The risk-based approach has been introduced to the General Data Protection Regulation (GDPR) to make the rules and principles of data protection law “work better”. Organisations are required to calibrate the legal norms in the GDPR with an eye to the risks posed to the rights and freedoms of individuals. This article is devoted to an analysis of the way in which this new approach relates to “tick-box” compliance. How can the law enhance itself? If handled properly by controllers and supervisory authorities, the risk-based approach can bring about a valuable shift in data protection towards substantive protection of fundamental rights and freedoms. While the risk-based approach has a lot of potential, it also has a risk of its own: it relies on controllers to improve compliance, formulating what it means to attain compliance 2.0.

A number of virological, epidemiological and ethnographic arguments suggest that COVID-19 has a zoonotic origin. The pangolin, a species threatened with extinction due to poaching for both culinary purposes and traditional Chinese pharmacopoeia, is now suspected of being the “missing link” in the transmission to humans of a virus that probably originated in a species of bat. Our predation of wild fauna and the reduction in their habitats have thus ended up creating new interfaces that favour the transmission of pathogens (mainly viruses) to humans. Domesticated animals and wild fauna thus constitute a reservoir for almost 80% of emerging human diseases (SARS-CoV, MERS-CoV, Ebola). These diseases are all zoonotic in origin. As if out of a Chinese fairy tale, the bat and the pangolin have taught us a lesson: within an increasingly interdependent world, environmental crises will become ever more intertwined with health crises. Questions relating to public health will no longer be confined to the secrecy of the physician’s consulting room or the sanitised environment of the hospital. They are now being played out in the arena of international trade, ports and airports and distribution networks. Simply put, all human activity creates new interfaces that facilitate the transmission of pathogens from an animal reservoir to humans. This pluri-disciplinary article highlights that environmental changes, such as the reduction in habitats for wild fauna and the intemperate trade in fauna, are the biggest causes of the emergence of new diseases. Against this background, it reviews the different measures taken to control, eradicate and prevent the emergence of animal diseases in a globalised world.

This article offers a critical discussion of the “Report on Liability for Artificial Intelligence and Other Emerging Digital Technologies” released by the Expert Group on Liability and New Technologies. In particular, the authors consider: the excessive diversity of applications encompassed through the notion of “artificial intelligence and other emerging technologies”; the distinction between high- and low-risk applications as a potential source of legal uncertainty; the primary reliance on evidentiary rules over substantive ones; the problematic role attributed to safety rules; the unclear relationship between the Product Liability Directive and other ad hoc liability regimes; the radical exclusion of electronic personhood as a way of addressing liability issues; and the limited contextualisation of compulsory insurance and no-compensation funds.

The precautionary principle in public decision making concerns situations where following an assessment of the available scientific information, there are reasonable grounds for concern for the possibility of adverse effects on the environment or human health, but scientific uncertainty persists. In such cases provisional risk management measures may be adopted, without having to wait until the reality and seriousness of those adverse effects become fully apparent. This is the definition of the precautionary principle as operationalized under EU law. The precautionary principle is a deliberative principle. Its application involves deliberation on a range of normative dimensions which need to be taken into account while making the principle operational in the public policy context. Under EU law, any risk management measures to be adopted while implementing the precautionary principle, have to be proportionate to ensure the chosen high level of protection in the European Community.

This article will illustrate the established practice concerning the release of genetically modified organisms into the environment and how the principle is implemented under hard law. The article also provides an outlook on what this may imply for the relative new case of nanotechnology and the use of precautionary principle within the context of soft law (use of codes of conduct).

Even though carbon pricing is widely accepted as the most efficient policy instrument for climate change mitigation, it has been severely held back by a lack of public support. Building on research in behavioural sciences, we propose a revenue recycling scheme that aims to foster public support for carbon taxes. The scheme has two main strengths: (i) it may allow the implementatin of carbon taxes with higher tax rates than those currently prevailing in most jurisdictions; (ii) it relies on a number of accessible technologies, and thus it can be implemented in a wide variety of settings, both in urban and rural areas of developing and developed countries.

Behavioural economics is helping illuminate the limits of rational individual choice. At the same time, even as research identifies failures in rationality, policy must inquire about the possibility and legitimacy of government intervention. In ‘Nudging’ Healthy Lifestyles: The UK Experiments with the Behavioural Alternative to Regulation and the Market, Adam Burgess critically describes the introduction of behavioural approaches into UK policy making. In particular, Burgess is concerned with the wholesale adoption of nudge-style programmes to promote healthier living among citizens. Unsurprisingly, the UK developments find equivalent developments in the United States. In January 2009, President Barack Obama suggested that “the principles governing regulation … be revisited.” Envisioning a ‘behavioural dream team’ of economists and psychologists to help lead the way, President Obama appointed Cass Sunstein, the co-author of Nudge, as Administrator of the White House Office of Information and Regulatory Affairs.1 President Obama further ordered the US Office of Management and Budget to “clarify the role of the behavioral sciences in formulating regulatory policy.” The parallels between the countries are striking. The new UK leadership has consulted with Nudge's other co-author, Richard Thaler. The new leadership has guided top administrators to read behavioural research and a “Behavioural Insight Team” has been newly formed within the Prime Minister's Cabinet Office. More operationally, each of the governments has adopted initiatives to nudge citizens to better behaviour, physically and financially.

Amidst a growing interest from European Union (EU) Member States, the European Commission recently announced that it would put forward a legislative proposal for the adoption of a harmonised and mandatory front-of-pack nutrition labelling scheme at the EU level. The present contribution discusses the implications of such an adoption, taking a behavioural, legal and policy angle. It introduces first the concept of front-of-pack nutrition labelling and the existing evidence regarding its effects on consumer behaviour and dietary habits. It then presents the legal framework currently applicable to (front-of-pack) nutrition labelling in the EU and discusses some of the main political and practical aspects involved with the development of a common EU front-of-pack label.

On 17 March 2020, the President of the European Council, Charles Michel, and the President of the European Commission (hereinafter, Commission), Ursula von der Leyen, announced further European Union (EU) actions in response to the COVID-19 outbreak. Since the pandemic reached Europe, the EU has adopted a number of trade-related measures, including the issuance of guidelines for national border management, as well as export authorisation requirements. On 14 March 2020, the Commission adopted “Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorisation”, temporarily restricting exports of “personal protective equipment” to destinations outside of the EU. On 14 April 2020, the Commission announced that it would narrow down export authorisation requirements to protective masks only and extend the geographical and humanitarian exemptions. Governments around the world have been implementing trade-related measures in response to the COVID-19 pandemic, some trade restrictive, but a number of countries have also called for the elimination of export controls and restrictions on essential goods. As the greater implications of the COVID-19 pandemic on trade are still difficult to assess, the emergency measures taken by affected countries already require legal scrutiny. At the same time, it must be noted that, as noted above for the EU measures, measures around the world are subject to change dynamically in view of the evolution of the pandemic.

There are two prominent motivations for why governments seek to promote the electric car: risk management and industrial policy. This article provides operational definitions of these two motivations and uses them to characterize the public policies of six political jurisdictions: California, China, the European Union, France, Germany, and the United States. The article finds that while the European Union is focused primarily on risk management, China, Germany and the United States are primarily engaged in industrial policy. California and France are intermediate cases with a substantial blend of industrial policy and risk management. Future research into the ramifications of industrial policy for liberalized international trade is recommended.

On 20 May 2021, the European Commission, Council and Parliament announced a breakthrough in the trialogue negotiations to establish the European Union (EU) Digital COVID Certificate. Originally, this standardisation effort was labelled as “Digital Green Certificate” and – “[i]n view of the urgency” – presented without a data protection impact assessment. It should allow citizens and residents of Member States to prove that they are either vaccinated against COVID-19, have recently tested negative or are currently immune against the virus. This article considers the proposal from a privacy perspective, taking into account the opinion of EU data protection authorities, ongoing negotiations in the EU institutions and relevant developments on the national and international level. While the European Parliament and others tried to improve the original Commission proposal, questions around the appropriateness and effectiveness of the framework remain. The technological and organisational implementation is essentially left to Member States, who already have started to develop their own tracing and identification systems.

By taking the EU Cyber Strategy as a case in point, this contribution examines how the distinction between external and internal security in contemporary EU law manifests itself in large-scale risk regulation and in particular, how the EU relies upon external norms to regulate risk. This article also maps the evolution of the rule-making processes themselves.

Emboldened by the Spitzenkandidaten process, the new European Commission emerges as the most political yet. The Commission asks EU citizens to judge its operation by its ability ‘to deliver solutions to the big issues that cannot be addressed by the Member States alone’. The Better Regulation Package translates this political commitment into an actionable approach assuring EU citizens that the Commission will remain ‘big on big things, small on small things’. To deliver on this promise, the Commission extends the Impact Assessment system, renews its consultation procedures and adds a few institutional mechanisms so as to enhance its ‘ability to deliver’ throughout the policy cycle. But in order to do so the Commission needs to bind – and somehow control – the European Parliament and the Council, on the one hand, and the Member States, on the other, in relation to their commitment to openness, participation and evidence-based policymaking. While legitimate, this attempt raises serious doubts about the compatibility of this reform with the principle of separation of powers and, in particular, that of institutional balance. A closer look at the Better Regulation Package reveals an entirely new understanding of the Commission's own prerogatives and the way it intends to exercise its legislative and regulatory powers. And this in spite of the apparent continuity between the new and old Better Regulation initiatives and the instruments it had chosen to attain the declared objectives. With a view to lay out a future research agenda on EU Better Regulation, this article identifies the most immediate questions raised by the publication of the Package and makes a first timid attempt at addressing some of them. It aims at determining how much better, if any, is the new Better Regulation Package. It does so by discussing, first, the major novelties enacted by the Commission within its own Better Regulation system and, second, those proposed in the framework of the IIA on Better Regulation.

Public food safety authorities in Europe and elsewhere have recently developed forms of coordination and collaboration with private compliance systems in the monitoring and enforcement of public food safety laws. Such policies bring with them the risk of regulatory capture, loss of transparency and fuzzy accountability relationships. In this paper we analyse how the Netherlands Food and Consumer Product Safety Authority (NVWA) assesses and monitors the functioning of private food safety control systems so it can use these private systems in its own enforcement activities. We do so by discussing two national private systems that have been formally accepted by the NVWA and are as such subject to its meta-control. The article examines the safeguards that the public enforcement agency uses while coordinating its own activities with private food safety controls, the advantages and risks involved in this strategy, and the extent to which this policy can be improved. From this we draw lessons for public agencies elsewhere willing to engage with private compliance mechanisms. The study is based on the analysis of policy documents, public and private regulation and open-ended interviews with representatives of the public and private sector in the Netherlands.

This report examines what has come to be known as “vaccine nationalism” through the lens of the early experience with the COVID-19 vaccination process. After explaining the meaning of the term, this report investigates how this phenomenon has manifested during the COVID-19 pandemic, identifying its epidemiological, economical, ethical and legal aspects. It also looks at the different international initiatives that have been adopted to deal with it, concentrating in this context on the COVAX project. The report concludes that the success of these initiatives has been limited. It also observes that COVID-19 vaccine nationalism appears to be a phenomenon that is characteristic of the high-income Western countries, while in aspiring non-Western powers the vaccine crisis is primarily seen as a way to advance their geopolitical goals.

COVID-19 hits all of the cognitive triggers for how the lay public misjudges risk. Robust findings from the field of risk perception have identified unique characteristics of a risk that allow for greater attribution of frequency and probability than is likely to be aligned with the base-rate statistics of the risk. COVID-19 embodies these features. It is unfamiliar, invisible, dreaded, potentially endemic, involuntary, disproportionately impacts vulnerable populations such as the elderly and has the potential for widespread catastrophe. When risks with such characteristics emerge, it is imperative for there to be trust between those in governance and communication and the lay public in order to quell public fears. This is not the environment in which COVID-19 has emerged, potentially resulting in even greater perceptions of risk.

Consumer desire for superior and new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. Until now, governments have been hesitant to respond to such demands given the evolving state of the scientific art and limited international agreement as to what nanotechnologies or nanomaterials “are”. Despite these challenges, in November 2009 the European Union formally embraced the idea of specifically regulating the use of nanomaterials in cosmetic formulations. To achieve this objective, the Parliament and Council had to define what they meant by nanomaterials within the context of the adopted text in order to regulate them. It appears likely that other instruments will be similarly amended so as to include nano-specific provisions, including definitions. This article explores this policy shift within the European Union and the implications of the Parliament and Council's stance at this stage due to the absence of a generally accepted definition within the international community.

Alcohol use has been identified in major United Nations (UN) initiatives, such as the Sustainable Development Goals and the Non-Communicable Disease Action Plan, as a major contributor to the global burden of disease. As a result, levels of alcohol use serve as an official indicator of progress towards these UN-set goals. Given current trends, UN targets for reduced alcohol consumption are unlikely to be met. Moreover, in many countries, especially in low- and middle-income countries, the alcohol-attributable burden of disease continues to increase. Pressure will need to be exerted on national and international decision-makers to arrive at more powerful and normatively persuasive instruments, such as a treaty.

Once more, while facing an analogous risk phenomenon affecting their predominantly homogeneous societal and economic interests, the two sides of the Atlantic seem to adopt diverging stances. Amid the publication of several new studies and a set of EFSA scientific opinions linking the use of the world's most widely used pesticides to bee decline, the European Union adopted a temporary ban on their use. While the Commission does not expressly rely on it, its restrictive decision is clearly based on the controversial precautionary principle. Yet, as it is discussed in this article, the conformity of this decision with the requirements that determine the legal invocation of this principle remains doubtful.

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement.