The Covid-19 crisis provided an opportunity for the European Union to offer an alternative regulatory response to the crisis of values by systemically linking European funding to respect for the rule of law. A rule of law conditionality mechanism for spending was introduced in the Recovery and Resilience Facility and in Regulation 2020/2092. It is both positive – in that it encourages Member States to implement reforms and investments aimed at improving the rule of law – and negative – in that it takes the form of financial sanctions. However, the development of the rule of law conditionality is leading to an economisation of the concept of the rule of law, insofar as it mainly concerns those dimensions of the rule of law that are conducive to growth – such as justice systems and the fight against corruption. As a result, it could paradoxically exacerbate the very crisis it is designed to resolve.

Following the contemporary debate surrounding two alternative perspectives on compliance – enforcement and management – this article suggests an analysis through the lens of the rule of law crisis. Specifically, the financial and techno-managerial strategy developed by the EU for the indirect protection of the rule of law relies on mechanisms that combine characteristics from both the enforcement and management approaches. This article will identify these mechanisms, namely the European Semester, the Conditionality regulation, the European Structural Investment Funds and the Recovery and Resilience Facility, in order to determine their nature, features, and tools for ensuring compliance with the rule of law. The hypothesis of this article relies on the idea that the EU’s tools are characterised by a mismatch between the causes of the identified problems and the chosen solutions. Considering that the deployment of the above measures has not re-established compliance, the EU strategy toes between inducing rule conformity on the one hand and deterring rule of law violations on the other. However, it seems that only the former can restore the rule of law, as the latter is considered ill-equipped to reverse or at least halt instances of backsliding. This mismatch explains why the Justice Scoreboard, the Framework, and the Review Cycle with its Annual Report have not made any difference, and more generally, why management strategies are unfit for dealing with deliberate backsliding.1

The European Semester is an economic governance tool that the European Union (EU) uses to monitor and coordinate national policies, but it has also evolved into a mechanism to address rule-of-law risks in Member States. By linking financial support to reforms, particularly through the Recovery and Resilience Facility (RRF), the Semester helps enforce rule-of-law standards and represents an innovative approach to safeguarding EU values. However, this process raises concerns about democratic accountability, and it overlooks broader societal concerns.

The Recovery and Resilience Facility reflects the generalisation of spending conditionality and the economisation of the rule of law in EU governance. The RRF performance-based approach also applies to measures related to rule of law protection, meaning that recovery funds can only be disbursed as long as the related conditions are met. While the academic literature has already highlighted the difficulty of applying performance frameworks to values, this article assesses how the RRF performance-based approach integrates the safeguard of the rule of law, based on a comparative study of the Slovak, Hungarian and Polish plans. Rule of law protection is set as a priority in the RRF. Yet, the economic and financial framing – in line with New Public Management and neoliberal governmentality – limits the potential impact of rule of law reforms. Overall, the effectiveness of rule-of-law spending conditionality depends more on the features of the performance regime and the attitude of political actors than the degree of financial pressure.

Over the last fifteen years, the European Union has built up its regulatory response to the rule of law crisis. That framework seeks to address rule of law-related undesirable events depending on whether or not they have already occurred. As risk prevention has a limited role in the EU’s rule of law policy, undesirable events are mostly dealt with in the context of crisis management. Evaluation, reaction and conditionality mechanisms are all affected by issues relating to operability and legitimacy which reduce their overall performance. The resulting moderate efficiency of crisis management tools may still be improved by making use of the upgraded rule of law mechanisms in a systemic way.

Since limiting judicial independence in Hungary and Poland, the politics of the rule of law crisis have been examined by various scholars discussing conflicts within and between EU and domestic institutions. The rule of law is no longer a purely national affair – it is of high political salience both for the Member States and the EU polity. The question addressed here is: how has the rule of law crisis reshaped the EU’s modes of governance? We argue that to safeguard this common value, the EU is evolving into a regulatory polity (3.0). This development marks a shift from Majone’s EU regulatory state’s focus on regulating markets (1.0) and regulation in core state powers in times of crises (2.0) to regulation on the core values of the polity (3.0). The article shows that in a context of growing dissensus over the rule of law, EU institutional actors have sought to strengthen “rulemaking,” “rule monitoring” and “rule enforcement” through a regulatory approach anchored in a market logic. It also shows that shifting from the traditional regulatory state 1.0 to regulation in core state powers 2.0, the regulatory polity 3.0 strengthens the EU’s institutional capacity to act when the rule of law is under strain through depoliticised “rule monitoring” and politicised “rulemaking“ and “rule enforcement“ as illustrated in the cases of Hungary and Poland discussed in this article.

This article examines the concept of materiality in sustainability reporting, tracing its development from financial materiality to the adoption of double materiality under the Corporate Sustainability Reporting Directive (CSRD). It explores the distinction between financial and impact materiality, highlighting the regulatory and ideological shifts that have shaped their integration. The discussion also includes the challenges companies face in implementing double materiality, such as data collection complexities, methodological inconsistencies, and the risks of selective disclosure. Additionally, the article contains an analysis of potential solutions, including additional regulatory guidance, independent oversight, and best practices for balancing transparency with strategic reporting. Ultimately, the author argues that double materiality represents a significant transformation in corporate governance, and that there exists concrete measures to be taken by both companies and regulators to improve the application of the CSRD.

The COVID-19 pandemic brought the EU health mandate under unprecedented scrutiny, providing a new impetus for action. The European Commission launched the ‘European Health Union’ (EHU), bringing a number of pre-existing and newer policy initiatives under a common umbrella. This contribution looks back at the recent developments in EU health law and policy, taking the 2019–2024 parliamentary term as a boundary. It offers an overview of what the EHU currently is, and what it could become. Despite its potential, the EHU is not yet a game changer. This can only happen if changes are brought to the EU’s competence and budgetary frameworks. The contribution provides first a brief introduction to the EU’s complex health competence framework and its general policy orientations in the field. We turn next to COVID-19, offering a condensed overview of the EU’s response and of the subsequent changes brought to the legal framework applicable to health emergencies. We finish by casting a closer look at the EHU, examining the descriptive and normative aspects of this concept, and making recommendations to increase the clarity, quality and legitimacy of EU action in the field.

The training of Artificial Intelligence (AI) models relies on extensive amounts of “data,” often sourced from content protected by copyright, related and sui generis rights. The discussion of whether and how to strike a balance between licensing and exceptions under copyright law is one of global relevance. While some countries have adopted or considered adopting specific exceptions to allow text and data mining (TDM), others (most) have not introduced any new legislation. In Europe, much of the attention has so far centred on Article 4 of Directive 2019/790 (DSMD), including in the context of a potential UK reform.

The starting point of this contribution is the following four-fold observation. First, TDM may be part of AI training processes, but it is neither synonymous with AI training nor is it all that AI training entails, including in terms of acts restricted by copyright and related rights. Second, from a European (thus including both the EU and the UK) perspective, limiting the attention to Article 4 DSMD is myopic, as national case law demonstrates. Third, calls have recently been made to relax EU copyright rules to facilitate “research,” seemingly including the President of the European Commission herself, who announced forthcoming legislative proposals “to make Europe the home of innovation again.” Fourth, the UK Government’s Copyright and AI consultation has recently ended: should no reform be ultimately undertaken, the application of the existing TDM exception will depend to a large extent on how courts construe the notions of “research” and the “non-commercial” requirement thereof.

Moving from the above, this study investigates whether and to what extent unlicensed AI training activities could be undertaken by relying, not on Article 4 DSMD as transposed into national law or a hypothetical reform of the UK system of exceptions, but rather on what appear to be so far potentially overlooked defences. Reference is made specifically to research and education exceptions, notably Article 3 DSMD and Article 5(3)(a) of Directive 2001/29 (InfoSoc Directive), also read in light of Article 5 DSMD. The discussion of other jurisdictions – including the US and countries, like South Korea and Singapore, which have adopted open-ended fair use-style defences – is also undertaken. This is done to determine whether unlicensed AI training, including training seemingly done for the purpose of research or education/learning, might be considered lawful.

In light of the context summarized above, the study tackles two key questions: (a) whether unlicensed AI training may be classified as “research” or even “learning” in the context of “teaching,” and (b) whether commercial AI developers may take advantage of the provisions above. Ultimately, both questions are answered in the negative, finding that no exception or open-ended defence fully covers unlicensed AI training activities. As a result, a licensing approach (and culture) appears to be the way for AI training to be undertaken lawfully, including when this is done for “research” and “learning.”

The European Union’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation aims to ensure high levels of human health and environmental protection, while also promoting alternatives to animal testing. REACH permits animal testing as a last resort only and imposes the 3Rs principle (Replacement, Reduction, and Refinement of animal testing). Nevertheless, the current regulatory practices still heavily rely on animal-based methods. This study underscores the scientific limitations of animal models and highlights the ethical and methodological burdens associated with their use. It synthesises the challenges and opportunities associated with integrating New Approach Methodologies (NAMs) into regulatory toxicity testing under REACH, as highlighted by various scientific experts. Key challenges identified include contradictory and inadequate legislative frameworks, slow and restrictive validation processes, low acceptance of NAMs by regulatory authorities, and legislative amendments expected to increase animal testing. To create a more flexible regulatory environment and advance the adoption of NAMs, there is a need for legislative reforms and increased collaboration between academia, industry and regulatory bodies. In this context, it is also necessary that more legal scholars begin to show interest in this field to help tackle the multidisciplinary challenges to non-animal testing for regulatory purposes. This article provides an introduction to the field of regulatory toxicology with a focus on the REACH framework from a legal perspective.

The Digital Markets Act (DMA) is a rare bird in competition policy. Indeed, it is a hybrid framework incorporating the institutional setting of a regulatory tool as well as the conduct already targeted by antitrust authorities in proceedings against digital platforms. From a policy perspective, the DMA seeks to prevent some anticompetitive practices. To this end, the EU legislator has construed an intricate set of provisions pursuing different policy goals. After setting out these goals in relation to the proclaimed legal interests protected by the DMA (ie, contestability and fairness), the paper uncovers the policy goals underlying each of the provisions. Relying on the first round of compliance reports issued by gatekeepers in March and October 2024, the analysis aims at providing adequate pathways to measure the DMA’s success, based on the explicit legal interests and implict policy goals fleshed out by the regulation. The paper maps out market scenarios where policymakers can assert that the DMA’s enforcement has been effective.

Harmonised standards are the cornerstone of efficient EU AI Act compliance. This paper presents one of the first systematic analyses of European technical and soon to be harmonised standardisation for organisations providing AI systems. Based on in-depth qualitative interviews with twenty-three leading European organisations developing AI applications across different sectors, such as Mistral and Helsing, and providing transparency regarding the status quo of draft standards, it examines how companies, especially start-ups and SMEs, are dealing with the contemplated standardisation under the EU AI Act and sectoral standardisation. Industry sectors covered include mobility, finance, manufacturing, healthcare, as well as defense and legal tech. Key challenges identified comprise an insufficient effective implementation period of likely less than 6 months compared to at least 12 months actually required for around thirty (partially referenced) technical standards, an imbalance of participation and influence in standardisation committees, double regulation and technical implementation hurdles as well as significant annual costs for harmonised standards compliance. Technical standards are currently reshaping global AI competition and will have a massive influence on the AI landscape as market entry barriers, particularly on start-ups. Hence, the paper offers policy recommendations based on the revealed challenges for AI providers.

This article conceptualises regulatory sandboxes in the food area, considering them as unique spaces with varying degrees of openness. Through an analysis of closed, semi-open and open spaces, it illustrates the regulatory landscape surrounding regulatory sandboxes of novel foods in the EU, particularly focusing on the concept of “placing on the market.” The article contends that the degree of openness of regulatory sandboxes impacts the application of the precautionary principle within these spaces. It explores scenarios where the sandbox tests various aspects of novel foods under EU soft and hard law. The characteristics of the regulatory sandbox (open, semi-open, closed) changes corresponding to what the regulatory sandbox tests in relation to a novel food, eg, a sensory characteristics or safety or other data points, such as effectiveness of labelling. This article contributes to the ongoing discourse on innovation-friendly laws surrounding regulatory frameworks applicable to novel foods in the EU.

The EU AI Act seeks to balance the need for societal protection against the potential risks of AI systems, with the goal of fostering innovation. However, the Act’s ex-ante risk-based approach might lead to regulatory obsolescence (already materialised in 2021 with the spread of LLMs and the consequent reopening of the regulatory process), as well as to over or under-inclusion of AI applications in risks’ categories. The paper deals with the latter outcome by exploring how AI uses in law and rulemaking hide risks not covered by the EU AI Act. It is then analysed as to how the Act lacks flexibility on amending its provisions, and the way forward. The latter is tackled without utopian and not really feasible proposals for a new act and risk-based approach, but focusing on codes of conduct and national interventions on AI uses by public authorities.

Since the eighteenth century, animal breeding has significantly evolved, culminating in the use of gene editing (GE) technologies like CRISPR-Cas9. These technologies offer unprecedented capabilities to modify animal genomes, potentially revolutionising breeding practices by achieving desired traits much faster compared to traditional selective breeding (SB). Because breeding programmes focussed on productivity traits have often compromised animal welfare, this article provides an analysis of the ethical issues underpinning the use of GE in animal breeding, and the current laws regulating such practices. In doing so, this article critically examines the European Union (EU)’s regulatory framework for SB and GE in farm animals, highlighting significant gaps and inconsistencies. Specifically, the use of GE animals is currently regulated under the EU’s GMO legislation, while SB is more loosely regulated, posing substantial risks to animal welfare. The authors advocate for a regulatory framework that prioritises animal welfare goals and proposes reforms to enhance animal protection objectives by ensuring a more consistent and humane approach to farm animal breeding.

Healthcare systems are increasingly exploiting the advantages of Internet of Things technologies: cloud-connected devices with perceptive sensors can gather very accurate health data from people even if they do not get to the hospital or private clinics. For potential innovators of new medical IoT devices, the legal framework applicable was until now limited to the application of the General Data Protection Regulation and the Medical Devices Regulation.

This paper will investigate what will happen when medical IoT-generated data are shared to create new products or services according to the framework now depicted by the Data Act and the European Health Data Space.

Given that the EHDS and the Data Act are both aimed at facilitating the secondary use of (health) data, the contribution will compare the two processes set up to establish a roadmap to solve health-data sharing theoretical and practical queries.

Some fishing vessels breach maritime laws by operating with their mandatory tracking systems (Automatic Identification System (AIS)) switched off. Marine insurers act as enablers of this practice since these vessels cannot operate without insurance. This article explores why insurers in England take on the risk of insuring them and assesses how the insurers are operating against the regulatory framework in doing so. It identifies the solutions that could raise standards in marine insurance and lead to increased legal compliance by the insured vessels. This would consequently enhance maritime safety, while increasing transparency in fisheries across all oceans. Importantly, by discouraging vessels from going dark, any illegal activities underlying the non-transmission of AIS data, such as human, drug or weapon trafficking, illegal fishing or sanctions evasion, would also be curbed.

The aim of this note is to shed some light on the “agreement in principle” concluded on 6 December in the light of the division of competences between the different EU institutions and the Member States. Whilst classification as an “agreement in principle” might initially appear to be primarily procedural in nature, the implications of its conclusion by the EU go beyond merely procedural issues. In effect, it touches on sensitive issues concerning the institutional balance between the European Commission, the Council of Ministers, the European Parliament and the Member States both within current negotiations and also in relation to the conclusion of a treaty with the MERCOSUR states. The possibility of splitting the trade limb from the political limb of a forthcoming association agreement is also addressed.

The implementation of the General Data Protection Regulation (GDPR) in the EU, rather than the regulation itself, is holding back technological innovation. The EU’s data protection governance architecture is complex, leading to contradictory interpretations among Member States. This situation is prompting companies of all kinds to halt the deployment of transformative projects in the EU. The case of Meta is paradigmatic: both the UK and the EU broadly have the same regulation (GDPR), but the UK swiftly determined that Meta could train its generative AI model using first-party public data under the legal basis of legitimate interest, while in the EU, the European Data Protection Board (EDPB) took months to issue an Opinion that national authorities must still interpret and implement individually, leading to legal uncertainty. Similarly, the case of Deepseek has demonstrated how some national data protection authorities, such as the Italian Garante, have moved to ban the AI model outright, while others have opted for investigations. This fragmented enforcement landscape exacerbates regulatory uncertainty and hampers EU’s competitiveness, particularly for startups, which lack the resources to navigate an unpredictable compliance framework. For the EU to remain competitive in the global AI race, strengthening the EDPB’s role is essential.