The process risk allocation is essential for effective PPP contracts, depending on the scope of defined tasks and responsibilities between the parties in their quest to deliver public services. However, risk in critical infrastructure is sui generis risk which could not be treated contractually and transferred by the public sector to the private sector or retained by the party to an arrangement which is suited best to borne such risks.

Risk in critical infrastructure, being either internal or external, is endemic to the relevant services andwhen critical infrastructure is delivered by public-private partnerships or owned by private actors, the treatment of such risk merits a third-party approach. Such third-party could be an industry in itself, such as insurance, re-insurance or hedge fund insurance bond finance, or a sector / industry approach which related to the owners/operators of the relevant infrastructure, by means of collective apportioning and mitigation of risks associated with the failure of providing services fromsuch infrastructure. The most innovative way of treating risk of critical infrastructure remains in the discretion of EU Member States, in the form of integrating costs related to risk assessment and security measurers to protect critical infrastructure into tariff arrangements of relevant services. In such manner, the enduser / consumer of services ensures and collectively insures their delivery against any type of risk which is not quantified and determined as part of corporate arrangements between the state and the private sector provider of services.

Safety regulations are too often disproportional in the sense that their costs outweigh the benefits. Although this is well known, years of trying to reduce safety related regulatory pressure has not resulted in much success. Two important causes for this have not received much attention up to now. One of these is a faulty perception of how the general public regards risk. We argue that the intractable citizen's behaviour needs better understanding. The second cause is the single-mindedness of risk experts which calls for specific instruments to be harnessed.

The risks of technological accidents in the energy sector and their potentially disastrous effects have been analyzed over the past decades, and are nowadays generally recognized to constitute a key factor in an encompassing assessment of energy security. In contrast, the issue of intentional attacks on energy infrastructures has received increased attentionmore recently, particularly due to growing dependence of energy imports fromand transit routes through regions considered less reliable and politically stable. Both types of risks, however, illuminate different vulnerabilities. Therefore, the focus of the present analysis was on these two risk categories: accidents and intentional attacks in the energy sector. Risk assessment resultswere based on quantitative data from the databases ENSAD (Energy-related Severe Accident Database) and EIAD (Energy Infrastructure Attack Database). Evaluations examined similarities and differences between technological accidents and intentional attacks in terms of frequencies and consequences, considering time-series trends and regional patterns. A key difference is that accidents are typically rare and independent events, whereas intentional attacks are often multiple events and concentrated both in time and space, resulting in distinct hotspots. Concerning consequences, the severity distribution for accidents generally stretches over a broad range, with low-probability high-consequence events being an important factor of both energy chain performance and as a measure of risk aversion. On the other hand, these types of consequences are usually less important for intentional attacks because targeted energy infrastructures are often of “linear” nature (e.g. pipelines and transmission lines) that are difficult to protect and usually lead through remote areas with low population density. However, when frequently attacked substantial business and supply disruptions can occur. In summary, the joint analysis of accidents and intentional attacks provides a comprehensive and complementary approach on two types of risks that have rather different properties, but are essential in an energy security perspective.

More than twenty years after the EU eliminated its internal land borders, the Union still lacks an integrated airspace. This seems to be the most immediate regulatory lesson of the recent volcanic ash crisis. Yet more research is needed before establishing its net effects. In this brief report, I will provide a first-hand analysis of the regulatory answer developed across Europe in the aftermath of the eruption of the Icelandic volcano Eyjafjallajökull. While reconstructing the unfolding of the events and the procedures followed by the regulators, I will attempt to address some of the questions that I have repeatedly asked myself when stranded in Washington DC between 16 and 25 April 2010. Who did the assessment of the hazard posed by volcanic ash to jetliners? Who was competent to take risk management decisions, such as the controversial flight bans? Is it true that the safe level of volcanic ash was zero? How to explain the shift to a new safety threshold (of 2,000 mg/m3) only five days after the event? Did regulators overact? To what extent did they manage the perceived risk rather than the actual one? At a time when the impact of the volcanic ash cloud crisis is being closely scrutinised by both public authorities and the affected industries, it seems particularly timely to establish what happened during the worst aviation crisis in European history. This report was written one week after the event and relied on a limited number of sources available by 30 April 2010.

Occupational exposures of pregnant workers can give rise to foetal damage. Two major types of strategies against detrimental effects on the foetus are described: differentiated protection that reduces only the exposure of pregnant workers (or only of female workers) and unified protection that reduces the exposure of all workers to a level that is sufficiently low to protect against detrimental effects on the foetus. The former strategy is shown to be inefficient, as it does not provide the desired protection. Protection only of pregnant workers is insufficient since protection is needed early in pregnancy when it is not known, and in the case of substances that are accumulated in the woman's body even prior to conception. Protection of all women is also insufficient to protect the foetus since evidence indicates that preconception exposure of the father can also give rise to malformations. Furthermore, differentiated protection that requires more costly protective measures for women tends to aggravate the already prevalent discrimination of women on the labour market. It is therefore concluded that unified protection is the only efficient and non-discriminatory strategy against foetal damage.

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws attention to the important role of EU food law in the regulation of this innovative approach to nutrition. It is argued that personalised nutrition challenges the regulatory borderline between health and lifestyle products or services and, furthermore, also pushes the boundaries of current food safety and health claims legislation.

Glyphosate’s authorisation will expire in 2022 and its re-approval will take place in a changed legal and political landscape: the national phase of risk assessment is entrusted to a taskforce of four Member States, and, from 2021, the reform of the general food law will apply, imposing, inter alia, more ambitious transparency standards. Taking stock of these developments, this contribution analyses, from a legal perspective, whether and how the glyphosate dispute has contributed to the development of the EU’s regulatory epistemology, with specific regard to food governance. It identifies the “manifesto” of the EU’s regulatory epistemology in the 2002 guidelines on the collection and use of expertise and reads them in the light of the glyphosate dispute. In particular, it focuses on the legal arrangements reflecting the principles established in the 2002 guidelines (quality, openness, effectiveness) and analyses them against the tensions that emerged throughout the dispute with regard to the sources, levels and purposes of EU regulatory knowledge-making. It then considers whether and how such tensions have been addressed by legislative reform and whether this has resulted in a further refinement of the EU’s regulatory epistemology.

This article discusses the role of European Union (EU) State aid law in the COVID-19 crisis. It contends that different Treaty derogations have played unique roles in addressing the core determinants of the economic risk linked to the pandemic (ie the “exposure” to lockdown measures and the “vulnerability” of certain sectors to them), and in increasing the resilience of national economies. Moreover, this article examines the extent to which EU State aid law has been used to manage and mitigate health risks, by allowing Member States to enhance the preparedness and capacity of their healthcare sector (broadly conceived) to respond to the pandemic. On the whole, this article maintains that State aid control has been used by the European Commission as an important “risk management tool”, and it highlights the role of the Commission as the crisis management authority.

Modern financial regulation has predominantly been economically-driven,1 progressing from addressing market failures to making markets more competitive and work better.2 The UK Financial Conduct Authority is expressly mandated to pursue regulatory objectives that maintain market integrity and protect consumers (addressing market failures) and to promote competition (making markets work better).3 Both the FCA and its sister regulator, the Prudential Regulation Authority (for banks), have recently adopted innovative regulatory initiatives to promote technologically-driven innovation, aimed at making markets work better. These initiatives are also a response to the recent explosion of technologically-led financial innovation outside of the regulatory perimeter.

In promoting financial innovation, we argue that the regulators have insufficiently focused on the need to govern financial innovation more generally. Although this concern may seem premature, the regulatory innovations are increasingly extending the perimeter for regulatory oversight of financial innovations. As the regulatory innovations have the potential to develop into more mature regulatory frameworks for governing financial innovation, we argue that regulators should manage the risks of their current approach and develop a regulatory strategy framework for balancing regulatory objectives and developing regulatory policy. We propose a framework anchored in rationality, consistency and accountability in governing financial innovation.

This section is meant to give readers an insight into the emerging field of nanotechnologies and risk regulation. It informs and updates readers on the latest European and international developments in nanotechnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, occupational health and consumer product, food and drug safety). The section analyzes how existing regulatory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientific freedom and technological progress with a responsible development and commercialization of nanotechnologies.

Over a decade ago I was involved in a group project that focused on developing a regulatory model concerning the implementation of the precautionary principle in the EU. The project involved a number of workshops and in those workshops I used to joke about the fact that while there were many different frameworks being produced to represent risk regulation, these diagrams basically fell into two different categories. In the first category there were those diagrams that characterised risk regulation as a linear process involving usually a scientific process of risk assessment and then political processes of risk management and risk communication. In the second category there were those diagrams that had lots of looping arrows going all over the place that represented the fact that risk regulation was an iterative process that constantly involved many scientific, socio-political and other inputs.

Behind my joking was a sense of hope. The linear diagrams did have their minimalist appeal, but the messy diagrams captured much of the reality of this area of regulatory practice.

In several ways, the revelations that Volkswagen used software to cheat on vehicle emissions tests echo common threads of greenwashing cases against car manufacturers. However, in one significant respect, the Volkswagen scandal is much more than just another example of greenwashing. That is, the German automaker's use of software to deceive brings a novel technological aspect to greenwashing. This article discusses the Volkswagen scandal in the context of automobile greenwashing cases and highlights this newhigh-tech greenwashing.

In the coming few decades, the world is facing three related problems.

First, agriculture contributes to climate change to a considerable extent. In its Fifth Assessment Report, the IPCC's Working Group III concludes that the AFOLU sector (agriculture, forestry and other land use) is responsible for just under a quarter (∼10 – 12 GtCO2eq/yr) of anthropogenic GHG emissions. Usually, a distinction is made between non-CO2 emissions, in particular methane (NH4) emitted by livestock and rice cultivation, and nitrous oxide (N2O) caused by the use of synthetic fertilizers and the application of manure on soils and pasture. Methane and Nitrous oxide have 25 times and 300 times stronger impact on the climate than CO2 respectively. CO2 emissions from agriculture are mainly caused by deforestation and peatland drainage. Emissions from agriculture have been rising on a yearly basis since 1990, although with important regional differences (they went down in Europe and up in Asia).

This article proposes and discusses the text of a Framework Convention on Alcohol Control, which would serve public health and welfare interests. The history of alcohol’s omission from current drug treaties is briefly discussed. The paper spells out what should be covered in the treaty, using text adapted primarily from the Framework Convention on Tobacco Control, but for the control of trade from the 1961 narcotic drugs treaty. While the draft provides for the treaty to be negotiated under the auspices of the World Health Organization, other auspices are possible. Excluding alcohol industry interests from the negotiation of the treaty is noted as an important precondition. The articles in the draft treaty and their purposes are briefly described, and the divergences from the tobacco treaty are described and justified. The text of the draft treaty is provided as Supplementary Material. Specification of concrete provisions in a draft convention points the way towards more effective global actions and agreements on alcohol control, whatever form they take.

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.

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).

On 2 March 2010 the European Commission authorised the cultivation of a BASF's genetically modified potato “Amflora” throughout the European Union. This came after a tortuous process commenced in 1996 and so far it is the only authorisation of a GMO for cultivation in EU since the current regulation was established. On 3 March 2010, President Barroso announced that the Commission intends to propose amendments to the current regulation to allow the Member States to prohibit the cultivation of GMO authorised for cultivation in the EU and it did so on June 13, 2010. This is one of the very few cases where decision-making power is effectively devolved back from Union to state level; it is even more impressive that this is happening on the initiative of the Commission and despite the obvious negative consequences for the internal market. In the meantime BASF botched the 2011 growing season for Amflora in Sweden and in 2012 announced that it withdraws its GM crops from the EU. This article follows the saga purports to find the reasons why it entailed an immediate change.

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.