inclusion of smallholders by lowering certification costs, increasing cohesion and competencies amongst rural development actors and increasing the reputation of PGS-certified local products.

Monitoring of Animal Feed Contamination by Mycotoxins: Results of Five Years of Official Control by an Accredited Italian Laboratory.

Mycotoxin contamination of animal feed is a complex issue in both animal wellness and food safety. The most diffused mycotoxins subject to the official control of animal feed are Aflatoxin B1 (AF), Zearalenone (ZEA), Deoxynivalenol (DON), Ochratoxin A (OCRA), Fumonisins (FUMO), and T-2/HT-2 toxins. This work describes the results of five years of monitoring focused on the evaluation of mycotoxin contamination of animal feed. Analytical determinations were carried out by means of accredited ELISA. The obtained results showed a non-alarming scenario, with several samples resulting as "non-compliant" according to the Maximum Residue Limits (MRLs) set in European Regulation No. 574/2011. Out of 722 analyzed samples coming from 2 Italian regions, Apulia and Basilicata, 14 samples were characterized by mycotoxin concentrations higher than related MRL; in particular, 5, 4, and 5 non-compliant samples for DON, AF, and ZEA, respectively. This study also evaluated the possible correlations between mycotoxin type and feed use with a special focus on animal sensitivity to mycotoxins.

Bien-être et bientraitance des animaux

Animal protection is a growing societal concern. It is closely linked to human well-being, which is why the concept of One Welfare emerges, integrated into that of One Health. This is a complex subject, particularly due to the great diversity of animal species and their respective status. European regulations on animal welfare are currently being revised.

What is Spanish regulation on the application of artificial intelligence to medicine like?

This article will attempt to analyze the current impact of Artificial Intelligence in Spanish healthcare, as well as the challenges that its application poses both from an ethical and legal point of view. Technological advances, which are already being applied in healthcare, make it necessary to adapt the legal system to the new trends that are emerging in society and force healthcare professionals to review their codes of ethics in the face of new ethical dilemmas, since these codes of ethics do not have clear guidelines for action on AI that raise relevant ethical problems to which no response is being given, except for the code of ethics for medicine, which has recently been included. After a review of the last 5 years of Spanish and European regulations in medicine, it can be concluded that the regulation and legislation of the application of AI is very deficient, both in the EU and in Spain. In order to try to identify different ways of resolving conflicts related to AI in medicine, jurisprudential sentences related to the rights and obligations of health professionals, patients and users have been analyzed and reviewed. Therefore, the paper concludes with the proposal of a series of aspects to be taken into account for the future regulation of the application of AI in medicine.

Evaluation of polycyclic aromatic hydrocarbon contents in marine products in South Korea and risk assessment using the total diet study

AbstractThis study investigated levels of eight polycyclic aromatic hydrocarbons (PAH8) compounds in both raw and processed marine products in South Korea. Katsuobushi exhibited the highest concentration of benzo[a]pyrene, at 14.22 µg/kg, exceeding the European Commission's regulation level of 5.0 µg/kg. The total PAH8 concentration in katsuobushi was 220.5 µg/kg. Among the product categories, shellfish had the highest detection rate (70%), followed by fish (19%) and crustacea (8%), with chrysene being the most prominent PAH8 congener in all marine products. Grilled fish predominantly contained pyrogenic PAHs from combustion byproducts, while shellfish primarily contained petrogenic ones from the aquatic environment. Grilling, smoking, and drying processes significantly contributed to the formation of PAH8 in these food products. Based on the results of a risk assessment using a margin of exposure approach through a total diet study, exposure to PAH8 from marine products is considered to pose low concern to the South Korean population.

Implementation of EU Regulations in Czechia

Abstract Implementation of EU regulations requires many changes in the Czech legal order. It is often necessary to repeal incompatible national provisions, provide for new penalties and provisions on competence of national institutions, or set up a new system only sketched by the EU regulations. Further, the implementation in Czechia has to match with the other parts of the Czech legal order to be effective. And it must comply with the Czech constitutional imperatives and legal drafting rules which follow from the principle of legal certainty and a rule of law. The main problem appears with European Parliament and Council regulations which establish only very general rules. Also, too many delegated and implementing regulations of the Commission are causing problems, specially when they have short implementation deadlines and change quickly. The article therefore contains examples of loopholes, presents methods to deal with them and sketches paths to be taken in the future.

On the possible impacts of a regulatory change on resource conservation: The case of the plumpox virus in France

Preserving natural resources in the context of global change includes looking at how to protect trees, whether in forests or for fruit production, from various epidemic diseases. A change in European regulation presently underway (EU 2016/2031; currently, in 2023, transitional measures are being implemented in France) transfers, from the public authorities to the profession (all the tree growers susceptible to be concerned), the responsibility for detecting plum pox virus, which has the potential to damage virtually all stone fruit orchards, and for eliminating the affected trees. Yet the disease is a viral one, transmitted by a vector (aphids) from tree to tree and from orchard to orchard. Within a few years, fruit from contaminated trees can no longer be marketed. We show here that, in the context of this new regulation, the heterogeneity of the tree growers (due to the size of the orchards, the diversification of the crops, the future of the farm...) can lead to a recrudescence of the disease throughout the stone fruit orchards. This would also imply all kind of negative effects on the economic (employment in the agricultural sector, national trade balance, processing and marketing sector activities...), social and environmental (landscapes...) levels. The results can easily be generalised to any problem of conservation of natural resources whose management is delegated to private stakeholders.

Study of two approaches for the process water management from hydrothermal carbonization of swine manure: Anaerobic treatment and nutrient recovery

Hydrothermal carbonization (HTC) is a promising alternative to transform biomass waste into a solid carbonaceous material (hydrochar) and a process water with potential for material and energy recovery. In this study, two alternatives for process water treatment by conventional and acid-assisted HTC of swine manure are discussed. Process water from conventional HTC at 180 °C showed high biodegradability (55% COD removal) and methane production (∼290 mL STP CH4 g−1 CODadded) and the treatment in an upflow anaerobic sludge blanket reactor allowed obtaining a high methane production yield (1.3 L CH4 L−1 d−1) and COD removal (∼70%). The analysis of the microbiota showed a high concentration of Synergistota and Firmicutes phyla, with high degradation of organic nitrogen-containing organic compounds. Acid-assisted HTC proved to be a viable option for nutrient recovery (migration of 83% of the P to the process water), which allowed obtaining a solid salt by chemical precipitation with Mg(OH)2 (NPK of 4/4/0.4) and MgCl2 (NPK 8/17/0.5), with a negligible content of heavy metals. The characteristics of the precipitated solid complied with the requirements of European Regulation (2019)/1009 for fertilizers and amendments in agricultural soils, being a suitable alternative for the recycling of nutrients from wastes.

Uroprotective and pain-relieving effect of dietary supplementation with micronized palmitoyl-glucosamine and hesperidin in a chronic model of cyclophosphamide-induced cystitis.

Feline idiopathic cystitis is a common, chronic-relapsing disorder of the lower urinary tract. In addition to environmental modification/enrichment, long-term and safe treatment targeting specific pathophysiological changes may be of help. In this context, effective dietary interventions hold clinical promise. Palmitoyl-glucosamine (PGA) and hesperidin (HSP) are safe and authorized feed ingredients for animal nutrition under European regulations. The current study aimed to investigate whether a 3:1 mixture of micronized PGA and HSP could represent a novel mechanism-oriented approach to chronic cystitis management. A newly validated rat model of cyclophosphamide (CYP)-induced chronic cystitis was used (40 mg/kg, three intraperitoneal injections every 3rd day). Animals were randomized to orally receive either vehicle or PGA-HSP at a low (72 + 24 mg/kg) or high (doubled) dose for 13 days, starting 3 days before the chronic CYP protocol, with mesna (2-mercaptoethane-sulfonate) being used as a reference drug. Higher PGA-HSP dose was effective at relieving chronic visceral pain, as measured by mechanical allodynia test (von Frey test). The severity of cystitis was also significantly improved, as shown by the reduced sonographic thickening of the bladder wall, as well as the decrease in edema, bleeding and bladder to body weight ratio compared to the vehicle treated group. A significant decrease of MPO activity, MDA level and fibrosis at Masson's trichrome staining was also observed in animals administered PGA-HSP in comparison to vehicle treated ones. The CYP-induced increase in bladder mRNA expression of pro-inflammatory cytokines was also significantly counteracted by the study mixture. Moreover, CYP-induced bladder mast cell accumulation and releasability were significantly decreased by PGA-HSP (even at the low dose), as determined by metachromatic staining, chymase and tryptase immunostaining as well as enzyme-linked immunosorbent assay for histamine and 5-hydoxytriptamine. PGA-HSP is able to block CYP-induced decrease of tight junction proteins, claudin-1 and occludin, thus preserving the urothelial bladder function. Finally, neuroinflammatory changes were investigated, showing that dietary supplementation with PGA-HSP prevented the activation of neurons and non-neuronal cells (i.e., microglia, astrocytes and mast cells) at the spinal level, and counteracted CYP-induced increase of spinal mRNA encoding for pro-inflammatory cytokines. Altogether, the present findings confirm the uroprotective and pain-relieving effect of PGA-HSP and pave the way to potential and relevant clinical applications of the study supplement in feline idiopathic cystitis.

Tracing the regulated emissions of field-aged gasoline/natural gas bi-fuel taxis from new to 160,000 km: Deterioration and environmental implications

Natural gas (NG) is considered an economically viable transport decarbonization option, especially for developing countries. However, as per the ongoing European and Chinese vehicle emission regulations, the durability and in-service compliance tests of the exhaust emissions from gasoline/NG bi-fuel vehicles are only mandated in gasoline mode, leaving the real-world emission performance of NG fueling at risk. To bridge this gap, the exhaust emissions from five gasoline/NG bi-fuel taxis were traced from new (less than 10,000 km) to 160,000 km after every 10,000 km of field driving. Both room-temperature cold-start and warm-start chassis dynamometer tests were performed over the certification drive cycle. This tracing study lasted for 3.5 years and covered the variations of seasons, routine services, and minor repairs. The results manifested that compared to gasoline fueling, NG had statistically lower carbon monoxide before 100,000 km of driving but higher total hydrocarbon and nitrogen oxides emissions throughout the useful life in both cold- and warm-start tests. By applying linear regression to the data points obtained across the 160,000 km tracing, NG fueling showed a noticeably quicker deterioration with mileage than gasoline. However, given that gasoline and NG modes shared the same catalysts, this is attributed to the less careful calibration of NG mode predominantly because of the void of regulatory requirements. On average, NG fueling produced about 20 % less carbon dioxide emissions than gasoline, but the observed fuel leakage in NG mode partially offset the global warming potential advantage. Overall, NG sees benefits and challenges in mitigating vehicle-related environmental issues. To better control this risk, it is strongly recommended that in future regulations, the durability and in-service compliance requirements of NG fueling shall be complemented, and fuel leakage shall be included in the control of evaporative emissions.

Professionally focused communicative competence of prospective foreign language university teachers as a modern trend in higher education

The article analyses the present condition of training foreign language teachers / university teachers using pertinent scientific sources. Its objective is to comprehend the scientific developments in cultivating intercultural communicative competence among prospective educators, which have been acknowledged in the scientific realm. This understanding is central to the creation of a theoretical structure for the establishment of professionally focused communicative competence (PFCC) in prospective English university teachers. Despite the progressions in artificial intelligence, teaching professions remain crucial, as automated systems cannot substitute them entirely. The study utilizes analysis, synthesis, comparison, and generalization to comprehensively examine scientific and methodological literature, as well as European and national higher education regulations. It presents a categorical evaluation of «professionally focused communicative competence», which is a subcategory of «intercultural communicative competence». The current state of methodological foundations and scientific support of the process of formation of prospective university specialists’ intercultural communicative competence outlines the following problems: incomplete detailing in the professionally focused foreign language training of bachelors and masters of education; lack of a state standard of higher language education for the training of future teachers / university teachers of English as a Foreign Language (EFL); limitations of textbooks and manuals for students of the second (master’s) level of higher education. For the successful implementation of the researched training in scientific theory and practice there is an understanding of the need to design: a holistic concept of intercultural foreign language teaching across various educational institutions, (proposed by S. Y. Nikolaieva), based on the principle of continuity; a foreign language training system for future educational specialists, taking into account the specifics of their specialty and further professional development, requirements for foreign language proficiency, needs of the rapidly changing labour market and, as a result, modernisation of professional training technologies, practical implementation of effective forms and methods of their training in the educational process of higher education institutions

Experiences and challenges with the new European Clinical Trials Regulation.

The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022).