Current European Regulations Research Articles

Decoding Seafood: Multi-Marker Metabarcoding for Authenticating Processed Seafood.

Given the recognized nutritional value of fish and shifting consumer lifestyles, processed seafood has become increasingly prevalent, comprising a significant portion of global food production. Although current European Union labeling regulations do not require species declaration for these products, food business operators often voluntarily provide this information on ingredient lists. Next Generation Sequencing (NGS) approaches are currently the most effective methods for verifying the accuracy of species declarations on processed seafood labels. This study examined the species composition of 20 processed seafood products, each labeled as containing a single species, using two DNA metabarcoding markers targeting the mitochondrial cytochrome c oxidase I (COI) and 16S rRNA genes. The combined use of these markers revealed that the majority of the products contained multiple species. Furthermore, two products were found to be mislabeled, as the declared species were not detected. These findings underscore that NGS is a robust technique that could be adopted to support routine food industry activities and official control programs, thereby enhancing the 'From Boat to Plate' strategy and combating fraudulent practices in the complex fisheries supply chain.

Environmental risk and market approval for human pharmaceuticals.

This paper contributes to the growing discussion about how to mitigate pharmaceutical pollution, which is a threat to human, animal, and environmental health as well as a potential driver of antimicrobial resistance. It identifies market approval of pharmaceuticals as one of the most powerful ways to shape producer behavior and highlights that applying this tool raises ethical issues given that it might impact patients' access to medicines. The paper identifies seven different policy options that progressively give environmental considerations increased priority in the approval process, identifies ethically relevant interests affected by such policies, and makes explicit tensions and necessary tradeoffs between these interests. While arguing that the current European regulation gives insufficient weight to environmental considerations, the paper highlights concerns with the strongest policy options, on the grounds that these may very well endanger patients' access to effective medication.

The Challenges of Blood Sample Delivery via Drones in Urban Environment: A Feasibility Study through Specific Operation Risk Assessment Methodology

In recent years, Unmanned Aircraft System (UAS) usage in the medical sector as an alternative to traditional means of goods transport has grown significantly. Even though the reduced response time achieved with UASs can be lifesaving in critical situations, their usage must comply with technological constraints such as range, speed and capacity, while minimizing potential risks. In this paper, the feasibility of a drone operation dedicated to the transport of blood samples in an urban area is studied through a safety risk analysis. The assessment utilizes the Specific Operation Risk Assessment (SORA) framework, in line with current European regulations, and extends it to define flight trajectories with minimal risk. A case study in the Helsinki urban area is used as a reference, with an exemplary case of commercial drone transportation of blood samples between the Töölö and Malmi Hospitals. By leveraging the drone performance capabilities and minimizing the risk for people on the ground, this approach demonstrates that medical delivery using drones in densely populated urban environments remains challenging. Nonetheless, it argues that the proposed method can enhance risk awareness and support the planning of feasible operations.

Suitable solutions and EU regulatory framework of electric light mobility vehicles for last-mile delivery: an overview

Due to current environmental European regulations in terms of pollutant emissions, electric cargo cycles are receiving growing interest compared to heavy-duty vehicles as a cheaper and healthier alternative for last-mile delivery of goods in urban and suburban areas. Within the PNRR Next Generation EU program, the Sustainable Mobility Center aims to design innovative e-cargo bikes considering technical features along with rider behaviour and infrastructure characteristics. The market offers plenty of solutions, which may differ in technical and design features. Nowadays a standardized terminology, widely shared among researchers for those light mobility vehicles does not exist. Several authors employ different terms or introduce classifications based upon the vehicle type of use or even on the vehicle layout (e.g., payload position or number of wheels). Concurrently, EU regulatory framework is undergoing rapid changes and appears unclear. Certain categories of light mobility vehicles might be ruled out from the type-approval system established by the regulation EU 168/2013. For those vehicles, harmonised standards are under drafting or approval. This situation requires a considerable effort among manufacturers in the identification of the proper product directives or regulations and the associated mandatory requirements and testing procedures for the introduction of a new vehicle model in the market. Within this context, an overview of the EU regulatory framework for these light mobility vehicles is presented. A literature evaluation with a structured and coded methodology of scientific databases, company websites and commercial reports is performed, evaluating commercial and prototype solutions of e-cargo bikes from a technical and legislative perspective. Furthermore, a case study is addressed, deepening the national legislation which rules the use of e-cargo bikes in Italy. The information provided in this work may be useful among manufacturers as a starting point for the design process of these types of vehicles. Moreover, this paper lays the foundations for a widely recognized taxonomy of e-cargo bikes based upon distinctive features.

Development and validation of an analytical method based on QuEChERS followed by UHPLC–ToF-MS for the determination of tropane alkaloids in buckwheat (Fagopyrum esculentum L.) and buckwheat products

A method was developed for the determination of tropane alkaloids (TAs), including atropine, scopolamine, anisodamine and homatropine in buckwheat and related products. This work presents an optimised methodology based on QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) extraction procedure followed by ultra-high performance liquid chromatography combined with time-of-flight mass spectrometry for the determination of TAs (atropine, scopolamine, anisodamine and homatropine) in buckwheat samples. The analytical methodology was successfully validated, demonstrating good linearity, low limit of quantification, repeatability (RSDr < 15%), inter-day precision (RSDR < 19%) and recovery (74–113%). Finally, 13 commercial samples of buckwheat were analysed and the results demonstrated that they were in compliance with the current European regulations regarding TAs.

Defining Best Available Technique Performances for Urban Wastewater Plants: A French Application

The treatment of wastewater (WW) and the resulting sludge in urban WW treatment plants (UWWTPs) is accompanied by a significant consumption of resources as well as the concomitant emission of pollutants into the environment. One of the objectives of the NEXT (next generation of wastewater treatment plants) project is to identify sufficiently long-term optimization opportunities for processes to be selected as best available techniques (BATs) within the meaning of the industrial emissions directive (IED). The methodological framework used in this article is based on multi-criteria statistical tools, processing data from industrial plants to classify the sites studied and identify the reference plants in order to propose BAT references and associated emission levels that are reachable. Two public databases available on the internet were used, and 1,010 plants served as samples. The application and results demonstrated the applicability of the methodology and validated the mathematical approach used, as the thresholds comply with current French and European regulations. In the framework of the analysis conducted, five techniques (membrane bioreactor, bacterial bed, sand filter, and high-load or medium-load activated sludge) were identified as BAT according to the range of regulatory classification requirements for WW treatment plants (WWTPs). In addition, an example of reference values that may constitute a possible basis for the regulatory thresholds has been proposed. In parallel, a few discussion points were identified, including the choice of the metric for the reference values, the lack of data for the sludge line limiting identification of the BATs to the water line alone, the approximate characterization in the databases of certain parameters, as well as the problem of technique coupling due to the identification of one main technique.

Leveraging Plasma-Activated Seawater for the Control of Human Norovirus and Bacterial Pathogens in Shellfish Depuration.

Cold plasma is a promising alternative for water treatment owing to pathogen control and a plethora of issues in the agriculture and food sectors. Shellfish pose a serious risk to public health and are linked to large viral and bacterial outbreaks. Hence, current European regulations mandate a depuration step for shellfish on the basis of their geographical growth area. This study investigated the inactivation of relevant viral and bacterial pathogens of three plasma-activated seawaters (PASWs), and their reactive oxygen and nitrogen species (RONS) composition, as being primarily responsible for microbial inactivation. Specifically, F-specific (MS2) and somatic (φ174) bacteriophage, cultivable surrogate (murine norovirus, MNV, and Tulane virus, TV), and human norovirus (HuNoV GII.4) inactivation was determined using plaque counts and infectivity assays, including the novel human intestinal enteroid (HIE) model for HuNoV. Moreover, the kinetic decay of Escherichia coli, Salmonella spp., and Vibrio parahaemolyticus was characterized. The results showed the complete inactivation of phages (6-8 log), surrogates (5-6 log), HuNoV (6 log), and bacterial (6-7 log) pathogens within 24 h while preventing cytotoxicity effects and preserving mussel viability. Nitrites (NO2-) were found to be mostly correlated with microbial decay. This research shows that PASWs are a suitable option to depurate bivalve mollusks and control the biohazard risk linked to their microbiological contamination, either viral or bacterial.

Small Robot Vehicle Developed for Multi-purpose Industrial Use

The small robotic vehicle presented in this article is a special, multifunctional vehicle that can perform diagnostic tasks in several different areas. Examination of heat release and heat losses, which characterizes the efficiency of processes in many technical areas. A device that penetrates into small spaces may be needed. In this area, an important task is to navigate the device to the right place under trucks and cars to perform thermal camera diagnostics. The examination of excessive heat emission is extremely important to filter out faulty transmission systems, faulty engines, and to detect excessively hot brake drums, which are unfortunately also responsible for causing many serious accidents and fires.The remote-controlled navigation robot with a camera presented in the article is perfectly suited for the above task, as it can also transmit the image of the thermal camera to a remote display. In addition to automotive applications, the device can also be used for other industrial purposes and machine diagnostic tasks. I According to the current European Union building energy regulations, new buildings must have almost zero energy requirements. The so-called thermal bridges must be calculated for both old and new buildings under construction.A useful solution to this problem can be the quick and cost-effective energetic measurement and classification of thermal bridges, factors, and structural elements that cause heat loss. The Heat Spotter robotic vehicle presented and built in the article is suitable for the above tasks, ready to be manufactured and quickly paying for itself.

Studies of Potential Migration of Hazardous Chemicals from Sustainable Food Contact Materials.

In recent years, due to modern techniques for the distribution, transport, and retail sale of food, the production of large amounts of non-biodegradable and bioaccumulative packaging waste has become a major environmental issue. To address this issue, new food packaging materials based on renewable biomass have been studied as eco-friendly, biodegradable, and biocompatible alternatives to synthetic materials. However, although these materials are not petrochemical derivatives, the presence of contaminants cannot be excluded. This work aims to extend the knowledge on bio-based packaging materials, researching the presence of contaminants potentially able to migrate to food at concentrations of concern. In this study, we focus on two classes of contaminants, organophosphate esters (OPEs) and perfluoroalkyl substances (PFASs), carrying out migration tests toward different simulants, according to the current European regulation. PFAS analysis was performed using high-resolution liquid chromatography coupled to ion trap-tandem mass spectrometry (QTrap). OPE analyses were performed both by gas chromatography-mass spectrometry (GC-MS) and high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (TQMS). Preliminary findings demonstrate the release of toxic OPEs and PFASs from bio-based food packaging, highlighting the need to investigate the presence of potentially harmful chemicals in these materials.

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.

Navigating quality, health and environmental risk: A novel framework for wastewater resource recovery products

The aim of this study is to establish a universal framework for the quality monitoring and risk evaluation of resource recovery products. This innovative framework addresses challenges inhibiting the uptake of wastewater resource recovery products by addressing quality, health, and environmental concerns. In contrast to the current European regulations, which primarily govern wastewater reuse for irrigation and limited nutrient recovery cases, this framework has a broader scope that includes various recovery scenarios, such as cellulose fibers, biocomposites, building materials and biochar. The framework is structured as three pillars: (i) ensuring access to a product of good quality, (ii) safeguarding public health, and (iii) environmental protection. It applies quantitative microbial risk assessment (QMRA) and quantitative chemical risk assessment (QCRA) to enable transparent monitoring and reporting for different actors across resource recovery value chains. The framework offers a means to cluster and leverage existing regulations, bridging gaps to ensure comprehensive oversight across various unregulated resource recovery scenarios and products.

Somatic Coliphages as an Operational Tool to Assess Loss of Bathing Water Quality after Heavy Rain Events

Rapid population growth and coastal development has led to increased fecal contamination of coastal surface waters worldwide, enhancing the potential risk of waterborne human pathogens in bathing areas. More frequent heavy rainfall events, attributed to global warming, have further exacerbated the problem by causing sometimes sewer overflows into recreational waters. As traditional bacterial indicators have limited accuracy for predicting health risks associated with waterborne viruses, the additional use of viral indicators such as coliphages is recommended. In this study, we compared the behavior of bacterial and viral indicators of water quality at 10 Barcelona beaches during three bathing seasons, in dry conditions, and after four rainstorms that caused specific pollution events due to rain runoff with combined sewer overflows (CSO). Levels of all target indicators increased after the rainstorms, but compared to Escherichia coli and intestinal enterococci, somatic coliphages exhibited a slower decline and higher environmental persistence following a rain event. Daily continuous sampling carried out during the days following a rainstorm allowed not only the determination of the decay kinetics of each target indicator but also the day when the water quality recovered the values established in the current European regulation in approximately 2 -3 days after each CSO. These observations indicate that the combined use of bacterial and viral indicators can enhance the surveillance of microbial quality of bathing waters. Moreover, coliphages can swiftly provide insights into transient fecal pollution linked to rainfall episodes, thanks to available analytical techniques that enable same-day recommendations. The management of urban wastewater and recreational water regulations should consistently employ microbial indicators to address rainwater runoff or sewer overflows resulting from heavy rainfall.

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.

Elemental profiling of red seaweed Neopyropia yezoensis used in fast authenticating the geographical origin and food safety assessment

The red seaweed Neopyropia yezoensis is one of the predominant seaweeds cultivated and consumed in China. Its quality characteristics and economic value are closely influenced by the environmental conditions. So developing a fast method to trace the geographical origins of N. yezoensis is urgent because it concerns consumers knowing the origin of the product, nutritional value and safety. In present work, the elemental profiling in a total of 132 subsamples of N. yezoensis collected from five areas along the eastern and northern coast of China was established. Results showed that the content of K was the highest among the analyzed elements, and the Na/K ratio in N. yezoensis was 0.37. The consumption of N. yezoensis was confirmed to be a good source of essential dietary elements. However, high levels of Cd must attract consumers’ attention, because about 20.5% of the samples was not compliant with the current European regulations. The influence of the geographical origin have a great difference on element profile. The linear discriminant analysis (LDA) with the stepwise method showed that the samples from Liaoning Province and Shandong Province could be well distinguished from those from Jiangsu Province. Based on the leave-one-out cross-validation method, the predictive ability was 80.3%, indicating a good performance of elemental fingerprints in fast authenticating of the origin of N. yezoensis in China. This discrimination made it possible to simultaneously characterize the samples according to their nutritional value and human consumption safety levels.

Combination of Nanodelivery Systems and Constituents Derived from Novel Foods: A Comprehensive Review.

Novel Food is a new category of food, regulated by the European Union Directive No. 2015/2283. This latter norm defines a food as "Novel" if it was not used "for human consumption to a significant degree within the Union before the date of entry into force of that regulation, namely 15 May 1997". Recently, Novel Foods have received increased interest from researchers worldwide. In this sense, the key areas of interest are the discovery of new benefits for human health and the exploitation of these novel sources of materials in new fields of application. An emerging area in the pharmaceutical and medicinal fields is nanotechnology, which deals with the development of new delivery systems at a nanometric scale. In this context, this review aims to summarize the recent advances on the design and characterization of nanodelivery systems based on materials belonging to the Novel Food list, as well as on nanoceutical products formulated for delivering compounds derived from Novel Foods. Additionally, the safety hazard of using nanoparticles in food products, i.e., food supplements, has been discussed in view of the current European regulation, which considers nanomaterials as Novel Foods.

NOx Emission Limits in a Fuel-Flexible and Defossilized Industry—Quo Vadis?

The reduction of CO2 emissions in hard-to-abate industries is described in several proposals on the European and National levels. In order to meet the defined goals, the utilization of sustainable, non-fossil fuels for process heat generation in industrial furnaces needs to be intensified. The focus mainly lies on hydrogen (H2) and its derivates. Furthermore, biofuels, e.g., dimethyl ether (DME), are considered. Besides possible changes in the process itself when substituting natural gas (NG) with alternative fuels, the emission of nitrogen oxides (NOx) is a major topic of interest. In current European standards and regulations, the NOx emissions are specified in mg per m3 of dry off-gas and refer to a reference oxygen concentration. Within this study, this limit specification is investigated for its suitability for the use of various fuel-oxidizer combinations in industrial combustion applications. Natural gas is used as a reference, while hydrogen and DME are considered sustainable alternatives. Air and pure oxygen (O2) are considered oxidizers. It is shown that the current specification, which is built on the use of fossil fuels, leads to non-comparable values for alternative fuels. Therefore, alternative NOx limit definitions are discussed in detail. The most suitable alternative was found to be mg per kWh. This limit specification is finally being investigated for its compliance with current regulations on various aspects of Continuous Emission Monitoring Systems.

Comparison of the Potential Relative Bioaccessibility of Zinc Supplements-In Vitro Studies.

The aim of this study was to determine the potential relative bioaccessibility of zinc (Zn) from selected dietary supplements during in vitro digestion. The bioaccessibility of Zn was evaluated in dietary supplements differing in the pharmaceutical form, content, dose, and chemical form of the element. The content of Zn was determined by flame atomic absorption spectrometry. The applied method was validated, and results were characterised by good linearity (R2 = 0.998), recovery (109%), and accuracy (0.02%). As a result of the tests conducted, it was found that the bioaccessibility of Zn from dietary supplements varied and ranged from 1.1% to 9.4%. The highest bioaccessibility was found for zinc diglycinate and the lowest for zinc sulphate. In 9 out of 10 tested dietary supplements, the determined Zn content was higher than the one declared by the producer (up to 161%). The estimated tolerable upper intake level (UL) was exceeded by five of the analysed dietary supplements (123-146%). The analysed dietary supplements were assessed in terms of compliance with the information contained on the product packaging, based on current Polish and European legal regulations. The qualitative assessment was performed according to the United States Pharmacopoeia (USP) guidelines.

A survey‐based study on diagnosis and management of vernal keratoconjunctivitis

A survey‐based study on diagnosis and management of vernal keratoconjunctivitis

The Bright and Dark Sides of Herbal Infusions: Assessment of Antioxidant Capacity and Determination of Tropane Alkaloids.

Herbal infusions are highly popular beverages consumed daily due to their health benefits and antioxidant properties. However, the presence of plant toxins, such as tropane alkaloids, constitutes a recent health concern for herbal infusions. This work presents an optimized and validated methodology based on the QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) extraction procedure followed by Ultra-High Performance Liquid Chromatography combined with Time-of-Flight Mass Spectrometry (UHPLC-ToF-MS) for the determination of tropane alkaloids (atropine, scopolamine, anisodamine, and homatropine) in herbal infusions, in accordance with criteria established by Commission Recommendation EU No. 2015/976. One of the seventeen samples was contaminated with atropine, exceeding the current European regulation regarding tropane alkaloids. In addition, this study evaluated the antioxidant capacity of common herbal infusions available on Portuguese markets, indicating the high antioxidant capacity of yerba mate (Ilex paraguariensis), lemon balm (Melissa officinalis), and peppermint (Mentha x piperita).

ACTUAL DIRECTIONS FOR THE IMPROVEMENT OF STATE BUILDING STANDARDS FOR THE DESIGN OF NEW AND RECONSTRUCTION OF EXISTING EDUCATIONAL INSTITUTIONS

The article provides an analysis of state building regulations that apply to the design of new and reconstruction of existing buildings of educational institutions, from the point of view of compliance with modern international requirements. The expediency of improving the state building regulations by supplementing them with the current requirements of European safety standards and standardizing the physical factors of the production environment has been demonstrated. It is shown that the requirements of individual national sanitary norms and rules, which are integral components of the considered state building norms, require coordination. Quantitative maximum allowable values of electromagnetic fields of individual frequency divisions, as well as approaches to determining integral indicators of electromagnetic load on the environment, require coordination. Organization of grounding and suppression of industrial frequency harmonics and interharmonics of electrical consumers with non-linear volt-ampere characteristics must be carried out at the stage of designing power supply systems for civilian buildings by improving the regulatory framework. Sanitary regulations and rules referred to by state building regulations must meet the requirements for the limit levels of infrasound and aeroionization of air, which should be implemented in view of the requirements of current European regulations.