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 each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.

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 commercial practices: (1) dark patterns in user interfaces; (2) behavioural advertising; and (3) personalisation through recommender systems. It explores whether and to what extent EU regulation addresses the risks to consumer autonomy of using artificial intelligence in markets in the long term. It finds that new EU regulation does bring novelties to protect consumer autonomy in this context but fails to sufficiently consider the long-term consequences of autonomy capture by professionals. Finally, the paper makes several proposals to integrate the long-term risks affecting consumer autonomy in EU consumer and data protection regulation. It does so through an interdisciplinary approach, drawing from legal research and findings in the study of long-term thinking, philosophy and ethics and computer science.

The European Commission’s 2020 draft Chemicals Strategy for Sustainability set the ambitious goal of achieving a “Toxic-Free Environment”. Those ambitions were harshly criticised by a team based in Germany’s Federal Institute for Risk Assessment (or BfR); they claimed that toxicological risks from chemicals had already been minimised and were optimally regulated. This paper outlines evidence to support the Commission’s implication that the European Union’s chemicals regulatory regime is suboptimal. It also criticises the BfR team’s contentions by reference to empirical findings (eg concerning tumours, congenital anomalies and the toxicity of mixtures) and by disentangling their conceptual confusions.

The scaling of urban climate action and its governance is rapidly becoming a central focus in the urban climate governance literature and policy debates. Building on the broader scaling literature and inspired by related initiatives in other fields, this article calls for the development of a systematic “science of scaling” for urban climate governance. Such a science of scaling may help to give a better understanding of how well-performing urban climate action and its governance can be multiplied, accelerated and broadened (ie horizontal and vertical scaling and scaling out, up and down), and it may help to uncover scaling trajectories towards systemic change in cities (ie deep scaling).

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 the EMA as part of a review process that led to significant tightening of regulatory restrictions on the prescribing of this class of antibiotics. The article argues that the public hearing enabled a group of patients who had been victims of a debilitating toxicity syndrome associated with Quinolone antibiotics to criticise the existing scientific evidence base around the safety of Quinolone. Deploying the quantitative Discourse Quality Index and an interpretive analytical approach, the article shows how patients challenged the evidence base in a manner that was efficacious in advancing knowledge in this area of risk regulation. When physically staged alongside interventions by professional experts, the article argues that patients facilitated a process of “negotiation” of expertise, leading professional representatives to propose methods of coordination in order to integrate the patients’ qualitative evidence of their suffering with the toxicity syndrome. Ultimately, this process led to the EMA proposing more stringent future guidelines for the prescription of Quinolone antibiotics in the EU.

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 and interviews with key actors, this research finds that the complainants utilised the opportunity to facilitate a strong public perception of intergenerational injustice set by the Fridays for Future movement. While the court’s response in the form of the intertemporal effect doctrine is ambiguous and does not constitute clear fundamental rights of future generations, the complainants reached their strategic goal to directly influence policymakers and draw public attention to the issue of climate protection as an intergenerational responsibility. An interplay of four different legal arguments and numerous actors associated with the climate movement was crucial to triggering this outcome. These findings from a sociolegal bottom-up perspective are of great relevance as they show that impactful climate litigation through intergenerational principles relies on the strategic utilisation of the cultural context beyond the legal sphere.

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques.

This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.

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 whether PAs who self-identify as young people are more likely than other PAs to justify their mandate by referring to the interests of young and future generations. Third, it examines whether PAs who self-identify as young people are more likely to indicate other young people as the target audience of their activities. The manual coding and quantitative analysis of the PAs’ web profiles revealed that members of older generations as well as parents and grandparents are most likely to rationalise their engagement in the programme by referring to young and future generations. The data also showed that young people do target other young people when they act as PAs, but they are not the only group to do so. When compared to individuals with other professional identities, educators are also more likely to flag young people as their target audience.

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 participation in risk regulation; however, the Commission faces numerous challenges in securing engagement, particularly concerning the complexity of policy issues and the formal procedures for institutionalised consultations. Considering the Commission’s work from a proceduralist perspective, the article engages with Vivien Schmidt’s notion of “throughput legitimacy” to explore recent procedural innovations emerging since the Better Regulation agenda that have sought to enhance accountability, transparency, inclusiveness and openness, ensuring fairer and more balanced input on EU policy performance. The article argues in favour of greater throughput legitimacy in ex post policy evaluation but recognises challenges to the promotion of evaluation tools and their use by citizens.

Rome is a complex metropolis. The city faces the challenge of imagining and shaping an inclusive and sustainable future for its inhabitants. On several occasions, city policies and interventions have not met the goal of preserving environmental resources. For their part, the inhabitants of Rome tend to doubt the ability of institutions to take care of the city’s resources. We focus on civic environmental monitoring led by the local independent association A Sud, aimed at assessing the environmental status of two of the city’s rivers. From a review of applicable literature on governance, environmental and social justice and climate urbanism, we build a theoretical frame to guide our analysis. We inquire how civic monitoring in a complex city can benefit urban resource governance and foster urban transitions. We also explore the extent to which these initiatives have the potential to inform or have actually informed the scientists and policymakers responsible for designing city adaptations. Our analysis demonstrates that citizen-gathered data can enrich the scientific knowledge base and trigger claims for interventions, bringing in information on local issues often overlooked by competent institutions. The initiatives also improved individual and collective attitudes towards the city and its resources, stimulating a sense of care and a watchful citizenship.

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation of powers plays in emergency management and how this system can impact health risk assessment. An explanation of the risk management system in Italian and European Union (EU) law is provided and the following key legal issues are addressed: (1) the notion and features of emergency risk regulation from a pandemic perspective, distinguishing between risk and emergency; (2) the potential and limits of the precautionary principle in EU law; and (3) the Italian constitutional scenario with respect to the main provisions regulating central government, regional and local powers. Specifically, this article argues that the administrative strategy for effectively implementing emergency risk regulation based on an adequate and correct risk assessment requires “power sharing” across the different levels of government with the participation of all of the institutional actors involved in the decision-making process: Government, Regions and local authorities.

COVID-19 has demonstrated the fragility of EU free movement rules when we are faced with an unknown virus of such magnitude and strength that it threatens our lives, health systems, economies and society. The aim of this text is to show the dynamics between the threat of COVID-19 and the rules imposed as a response to the pandemic, which have impacted the functioning of the EU internal market and the Schengen area. The text will concentrate on the application of the precautionary principle and public health restrictions, caused by COVID-19, to free movement of persons in the EU. The analysis will lead to three conclusions. First, it will be shown that the decisions to apply free movement restrictions and the logic followed in the EU COVID-19-related documents can be viewed as a triumph of the precautionary principle. Second, it will be argued that implementing the precautionary principle has a transformative effect on the application of the principle of proportionality in EU law. Finally, it will be shown that COVID-19 has emphasised and increased the difference between the conditions for the applicability of public health restrictions when compared to restrictions based on public policy and public security grounds.

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 takes place. In this article, we aim to investigate how intermediation takes shape in the acceleration stage of the energy transition. Drawing on the literature on transition intermediaries and intermediation at the local level, we explore the role of transition intermediaries in two local energy projects in the Netherlands. Through extensive qualitative research, we find that various actors can act as transition intermediaries and that a single actor can fulfil different intermediary roles simultaneously. Our findings contribute to the literature on transition intermediation and urban intermediaries, emphasising the key role intermediaries play in aligning innovations with existing institutional configurations. Furthermore, we highlight their role in connecting the energy transition to broader societal developments, including through citizen involvement in local and regional governance arrangements.

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 to humanity, their ambition has historically vastly outweighed their capability. Nonetheless, three pathways to existential harm exist: existential attack, existential spoilers and systemic harm. Each pathway varies in its risk dynamics considerably. Although an existential attack is plausible, it would require extraordinary levels of terrorist capability. Conversely, modest terrorist capabilities might be sufficient to spoil risk mitigation measures or cause systemic harm, but such actions would only result in existential harm under highly contingent circumstances. Overall, we conclude that the likelihood of terrorism causing existential harm is extremely low, at least in the near to medium term, but it is theoretically possible for terrorists to intentionally destroy humanity.

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the authorisation of plant protection products. Many legal issues are unclear in this respect due to the lack of European and national case law. The German Administrative Court of Braunschweig had to decide in an urgent procedure on the effects of Brexit with regards to the authorisation of a plant protection product in the mutual recognition procedure.

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 ex ante cybersecurity and also (when price elasticity is not too low) reduce ex post ransom payments. In addition, a tax in combination with a smartly designed subsidy could have benefits.

Climate adaptation planning in pursuit of resilient and sustainable societies has become a focal point in urban policy. Climate adaptation planning is generally regarded as separate from traditional urban planning practices. Globally and in Europe, however, cities are increasingly integrating climate adaptation planning into their traditional urban planning instruments and processes. Recent research indicates that the scope of such integration is at varying stages. The City of Rotterdam (Netherlands) and the City of Antwerp (Belgium) have been identified as two European cities that face similar climate impacts and risks given their proximity to a large river delta. Both cities aim to integrate climate adaptation into their respective urban planning policies, but the scope of their integration differs. This paper critically analyses the urban planning policies of these two cities to distil key lessons learnt that cities with similar climate impacts and approaches to urban planning may potentially face in integrating climate adaptation planning into urban planning policies. The paper finds that identifying and evaluating the synergies, co-benefits or trade-offs of adaptation measures is a key challenge to integrating climate adaptation into urban planning policy. It is a potential stumbling block for long-term sustainable development and climate resilience.

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 and its risk transfer mechanisms, and it has played an important role in dealing with some types of long-term risk, such as floods and earthquakes. Increasingly, insurance also contributes to disaster mitigation through regulating the conduct of policyholders by creating incentives for policyholders to counter short-termism and invest in reduction measures regarding long-term risks. In addition, it has been shown that supply-side problems and behavioural anomalies make it difficult to insure against long-term risks. Innovative long-term insurance solutions and a combination of public and private partnerships are proposed to overcome these restrictions.