European Regulatory Framework Research Articles

Analysis of yellow mealworm (Tenebrio molitor) frass as a resource for a sustainable agriculture in the current context of insect farming industry growth

With the ongoing rapid growth of the human population, the industrial development of mass insect rearing for feed and food is gaining momentum. This approach has proved to be a more efficient and effective alternative to traditional livestock to produce animal protein. In this context, the Tenebrio molitor production sector emerges as highly promising in the edible insect market, being among the most commonly bred species in the large-scale insect rearing industry. A recent modification of the European regulatory framework in this matter has authorized insect-produced feed for pigs and poultry, which will boost the creation of new insect industries, resulting in huge quantities of frass, the insect excrement, that could be valorized. This by-product holds substantial amounts of nutrients and advantageous microorganisms that have enormous potential for organic farming. It typically exhibits high organic content and an abundance of essential nutrients like nitrogen (N), phosphorus (P), and potassium (K), alongside a narrow carbon (C) to nitrogen (N) ratio. In addition to providing plants with essential macronutrients, frass has been discovered to boost soil microbial biomass and introduce biomolecules and microbes that foster plant growth. The study of utilizing frass in sustainable agriculture is a relatively new and actively researched field in recent years. By conducting a comprehensive review of peer reviewed works, this article highlights the advantages associated with the effects of its use as organic fertilizer. Among these, the effect of frass as (1) a plant growth promoter and productivity enhancer and as (2) phytofortifyer against biotic and abiotic stresses, has been underlined in recent studies. With regard to its promoting effect, it has been observed that the effects of frass depend very much on its dose and the type of crop, with remarkably favorable results in many of the tests carried out. Hence, frass derived from the mass rearing of yellow mealworm for feed and food, could serve as an important and potent source of organic fertilizer in intensive horticultural crops or in high-value woody crops, contributing to a more sustainable agriculture, which can decrease the use of conventional synthetic agrochemicals.

Demo-scale up-flow anaerobic sludge blanket reactor coupled with hybrid constructed wetlands for energy-carbon efficient agricultural wastewater reuse in decentralized scenarios

The impact of climate change on water availability and quality has affected agricultural irrigation. The use of treated wastewater can alleviate water in agriculture. Nevertheless, it is imperative to ensure proper treatment of wastewater before reuse, in compliance with current regulations of this practice. In decentralized agricultural scenarios, the lack of adequate treatment facilities poses a challenge in providing treated wastewater for irrigation. Hence, there is a critical need to develop and implement innovative, feasible, and sustainable treatment solutions to secure the use of this alternative water source. This study proposes the integration of intensive treatment solutions and natural treatment systems, specifically, the combination of up-flow anaerobic sludge blanket reactor (UASB), anaerobic membrane bioreactor (AnMBR), constructed wetlands (CWs), and ultraviolet (UV) disinfection. For this purpose, a novel demo-scale plant was designed, constructed and implemented to test wastewater treatment and evaluate the capability of the proposed system to provide an effluent with a quality in compliance with the current European wastewater reuse regulatory framework. In addition, carbon-sequestration and energy analyses were conducted to assess the sustainability of the proposed treatment approach. This research confirmed that UASB rector can be employed for biogas production (2.5 L h−1) and energy recovery from organic matter degradation, but its effluent requires further treatment steps to be reused in agricultural irrigation. The AnMBR effluent complied with class A standards for E. coli, boasting a concentration of 0 CFU 100 mL−1, and nearly negligible TSS levels. However, further reduction of BOD5 (35 mg L−1) is required to reach water quality class A. CWs efficiently produced effluent with BOD5 below 10 mg L−1 and TSS close to 0 mg L−1, making it suitable for water reuse and meeting class A standards. Furthermore, CWs demonstrated significantly higher energy efficiency compared to intensive treatment systems. Nonetheless, the inclusion of a UV disinfection unit after CWs was required to attain water class B standards.

Navigating the Virtual Realm of Hate: Analysis of Policies Combating Online Hate Speech in the Italian-European Context

The aim of this article is to conduct an in-depth analysis of the effectiveness of policies to counter online hate speech on social platforms. This analysis is approached through an interdisciplinary approach that combines sociological and legal perspectives to provide a non-partisan understanding of the phenomenon. The research consists of two phases: the first phase provides a general framework for the subject under examination, attempting to clearly delineate – on a definitional level – hate speech, emphasising its growing relevance in contemporary social dynamics; the second phase, focuses on an examination of the European value and regulatory framework, with particular reference to the civil law remedies that can be used in the Italian legal system to counteract the spread of online hate speech. This methodology makes it possible to identify the countervailing tools to which private individuals can resort in order to meet the requirements of justice and fairness. In this sense, the article aims to offer a broad overview of the subject matter, providing a contribution to the academic debate and to the understanding of the challenges related to the fight against online hate speech on social networks.

Commercial spaceflight: Regulatory framework assessment and safety perspectives

Recent years are witnessing the rapid technological development in airspace domain, actually paving the way to the development of a commercial space market. Until the recent past, space operations have been essentially performed by research centers or military agencies, in usually segregated areas to ensure third parties’ safety, governed by launch base regulations and organized in an unscheduled manner. However, with the entry of private companies into the space domain, a new market niche is being created: that of commercial space transportation. For example, a promising area is the one related to operations performed by commercial suborbital flights, whether aimed at space tourism or simply transporting things and/or passengers from one point to another on the Earth's surface. The traffic volumes are supposed to increase in next years and segregating airspace does not represent a sustainable solution for the future.The present paper will first assess the state of the art of the regulatory framework currently applicable to operators in order to obtain authorization to perform space missions for commercial use, then propose a comparison between the United State of America and European regulatory frameworks. Main challenges related to regulatory aspects will be identified and perspectives on possible higher airspace operations integration in the medium-long term will be derived. Finally, safety considerations deriving from a seamless accommodation of higher airspace operations in current Air Traffic Management will be derived for the medium-long term. In conclusion, this work reveals that neither the United States nor Europe has formally approved a legal framework establishing certification procedures for sub-orbital space transport systems. Currently, the US legislation is the most applicable as it has comprehensive rules to allow operators to obtain flight authorization ensuring compliance with requirements through a compliance matrix periodically updated.

The Governance of Algorithms: Profiling and Personalisation of Online Content in the Context of European Consumer Law

This contribution aims at analysing the current European regulatory framework aimed at protecting online users against the risks of digital content profiling and personalisation practices by online platforms.
 Indeed, algorithms exploit human weaknesses and emotions to influence users' purchasing behaviour in a context where the line between mere persuasion (accepted within a certain limit by law) becomes manipulation. After analysing the current regulation on the subject and giving an account of its major criticalities, some final considerations will be provided in order to identify possible future developments in the EU consumer discipline to ensure greater protection against algorithm abuse.

Innovative Immunotherapy for the Treatment of Atopic Dermatitis: Focus on the European and Latin American Regulatory Frameworks

Innovative Immunotherapy for the Treatment of Atopic Dermatitis: Focus on the European and Latin American Regulatory Frameworks

Opportunities and challenges in upcycling agri-food byproducts to generate insect manure (frass): A literature review

A range of issues related to sustainability in the agrifood industry have spurred interest in mass production of insects as human food and animal feed alternatives. This rapidly evolving sector addresses several challenges, including the management of food waste or agrifood by-products and the production of alternative animal proteins demonstrating low environmental impacts that improve sector circularity. The mass production of insects on agrifood processing wastes or by-products represents an opportunity to address these challenges. While the production of insects offers prospects for sustainable protein production, a major side stream is the production of frass or larval excrement including uneaten feed and chitin-rich exuviae (derived from multiple larval moults). The production of each tonne of edible insects generates 2 to 4 tonnes of frass with an interesting potential in agriculture versus traditional organic amendments (compost, manure, biochar). This review aims to demonstrate the characteristics of frass, its common harvest and conditioning methods, its optimal application rates for planting crops, the mechanisms by which it can protect plants against biotic and abiotic stresses and demystify the risks and potential associated with its application in agriculture. The characteristics of frass are compared with those of conventional fertilizers or other. This report also compiles the Canadian, US and European regulatory frameworks as a novel plant fertilizer and aims to pave the way for future research necessary for its valorization in plant production.

Data Act: New Rules about Fair Access to and use of Data

Data-driven technologies are becoming more and more relevant every day. The constant increase in products connected to the Internet corresponds to an increase in the volume of data generated, the content of which represents a fundamental resource both for technological and economic evolution and with a high impact for businesses, citizens, and the public sector on the whole. This is the underlying motivation behind the approval of the Data Act, the new EU Regulation adopted on 27 November 2023 which aims to create a European regulatory framework based on clear rules on data sharing, a fair and guided data economy in the European Union. Keywords: Data economy; Market regulation; EU policies; Data Protection; Data Circulation; Access; Sharing; Interoperability.

The energy renovation pathway to ZEB in Italy: Analysis of typical buildings and methodological aspects

The evolution towards high-energy efficient buildings is one of the most important challenges today and is in line with the objectives set by the new European Directive on the Energy Performance of Buildings (EPBD) which provides for the decarbonization of entire building stock by 2050. The study starts from the analysis of the current regulatory framework in Europe and Italy, highlighting the lack of homogeneity in the methods of transposition of European directives by the Member States already at the “nearly zero energy buildings” level (nZEB). Starting from these considerations, the critical analysis of the European and Italian context highlights the need to overcome the standards currently in force and investigate new perspectives for the design of high-efficient buildings in the direction of “zero energy and zero emissions”. For this reason, two residential and office buildings typologies are examined to confirm whether the net Zero Energy Building (ZEB) objective can be achieved through the legislation in force in Italy, starting from nZEB level. The study analyses the energy balance through dynamic simulations and evaluates energy needs of buildings and renewable energy production in order to verify the compliance to ZEB target, on yearly and monthly basis.

Environmental reclamation of limestone mining sites in Italy: Financial evaluation, challenges and proposals for sustainable development

Currently the environmental restoration of former extraction sites of limestone materials to be used in construction sector is still an open issue, challenging the opportunities for a more sustainable development of local communities.The present study evaluates the multiple causes underlying the abandonment of former limestone quarries and the lack of their reclamation as well as proposals to promote their environmental restoration.We primarily frame the issue in both the European and Italian regulatory framework. Then, the present study applies an innovative Cost Revenue Analysis to a case study of a generic environmental restoration project of a former extractive limestone site. Such analysis deepens on investment and operating costs, revenues, Net Present Value and Revenue/Costs ratio. Results show that restoration activities, performed in agreement with current regulations, involving the creation of terraces in embankments by means of excavation materials from external construction sites or even acting directly on the existing quarry, are currently discouraging for entrepreneurs, since they do not generate enough revenues to cover the costs of restoration. As a result, we suggest some solutions to strengthen the current regulatory and political framework, to make the restoration activities more convenient in financial terms. Such solutions would be also beneficial for the society and environment.

Comparative Analysis of the European Regulatory Framework for C&D Waste Management

This article presents a comprehensive analysis of construction and demolition waste (C&D waste) management in European Union (EU) Member States. The study utilizes official data and reports to assess the current C&D waste management status, revealing substantial disparities in recycling rates across countries, ranging from 100% to 24%. These variations emphasize the importance of knowledge sharing and collaborative efforts to improve C&D waste practices. The paper explores the complex factors influencing C&D waste management performance, offering a nuanced discussion of these dynamics. It provides a comprehensive set of practical strategies to address existing challenges, with a focus on reducing C&D waste sent to landfills or incineration. These recommendations align with the EU’s commitment to sustainable resource management and the transition to a circular economy. The research’s informed measures, driven by environmental responsibility and economic prudence, can significantly diminish C&D waste’s environmental impact. Policymakers, environmentalists, and industry stakeholders can utilize these findings to develop and implement improved C&D waste management practices, promoting sustainability and resource efficiency across the EU. This research contributes valuable insights to the field of C&D waste management, offering a road map for improvement and highlighting the need for collaboration among EU Member States to create a more sustainable and resilient future.

“I participate. You participate. He participates. We participate. You participate. Do they profit?” Brief reflections on the forms of citizen participation according to the Directive (EU) 2019/944 on the Internal Market of Electricity and the Directive (EU) 2018/2001 on Renewable Energy Sources

This article aims to identify the primary forms of citizen participation within the European energy regulatory framework, focusing on decentralised energy production and its intersection with the right to the city and environmental, climate, and energy-related concerns. The article is structured in two sections. The first section addresses the rise of the right to the city, tracing its emergence as a category within urban sociology until its legal recognition as a human right, which guarantees the fruition of urban rights and the promotion of democratic participation in the construction of the urban model. It also analyses the urban phenomenon as a result of the expansion of the urban fabric and a way of life supported by a model of entrepreneurship and commodification of cities. In the second section, there is a brief contextualisation of the development of European energy policy, and it identifies the forms of citizen participation outlined in the Directive (EU) 2019/944 on the Internal Electricity Market, and the Directive (EU) 2018/2001 on Renewable Energy Sources, especially the Citizen Energy Communities (CEC) and Renewable Energy Communities (REC). Finally, the article highlights some risks that should be considered to ensure that market interests do not co-opt mechanisms of citizen participation in the energy sector to the detriment of promoting the right to the city.

Implementation of EU Rules on Circular Economy in Romanian EEE Sector: Targets and Results

Our review is focused on the complex issue of circularity in the Electrical and Electronic Equipment (EEE) sector in Romania, taking into account the European regulatory framework and those pressing factors justified by the growing concerns for maintaining a clean environment and protecting public health. Emphasizing the issue of Waste Electrical and Electronic Equipment (WEEE) and the imperative of their inclusion in the circular economy, we compellingly highlight the most significant aspects of this theme, at both the European Union and Romanian levels. Special attention is given to the analysis of norms, practices, and outcomes regarding the man-agement of WEEE at the national level, simultaneously highlighting the main problems and dif-ficulties faced by the addressed field. Clearly, in the conclusion of the paper, we also make a series of proposals for improving the situation. Striving for a comprehensive treatment of the issue, we believe that the work can be of great value to researchers, industry professionals, decision-makers, legislators, as well as entrepreneurs who perceive the EEE/WEEE sector as one where profitable businesses can be conducted.

Development of the Single European Sky

The objective of the research is to present the development of the Single European Sky initiative and to outline its importance for the European economy and the European aviation industry. The paper reviews in detail the concept of the Single European Sky, the economic factors that have led to its formation and the European regulatory framework comprised of a set of EU-wide rules on Air Traffic Management (ATM) safety, on the provision of ATM services, on airspace management and on interoperability within the network, as well as financial support to the technological modernization programme (the SESAR project). It presents the rulemaking activity of the European Commission to deal with the inefficiency of the European ATM System due to the fragmented character of international airspace, fragmented into smaller air traffic control centres divided by the national boundaries, effectively limiting integration, interoperability, and economies of scale, and leading to induced delays, excessive air-traffic control costs and uneconomical flight trajectories. The applied research methodology includes content analysis, analysis of statistical data, historical data, conclusions, and generalizations. The hypothesis is that the strategic goals of the Single European Sky initiative and its implementation are beneficial for the competitiveness of the European aviation industry, and the common rules and the introduction of a harmonized legislative framework will contribute to improving the efficiencies of ATM while accounting for the interests and singularities of all stakeholders in the European aviation value chain.

БЕЗПЕКА ПАСАЖИРСЬКИХ ПЕРЕВЕЗЕНЬ ТА РОЗВИТОК ТЕХНІЧНОГО КОНТРОЛЮ АВТОБУСІВ ГРОМАДСЬКОГО ТРАНСПОРТУ

The results of research indicating how the physical and mechanical properties of public transport bus bodies change during operation are shown. The regularities of reducing the thickness of the load-bearing elements of the body frame depending on the mileage and service life of buses are presented. The results of simulation modeling of the com-pliance of the bus with the UNECE Rules № 66 with a service life of 8 years, indicate the unacceptable further exploitation of such a bus. Such a bus has increased deformations of the racks during rollover and does not provide proper living space for the cabin. It is proved that in Ukraine the technical control of buses regarding their technical condition in ac-cordance with the existing regulatory framework has a formal approach using visual control methods. On the basis of review and analysis of the current situation in the sector of safety of passenger transportation by bus public transport and studies of changes in the strength of bus bodies during operation, the main provisions of the formation of technical control are presented as well as the corresponding changes – updating State standard of Ukraine 3649: 2010 ‘Wheeled vehicles. Requirements for safe technical condition and control methods’. The proposed provisions provide for the control of bodies during operation to be carried out taking into account the European regulatory framework and features of operation in Ukraine. With such controls it is proposed to use progressive means of assessing the deterioration of the thickness of the walls of load-bearing racks of the frame and their physical and mechanical properties. This way will al-low for a reliable assessment of the technical condition of bus bodies which will ensure the proper technical condition of buses and its passive safety throughout the entire service life. Key words: safety, bus, technical control, body, corrosion, fatigue strength, standard.

Feeding Next-Generation Nanomedicines to Europe: Regulatory and Quality Challenges.

New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.

Food or medicine? A European regulatory perspective on nutritional therapy products to treat inborn errors of metabolism.

Dietary or nutritional management strategies are the cornerstone of treatment for many inborn errors of metabolism (IEMs). Though a vital part of standard of care, the products prescribed for this are often not formally registered as medication. Instead, they are regulated as food or as food supplements, impacting the level of oversight as well as reimbursed policies. This scoping literature review explores the European regulatory framework relevant to these products and its implications for current clinical practice. Searches of electronic databases (PubMed, InfoCuria) were carried out, supplemented by articles identified by experts, from reference lists, relevant guidelines and case-law by the European Court of Justice. In the European Union (EU), nutritional therapy products are regulated as food supplements, food for special medical purposes (FSMPs) or medication. The requirements and level of oversight increase for each of these categories. Relying on lesser-regulated food products to treat IEMs raises concerns regarding product quality, safety, reimbursement and patient access. In order to ascertain whether a nutritional therapy product functions as medication and thus could be classified as such, we developed a flowchart to assess treatment characteristics (benefit, pharmacological attributes, and safety) with a case-based approach. Evaluating nutritional therapy products might reveal a justifiable need for a pharmaceutical product. A flowchart can facilitate systematically distinguishing products that function medication-like in the management of IEMs. Subsequently, finding and implementing appropriate solutions for these products might help improve the quality, safety and accessibility including reimbursement of treatment for IEMs.

Comparison of the European Regulatory Framework for the deployment of Offshore Renewable Energy Project

The REPower EU Plan has set a minimum of total renewable energy generation capacity of 1,236 GW by 2030. Achieving this target, and emission reductions by 2050, will require the extensive deployment of offshore energy facilities, especially offshore wind (OW) and wave energy converters (WECs). However, an incomplete and sometimes unfavourable regulatory framework still jeopardises the feasibility of both prototypes and large-scale installations. There are, for example, significant differences between the permitting procedures in different Member States and regions. Moreover, following the transposition of the Directive 2014/89/EU “establishing a framework for maritime spatial planning”, important differences pertain to the way environmental and heritage protection is dealt with. An overview of the offshore permitting schemes for offshore wind in ten European counties (Germany, Denmark, Scotland, Sweden, France, Spain, Portugal, Italy, Belgium, and Ireland) is provided, demonstrating a mismatch between the current members’ complex regulations and the future offshore wind targets. Using customised key performance indicators, we describe and assess the extent to which the regulatory frameworks are conducive to installing industrial devices in achieving the country’s 2030 target. Finally, we propose actions to facilitate the installation of OW while ensuring both environmental protection and industry development in the countries under investigation.

Web accessibility and inclusivity of tourist destinations at social media management. An intercultural analysis of Andalusia and Northern Morocco

AbstractTourists with disabilities, representing approximately 15% of the world's population, especially need everything planned for their tourist experiences. Therefore, the contents and level of digital accessibility are vital and significantly impact the final decision to travel to one destination.This work analyses a total of 165 digital contents (152 in Andalusia and 13 corresponding to Northern Morocco) from the perspective of web accessibility and inclusive communication in social media. The method used is multidisciplinary, carrying out a series of analyses through the statistical language R, TAW as an online tool to analyse the website's accessibility and synthesise guidelines for communicating inclusively in social networks.The main results show the scarce involvement of public bodies in inclusive communication and digital accessibility, designing content from the universal design perspective. There is no substantial difference between the two regions studied, identifying that European legislation and national regulatory framework in Andalusia's case do not favour a better level of web accessibility, although this is a mandatory aspect. Furthermore, very few differences have been noted in analysing the level of Smart Tourism Destinations when accessibility is fundamental in their conceptualisation. Finally, this research can be identified as state-of-the-art in tourism marketing as a conceptual approach and a starting point for measuring inclusive communication in social networks.Nowadays, accessible tourism is an opportunity to be placed at the centre of recovery plans in the post-COVID-19 era. Therefore, let us facilitate more inclusive societies, using tourism as a lever to achieve this goal.

REGULATION OF ONLINE PLATFORMS, INTERMEDIARIES, AND MARKETS IN THE EUROPEAN UNION AND CHINA

The EU and the PRC have recently introduced new regulatory standards governing specific online platforms, intermediaries, and markets. As an agenda to enhance digital governance, regulatory initiatives have been made on various frontiers governing digital services and digital markets to enhance both domestic and cross-border online transactions. These developments arguably enhance the relevance of the evolving European and Chinese regulatory frameworks as a stimulating subject for comparative law studies. The present paper examines the evolving key regulatory standards governing digital services and markets in Europe and the PRC and assesses their effectiveness in enhancing digital governance. The paper examines the specific regulations governing online platforms, intermediaries, and digital markets to determine the interests, obligations, and liabilities of key stakeholders. The paper assesses the effectiveness of newly introduced market regulatory standards to protect businesses and end users from the dominance of key online players. The paper argues the need for other key jurisdictions, including China, to rejuvenate their domestic digital regulatory framework with reference to the evolving European regulatory standards. The paper concludes with an analysis based on the key findings of the paper and points out the referential utility of the European experience for prospective legal harmonization needs.