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.

This article discusses the EU supply chain legislation, by virtue of the recently adopted Corporate Sustainability Due Diligence Directive (CSDDD) which aims to reduce negative sustainability impacts in global supply chains with regard to a list of human rights and environmental standards specified in its Annex I of the CSDDD.

We argue that the CSDDD marks a fundamental change on the EU level, from disclosure duties to mandating prevention of, and compensation for, adverse sustainability impacts in supply chains.

We further find that the CSDDD is a legal transplant combining the principles laid down in the OECD Guidelines for Multinational Enterprises on Responsible Business and those of the UN Guiding Principles on Business and Human Rights, along with elements of French supply chain legislation from 2017 (which relies on a private enforcement model) and the German supply chain law from 2021 (which is based on a public enforcement model). Like all legal transplants, the resulting legal text generally prompts questions about consistency and specifically raises doubts as to whether combining all of the components of a private and a public enforcement model is proportionate for the purpose of the CSDDD which is to ensure that companies take effective steps to counter violations of human rights and environmental standards in global supply chains. The scope provisions (including smaller in-scope EU firms while leaving non-EU peers of a similar size aside) paired with significant high compliance burden provide grounds to argue that the CSDDD impacts on the competitiveness of these smaller in-scope EU companies, and thus the EU economy at large.

The paper offers a comprehensive overview of Hungary’s emergency law and its misuse over the four years since its introduction in March 2020. Hungary serves as a clear example of how a “state of danger” – initially intended as an exceptional legal measure – can become normalised through repeated declarations. The populist government’s continuous use of emergency powers has led to unchecked lawmaking and the manipulation of legal frameworks to advance populist agendas. The article argues that while Hungary’s detailed emergency provisions in the Fundamental Law were intended to serve as a form of constitutional risk management, after four years of living in a permanent “state of danger”, the scholarly debate has shifted to whether this very risk management has itself become the risk. According to emergency law theory, managing constitutional risks is equally vital in the emergency legal order. Yet in Hungary, both the black letter of the law and the constitutional practices observed during and after the COVID-19 pandemic – along with the Ninth Amendment to the Fundamental Law, which introduced a new emergency regime in 2021 – reveal that constitutional risk management has ultimately failed. This is manifest in the erosion of the separation of powers, the weakening of judicial review, and the shrinking of human rights protections. The article substantiates its argument by examining the related constitutional framework and constitutional practice in Hungary between 2020 and 2024.

This article analyses the constitutional framework regulating states of emergency in Poland and addresses key issues related to their interpretation and implementation. The first part discusses the conditions for declaring martial law, a state of an extraordinary situation, and a state of natural disaster, as well as the specific rules for the operation of public authorities in such emergencies. The next part analyses the practice, revealing the consistent reluctance of Polish authorities to invoke states of emergency, even in circumstances that seem to justify such measures. Consequently, a state of emergency under the 1997 Constitution was declared in Poland only once – in 2021, in response to a migration crisis on the border with Belarus. No constitutional emergency was declared during the COVID-19 pandemic, despite the introduction of far-reaching restrictions on individual rights and freedoms. The article argues that state authorities can abuse emergency regulations, either through their unjustified application or by deliberately circumventing them.

The impact of the European Union (EU) in strengthening nanotechnology risk regulation in non-EU countries is still an under-researched topic. This article focuses on the EU’s influence on its trading partners, using the case study of Israel, which in 2023 adopted restrictions on nanotechnology in cosmetics products following the EU. It is argued that EU risk regulation have been both a trigger and a formative factor for the development of Israeli nanomaterials restrictions. The importance and economic interdependence in the EU market for cosmetics has prompted a response from Israeli policymakers. In addition, the EU regulatory capacity through its expertise and sanctioning authority have influenced the Israeli regulatory agenda. The article shows that the impact of EU regulation also coincided with domestic economic factors, concerns about technology policy and policymakers’ preference for stringent standards. Israel’s risk regulation of nanomaterials in cosmetics provides a useful case study for analyzing the EU’s regulatory impact on its trading partners. Once again, stricter EU’s health and safety regulation drives those of its trading partner upward.

This introductory article outlines three fundamental regulatory developments in the EU’s legislation addressing digitalization and automation of decision-making: One is that across many acts we see a move towards more complex multi-level composite procedures, involving not only public structures with agencies, EU bodies, national agencies, but also co-regulation through standardisation in combination with – in several areas – audited self-regulation. A second feature of much of the current legislation in digital matters is that obligations imposed therein require an increased attention to information management – from sourcing to use, dissemination, sharing. This is a requirement for both public and private actors imposing ever more ‘granular’ knowledge and reporting of information flows in economic operators. A third is the growing role of interoperability which is being firmly established as a tool to create data exchange possibilities The diverse regulatory tools and methods are creating complex networks of legal relations and obligations which appear difficult to submit to oversight and compliance without strong protection of individual rights and procedural structures ensuring their enforcement.

Large Language Models (LLMs) could facilitate both more efficient administrative decision-making on the one hand, and better access to legal explanations and remedies to individuals concerned by administrative decisions on the other hand. However, it is an open research question of how performant such domain-specific models could be. Furthermore, they pose legal challenges, touching especially upon administrative law, fundamental rights, data protection law, AI regulation, and copyright law. The article provides an introduction into LLMs, outlines potential use cases for such models in the context of administrative decisions, and presents a non-exhaustive introduction to practical and legal challenges that require in-depth interdisciplinary research. A focus lies on open practical and legal challenges with respect to legal reasoning through LLMs. The article points out under which circumstances administrations can fulfil their duty to provide reasons with LLM-generated reasons. It highlights the importance of human oversight and the need to design LLM-based systems in a way that enables users such as administrative decision-makers to effectively oversee them. Furthermore, the article addresses the protection of training data and trade-offs with model performance, bias prevention and explainability to highlight the need for interdisciplinary research projects.

The ECtHR’s landmark judgment in the case Verein KlimaSeniorinnen Schweiz and Others v. Switzerland contains novel findings on procedural and substantive aspects of human rights protection in the climate change context. To reconcile effective protection of Convention rights with the exclusion of actiones populares, the Court set a high threshold for the individual applicants’ victim status while applying mostly formal criteria to the locus standi of the applicant association. On this count, only the association’s application was admissible. On the merits, the Court found violations of Articles 8 and 6(1) ECHR because Switzerland failed to comply with its positive obligation to protect individuals from the adverse effects of climate change and its courts did not engage seriously with the applicant association’s action. This case note takes a closer look at the ECtHR’s interpretation of standing for individuals and associations and discusses its (non-)alignment with previous case law. In particular, it reflects on the Court’s implicit understanding of the concept of victim in KlimaSeniorinnen and explores whether allowing representative standing is justified based on the Court’s existing case law. The case note concludes with an outlook on the enforcement of collective human rights issues through associations.

This paper traces the legislative process of the EU Artificial Intelligence Act (AI Act) to provide an empirical and critical account of the choices made in its formation. It specifically focuses on the dynamics that led to increasing or lowering fundamental rights protection in the final text and their implications for fundamental rights. Adopting process-tracing methods, the paper sheds light on the institutional differences and agreements behind this landmark legislation. It then analyses the implications of political compromise for fundamental rights protection. The core message it aims to convey is to read the AI Act with its institutional setting and political context in mind. As this paper shows, the different policy aims and mandates of the three EU institutions, compounded by the unprecedented level of redrafting and the short time needed to reach a political agreement, influenced the formulation of the AI Act. Looking forward, the paper points to the role of implementation, enforcement and judicial interpretation in enhancing the protection of fundamental rights in the age of AI.

In the past decade, the legal and economic literature on blockchain technology and its applications has flourished. This new technology holds great promise for enhancing the efficiency of contracting. Building on the classic Coase theorem, blockchain as a decentralised mechanism of decision-making should be superior to centralised regulation, possibly yielding substantial efficiency gains. Notably, it also has the potential to improve the allocation of property rights and reduce transaction costs.

However, many of these enthusiastic views about what blockchain technology may bring are overblown. This article demonstrates that blockchain creates a variety of new externalities, which cannot be addressed by the decentralised actors using it. The most obvious of them is the environmental externality stemming from the energy-intensive mining process. In addition, more immediate externalities emerge, for example through the operational and legal risks of being part of a blockchain transaction, which are particularly evident in the crypto economy. Moreover, issues surrounding blockchain governance may exacerbate these challenges.

In conclusion, we propose several regulatory strategies to mitigate these shortcomings and harness the full potential of blockchain technology.

The aim of this article and the ensuing Special Issue is to assess, après fifteen years, the effects on the EU legal and political system of the overhaul of executive delegated powers inaugurated by the Lisbon Treaty. It identifies core parameters – i.e. (institutional) balance of powers, (democratic) legitimacy, control and accountability, effectiveness of EU policy implementation – considered by the contributions to this Special Issue to map and examine, both constitutionally and normatively, the EU system of delegated powers in law and practice. It also puts forward seven overarching reflections revealing some of the core issues and challenges posed by the current stage of development of the post-Lisbon EU system of delegated powers.

A Decentralised Autonomous Organisation (DAO) is a new form of digital enterprise that operates on blockchain networks. It enables a new model of collaboration through diverse capital contributions and equitable sharing of benefits and risks. This paper explores the legal dimensions of DAO token transferability, a vital aspect for the expansion of DAO operations. First, it evaluates how property law (including the proposal by the Law Commission of England and Wales for a third category of digital asset ownership) might apply to DAO tokens so as to mitigate legal risks and ensure smooth transferability. Secondly, it investigates the potential for DAO software protocols to implement contractual transferability restrictions and examines their technological design. Finally, it looks at the legal enforceability of such restrictions and the policies needed to support their legal recognition.

Regulatory norms, rules, and arrangements enshrined in and established by EU pharmaceutical law travel internationally and influence foreign legal systems, regulatory practices, pharmaceutical company conduct, health systems’ functioning, and ultimately patient access to medicines and human health worldwide. This paper applies the mechanisms of Europeanisation (conditionality, socialisation, externalisation, and mimicry) to explain how these EU norms, rules and arrangements are diffused globally, with a focus on developing economies. Using the ongoing revision of the EU’s pharmaceutical legislation as a case study, this paper selects three innovative legislative proposals therein (i.e. environmental risk assessments for antimicrobials; reporting of public funding for medicines R&D; revised clinical test data and market protection, including a transferrable exclusivity voucher). Through the lens of Europeanisation, this paper postulates how these three legislative proposals, if adopted, would travel globally to developing economies, under which conditions, and with which likely impacts. This paper addresses several gaps in the literature, namely by introducing a global lens to the existing analyses of the EU’s revision of pharmaceutical law, by revealing the theory behind the emerging evidence of the EU’s influence over global pharmaceutical markets, and by positioning the case of pharmaceutical regulation in low- and middle-income countries among the scholarship on the global regulatory influence of EU internal market law.

During the COVID-19 pandemic, the European Union (EU) observed a major centralisation of competence in public health policy – the EU Vaccines Strategy. Yet increased centralisation or integration is not always desirable because the EU lacks a layer of democratic control to ensure transparency and accountability. This feature highlights the need to better understand and assess the EU’s actions during the pandemic. This paper aims to assess the effectiveness of the EU Vaccines Strategy and contributes to the wider debate on the centralisation of power at Union level. The joint procurement of COVID-19 vaccines is considered a success, as it avoided a “vaccine scramble” by the EU Member States. However, the fact that the Member States were obliged to purchase more than they needed and the lack of transparency in the negotiations with companies on the procurement of vaccines have raised questions about the integrity of the Commission’s exercise of executive power.

Drawing on the findings from the contributions to this Special Issue, this article maintains that, fifteen years after Lisbon, a debate on the law and politics of delegated rulemaking in the European Union (EU) is as relevant as ever. That is because the functional and procedural integration of the Member States in the EU multilevel and multi-jurisdictional legal system, supplanted by unprecedented challenges for supranational crisis management in the recent years, often led to unpredictable and often controversial configurations of delegated rulemaking. One may thus conclude that, fifteen years later, the constitutional framework put in place in the Lisbon Treaty has not been able to effectively constrain the normative development that evolved from delegated rulemaking, which often followed a different path. Hence the Lisbon Treaty provides only a partial blueprint for delegated rulemaking, leaving out rulemaking by EU agencies, regulatory frameworks and private parties, as well as increasingly composite and hybrid cooperation formulas involving EU and national executive actors. The future of EU delegated rulemaking will very much depend on the capacity to reach consensus on important meta-principles and political conceptions, such as democratisation and parliamentarisation, shaping the normative spaces generated within the sui generis dynamic European model of governance.

The 2022–2023 Qatargate scandal – which entailed the widespread undermining of Union democracy by members of the European Parliament acting on behalf of third countries – has rocked the European Union to its core. The proposal by the Commission aimed at establishing transparency and accountability surrounding such activities cannot therefore come at a more appropriate time. But does the proposal live up to its objectives? Here, this piece casts doubt on whether that is the case, with this piece exploring Qatargate as an example, as well as the content, constitutionality, and criticism of the proposal. This Article also makes comparisons to Union-based representation activities and the Commission’s approach to antidumping, and shines light on the Commission’s treatment of third-country actors and representatives thereof.

The COVID-19 pandemic has clearly demonstrated that international cooperation to combat pandemics is insufficient. The World Health Organization has, therefore, recently reformed the International Health Regulations based on the experience of the COVID 19-pandemic. The World Health Assembly also plans to adopt a new Pandemic Agreement to further strengthen international cooperation. However, negotiations have not yet been successful, and this year’s World Health Assembly agreed to extend the negotiations for the Pandemic Agreement by one year. Reason enough to analyse and critically evaluate the reform efforts in detail, and to give an outlook on the future of international pandemic law.

Small claim. Regulation 861/2007 (European Small Claims Procedure Regulation). Unfair term in terms of service agreement. Breach of contract through shadowbanning. Infringement on Articles 12 and 17 of Regulation 2022/2065 (Digital Services Act).