Comparative characteristic between European and Ukrainian legal mechanisms for regulating the discharges of pollutants

The article examines and compares the structures and basic norms of legal mechanisms for controlling the discharge (CD) of polluting substances (PS) from point technogenical sources into surface waters of EU and Ukrainian legislation. To analyze the systemic construction of the European CDPS and a meaningful study of its main elements, a tool has been identified, which is the chain of spreading of restrictive (limiting) legal influence, its legislative links and regulative norms. The structure and composition of this chain of European CDPS are identified, PS flows and information links between restrictive standards are studied. It is noted that the main branches of the structure of the European CDPS are technological and environmental legal influences. The second branch is additional. It complements the first one for some priority substances and it uses to limit the discharge of PS properties of the area of the water body which adjacent to the discharge of PS, the so-called mixing zones (MZ). The place and significance of the CDPS subinstitution in the European water legislation are investigated. The peculiarities of the European regulatory standards of the CDPS are determined. The comparison of the European and Ukrainian CDPSs using the scale of features that characterize the links in the chain of limiting legal influence is fulfilled. The concordance of the features of the Ukrainian CDPS to the European one was assessed by the categories: “fully compliant”, “partially compliant”, “does not contradict”, “does not comply”, “not regulated by EU legislation”. The distribution of concordance assessments testifies to the fundamental difference between the European CDPS and the Ukrainian one. The most important differences of legal discordance are investigated. It is concluded that the main difference between the two CDPS subinstitutions is that Ukrainian regulation is based only on the economic use of the assimilative capacity of the MZ. It is emphasized that the concept of MZ for more than 60 years of its actual use has not received proper legal justification in Ukrainian law. In contrast to the Ukrainian regulation, the main influence of the European CDPS is aimed at directly limiting the sources of PS. The priority changes in the water legislation of Ukraine for the implementation of the requirements of the EU legislation on CDPS, have been proposed.

Agronomic Factors Influencing the Scale of Fusarium Mycotoxin Contamination of Oats

Seven agronomic factors (crop season, farming system, harvest date, moisture, county, oat variety, and previous crop) were recorded for 202 oat crops grown across Ireland, and samples were analysed by LC-MS/MS for four major Fusarium mycotoxins: deoxynivalenol (DON), zearalenone (ZEN), T-2 toxin and HT-2 toxin. Type A trichothecenes were present in 62% of crops, with 7.4% exceeding European regulatory limits. DON (6.4%) and ZEN (9.9%) occurrences were relatively infrequent, though one and three samples were measured over their set limits, respectively. Overall, the type of farming system and the previous crop were the main factors identified as significantly influencing mycotoxin prevalence or concentration. Particularly, the adherence to an organic farming system and growing oats after a previous crop of grass were found to decrease contamination by type A trichothecenes. These are important findings and may provide valuable insights for many other types of cereal crops as Europe moves towards a much greater organic-based food system.

Energy Management in the Railway Industry: A Case Study of Rail Freight Carrier in Poland

Energy is crucial to economic development, but its production usually has a negative impact on the environment. This ambivalence leads to the need for methods to improve energy efficiency. Transportation is one of the largest global energy consumers. Therefore, improving the energy efficiency of transportation is crucial for sustainable development. The aim of this article is to show the limitations of energy management in railways, resulting from the model of market regulation. The question in this context is whether only technological methods can be used in railways to steer its energy efficiency, as is suggested by the existing research. Critical analysis, desk research and a case study of Polish railway undertaking were used to find an answer to the research question. The discussion of the results shows that the European regulatory system leads to greater complications in the field of energy management than in other global regions, where railways are also important for the economy. Due to these limitations, rail operators use indirect methods to measure energy efficiency. Results indicate that although energy efficiency improvements are being achieved, they are mainly due to organizational measures and not technological ones as could be expected based on previous research.

Agronomic Factors Influencing the Scale of Fusarium Mycotoxin Contamination of Oats

Seven agronomic factors (crop season, farming system, harvest date, moisture, county, oat variety, and previous crop) were recorded for 202 oat crops grown across Ireland, and samples were analysed by LC-MS/MS for four major Fusarium mycotoxins: deoxynivalenol (DON), zearalenone (ZEN), T-2 toxin and HT-2 toxin. Type A trichothecenes were present in 62% of crops, with 7.4% exceeding European regulatory limits. DON (6.4%) and ZEN (9.9%) occurrences were rela-tively infrequent, though one and three samples were measured over their set limits respectively. Overall, the type of farming system and the previous crop were the main factors identified to significantly influence mycotoxin prevalence or concentration. Particularly, adherence to an organic farming system and growing oats after a previous crop of grass were found to decrease contamination by type A trichothecenes. These are important findings and may provide valuable insights for many other types of cereals crops as Europe moves towards a much greater organic based food system.

Introduction

This chapter begins with the early regulation of medicines, which was concerned with quality rather than any scientific assessment of efficacy and safety. It describes the latter half of the nineteenth century wherein the need for objective scientific assessment of the safety and efficacy of new medicines and the concept of risk–benefit of medicines was born. It also talks about the configuration of the Licensing Authority in the UK and the European Medicines Evaluation Agency (EMEA) as a key provision of both the Medicines Act 1968 and the European medicines legislation. The chapter analyses Directive 2001/83/EC, which governs all the requirements for the contents of the application dossier and grant of marketing authorisation of medicinal products. It recounts the development of statutory controls in the UK that was consistent with the evolution of the overarching European medicines legislation and the formation of the central European regulatory agency.

Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis

Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (https://eur-lex.eur-opa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L0079&qid=1628781352814) to IVDR 2017/746 https://eur-lex.europa.eu/eli/reg/2017/746. Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its “droit d’exister”.