Journal articles on the topic 'Environmental risk assessment – Law and legislation – European Union countries'

This article analyzes issues in criminal environmental law in Poland, the Czech Republic and Germany, which implemented the provisions of the European Commission Directive 2008/99/EC. The provisions of this directive changed the scope of protection of environmental resources in these countries’ penal codes to varying extents. These three countries have been relatively successful in comprehensively implementing criminal directive provisions. This included changes in the special protection of Natura 2000 sites and ozone depleting substances. Legal systems are generally based on prevention and risk assessment, and the basic conditions of criminal responsibility for environmental crimes include “significant damage, causing damage to the health of another or animals and plants, damage to other property and also water, air, soil and environmental components which have significant value”. Additional aspects include environmental damage over larger areas and restoration costs. However, the greatest current problem is the vague definition of conditions of criminal responsibility, which makes it difficult to enforce legislation. The following postulates de lege ferenda were formulated: clarify the premises for offenses against the environment, specify the costs of remedying environmental damage, define critical emission standards for environmental crime, as well as specify activities in protected areas that threaten objects. This article emphasizes that an increased and better definition of the conditions of criminal responsibility for environmental crimes enacted by EU countries may contribute to more effective enforcement of infringements of environmental protection law.

The paper focuses on formal and practical problems in the field of environmental protection, which occur as a consequence of omissions of the legislative and executive authorities in Serbia. The text analyzes the positive legislation and compliance of domestic legal regulations with international declarations and conventions ratified by our country (from the Stockholm Declaration and the Council of Europe Convention on Civil Liability for Damage Caused by Dangerous Activities to the Environment to the Rio Declaration), as well as with European Directives (EU Directive on Industrial Emissions) and Regulations (Regulation No. 525/2013 on monitoring and reporting of greenhouse gas emissions and reporting on other information relevant to climate change). The candidacy for equal membership in the European family of nations obliges the Serbian Parliament and the Government to make additional efforts in the direction of harmonizing our law with the European one. The paper takes a de lege ferenda approach, so the author explains the need to amend a number of laws, such as the Law on Environmental Impact Assessment, the Law on Strategic Environmental Assessment, the Law on Fees for the Use of Public Goods and the Law on Budget system, as well as the enactment of the Law on Climate Change and the Serbian Civil Code as soon as possible (in which dilemmas that hinder the subjects of law in using the environmental lawsuit as an instrument of environmental protection should be resolved). An unacceptable deviation from one of the fundamental principles established by the Rio Declaration was pointed out, which brings with it a number of structural problems and the inability of both the Green Fund institutions and a number of organizations that focus on ecology. The consequences of the discrepancy between the intentions proclaimed by the Constitution of Serbia and the National Strategy of Serbia for the accession of Serbia and Montenegro to the European Union from 2005 on the one hand and the absence of adequate legislative and executive activities in environmental protection, on the other hand, are obvious in the reports of the European Commission and the European Environment Office, as well as in the health risk and increased mortality of a large number of citizens of Serbia and other European countries, due to harmful emissions that cause pollution of air, water and soil in our country. In addition to the proposals for changes in the formal framework in the field of environmental protection, the paper points out the need to use those mechanisms of civil protection, such as environmental lawsuits (established by the Law on Obligations 1978), which is, by its nature, actio popularis and in that sense accessible to the widest range of subjects. The defense of the standards established by the Kyoto Protocol and the Basel Convention would, through the extensive use of this procedural instrument, be placed not only in the hands of representatives of the legislature and the executive, but also, the judiciary (conditionally, of course, because courts can decide only initiate a civil action, but not on its own initiative).

The Czech Republic and Romania present two very different levels of development of environmental impact assessment ( EIA ) , even though both countries gained their independence in the same year (1989) and both have aspirations to join the European Union (EU). This article examines the various driving forces for EIA legislation, analyses the different EIA concepts and identifies the strengths and weaknesses of the two regimes. While the Czech Republic introduced an EIA Act in 1992 (based mainly on the EC Directive 851337jEEC), Romania has yet to draft any ElA-specific legislation. Furthermore, the concept of EIA in Romania is very different to that in the Czech Republic and the EU. While all indicators suggest that the Romanian EIA system is ineffective, little research has so far been carried out to verify this. The Czech Republic, by contrast, shares many weaknesses of its EIA system with those of EU countries. Both share common problems of many Central and Eastern European countries, including low or variable public environmental awareness, an immature NGO movement (but gaining in strength and experience), a history of minimal public involvement in decision-making, and internal conflicts within government which inhibit the development of EIA and wider environmental legislation.

The article is devoted to the legal and economic aspects of Arctic seaport developments, using the example of the Russian Federation and the Northern Dimension (ND) partner countries, namely, Iceland and Norway. The authors consistently reveal all the specific points related to the legal regulation of Russian seaport management (ranging from international legal cooperation to domestic strategies and national legislation), and conduct an assessment of the economic prospects for Arctic port development according to the latest data and trends in the field of logistical flows. They also provide a description of the ND countries’ seaport developments, primarily economic, taking into account the global environmental agenda. In conclusion, the authors make their constructive proposals for multilateral cooperation in this area.

This article explores the challenges faced by developing and transitional countries (For the purposes of this article, Former Soviet Union (FSU) countries now mostly in the Commonwealth of Independent States (CIS), with the exception of the Russian Federation itself, are included in the term ‘developing countries’.) in international trade in agricultural goods and other natural resource products in compliance with the normative framework of the World Trade Organisation, and in particular of the Agreement on the Application on Sanitary and Phytosanitary Measures (‘SPS Agreement’). It details the legislative and administrative measures, as justified by ‘scientific evidence’ and ‘risk assessment’, that a WTO member may take to prevent the importation of unsafe food and animal feed, and pests and disease organisms. As well as considering the policy implications and constraints to relevant legislative reform, the article also draws on the author’s experience in biosecurity legislative review and drafting in Africa, Caribbean, Eastern Europe and Central Asia using the umbrella concept of ‘biosecurity’ to reflect on the challenges facing drafting of legislation consistent with the normative international frameworks for biosecurity. Taken into account is the impact of the SPS Agreement on the terms of food trade imposed on developing countries and the connection between international trade and environmental protection.

The principle that the “polluter should pay” has been one of the guidelines of EC environmental policy for decades. Nonetheless, a number of problems continue to stand in the way of its effective application. Most importantly, the principle itself does not define who the polluter is, what pollution is or to what extent the polluter needs to pay. This article is an assessment of the role the European Court of Justice (ECJ) has played in answering these questions. It is argued that the Court has adopted an extensive interpretation of the principle, especially in the recent Erika judgment. In that sense, the ECJ has certainly contributed to a more effective and enforceable polluter-pays principle in the EC legal order. However, the impact of the ECJ’s interpretation is of course limited by the boundaries set by EC legislation. Policies are needed to move towards a European Union in which the polluter actually does pay. Judgments can only serve to buttress and clarify such legislation. This article provides a comprehensive analysis of the three main cases in which the ECJ has been called upon to interpret the polluter-pays principle (Standley, Van de Walle and Erika). The focal point is the Erika judgment, as this is both the most recent and most far-reaching. In all three judgments, the Court emphasizes that any application of the principle has to be proportional. Polluters cannot be asked to pay for pollution damage beyond their contribution to the creation of that pollution. The Court has not shied away from defining “pollution” in a broad sense in both Van de Walle and Erika. Establishing who the “polluter” is, however, has proven far more difficult. Of particular interest is whether the producer of the product might be held liable in the case of the accidental creation of pollution, such as an environmental disaster. In the Erika case, the Court very significantly introduces a risk liability standard; product producers might be deemed “polluters” solely on the basis of their contribution to the risk of pollution. This is a significant development from Van de Walle, in which the Court considered a direct causal link or negligent behaviour necessary for product producer liability. In addition, Erika underlines that Member States cannot limit the scope of the polluter-pays principle in EC secondary legislation, even if this leads to a contradiction with a Member State’s international obligations such as the International Oil Pollution Compensation regime. In short, the Erika judgment builds on Standley and Van de Walle but adds significant impetus to the polluter-pays principle at the EC level. However, the risk liability standard it establishes will be difficult to apply and it remains to be seen how the legislator will react to the Court’s extensive interpretation.

Exposure to environmental xenobiotics, which influence the everyday life of all humans in our times, has become a subject of intensive analysis by scientists, authorities of environmental hazards, state authorities and authors of legislation. Toxicological risk assessment of chemicals in contaminated food and water as well as polluted air is expressed in basic ‘toxic units’. A broad-scale human biomonitoring (HBM) for environmental toxicants is the strategy of a cause-effect analysis of chemical exposure to environmental xenobiotics. HBM demonstrates the relationships between exposure to xenobiotics and the following health disorders: obesity, impaired reproduction, type 1 diabetes (T1D), autism, cancers and other diseases in the society. Developing effective toxicological tools and legislative standards is expected to help in eliminating endocrine disruptor chemicals (EDCs), which cause infertility. The exceptional category of xenobiotics, which highly influences human health, and is treated as a priority problem to be controlled in the European Union, form genotoxic carcinogens. According to a current assessment, hundreds of chemical xenobiotics and their metabolites, in the minimum detectable quantity, mostly all of anthropogenic origin, can be found in the organisms of inhabitants in western countries. Despite the permanent presence of xenobiotics in human environment, it is worth taking into consideration practical methods to limit and avoid contacts with environmental chemicals. It concerns the provision of water and air filters, the thermal processing of food, the selection of food products, and other aspects of everyday life.

In accordance with the legislative framework of the system for regulating liquid and airborne discharges of radioactive substances into the environment in force in the Russian Federation, this system is equally designed to regulate discharges of the radionuclides of both artificial and natural origin. The mechanisms of radiological impact of the discharges of natural origin radionuclides on the environment and population do not have any specificity in comparison with the ones of artificial origin radionuclides. Nevertheless, to date, the law enforcement of the Russian system for regulating discharges of the radioactive substances is applied only in relation to the discharges of the radionuclides of artificial origin carried out by nuclear facilities. At the same time, regulation of the discharges of natural origin radionuclides, in accordance with the safety standards of the International Atomic Energy Agency, is the best practice in the field of environmental protection, and the levels of radiation exposure, which characterize such discharges, are not low enough to be neglected. Regulation of the discharges of natural origin radionuclides is provided for in the norms of the European Union and is practically applied in the number of countries of the European Union, where the legislation provides for the regulation of activities, in which the raw materials containing radionuclides of natural origin are used, and the types of economic and other activities subject to this regulation are determined. The Russian system of regulation of discharges of the radioactive substances into the environment is built on the same basic principles and criteria that underlie foreign regulation systems, and which are recommended by the International Atomic Energy Agency. The regulatory and methodological base formed to date in the Russian Federation contains all the required legal mechanisms for the regulation of discharges of the radioactive substances from nuclear facilities, is based on the best international practices and fully complies with the standards of the International Atomic Energy Agency.

The adoption of sustainable waste management strategies is a challenge faced by most European countries, mainly due to the need to generate less waste and replace landfills with new methods of waste treatment, associated with increases in the separate collection of waste and recycling rates. This paper highlights the significance of environmental legislation regarding waste removal to protect ecosystems. The aim was to predict ecological responses to heavy metals in soil exposed to hazardous waste and to identify environmental hazards in landfills, small illegal waste dumps, and litter, in addition to identifying if heavy metal accumulation in the investigated soil samples showed a single or cumulative risk. This is an innovative method to predict the ecological risk generated by hazardous waste landfills. The assessment of ecological risks was based on the evaluation of a heavy metal soil contamination factor, pollution index of soil loadings, a geo-accumulation index for heavy metals, and potential ecological risk. The current study is also the first to attempt to identify the dimension of risk based on the type of waste deposit (landfill, small illegal waste dump, and litter) and to identify potential patterns. The geological index corresponding to cadmium Igeo(Cd) showed heavy contamination in the soil samples from the landfill and moderate contamination for those from the illegal waste dumps. These findings indicate that soil contamination is influenced by contamination time, anthropogenic processes, and a history of industrial activity, and not only by waste composition and storage. The present study shows that cadmium might be considered a latent fingerprint for waste disposal, which is correlated to the industrialization level and rehabilitation procedures.

IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.

This is the title of the third issue in the twenty-fourth volume of the Contemporary Military Challenges. We started from the changes that have taken place over the last few years. We have had in mind the increased migration flows towards the European Union, the experience of the Covid 19 epidemic, the climate change that surprises us time and time again, despite the fact that we are aware of it, and that we are trying to adapt and respond to it accordingly. In March this year, the "Strategic Compass for Security and Defence - For a European Union that protects its citizens, values and interests and contributes to international peace and security" was launched, and at the end of June, the new NATO Strategic Concept. Both with the aim of rethinking, aligning and unifying the way we look at existing security challenges and developing new security perspectives. At the beginning of this year, we were taken by surprise by the Russian Federation's armed attack against Ukraine. Some had predicted it; others only foresaw it. Many were convinced, however, that such a phenomenon was not possible in a modern democratic society. Huntington's theory of a clash of civilisations, which seemed to have outlived its usefulness in modern European society, has become relevant again. A realistic view of the contemporary security, social and political situation in the world and, above all, the crisis of values and the consequent need for unification have encouraged the European Union to aspire to become a global security actor in the international environment. The war in Ukraine is forcing the European Union to act. It has prepared a package of economic measures or sanctions to influence the Russian Federation in terms of expressing its disapproval of its unilateral moves. However, the Member States are not entirely united on how to confront and counter the situation. Without unity, united political positions and united action, the European Union cannot become the global security actor that it has claimed to be in its strategic compass. In this context, it is also worth mentioning its Common Security and Defence Policy, which is first and foremost a policy, and the fact that the European Union does not have its own military capabilities to manage. The Member States have military capabilities, and they spend varying amounts on their defence. Over the last decade, most Member States have been reducing their defence expenditure, despite the fact that it was agreed at the NATO summit in Wales in 2012 that it would amount up to 2% of GDP. Not all Member States of the European Union are members of the Alliance, but there are twenty-one of them that are members of both. Douglas Barrie and his colleagues produced a special report in 2020 on 'European defence policy in an era of renewed great-power competition', which concluded that, assuming that all Member States did indeed spend 2% of GDP on defence, the European Union and its Member States would need ten to fifteen years to be adequately prepared in terms of security capabilities for a possible aggression by a country with the military capabilities of the Russian Federation today. With investments in this area as they are in 2022, it would take twenty years. This leads to the logical conclusion. There are only two ways of stopping the Russian Federation in its territorial and, of course, political ambitions. The first and most appropriate is political, the second military. Since the European Union does not represent a serious opponent in defence and military terms to this large and militarily powerful country, the only way for it to achieve its status as a global security actor is politically. The military conflict in Ukraine is a major test for both the Union and the Alliance. The European Union now has the opportunity to test how strong and credible its ideals, values and beliefs are. Are its senior representatives wise and innovative enough to look beyond economic sanctions to other diplomatic avenues to achieve what they have written in their strategic compass – to be a global player? Time will answer this question. Until then, however, scholars and other experts will be studying the various influences and phenomena in the security domain. Some of them will also share them with the readers of Contemporary Military Challenges. In a time of economic sanctions imposed by the European Union, Tamas Somogyi and Rudolf Nagy focus on the protection of critical infrastructure, of which the financial sector is an important part. In their article Cyber threats and security challenges in the Hungarian financial sector, they explore the security risks facing the banking system in their country. The paper Geostrategic perspectives of Slovenia in a changing world draws on two geopolitical theories by Mackinder and Spykman, who develop their views on the European space. Uroš Tovornik explored Slovenia's geostrategic position on the basis of their theories, focusing on its geopolitical characteristics. He summarised his findings into four possible scenarios, which are determined by these characteristics and from which possible future geopolitical orientations are derived. Olusola Kolawole Oluwagbire explored the influence of the world’s major powers and how this is reflected in the case of each country. Africa, as a very large continent, is made up of many and diverse countries. The influence of the major powers has always been very strong and integral to African life and the security of its people. In his article An assessment of the impact of relations with major powers on national security: Nigeria in perspective, the author presents how this has changed in recent years and how it affects the security of each country in. Mariann Minkó-Miskovics and Csaba Szabó note that there is an inconsistency between European and Hungarian legislation in the field of dual-use regulation, i.e. for civil and defence purposes. Moreover, they are convinced that this inconsistency may pose a security risk. What this means in practice is presented in the article Interpretation of civil vs. military equipment in European case law - EU and Hungary. Jarosław Włodarczyk writes on the importance of a proper understanding of language between different stakeholders in the international military environment. His study focuses on the teaching of English among military personnel in Poland and on those types of words that do not have a direct translation from Polish into English or vice versa. A particular challenge here is how to adequately explain and teach this to military personnel in the educational process. He summarised his findings in his paper The problem of lexical gaps in teaching military English.

Healthcare workers (HCWs) are at increased risk of both exposure and transmission of infectious disease. Two European Union (EU) directives state that health services are responsible for assessing their employees’ potential exposure to infectious diseases and offering immunisation free of charge. We assessed current policy for immunisation of HCWs and the availability of vaccine coverage data in the Nordic countries by surveying national vaccination experts in Denmark, Finland, Iceland, Norway and Sweden, as well as Swedish county medical officers (CMOs). All national experts and 17 of 21 Swedish CMOs responded. All EU countries had transposed the European directives into national law, while Norway and Iceland had similar national legislation. Recommendations or guidelines were issued in Denmark, Finland, Iceland, Norway and 15 of 17 responding Swedish counties. The range of diseases covered differed by countries and Swedish counties. HCW vaccine coverage data were not systematically collected; incomplete estimates were only available for Finland and two Swedish counties. In conclusion, recommendations or guidelines exist in the Nordic countries, but their impact cannot be assessed, as vaccine uptake among HCWs is not currently measured. Systematic collection of data is a necessary step towards improving HCW immunisation policy and practice in the Nordic countries.

Legislation that governs the health and safety of communities near major-hazard installations in South Africa is largely based on existing legislation that had been developed in the United Kingdom and other European Union countries. The latter was developed as a consequence of several major human-induced technological disasters in Europe. The history of the evolution of health-and-safety legislation for the protection of vulnerable communities in European Union (EU) countries, France, Malaysia and the USA is explored through a literature survey. A concise comparison is drawn between EU countries, the USA and South Africa to obtain an exploratory view of whether current South-African legislation represents an optimum model for the protection of the health-and-safety of workers and communities near major-hazard installations. The authors come to the conclusion that South-African legislation needs revision as was done in the UK in 2011. Specific areas in the legislation that need revision are an overlap between occupational health and safety and environmental legislation, appropriate land-use planning for the protection of communities near major-hazard installations, the inclusion of vulnerability studies and the refinement of appropriate decision-making instruments such as risk assessment. This article is the first in a series that forms part of a broader study aimed at the development of an optimised model for the regulatory management of human-induced health and safety risks associated with hazardous installations in South Africa.

Atmospheric air is one of the main vital elements of the environment. The constant growth of the negative anthropogenic impact on it leads to a deterioration in the ecological state of the environment, an increase in morbidity and an increase in the risk of mortality among the population. This article explores the basic principles of legal protection of atmospheric air, on which EU legislation is based. In particular, ‒ is taking into account influences, practical reach, the principle of universality, uncertainty of requirements for specific technologies, the principle of the best available technologies, as well as the principle of "pollutant pays". The authors also analyzed the standards and standards of air quality of the EU, proposed ways to solve the problem of improving national legislation in this area, bringing it in line with international standards. The experience of some European countries proves the need and importance of implementing effective standards of air pollution, since ignoring such normalization can lead to detrimental consequences not only in Ukraine but also around the world. The article states that the regulatory and legal regulation of this sphere in the EU is effective and in a sense exemplary, because with the help of various legal instruments effective air protection is carried out, adaptation to climate change, which makes it possible to properly ensure environmental safety of the population not only in Europe, but also around the world. Ukraine, by adopting relevant regulations at the present stage of the development of legal regulation, takes generally successful steps in the field of approximation of its environmental legislation to EU legislation. However, this process is still gaining momentum and does not exclude problems, contradictions that can inhibit this approximation.

Abstract As a response to the pandemic, the Commission's communication of 11 November 2020 proposed building blocks for a European Health Union (EHU) and advocated the strengthening of existing structures and mechanisms for better EU level protection, prevention, preparedness and response against human health hazards. It recommended a reinforced framework for cross-border cooperation against all health threats to protect better human lives and the internal market as well as to maintain the highest standards in the protection of human rights and civil liberties, and a strengthened EU role in international cooperation to prevent and control cross-border health threats and improve global health security. By upgrading the EU health security framework for cross-border health threats, the building blocks of the European Health Union bring greater overall impact while fully respecting the Member States’ competence in the area of health. Concretely, before the end of 2022, two pieces of legislation will have been adopted: the upgrading of Decision 1082/2013/EU and the strengthened mandate of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) that go hand in hand. The new Regulation on serious cross-border threats to health, the overarching legislative piece of the EU Health Union Package, aims at a stronger and more comprehensive legal framework for the Union to better prepare and respond to serious cross-border threats to health and public health emergencies. It better governs actions at Member States and Union level on prevention, preparedness and response, surveillance, risk assessment, and early warning. Further, it ensures better arrangements for joint procurement at EU level. With its revised mandate, the ECDC will be able to issue recommendations to Member States regarding preparedness and response, host a new network of EU reference laboratories and establish an EU Health Task Force for crisis preparedness and rapid public health interventions in case of a major outbreak. The regulation reinforcing EMA's role in crisis preparedness and management of medicinal products and medical devices puts some of the structures and processes established during the COVID-19 pandemic on a permanent footing. EMA is now responsible for monitoring medicine shortages, as well as reporting shortages of critical medicines during a crisis. It will also coordinate responses of EU / EEA countries to shortages of critical medical devices and in-vitro diagnostics in crises. The EU Health Security Framework will link up to IHR (where EU is requesting to become a contracting party) and the pandemic treaty, and the parallel developments to improve pandemic preparedness and response in G7 and G20 framework (also new global health strategy). The revised legislation addresses the weaknesses evidenced by the COVID-19 pandemic and support actions that can be financed via the EU4Health programme and other EU funding instruments. DG SANTE and ECDC will present the new legislation; two Member States will share their views on the newly adopted legislation. HaDEA will present the funding opportunities through EU4Health to support the implementation of th e two new legislation. Speakers/Panellists Ingrid Keller European Commission, Luxembourg, Luxembourg Florina Telea European Commission, Brussels, Belgium