Risk regulation has increasingly expanded in European digital policy, yet it is diverging from its roots, especially the precautionary principle. Rather than traditionally focusing on scientific evidence and knowledge, the European approach to risk regulation has been increasingly based on constitutional values such as the protection of fundamental rights and democracy. This article seeks to unravel the logic that has led the Union to move from an approach to risk more based on science to a model which considers constitutional values as parameters to assess and mitigate risks. By focusing on European digital regulation, primarily the GDPR, the DSA and the AI Act, this work underlines how the constitutional rationale of this transformation comes as a response to the intangibility of risks resulting from digital technologies and to imbalances of information and knowledge coming from the concentration of private power in the digital ecosystem. The primary argument is that risk regulation in European digital policy does not seek to rationalise uncertainty through science but to govern epistemological uncertainty through the instruments of constitutionalism, with the goal of addressing the impact of digital technologies on fundamental rights and imbalances of power.

What is adaptive regulation? Why does it matter? How can it be measured, and how can regulation be made more adaptive? I answer each of these four questions.

This article examines the growing tension between protections for political satirical expression under article ten of the European Convention on Human Rights (ECHR) and emerging European regulatory efforts to combat disinformation through content moderation in the Digital Services Act (DSA). In this study, the case law from the European Court of Human Rights (ECtHR) have provided insights into the scope and contours of protected political satire under the ECHR, showing that the Court’s jurisprudence indicates strong protection for political satire. Meanwhile, in the social media landscape today, satire is merging with disinformation, not least around elections, potentially creating a “loophole” to spread malicious disinformation disguised as satire. Both human and automated moderation systems can easily misclassify such content, and the risks for over-removal as well as under-removal are imminent. This article therefore argues that while protection of satire and parody is essential in a democratic society, the use of it for malicious purposes speaks to the need for regulatory clarifications on how to conduct efficient content moderation to avoid over-moderation and a chilling effect on political satire, while still identifying and mitigating risks under the DSA.

The paper examines challenges in implementing interoperability requirements in digital markets. Designed to foster innovation and competition in retail payments, interoperability has been central to the EU’s open banking framework under the PSD2. It also plays a key role in the DMA, where interoperability requirements are aimed at supporting innovation and the framework’s goals of contestability and fairness. The paper identifies similarities between the PSD2 and DMA approaches to interoperability and outlines lessons DMA enforcers can learn from the implementation of open banking.

On June 19, 2024, the Anti-Money Laundering Regulation (“AMLR”), the Regulation establishing the Anti-Money Laundering Authority (“AMLAR”), and the Sixth Anti-Money Laundering Directive (“AMLD6”) were published in the Official Journal of the EU, signaling a significant shift in the institutional and substantive architecture of anti-money laundering (“AML”) frameworks within the Union. More than simply enhancing existing rules, the new regime introduces innovative solutions to address persistent deficiencies in previous AML/CFT frameworks, particularly the fragmentation across Member States. A notable innovation is the extension of the AML regulatory framework to the professional football sector, which has become increasingly vulnerable to illicit financial activity due to its complex organisation, large financial flows and opaque ownership structures. As a result, professional football clubs and football agents are now subject to AML requirements, including customer due diligence, transaction monitoring and reporting suspicious transactions. This article examines the recently introduced AML obligations for the football sector, navigating the complex regulatory framework and mapping out the underlying requirements. The aim is to increase awareness and understanding of these obligations, thereby aiding football clubs and agents in complying with them and ensuring the integrity of the European football industry.

This article examines the systemic risk management regimes introduced by the Digital Services Act (DSA) and the Artificial Intelligence Act (AI Act) through the lens of EU constitutional law. Under both frameworks, private actors assess and mitigate systemic risks to public and private interests, while the European Commission acts as the exclusive supervisory and enforcement authority. Drawing on the Meroni doctrine and the case law on Article 290 TFEU, the article argues that these regimes delegate political discretion – among others, the authority to make normative decisions about contested public values. It explores the boundaries of political discretion reserved to the legislature under primary EU law. Based on this analysis, the article demonstrates how vague legislative definitions and broad discretion in systemic risk management enable regulated entities and the European Commission to make political choices that should remain within the competence of the EU legislator. By scrutinising how systemic risk management may exceed permissible limits on the delegation of power, the article provides a framework for assessing the legality of this emerging regulatory model in EU digital legislation. It concludes with a call for empirical research and normative guidance on how systemic risk management should be conducted in practice.

The global financial crisis exposed the sovereign-bank nexus as a driver of financial instability and an impediment to economic growth. Little attention has been paid to the interaction of banking regulation and public finance. This study analyzes the interaction between the prudential regulation of banks’ capital requirements and constitutional fiscal rules. We hypothesise that a conflict occurs between the regulatory privileged treatment of sovereign bonds held by banks and the market exposure logic enshrined in constitutional fiscal rules. This is particularly problematic in currency unions such as the US and the euro area. Our legal analysis builds on an empirical econometric assessment showing that peripheral euro area governments increase their debt following a tightening in macroprudential capital regulation, laying bare the undesired interaction between banking regulation and constitutional rules.

Medical device innovation is key to advancing healthcare and fostering economic development. As the global medical technology market expands, the capacity of regions and countries to attract and support innovation has become increasingly significant. This article examines the growing perception that China is becoming a more attractive environment for medical device development than Europe, focusing on key regulatory differences that may influence this shift. It compares the hierarchical structure of legislation, regulatory oversight bodies, and classification procedures, particularly for emerging technologies like artificial intelligence (AI). For instance, while Europe’s decentralised system of notified bodies offers developers flexibility, China’s centralised regulatory agencies and more adaptable classification system – alongside the absence of stringent AI-specific regulations like the EU’s AI Act – may present a different set of trade-offs and facilitate faster market entry for innovative technologies. Despite these differences, the paper argues that regulation alone does not fully explain China’s rising attractiveness. Other contributing factors, such as its vast market size, significant government support, and broader R&D policies, must also be considered. The analysis concludes that while regulatory structures are influential, they represent just one component of a multifaceted ecosystem that shapes the global geography of medical device innovation.

Despite sophisticated pre-market scientific assessment frameworks, the EU lacks systematic post-market surveillance for botanical food supplements, creating a critical regulatory imbalance. This analysis examines real-world safety incidents that demonstrate how fragmented national responses and inadequate monitoring systems fail to protect consumers effectively. Several Member States have developed nutrivigilance initiatives yet remain uncoordinated and insufficient for union-wide risk detection. The existing framework exhibits a fundamental contradiction: Article 8 procedures under Regulation (EC) no 1925/2006 require scientific evidence of harm to justify restrictions, but no harmonised mechanism exists to systematically collect such evidence. Current tools like RASFF capture acute compositional violations but cannot monitor chronic health effects or supplement–medicine interactions that characterise modern botanical supplement risks. This paper argues that mandatory EU-wide nutrivigilance represents the missing institutional link needed to transform reactive crisis management into proactive risk prevention. A harmonised system built on centralised reporting, standardised causality assessment, and formal regulatory follow-through mechanisms would provide the evidence base necessary to develop Union-wide restrictive lists and support coherent enforcement under existing legal frameworks. Such reform would address the most glaring gap in EU food safety architecture and provide legal certainty for industry operators across the internal market.

This paper provides a comprehensive analysis of the legal implications of New Genomic Techniques (NGTs) “from vineyard to glass” in the European Union (EU). NGTs promise to address sustainability challenges in the wine sector by enhancing grapevine resilience while preserving varietal identity. Yet their use in the EU remains legally complex. The paper explains their treatment under the current framework for genetically modified organisms and the ongoing reform proposal aimed at establishing a separate regime for NGT-derived plants. It then examines how NGTs challenge the legal notion of “variety” that underpins the regimes for Plant Variety Rights, Plant Reproductive Material and Wine Law. Finally, it discusses legal options to accommodate NGTs while protecting market structures and varietal heritage. It argues for an autonomous definition of variety in wine law that better reflects the expectations of both producers and consumers.

The Council of Europe has very recently adopted the Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law. This article provides an initial analysis of the CoE AI Convention. It emphasises the necessity of understanding the CoE AI Convention within the context of its adoption as an international treaty negotiated within the Council of Europe. This context has affected its scope in terms of how the treaty includes the regulation of the usage of AI systems by both public authorities and private actors. The detailed review of the available negotiation documents reveals that the concrete level of protection offered by the Convention has been lowered. This includes the risk-based approach, which shapes the obligations undertaken by States under the treaty. This approach is explained and contrasted with the approach under the EU AI Act. The argument that emerges is that the absence of categorisation of risk levels in the treaty is related to its higher level of abstraction, which does not necessarily imply less robust obligations. The content of these obligations is also clarified in light of the requirement imposed by the treaty of consistency with human rights law. An argument is advanced that the principles formulated in the treaty – human dignity and individual autonomy, transparency and oversight, accountability, non-discrimination, data protection, reliability, risk-management – can offer interpretative guidance for the development of human rights standards.

This article advances a law-and-economics critique of fractional-reserve banking, focusing on the legal taxonomy of bank contracts and the risk externalities of maturity transformation. We argue that the conflation of custody-like deposits with mutuum loans blurs property-rights boundaries and weakens liability discipline. Drawing on Austrian monetary theory, we link fiduciary media and demandable debt to pro-cyclical liquidity, run dynamics and the amplification of systemic risk. We reassess the real-bills doctrine and “demand loans,” showing why they do not neutralise run risk in practice and may obscure solvency–liquidity interactions. We then outline institutional reforms – 100%-reserve custodial deposits and a strict functional separation between custody and intermediation – together with market-based loss allocation. The article concludes with regulatory implications for lender-of-last-resort, deposit insurance, and capital/liquidity regimes consistent with risk reduction and legal coherence.

This article explores the development of Ukraine’s legal framework on genetically modified organisms (GMOs) in the context of European Union integration and post-war recovery. It analyses key regulatory challenges, including outdated biosafety laws, insufficient enforcement mechanisms and gaps in GMO detection and co-existence frameworks. Focus is placed on the 2023 Ukrainian GMO Law, which aligns with EU standards but is subject to delayed implementation. The article examines the legal tension between the EU’s interpretation of the precautionary principle in GMO law and Ukraine’s WTO obligations, highlighting the need for balanced, science-based regulation. In light of wartime agricultural disruption, the article argues that a robust, science-based GMO regulatory regime is essential for ensuring biosafety, facilitating market access and enabling the development of a resilient bioeconomy. GMO reform is thus positioned as a strategic necessity for Ukraine’s legal modernisation, economic recovery and long-term integration into the European and global systems.

The EU Artificial Intelligence Act (AI Act) establishes a novel risk-based regulatory model for AI systems, categorising uses into four tiers: unacceptable (prohibited), high-risk (tightly regulated), limited-risk (transparency obligations), and minimal-risk (largely unregulated). This article develops a rigorous conceptual framework to analyse the Act’s logic of risk, reasonableness, and residual harm. It explains how the principles of precaution and proportionality shape the AI Act’s ex ante controls, requiring providers to anticipate reasonably foreseeable misuse and apply measures that reflect the state of the art.1 We propose criteria for calibrating key requirements (data governance, transparency, human oversight, robustness or cybersecurity) to the severity and uncertainty of risks, drawing on risk-regulation theory (e.g., Baldwin and Black’s responsive regulation and Sunstein’s cost-benefit rationality). The analysis also situates the EU approach within a comparative context, noting alignments and divergences with US and OECD AI frameworks – for example, the EU’s precautionary bans on biometric mass surveillance contrast with the US reliance on voluntary risk management guidelines. Specific high-impact use cases (biometric identification in public spaces, AI in critical infrastructure) illustrate how risk severity triggers stricter controls. The article concludes by discussing policy implications for implementation, including the role of harmonised standards and presumptions of conformity, the interface with parallel cybersecurity regimes (NIS2, DORA) as “risk multipliers,” and the need for further guidance and delegated acts to ensure that the AI Act’s proportional safeguards remain effective in the face of technological change.

This article investigates the role of European Union regulation in shaping EU companies’ resilience when their supply chains encounter risks in the EU internal market, focusing on the Corporate Sustainability Due Diligence Directive (CSDDD) as a representative case. In light of increasing global disruptions, the EU has adopted regulatory measures that embed sustainability, human rights, and environmental protection into corporate governance. Through doctrinal analysis and structured coding of legal provisions, the article examines how the CSDDD influences EU companies’ capacity to anticipate, absorb and adapt to supply chain shocks. It argues that while integrating multiple policy objectives within a single legal framework is both necessary and inevitable, doing so requires legal flexibility and institutional design that account for EU companies’ interdependent resilience capabilities. The analysis highlights the importance of adaptive regulatory mechanisms in ensuring that EU law remains effective and coherent in a rapidly changing global environment.

In a ruling delivered on 1 August 2025, the Court of Justice upheld a General Court judgment annulling the classification as a suspected carcinogen of titanium dioxide in powder form containing at least 1% of particles of a diameter equal to or below 10 μm. Both EU Courts criticise the scientific assessment underlying that classification, but the Court of Justice relies on conceptual distinctions that reveal its reluctance to perform a genuine “manifest error of assessment” review. While these issues are not addressed by the Court of Justice, the case also raises thorny questions regarding the meaning of “intrinsic properties” of a substance.

This case note analyses the General Court’s judgment in Arysta Lifescience v EFSA (Case T-222/23), which addresses the tensions arising from the disclosure of the lists of co-formulant in the context of the EU risk assessment of pesticides. The decision consolidates the General Court’s interpretation of “information relating to emissions into the environment” under Article 6(1) of Aarhus Regulation, confirming its applicability to the list of co-formulants contained in representative products.