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Prioritisation under Value Chain Due Diligence European Journal of Risk Regulation Pub Date : 2024-03-19 João Teixeira de Freitas
This article analyses the mechanisms of prioritisation and hierarchisation of risk contained under influential soft law frameworks on value chain due diligence. It identifies the main stages of the due diligence process where prioritisation may be required and clarifies the criteria that may be used by corporations for prioritisation decisions. The article contributes to the development of the literature
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The Right to Refuse Equivalence of Sanitary and Phytosanitary Measures: Trading on Regulatory Trust? European Journal of Risk Regulation Pub Date : 2024-03-14 Christian Delev, Jochelle Greaves Siew
Equivalence is an essential discipline for liberalising trade between States whose sanitary and phytosanitary (SPS) measures are based on divergent regulatory approaches. During the Uruguay Round negotiations, “equivalence” under the SPS Agreement was regarded by negotiators as being “of great importance”, and it was even considered to establish a right for exporting States. In practice, the discipline
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Groups of Persons in the Proposed AI Act Amendments European Journal of Risk Regulation Pub Date : 2024-03-11 Liubomir Nikiforov
This article explores the proposed amendments to the AI Act, which introduce the concept of “groups of persons”. The inclusion of this notion has the potential to broaden the traditional individual-centric approach in data protection. The analysis explores the context and the challenges posed by the rapid evolution of technology, with an emphasis on the role of artificial intelligence (AI) systems
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International Standards for Regulatory Deference Relating to National Food Control Systems: More to Do? European Journal of Risk Regulation Pub Date : 2024-03-07 Steve Wearne, Nicola Hinder, Tom Heilandt
This paper describes how the development of texts on regulatory deference by the Codex Alimentarius Commission (CAC) addresses relevant recommendations of the World Trade Organization (WTO) and supports Member countries of CAC in their negotiation and implementation of equivalence agreements. We consider the role and function of CAC within a rules-based multilateral framework, particularly in relation
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Between Aims and Execution: Value Trade-Offs in the Practical Implementation of the European Arrest Warrant? European Journal of Risk Regulation Pub Date : 2024-03-05 Bjorn Kleizen, Jay Wynen, Veronica Junjan
The European Union (EU) increasingly develops and implements policies infused with salient and sometimes conflicting values – for instance, in migration and criminal law cooperation. However, policy implementation studies have not frequently considered how such complex value trade-offs may affect practical implementation within Member States. This article therefore quantitatively and temporally examines
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Air Pollution as a Whole: The Court of Justice Strengthens Environmental Standards in the Ambient Air Quality Directive over Contrasting Industrial Emissions Directive Derogations European Journal of Risk Regulation Pub Date : 2024-02-29 Walter Bruno
On 9 March 2023, the Court of Justice (Second Chamber) delivered a preliminary ruling about the coordination of two European Union measures against air pollution: the Industrial Emissions Directive and the Ambient Air Quality Directive. Upon assessment, the Court reinforced the mandatory nature of the air quality limit values vis-à-vis possible derogations foreseen in the Industrial Emissions Directive
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“More than Words”: A Legal Approach to the Risks of Commercial Chatbots Powered by Generative Artificial Intelligence European Journal of Risk Regulation Pub Date : 2024-02-29 Sara Migliorini
The recent commercial release of a new generation of chatbot systems, particularly those leveraging Transformer-based large language models (LLMs) such as ChatGPT, has caught the world by surprise and sparked debate about their potential consequences for society. While concerns about the existential threat posed by these technologies are often discussed, it is crucial to shift our focus towards the
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Shell and the Climate Case: Is the Shell Group the “Cheapest Cost Avoider”? European Journal of Risk Regulation Pub Date : 2024-02-29 Arnald J. Kanning
The Hague District Court in the Netherlands faced a novel tort law issue in 2021 in Milieudefensie et al v Royal Dutch Shell plc – namely, whether Shell is liable in tort for the reduction costs of carbon dioxide produced in the end use of energy-carrying Shell products. The civil lawsuit aims to make Shell (re)search for adequate substitutes so as to enable Shell’s customers to reduce their consumption
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Assessing the quality of European Impact Assessments European Journal of Risk Regulation Pub Date : 2024-02-19 Diana-Maria Danciu, Laura Martens, Wim Marneffe
This paper explores the possibility of developing a framework to assess the quality of Impact Assessments (IAs) by examining the common elements found in the existent academic literature around this concept, the stocktaking exercises carried out by the European institutions and the opinions of the Regulatory Scrutiny Board. At this intersection, we find that diversity in the interpretation and application
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The Magnificent Seven: Exemption, Relief, Equivalence, Recognition, Substitution, Deference, Trust – Reducing Regulatory Duplication and Frictions in the Cross-Border Supply of Financial Services European Journal of Risk Regulation Pub Date : 2024-01-02 Jonathan R.M. Foster
A financial services supplier authorised in its home state that wishes to supply services cross-border into another state will, absent any relief, have in addition to meet the regulatory requirements of that host state to trade in it. Regulatory frictions including duplicative regulatory requirements are barriers to cross-border trade. This article considers certain techniques deployed to reduce such
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Political Institutions and Long-Term Policymaking: How Parliamentary Future Committees Can Make a Difference European Journal of Risk Regulation Pub Date : 2024-01-02 Vesa Koskimaa, Tapio Raunio
Responding to the need to make democratic governance more anticipatory, during recent decades parliaments have increasingly made efforts to involve elected legislators directly in addressing future risks and envisioning long-term developments. At the level of general democratic-institutional principles, engaging legislators in national-level foresight is expected to enhance the general legitimacy of
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Protecting Future People’s Future: How to Operationalise Present People’s Unfulfilled Promises to Future Generations European Journal of Risk Regulation Pub Date : 2024-01-02 Alberto Alemanno
As societies become more concerned with their impacts on future generations, the question of how to translate that concern into greater consideration in contemporary decision-making is coming to the fore. Despite growing societal acceptance of the ethics of obligations to the future – as reflected in record-high number of future-sensitive constitutions and international treaties – present generations’
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Regulatory “Reliance” in Global Trade Governance European Journal of Risk Regulation Pub Date : 2023-12-28 Andrew Lang
One of the most significant recent trends in global trade governance has been the increasing use of regulatory “reliance” arrangements as a significant element of trade alliances. Against this backdrop, an important set of questions are raised about how existing institutions of global trade governance – especially the World Trade Organization and international regulatory standards organisations – should
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Disciplining Health Regulations through the World Trade Organization’s Agreement on the Application of Sanitary and Phytosanitary Measures: Science and the Rule of Law European Journal of Risk Regulation Pub Date : 2023-12-22 Denise Prévost
The World Trade Organization’s (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) disciplines WTO Members’ health regulations to prevent their misuse for protectionist purposes. In doing so, its obligations reflect several elements of the rule of law, including legal certainty, non-arbitrariness and non-discrimination, as well as a recognition of the rights of individuals. Through
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States of Emergency, Simultaneous Overreach and Underreach and the COVID-19 Pan(dem)ic European Journal of Risk Regulation Pub Date : 2023-12-13 Max Steuer
Previous research has neglected how repeated declarations of states of emergency (SsoE) in response to the same emergency may combine with executive overreach and underreach within a single jurisdiction, undermining the authority of the SsoE as a legal institution and increasing the vulnerability of the constitutional system as a result. This article examines how decision-makers’ commitment to a culture
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Regulating Gatekeeper Artificial Intelligence and Data: Transparency, Access and Fairness under the Digital Markets Act, the General Data Protection Regulation and Beyond European Journal of Risk Regulation Pub Date : 2023-12-13 Philipp Hacker, Johann Cordes, Janina Rochon
Artificial intelligence (AI) is not only increasingly being used in business and administration contexts, but a race for its regulation is also underway, with the European Union (EU) spearheading the efforts. Contrary to existing literature, this article suggests that the most far-reaching and effective EU rules for AI applications in the digital economy will not be contained in the proposed AI Act
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Introducing a Research Programme for Quantum Humanities: Theoretical Implications European Journal of Risk Regulation Pub Date : 2023-11-30 Astrid Bötticher, Jose Hernandez, Matthias C. Kettemann, Volker Gast, Rodrigo Araiza Bravo
Quantum computing is a form of computing based on the principles of quantum mechanics. Quantum computing promises to revolutionise society through technological solutions to previously unsolvable problems or by enhancing the capacities of current computational technologies. Additionally, quantum computing has the potential to revolutionise the humanities and social sciences. We denote the study of
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European Union Regulation of Water Stress Risks European Journal of Risk Regulation Pub Date : 2023-11-16 Riccardo Stupazzini
Water stress is a growing concern in Europe, partly due to the changing climate context. Despite the cross-cutting impacts that water availability has on different areas under the competence of the European Union (EU), there is not currently a comprehensive and systematic legal framework addressing this issue. The purpose of this article is therefore to examine the EU legislation that concerns the
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Much Ado About Nothing? Reflections on the European Commission’s Proposal for an Inter-institutional Ethics Body European Journal of Risk Regulation Pub Date : 2023-11-13 Danai Petropoulou Ionescu, Andreea Năstase
On 8 June 2023, the European Commission published a long-awaited proposal for the establishment of an interinstitutional ethics body, meant to restore the public’s faith in the European Union’s administration following the Qatargate corruption scandal. Alas, the Commission’s proposal outlines a body that lacks investigative and sanctioning powers, has minimal administrative capacity and for the most
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Strategic Foresight and Policy Evaluation: Insights for an Integrated Approach European Journal of Risk Regulation Pub Date : 2023-11-09 Laura De Vito, Gaia Taffoni
Grand challenges are shaping twenty-first-century politics. Threats connected to health, climate, demographics and welfare are increasingly intruding on the lives of citizens. Still, governments are often found off-guard, and policymakers need strategies grounded in longer-term perspectives. Strategic foresight (SF) helps us to design and shape policies to prepare to withstand shocks, anticipating
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Encoding the Enforcement of Safety Standards into Smart Robots to Harness Their Computing Sophistication and Collaborative Potential: A Legal Risk Assessment for European Union Policymakers European Journal of Risk Regulation Pub Date : 2023-11-06 Riccardo Vecellio Segate, Angela Daly
Until robots and humans mostly worked in fast-paced and yet separate environments, occupational health and safety (OHS) rules could address workers’ safety largely independently from robotic conduct. This is no longer the case: collaborative robots (cobots) working alongside humans warrant the design of policies ensuring the safety of both humans and robots at once, within shared spaces and upon delivery
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An Attribute Perspective on Regulatory Regimes in Risk Governance European Journal of Risk Regulation Pub Date : 2023-10-26 Morten A. Langøy, Geir Sverre Braut
Increasing interest from stakeholders has brought new focus on risk governance and risk regulation, such as the regulator’s execution of duty and tangible results on safety and environmental protection in oil and gas industry. One recent example, from 2019, is the Office of the Auditor General Norway’s (OAG) investigation of the Petroleum Safety Authority’s (PSA) follow-up on health, safety and the
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EU–US Data Privacy Framework: A First Legal Assessment European Journal of Risk Regulation Pub Date : 2023-10-26 Sergi Batlle, Arnaud van Waeyenberge
The purpose of this contribution is to briefly present the content of the EU–US Data Privacy Framework recently adopted by the European Commission and then to assess whether it meets the expectations expressed by the Court of Justice of the European Union in its Schrems II judgment and related case law.
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Post-crisis Emergency Legislation Consolidation: Regulatory Quality Principles for Good Times Only? European Journal of Risk Regulation Pub Date : 2023-10-23 Katarina Staronova, Nina Lacková, Matúš Sloboda
This article analyses how emergency legislation has affected law-making and regulatory quality principles (RQPs) before, during and after the COVID-19 pandemic (2019–2021) from stakeholders’ perspectives. It takes Slovakia as a case study, as this country was considered a high performer in the adoption of RQPs before the crisis, while empirical findings suggest a subsequent decline in their use. We
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The Age of Consumer Law Enforcement in the European Union: High Hopes or Wishful Thinking? European Journal of Risk Regulation Pub Date : 2023-10-09 Alexandre Biard
Not since 2018 and the “New Deal for Consumers” package has the European Union (EU) seemed so close to stepping up the enforcement of consumer protection rules. The European Commission is expected to unveil a new “consumer enforcement package” by the end of the year, which should include revisions of the Regulation on Consumer Protection Cooperation, the Directive on Consumer Alternative Dispute Resolution
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Understanding the Policy Integration Challenges of Sustainable Urban Mobility in the Context of Rapid Decarbonisation European Journal of Risk Regulation Pub Date : 2023-10-06 Carlo Maria Colombo, Marc Dijk
Given the state of the climate emergency, European Union (EU) cities must find innovative ways to achieve a sustainable and decarbonised urban mobility trajectory. This requires integrated and cross-sectoral approaches that enable all sectors influencing such mobility to contribute to this goal. Building on the concept of the climate-connected city and drawing on an extensive empirical investigation
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Adjudication of Artificial Intelligence and Automated Decision-Making Cases in Europe and the USA European Journal of Risk Regulation Pub Date : 2023-09-25 Elif Kiesow Cortez, Nestor Maslej
Artificial Intelligence (AI) has started to impact many facets of the economy and people’s routine activities. This article contributes to our understanding of how the legal system is reacting to the ongoing uptake of AI and the disputes or right infringements this uptake creates. Select legal cases regarding the use of AI technology for automated decisions are reviewed, with a focus on filings in
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Artificial Intelligence, Climate Change and Innovative Democratic Governance European Journal of Risk Regulation Pub Date : 2023-09-25 Florian Cortez
This policy-oriented article explores the sustainability dimension of digitalisation and artificial intelligence (AI). While AI can contribute to halting climate change via targeted applications in specific domains, AI technology in general could also have detrimental effects for climate policy goals. Moreover, digitalisation and AI can have an indirect effect on climate policy via their impact on
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The Glyphosate Saga in Luxembourg: The Annulment by the Judiciary of the Legislative Ban of Glyphosate-Based Products – A Breach of European Union Law? European Journal of Risk Regulation Pub Date : 2023-09-22 Alessandra Donati
Administrative Tribunal of Luxembourg, 15 July 2022, case no 44377 and Court of Appeal of Luxembourg, 31 March 2023, case no 47873C On 15 July 2022, the Administrative Tribunal of Luxembourg annulled the decisions by which the Luxembourg Minister for Agriculture, Viticulture, and Consumer Protection had banned all glyphosate-based products. On 31 March 2023, the Court of Appeal upheld the ruling of
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One Step Closer to Zero Chemical Pollution: The Legal Adoption and Implications of the Per- and Polyfluoroalkyl Substances Restriction Proposal European Journal of Risk Regulation Pub Date : 2023-09-20 Viktoria Obolevich
This paper focuses on the legal adoption and possible implications of the proposed per- and polyfluoroalkyl substances (PFAS) restriction. In the case of PFAS, this restriction puts value on the regulatory efforts to implement far-reaching and ambitious targets amid a high level of scientific uncertainty. The purpose of this paper is to present a report rather than conducting an in-depth analysis of
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ChatGPT: A Case Study on Copyright Challenges for Generative Artificial Intelligence Systems European Journal of Risk Regulation Pub Date : 2023-08-29 Nicola Lucchi
This article focuses on copyright issues pertaining to generative artificial intelligence (AI) systems, with particular emphasis on the ChatGPT case study as a primary exemplar. In order to generate high-quality outcomes, generative AI systems require substantial quantities of training data, which may frequently comprise copyright-protected information. This prompts inquiries into the legal principles
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Reproducing Responsible Gambling through Codes of Conduct: The Role of Trade Associations and Codes of Conduct in Shaping Risk Regulation European Journal of Risk Regulation Pub Date : 2023-08-29 Donal Casey
Online gambling emerged in the 1990s in the midst of a process of market liberalisation. Here, scholars have argued that the gambling industry actively seeks state regulation to authorise and legitimate its activities. Why then, since the emergence of the online gambling industry, have trade associations continually sought to develop responsible gambling codes of conduct? In this paper, I address this
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How to Open Representative Democracy to the Future? European Journal of Risk Regulation Pub Date : 2023-08-22 Manon Revel
In recent years, various innovations aimed at counteracting perceived presentism and democratic decline have emerged. One primary concern is the issue of inadequate representation in parliaments, which has prompted the development of various proposals for reforming the selection mechanisms of parliamentarians. In this context, lottocracy (selection of representatives at random) and proxy democracy
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Acceptable Risks in Europe’s Proposed AI Act: Reasonableness and Other Principles for Deciding How Much Risk Management Is Enough European Journal of Risk Regulation Pub Date : 2023-08-18 Henry Fraser, José-Miguel Bello y Villarino
This paper critically evaluates the European Commission’s proposed AI Act’s approach to risk management and risk acceptability for high-risk artificial intelligence systems that pose risks to fundamental rights and safety. The Act aims to promote “trustworthy” AI with a proportionate regulatory burden. Its provisions on risk acceptability require residual risks from high-risk systems to be reduced
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Excessive Pricing in Pharmaceuticals under Article 102 TFEU European Journal of Risk Regulation Pub Date : 2023-08-18 Jacquelyn D. Veraldi
High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse
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Existential Terrorism: Can Terrorists Destroy Humanity? European Journal of Risk Regulation Pub Date : 2023-08-04 Zachary Kallenborn, Gary Ackerman
Mass-casualty terrorism and terrorism involving unconventional weapons have received extensive academic and policy attention, yet few academics have considered the broader question of whether such behaviours could pose a plausible risk to humanity’s survival or continued flourishing. Despite several terrorist and other violent non-state actors having evinced an interest in causing existential harm
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For Young and Future Generations? Insights from the Web Profiles of European Climate Pact Ambassadors European Journal of Risk Regulation Pub Date : 2023-08-03 Jale Tosun, Lucas Geese, Irene Lorenzoni
The European Climate Pact provides opportunities for individuals, communities and organisations to declare their commitment to climate action. This study analyses the publicly available web profiles of the European Climate Pact Ambassadors (PAs) as of January 2023. First, it explores the extent to which people who volunteer as PAs demonstrate commitment to young and future generations. Second, it investigates
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Preserving Consumer Autonomy through European Union Regulation of Artificial Intelligence: A Long-Term Approach European Journal of Risk Regulation Pub Date : 2023-08-03 Sébastien Fassiaux
Personal autonomy is at the core of liberal societies, and its preservation has been a focus of European Union (EU) consumer and data protection law. Professionals increasingly use artificial intelligence in consumer markets to shape user preferences and influence their behaviours. This paper focuses on the long-term impact of artificial intelligence on consumer autonomy by studying three specific
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Promoting the Apocalypse? The Legality of a Ban on Advertising for Fossil Fuels and Other Carbon-Intensive Products under European Law European Journal of Risk Regulation Pub Date : 2023-07-28 Clemens Kaupa
Climate policy requires a steep and rapid reduction of greenhouse gas emissions, which are mainly caused by fossil fuels. Advertising that promotes fossil fuels and other carbon-intensive products undermines this objective. It normalises unsustainable consumption patterns and enables producers of harmful commodities to manipulate public discourse in order to delay or derail the energy transition –
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Exploring the Role of Intermediaries in the Acceleration Stage of the Energy Transition: A Comparative Case Study of Two Local Energy Projects European Journal of Risk Regulation Pub Date : 2023-07-24 Petra Hofman, Michiel Stapper, Martijn Groenleer
Transition intermediaries are expected to play an important role in the acceleration stage of the energy transition. While existing scholarship helps us understand the role of transition intermediaries in the early stages of transitions, it remains unclear what role intermediation plays in subsequent transition stages, especially at the local level where the implementation of policies and legislation
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Europe’s Refugee “Crises” and the Biopolitics of Risk European Journal of Risk Regulation Pub Date : 2023-07-20 Veronica Corcodel, Dimitra Fragkou
This paper provides an analysis of the legal and policy foundations of the different approaches adopted by the European Union (EU) in relation to the 2015/2016 and 2022 refugee “crises”. Its main objective is to show how a risk-based biopolitical framework can bridge the gap between EU institutional narratives and the critique of Europe’s racialised governance schemes. The two “crises” have been largely
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The Law Is Elastic but Does Not Bend: A Literal Interpretation of European Union Chemical Legislation Could Leave Health and the Environment Unprotected European Journal of Risk Regulation Pub Date : 2023-07-18 Carme Ribes Ortega
This piece addresses Case C-458/19 P before the Court of Justice of the European Union (CJEU) concerning a substance of long-term exposure, namely bis(2-ethylhexyl) phthalate (DEHP). The case concerned the interplay of two complex procedures of European chemical law, namely: the procedure for authorising the use of a substance listed in Annex XIV of Regulation (EC) No 1907/2006 (REACH Regulation);
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Quantum Computing: Bridging the National Security–Digital Sovereignty Divide European Journal of Risk Regulation Pub Date : 2023-07-14 Anders Liman, Kate Weber
Quantum computing research and development efforts have grown dramatically over the past decades, led in part by initiatives from governments around the world. Government quantum computing investments are often driven by national security or digital sovereignty concerns, with the language used depending on the geography involved. For example, a focus on “national security” and quantum computing is
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The European Pesticides Harmonised Risk Indicator HRI_1: A Clarification About Its Displayed Rendering European Journal of Risk Regulation Pub Date : 2023-07-13 Marie-Cécile Vekemans, Patrice A. Marchand
Since the EU Directive (EC) No 128/2009 (SUD) was approved by the European Parliament, the establishment of a general framework aimed at securing the sustainable use of pesticides was laid down, and European Union (EU) Member States adopted National Action Plans in accordance with this Directive. Specifically, for EU Member States, pesticides, objectives and quantitative targets were created. Therefore
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Intergenerational Justice as a Lever to Impact Climate Policies: Lessons from the Complainants’ Perspective on Germany’s 2021 Climate Constitutional Ruling European Journal of Risk Regulation Pub Date : 2023-06-06 Till Steinkamp
Climate litigation based on the constitutional rights of future generations is an emerging and promising approach to enforcing long-term policies based on intergenerational and climate justice. In Germany, a high-profile constitutional judgment triggered by climate activists ruled that the German climate policy infringes future freedom rights. Based on an assessment of legal opportunity structures
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The Prevention Cycle: State Investments in Preventing System Risks over Time European Journal of Risk Regulation Pub Date : 2023-05-24 Bas Heerma van Voss
The policy drivers for preventing system risks – risks that threaten vital parts of society – represent an as-yet understudied subject. A fundamental characteristic of an effective prevention policy for system risks is long-term investment. This article presents evidence that long-term investment in prevention follows a cyclical rather than a stable pattern, which implies large costs to the welfare
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One Size Fits All? Handling Public Health and Environmental Risks in French Whistleblowing Legislation European Journal of Risk Regulation Pub Date : 2023-05-22 Olivier Leclerc
French whistleblower legislation establishes a unified legal regime for the treatment of reports and for the protection of whistleblowers. Drawing on French whistleblower law, recently amended by the transposition of Directive 2019/1937 of 23 October 2019, this article examines whether the specific features of whistleblowing in relation to public health and environmental risks are adequately addressed
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Regulation by Design and the Governance of Technological Futures European Journal of Risk Regulation Pub Date : 2023-05-17 Marco Almada
Regulation by design is an increasingly common approach in the governance of digital technologies. Under this approach, the developers of digital systems must adopt technical measures that implement the specific requirements mandated by law in their software. Some jurisdictions, notably the European Union (EU), have turned to regulation by design as a mechanism to automatically enforce legal requirements
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Exploring the Throughput Legitimacy of European Union Policy Evaluation: Challenges to Transparency and Inclusiveness in the European Commission’s Consultation Procedures and the Implications for Risk Regulation European Journal of Risk Regulation Pub Date : 2023-05-03 Paul Stephenson
In its evaluation cycle, the European Commission emphasises the importance of good data and the systematic involvement of a plurality of policy stakeholders, including citizens. Findings from European Union policy evaluation should inform further law-making, encourage learning and provide accountability. Transparent and inclusive formal procedures and tools are seen as essential for securing citizen
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Mitigation of Long-Term Risks and the Role of Insurance: A Behavioural Law and Economics Perspective European Journal of Risk Regulation Pub Date : 2023-04-17 Qihao He, Michael Faure
In a world of rising long-term risks and their ensuing syndromes, the mitigation and financing of long-term risks are therefore arguably some of the most critical issues facing society. However, long-term thinking involving future generations draws limited attention in current political and social systems. Private insurance has received increased attention due to its expert role in risk management
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Enhancing Vulnerable Groups’ Participation in Medicines Risk Regulation: The Case of the European Medicines Agency’s Public Hearing on Quinolone Antibiotics European Journal of Risk Regulation Pub Date : 2023-03-20 Matthew Wood
What is the value of including vulnerable people in risk regulation decision-making in the European Union (EU)? This article examines a distinctive approach employed by the European Medicines Agency (EMA): public hearings integrated within safety reviews of medicinal products. The article presents findings from a case study of the EMA’s public hearing on Quinolone antibiotics, which was included by
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Lessons for Participation from an Interdisciplinary Law and Sustainability Science Approach: The Reform of the Sustainable Use of Pesticides Directive European Journal of Risk Regulation Pub Date : 2023-03-15 Annalisa Volpato, Astrid Offermans
Stakeholder participation is an important tenet for European Union (EU) policymaking and it can be approached from different disciplinary angles. The legal literature tends to refer to participation as a formal consultative opportunity in regulatory processes, resulting in rather homogeneous institutional arrangements for participation across policy fields and different sets of problems. Sustainability
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The Good, the Bad and the Rest: How the European Union Responded to the COVID-19 Pandemic in the Transport Sector European Journal of Risk Regulation Pub Date : 2023-03-01 Pierpaolo Settembri, Rishi Kumar
Due to its severity, the COVID-19 pandemic is one of the greatest crises to have tested the European Union’s (EU) ability to take effective action. The restrictive measures adopted by the Member States to curb its spread affected in particular the free movement of people and partly of goods. This prompted the EU to take action inter alia to maintain essential travel, protect supply chains, enhance
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Shaping Interoperability for the Internet of Things: The Case for Ecosystem-Tailored Standardisation European Journal of Risk Regulation Pub Date : 2023-03-01 Giuseppe Colangelo, Oscar Borgogno
No matter how good a smart device may be, it remains useless outside the context of a digital ecosystem. Internet of Things (IoT) environments are possible as long as services and products can interconnect smoothly and exchange data in real time. Therefore, interoperability ranks high in global policy agendas, with the promise of bringing an end to network effects slanted in favour of ecosystem orchestrators
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Climate Change Risk and Climate Justice in France: The High Administrative Court as Janus or Prometheus? European Journal of Risk Regulation Pub Date : 2023-02-09 Marta Torre-Schaub
Climate change emergency requires rapide and determined action. The procrastination of the French state is not without consequences. One of them is that the High Administrative Court (Conseil d'Etat) found that climate risk is not taken seriously enough and is insufficiently addressed. In two decisions ruled in 2020 and 2021, the Conseil d'Etat in France had the opportunity to express itself on these
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Risk Management in the Artificial Intelligence Act European Journal of Risk Regulation Pub Date : 2023-02-08 Jonas Schuett
The proposed Artificial Intelligence Act (AI Act) is the first comprehensive attempt to regulate artificial intelligence (AI) in a major jurisdiction. This article analyses Article 9, the key risk management provision in the AI Act. It gives an overview of the regulatory concept behind the norm, determines its purpose and scope of application, offers a comprehensive interpretation of the specific risk
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The Uneasy Case for a Ransom Tax European Journal of Risk Regulation Pub Date : 2023-02-01 Bernold Nieuwesteeg, Michael Faure
The goal of our paper is to demonstrate the potential effects of a tax on paying a ransom on the incentives of stakeholders involved: both the perpetrators (the attackers placing the ransomware) as well as the potential victim. We do think that there is a case for a ransom tax, but we do also realise that it is not easy to make that case, and hence we express this doubt in our title. A tax could stimulate
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The EU Vaccines Strategy: A Missed Opportunity for EU Public Health? European Journal of Risk Regulation Pub Date : 2023-01-25 Francesco Saverio Della Corte
The response to the COVID-19 crisis implied an unprecedented involvement of the European Union (EU) executive in public health matters. In June 2020, the Member States agreed upon a joint EU Vaccines Strategy, whereby the European Commission was enabled to negotiate, support and allocate vaccine doses on their behalf. Entailing political and redistributive choices, the Commission’s centralised procurement
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Fragmented Transparency: The Visibility of Agency Science in European Union Risk Regulation European Journal of Risk Regulation Pub Date : 2023-01-25 Alie de Boer, Marta Morvillo, Sabrina Röttger-Wirtz
Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with
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Farm Animal Welfare and Food Information for European Union Consumers: Harmonising the Regulatory Framework for More Policy Coherence European Journal of Risk Regulation Pub Date : 2023-01-18 Alice Di Concetto
Today, there are a dozen labelling schemes pertaining to farm animal welfare in at least seven Member States. Despite the proliferation of animal welfare labels, European Union rules on food information to consumers concerning the treatment of farmed animals used in animal-source food production remain fragmented and incomplete. On the one hand, the rules contained in agricultural regulations primarily