It is a striking feature of European Union (EU) health law and policy that it has developed in a relative lack of awareness from the general public. This situation can be partly explained by the existence of only a limited competence in the field and the recourse to other legal bases to enact public health measures, particularly Article 114 TFEU. The use of internal market powers to conduct EU health policy has given rise to several problems, affecting the legitimacy of EU action and its capacity to adequately protect human health. Only a Treaty change can provide the EU with the clear competence and the solid legislative powers that it needs to tackle the various health challenges that Europe faces and will continue to face.

Currently, there is ongoing discussion about the role of regulatory oversight bodies in relation to the implementation of regulatory impact assessments (RIAs). In fact, one can witness a diffusion of regulatory oversight systems, including in CEE countries, where introduction of an RIA oversight body became part of the modernisation of the overall RIA process to become more effective. In fact, the regulatory oversight mechanism is seen as a tool for the instrumental role of regulation governance. However, this approach does not adequately explain the rationale behind setting up such a body; strategic and symbolic roles may be significant as well. This article first compares the manner in which oversight mechanisms have been institutionalised in five Central and East European countries: the Czech Republic, Estonia, Hungary, Slovakia and Slovenia. Second, it explores how differences in institutionalisation and operation shed light on understanding what stakeholders expect and understand in relation to control of RIA quality. The paper concludes that there are marked differences in regulatory oversight set-up and roles across Central and Eastern Europe, notably as a consequence of the presence or absence of internal learning.

This paper suggests how the regulation of Solar RadiationManagement (SRM) field research in Europe could be designed to maximise the possibility of securing legitimacy. It argues that legitimacy is maximised when regulatory frameworks are legal, and also responsive, flexible, deliberative and inclusive. By adopting an ‘incorporated’ approach to assessing the risk of Solar Radiation Management (SRM) field research, the EU can import elements of ‘directly deliberative polyarchy’ into its otherwise orthodox constitutional regulatory approach thereby maximising legitimacy. The argument is new in so far as it juxtaposes two conceptions of procedural legitimacy – one institutional and the other functional – in the context of significant scientific uncertainty in the technocratic regulatory paradigm of the EU. The significance of the work is that it draws on these conceptions of legitimacy to advance a pragmatic model of institutional design which comprises procedures that maximise legitimacy with minimal disruption to the EU's institutional balance of powers.

Reality is complex, and often does not lend itself to generalization or simplifying explanations. Yet at the same time, explaining reality often requires the shaping of notions and concepts of it through generalization and the reduction of complexity. This tension between complexity and particularity on the one hand and generalization and the search for abstracting explanatory patterns on the other is beautifully illustrated by two recently released publications on precaution and risk regulation in the United States and Europe, namely “The Politics of Precaution” by David Vogel1 and “The Reality of Precaution” edited by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand.

Both books together can be seen as the latest significant contribution to the ongoing debate on the role of the precautionary principle in risk regulation in a comparative EU-US perspective. Both contributions are significant in that they consolidate the trend towards an empirically informed analysis of the actual practice of the application of precaution in risk regulation.

The dispute over ractopamine in the Codex Alimenta-rius Commission (CAC) exemplifi es changes in Codex proceedings. In its early days, the CAC resembled to an honourable Club of senior food safety offi cials aim-ing at setting food standards in a consensual manner. However, with the WTO connexion established in 1995, CAC proceedings are overshadowed by looming trade disputes and increasingly decided by majority voting. The tendency towards majority voting in the CAC may ultimately undermine the universality of food safety standards and the legitimacy of the CAC as an inter-national standard setting body.

Over the last decade complexity has impaired financial regulators’ and supervisors’ ability to cope with informational asymmetries, moral hazards and other market failures. Recent regulatory responses have been to include external auditors in the range of “gatekeepers” and “watchdogs” that serve regulatory objectives. On the other hand, the compliance function gained greater prominence as a form of internalised law enforcement, being increasingly seen as facilitating the achievement of public regulatory needs in maintaining the safety and soundness of financial institutions. Yet, uncertainty has pervaded the issue of what modes of interaction supervisors, compliance and external auditors should be subject to. International experience and anecdotal evidence show, in fact, that the current informal, discretion-based, relationship between such gatekeepers brings about risks of knowledge fragmentation and ambiguity, calling for better gathering and use of “gatekeepers’ knowledge”. The objective of this article is to address and rectify problems of multiple centres of knowledge construction, by approaching questions pertaining to the interaction between the “internal” and “external” gatekeepers. A primary contribution of this article is to examine this problem by reconciling the strand of research concerning multiple gatekeepers´ liability and the developing legal scholarship on compliance as a delegated form of external enforcement. The explanatory nature of multiple gatekeepers’ liability is twofold: first, it contributes in emphasising the complexity stemming from the interactions between multiple gatekeepers; second, it offers a solid working hypothesis to detect the market failures that can arise from such complexity, namely relating to fragmentation – and construction – of knowledge.

Good regulation is essential, to protect employees, consumers and the public, as well as the environment. To argue that the market should be allowed to be the determinant of working conditions, together with a bit of exhortation to employers to behave decently, is to accept the Victorian approach that allowed children to work in coal mines.

The massive problems in the finance sector recently also show only too well the impact of weak regulation and de-regulation.

That said, Governments do not always get it right when they do regulate and there is undoubtedly some regulation that is no longer necessary, or is out of date, or is over-complicated or hard to enforce. Neither have Governments showed themselves to be very good at assessing public risk or balancing public health and environment protection with innovation and growth. As the former Risk and Regulation Advisory Council suggested, risk is often assessed through the prism of media sensationalism, political point scoring, civil service attachment to legislation and “risk mongers” such as insurance companies that have a vested interest in talking up risk.

EU and UK animal protection laws are underpinned by arguments based on the perceived desirability of reducing animal suffering. Technological innovations, however, give rise to ethically problematic situations in which suffering is not present or where it is not necessarily the only issue. Moreover, these developments further expose non-suffering related problems that were already present in existing areas of animal use. The existing animal protection laws are not capable of adequately addressing these problems. The concept of dignity might be a promising alternative. It is capable of covering situations other than those in which welfare is an issue, and using it might make the law more internally consistent.

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 puzzle by documenting and tracing the development and deployment of responsible gambling codes of conduct by trade associations from the emergence of the online gambling industry in the early 1990s and through processes of increased market liberalisation at the national level and market integration at the European Union level. I argue that online gambling trade associations deploy responsible gambling codes of conduct at particular moments of opportunity to shape their members’ external legal and regulatory environment and to reproduce and embed a particular understanding of how gambling-related risks should be regulated.

Greece emerged as the EU’s poster child in the fight against COVID-19 during the first few months of the pandemic. In this contribution, we assess Greece’s use of soft regulation in its regulatory response to COVID-19. Using “acts of legislative content”, which can be broadly conceptualised as softly adopted hard law, the Greek government largely achieved flexibility and simplified adoption procedures without having to resort to soft law per se. The role of soft law was limited - it complemented hard law rather than constituting the primary basis of COVID-19 restrictions - but not completely negligible. Soft law instruments regulated the processing of personal data, and was also pivotal in clarifying the criminal sanctioning of COVID-related rule violations. Greece’s success in handling the first wave of the pandemic, while effective, was arguably unfair to asylum seekers who saw their right to apply for asylum curtailed, and their right to freedom of movement restricted when limitations on the rest of the population were lifted. With a second wave of infections currently in full swing, it is imperative to keep scrutinising regulatory responses to ensure that they place the health and dignity of every individual (whoever they might be) at their core and fully respect their fundamental rights.

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.

Joined Cases C-358/13 and C-181/14, Markus D. and G.

Substances which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health do not fall within the scope of the definition of a “medicinal product” in the Directive 2001/83 (official headnote).

Consumer safety and medicines control legislation is not suitable to penalise the introduction of new psychoactive substances on European markets (author's headnote).

Art 1(2)(b) Directive 2001/83

I am delighted to announce the birth of the European Journal of Risk Regulation. This new academic journal reflects the growing importance of both national and European regulations intended to protect health, safety, security and the environment – as well as the accompanying institutional challenges for the European Union governance.

This large body of law is known as risk regulation. It seeks to reduce the risks of harm to individuals and society, stemming from all threats whether industrial or natural, voluntary or involuntary. Arguably, this portion of EU legislation already represents the most important and widespread part of the internal market acquis and, due to its international success, it contributes to make the EU a de facto global regulator. As such, it provides a new and valuable lens through which to analyse the European integration process.

This article reviews the way in which the concept of precaution, as commonly referenced in EU law, is received in the WTO. It argues that precaution is not a principle, but one facet of a principle of making rational judgments based on available information, the other facet of which is “that risk is worth taking”. Systematically pursuing high cost measures in response to low risks is not a balanced approach, and has probably contributed to the scepticism with which the concept is viewed in the WTO. However, this article goes on to argue that, without needing to be a principle, precaution is the determining legal feature in the SPS Agreement, because, unlike in the European Union, there is no legislative harmonisation of SPS measures at international level, WTO Members being free to set their own appropriate level of protection. In fact, the concept of precaution is relevant in the context of many other WTO provisions and is in some respects quite close to the concept of subsidiarity. Notwithstanding this, the first WTO SPS cases, driven by regulatory exporters and an interventionist WTO, have excessively emphasised scientific issues, masking policy judgments that the WTO has neither the legal nor the political authority to sustain. The article concludes that the proper way forward necessitates closer political, legal and administrative links between the WTO and other relevant international organisations, and a move away from consensus in the latter.

The scientific dimension of risk regulation is obvious. It is accepted that a measure banning a pesticide is to be based on toxicology studies and in particular on the data proving harmful effects for human health or the environment. A more subtle determinant of risk regulation is the ethical dimension of the decisions adopted to control the social risks emerging from new technologies. It is in this context that a document such as the Encyclical letter Laudato Si, on care of the common home of Pope Francis could offer important reflections on how public policy on science and technology could be enriched by including an ethical perspective. The Laudato Si encyclical letter has been accompanied by wide public attention, spurred on by both the huge popularity of Pope Francis and the announced choice of devoting, for the first time in the history of the Catholic Church, an entire document to environmental issues.