European Journal of Risk Regulation最新文献

{"title":"The Regulatory Environment for the Safety of the Internet of Medical Devices Users in the European Union and the United States","authors":"Katarzyna Biczysko-Pudełko","doi":"10.1017/err.2024.33","DOIUrl":"https://doi.org/10.1017/err.2024.33","url":null,"abstract":"\u0000 The Internet of Medical Things (IoMT) devices, as well as the Internet of Things phenomenon itself, are gaining a new group of customers every day, for whom it is almost a matter of course to use a wide range of devices, such as Internet-connected complex life support equipment or “smart” watches monitoring basic life parameters. With the growing popularity of such devices, however, questions about the safety of their users begin to arise, because almost in proportion to the number of benefits associated with the use of these products, the number of risks associated with them increases – eg improper functioning of Internet-connected life support equipment, in addition to threatening the life or health of its user, may affect the physical security of the product itself, the security of both personal and technical (eg non-personal) data processed by the specific product, or finally the cyber-security of the product. While the issues related to the protection of personal data and privacy, in general, have been discussed many times by the doctrine, the issues related to the protection of users of these devices under consumer law have not been considered much.\u0000 In this context, the question arises whether the current legal regulations provide an adequate and sufficient level of protection for IoMT users. In particular, whether the average IoMT user can actually exercise their rights under the provisions of consumer law and whether the protection afforded to him – both in terms of the scope of their rights and the scope of obligations and liability of manufacturers and suppliers of these devices – is not only illusory? In order to answer the above questions, the author will evaluate the prevailing market practices – still focused around the doctrine of “caveat emptor” or “let the buyer beware” – and compare them with these regulations and juxtapose them with relevant legal regulations. However, given the lack of geographical borders in the field of cyber security and privacy, the author will not only analyse EU cyber security legislation, but also US legislation in a comparative legal analysis. The choice of jurisdictions to be compared is also related to the size and importance of both the US and the EU for the global IoMT market. It should be noted that the United States has a dominant position in the IoMT, while the European Union is estimated to have the second largest IoMT market globally. At the same time, however, there are differences in legal systems between the two economic areas. An analysis carried out in this way will make it possible not only to answer the question posed above, but also to possibly identify those areas of regulation that need to be changed or adapted to the realities of IoMT.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141110682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Risk Analysis in EU Food Governance: Balancing Scientific Food Safety Factors and External Factors that Inform Risk Management for Healthier Food Systems","authors":"Maria El Gemayel","doi":"10.1017/err.2024.14","DOIUrl":"https://doi.org/10.1017/err.2024.14","url":null,"abstract":"\u0000 Scientific consensus links dietary choices to health outcomes, highlighting the urgency to prioritise healthy food production in food systems. At the EU level, however, defining healthy food and integrating it into food governance remains a challenge, particularly regarding the inclusion of health-related characteristics in food safety assessments. While the EU primarily relies on the risk analysis principle to address food safety concerns, the process still exhibits weaknesses that hinder its direct impact on fostering a healthier food production landscape. This review demonstrates how the risk analysis process, particularly scientific opinions in risk assessment and external factors (economic and political) in risk management, impact food governance and the healthiness of food systems. We find that while external factors play a crucial role in risk management decisions by incorporating non-food safety considerations, they often stem from an imbalance of power favouring major industry and political stakeholders. This imbalance disproportionately influences decision-making, often overshadowing nutritional and health aspects. To address these challenges, we recommend directing research towards filling knowledge gaps and exploring minority scientific findings, and separating external factors from risk management’s decision-making process, to ensure that food governance prioritises public health and healthy food production.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141121118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tricks under Trade: How International Trade Both Facilitates and is Facilitated by Corporate Environmental Crime in the Waste and Hydrocarbon Sectors","authors":"Giulia Giardi","doi":"10.1017/err.2024.32","DOIUrl":"https://doi.org/10.1017/err.2024.32","url":null,"abstract":"\u0000 Legal scholarship in the realm of international economic law has a blind spot: the practice of international trade. Cargo and container shipping is the blood and guts of international trade, and it is fuelled by bunker oil – a hydrocarbon mixture of the dirtiest petroleum-based products. Worryingly, there is empirical evidence of bunkers being intentionally contaminated with waste oils. This fraudulent contamination violates numerous international, national, and EU rules on waste management and poses immense risks to the health of planet and people alike. These same acts of fraud are also extremely profitable, and they facilitate the smooth functioning of our global economy. The fraud is itself not just incentivised in the tight-margins reality of international trade, but it is facilitated by the lack of proper legislation and the vulnerability of the existing means of enforcement in the areas where there is legislation to comply with. Economic operators often use falsified documents to market fuel oil that should be considered as waste. Systematic wrongdoing of this kind is detrimental to the environment and risks eroding the rule of law in both its formal and substantive conceptualisations.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140972677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"“The WTO Agreement on Sanitary and Phytosanitary Measures. A Commentary” by Lukasz Gruszczyński, Oxford University Press 2023, 384 pp. £175. Hardback","authors":"Lena Helińska","doi":"10.1017/err.2024.30","DOIUrl":"https://doi.org/10.1017/err.2024.30","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140973648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The “Safe and Sustainable by Design” Concept – A Regulatory Approach for a More Sustainable Circular Economy in the European Union?","authors":"Leonie Reins, Julia Wijns","doi":"10.1017/err.2024.29","DOIUrl":"https://doi.org/10.1017/err.2024.29","url":null,"abstract":"The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140933999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Reform of International Investment Law: Whose Rule of Law?","authors":"Ivana Damjanovic","doi":"10.1017/err.2024.28","DOIUrl":"https://doi.org/10.1017/err.2024.28","url":null,"abstract":"<p>Public and political controversies over Investor–State Dispute Settlement (ISDS) have prompted reform processes in international investment law, at bilateral, regional and multilateral levels, with different actors shaping the future of international investment governance. In its essence, the options for the ISDS reform reflect the diverging perspectives on the rule of law in international law. Ultimately, they present a choice about who should control power over States’ action in issues of public importance – the States who have created the system, or international investment tribunals who have shaped the legal development of the system. This paper considers the application of the rule of law as a normative meta-principle to international investment law and its dispute settlement, and it sheds light on different perspectives of this concept, as they shape the ongoing ISDS reform(s).</p>","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140809710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enforcement of Multilateral Trade Regulation by Non-State Actors – Desirable and Feasible?","authors":"Iveta Alexovičová","doi":"10.1017/err.2024.20","DOIUrl":"https://doi.org/10.1017/err.2024.20","url":null,"abstract":"Since its inception, the inter-state dispute settlement system of the World Trade Organisation has generally been praised for effectively protecting the rule of law in international trade relations. While the relatively recent dismantling of this system does not necessarily mean the end of the WTO nor of the binding nature of its rules, the current crisis may be a good opportunity to reconsider the role of the rule of law in international trade relations and the ways in which it could further be accommodated. One suggestion, occasionally raised in the past, would be strengthening the enforcement of WTO rules by opening it to private action, either before national courts or through international adjudication. After all, the latter has been widely available to foreign investors covered by thousands of international investment agreements in force for decades. This contribution recalls the reasons behind the current lack of private enforcement of WTO law and argues that developments in international trade relations and experiences with investor-state dispute settlement are likely to work against rather than in favor of its introduction in the foreseeable future. Increased transparency and institutionalisation of non-state actors’ role in trade enforcement is therefore recommended instead.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140634921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Between Aims and Execution: Value Trade-Offs in the Practical Implementation of the European Arrest Warrant? – ERRATUM","authors":"Bjorn Kleizen, J. Wynen, Veronica Junjan","doi":"10.1017/err.2024.31","DOIUrl":"https://doi.org/10.1017/err.2024.31","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140683208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consumer Decision-Making Autonomy in the Digital Environment: Towards a New Understanding of National Courts’ Obligation to Assess Ex Officio Violations of Fair Commercial Practices","authors":"Zanda Davida","doi":"10.1017/err.2024.11","DOIUrl":"https://doi.org/10.1017/err.2024.11","url":null,"abstract":"Digitalisation has changed traders’ possibilities of influencing the autonomy of consumer choice in the digital environment. The digital market of the European Union involves a wide spectrum of commercial practices – such as dark and addictive patterns, target advertising and personalisation – that nudge consumers to take decisions that are not in their favour. One of the main aims of the Unfair Commercial Practices Directive 2005 is to protect the freedom of consumer decision-making. However, currently, the Directive’s capacity to safeguard consumer choice in the digital environment is not sufficiently effective. Through the lens of law prohibiting unfair commercial practices, this article analyses the means available to consumer courts to strengthen consumer decision-making autonomy in the digital environment. The article argues that regulation of prohibition of unfair commercial practices regarding the digital environment should be modernised by obliging – in certain circumstances – national courts <jats:italic>ex officio</jats:italic> to assess violations of fair commercial practices and by reversing the burden of argumentation and proof.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140630061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Behavioural Economics and Regulation: The Design Process of Regulatory Nudges by Maria C de Campos, London, Routledge, 2023, 232 pp.","authors":"Ollie Bartlett","doi":"10.1017/err.2024.18","DOIUrl":"https://doi.org/10.1017/err.2024.18","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140683095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}