The centralised authorisation of GMOs in the European Union (EU) has received considerable academic attention in recent years, partly due to the fact thatMember States have not been able to agree on authorisation decisions in the comitology committee. As a consequence, these authorisations are given by the European Commission. These decisions are invariably in favour of authorisation despite the fact that Member States had been divided on this issue. Apart from the on-going discussions on a possible reform of the GMO authorisation (allowing for national restrictions or prohibitions), the new comitology rules brought about by the Lisbon Treaty are of equal importance as they might affect the authorisation of GMOs. In this article we discuss some of the changes to comitology and present empirical material on the first authorisation decisions after the entering into force of the new comitology rules. By drawing on delegation theory we will argue that, for the time being, the level of politicisation ofGMOauthorisation is unlikely to change.

In this contribution we focus on the role of experts in the assessment of tort damages from an economic point of view. We distinguish two different aspects.

First, we examine the role which economists might play in assessing damages in tort cases. This approach focuses on the insights that Law and Economics provides regarding the correct assessment of damages. We pay specific attention to two problematic forms of losses where economic insights may play an important role: pure economic loss and personal injury damage (both loss of income and compensation for immaterial losses due to fatal and non-fatal accidents).

Second, we investigate from a Law and Economics point of view the role of experts in general (not only economists) in the assessment of damages. We discuss i.a. the question why experts may be involved in the assessment of damages, the potential problems (and the possible solutions) when using experts, and differences between party appointed experts and court appointed experts.

It turns out that the economic analysis can provide a different, insightful viewpoint in some respects, such as the fact that market based mechanisms may help to provide incentives to party appointed experts to provide an accurate and objective damage assessment.

The marketing of tobacco, alcohol, unhealthy food and gambling services is harmful to public health, the European economy and sustainability. If the European Union (EU) has embraced the regulation of cross-border marketing for tobacco products for over two decades, it has consistently resisted evidence-driven calls to regulate the marketing of other harmful commodities, preferring instead to rely on ineffective industry pledges. This contribution reflects on why the EU has failed to use its competence to regulate cross-border marketing more systematically to protect health and highlights why the time is ripe to reconsider the issue, before concluding with a possible way forward.

On 23 October 2019 the European Union enacted the Whistleblower Protection Directive. The directive introduces important common standards of protection for whistleblowers reporting on breaches of EU law and significantly increases the level of protection afforded to whistleblowers in many EU Member States. Many of the features of the directive go further than pre-existing national whistleblower protection regimes, particularly in relation to the categories of persons who may benefit from the protections under the directive and in terms of the flexibility of the prescribed reporting procedures. Nevertheless, the directive's effectiveness may be limited by certain grey-areas and missed opportunities in the final text of the instrument.

The specific status of active substance candidates for substitution (CfS) is detailed by Article 24 of plant protection Commission Regulation EC No 1107/2009 (PPP Regulation). The criteria of candidates for substitution are now clearly defined: low acceptable daily intake/acute reference dose/acceptable operator exposure level or two persistent, bio-accumulative or toxic criteria, or by nature of the critical effects: non-active isomers, carcinogen 1A/1B, toxic for reproduction 1A/1B or endocrine disruption properties, with these later properties now being well characterised. The total number of active substances CfS has been in constant evolution since 2011, with the first batch of candidates for substitution being published in 2015 and updated since then. After a slow decrease, growth is again observed, with another list of active substances being granted this status. CfS are substances targeted by the PPP Regulation that are supposed to be cancelled or non-renewed at the active substance level or substituted at the market authorisation level. CfS are also supposed to be replaced by substances with better toxicological profiles. However, after five years of implementation of the status, their number, which is intended to decrease, remains high, at sixty residual CfS. We exhibit here their evolution.

This article contributes to the discussion about managing the risks and uncertainties of emerging technologies through increased stakeholder participation. Authorities have increasingly invited stakeholders from high-technology sectors to participate in assessing the risks of, and designing responses to, new technologies. Yet authorities often struggle to attract stakeholders from such sectors to participate; a critical challenge identified but still undertheorised in the literature. Responding to this gap, this article presents a case study of the UK’s regulatory sandbox for financial technologies, applying a document study, questionnaire and interviews to explore fintech firm motivations and apprehensions about participation. Drawing on the bureaucratic reputation literature, the study finds that fintech firms have a range of practical, reputational and normative motivations to participate, and these motivations are inextricably tied to the regulator’s strong reputation with the sector as procedurally correct, high-performing and morally committed to facilitating innovation. On this basis, recommendations for practitioners and hypotheses for future research into the drivers of stakeholder participation in regulatory decision-making surrounding emerging technologies are proposed.

The objective of the article is to analyse the use of Humanities and Social Sciences (HSS) in public risk assessment and risk management organisations in France, Germany, the UK, the Netherlands, Canada and the United States based on more than a hundred interviews conducted with social sciences experts employed by or working for these organisations. If the added value brought by the integration of social scientists is recognised, the use of social sciences differs from one organisation to another. The article compares the different positions given to social scientists inside and outside the organisation, the various methods used and the different contents produced. The survey highlights a set of initiatives that are scattered, differentiated and ultimately have little in common – except that they often play a marginal role in the main activities of the agencies concerned.

In September 2011, the World Trade Organization (WTO) panel report in US – Clove Cigarettes was released. The report addressed a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The dispute is one of a number of contemporary disputes under the WTO Agreement on Technical Barriers to Trade (TBT Agreement). Given that relatively few disputes have been resolved under the TBT Agreement, the outcome may have significant implications for interpretation of the agreement and risk regulation through technical regulations. The panel report may also have more specific implications for risk regulation in the context of tobacco products (author's headnote).

In Fra.bo, it was held by the Court of Justice of the European Union (“CJEU”) that “Article 28 EC must be interpreted as meaning that it applies to standardisation and certification activities of a private-law body, where the national legislation considers the products certified by that body to be compliant with national law and that has the effect of restricting the marketing of products which are not certified by that body” (author's headnote).

COVID-19 emerged as a cross-cutting problem across governance sectors and levels, urging the creation of a European Health Union. There are already a number of integrated European governance strategies – such as the European Energy Union (2015) and the European Green Deal (2019) – adopted for overcoming problems of governance fragmentation and inadequacy of fragmented policy responses to cross-cutting policy challenges. Past studies focused on the interaction between crisis and policy change and investigated the activation of different mechanisms to enhance integration. This article contributes to the debate over the creation of a European Health Union by unpacking the acknowledged dimensions of policy integration – policy frame, subsystem involvement, policy goals and policy instruments – in order to assess their manifestations in the new EU4Health policy and to establish what contextual conditions triggered the activation of the integration-enabling mechanisms that led to a more integrated European Health Union. In so doing, it offers an analytical illustration and discusses implications for decision-making.

Against the backdrop of contemporary climate change lawsuits, this article presents preliminary research findings regarding a remarkable and underappreciated moment in the common law pre-history of modern environmental, health, and safety regulation. The findings complicate the conventional academic story about the limited capabilities of tort law and its inevitable displacement by more institutionally robust and sophisticated forms of regulation. Section I offers a brief introduction, followed in Section II by a review of existing academic literature on the pros and cons of utilising tort law as a regulatory device. As will be seen, the consensus view seems to be that tort law is a clumsy and imperfect mechanism for addressing most environmental, health, and safety risks. Section III argues that the debate over tort law’s potential as a risk regulation mechanism ignores the distinctively private law history and character of that body of law, essentially asking tort to serve a purpose for which it was neither intended nor designed. Section IV then presents a case study of nuisance litigation in which the tort system achieves a remarkable and underappreciated risk regulation effect precisely by focusing narrowly on the traditional task of adjudicating alleged wrongs between private parties. Section V concludes.

Some EU agencies have been recently entrusted with enforcement powers, which imply a crucial extension of their regulatory reach. However, other comparable agencies did not receive such powers. This paper explores the case of energy regulation as an instance of these “negative” cases, and suggests that the lack of enforcement powers may have been partially determined by business interest groups. To illustrate this argument, this article firstly relies on official documentation to show that key interest groups were consistently opposed to the option of granting enforcement powers to the EU agency in charge (ACER). Secondly, it is suggested that these interest groups, which have been largely incorporated in regulatory networks during the prehistory of the agency, had access to, and exerted influence in, the governance of EU energy policy, and could plausibly have been able to concretise their preferences. A systematic examination of the representation of interest groups in the European network of energy regulators (CEER/ERGEG) during the period 2004–2011 is undertaken to corroborate this point. The conclusion draws attention to the fact that, although interest groups are less visible than other actors and their presence is less formalised, they could be very influential on decision-making processes within European networks and agencies.

In the last twenty months, the Obama Administration has been taking an approach to regulation that is distinctive in three ways.

First, we have approached regulatory problems not with dogma or guesswork, but with the best available evidence of how people really behave.

Second, we have used cost-benefit analysis in a highly disciplined way, not to reduce difficult questions to problems of arithmetic, but as a pragmatic tool for cataloguing, assessing, reassessing, and publicizing the human consequences of regulation – and for obtaining public comment on our analysis. This emphasis on human consequences – on reducing or eliminating unjustified burdens on the private sector and on ensuring that high costs are justified by high benefits – is especially important in a period of economic difficulty. We have worked to put into place important safeguards while also making regulation compatible with the economic recovery, and while reducing the risk that costly regulations will have adverse effects on job creation, wages, prices, and economic growth as a whole.

Banks are informational intermediaries whose efficient operation is strongly tied to the maintenance and continuance of the trust and confidence produced by them and by external sources. The literature on trust and confidence with relevance to banking has shown particular interest in their links with panics and bank runs, together with their wider resulting implications on the macro-stability of the financial system. However, on the micro level, an initial outcome emanating from a lack of trust and confidence would be the disruption of the information production that ultimately paves the way for further deterioration, leading to a vicious circle. To investigate this further, this article will shed light on this micro aspect of bank information production and its relationship with public trust and confidence.

Directive (EU) 2015/412 allows Member States to restrict the cultivation of genetically modified seed or propagating material, although their placing on the market has been authorized. This so-called opt-out is meant to resolve the current Member States’ conflict about gene technology by facilitating differences of states concerning cultivation regulations. The concept has at the same time the potential to pioneer a general reorientation of European and even global principles of free trade. Where as trade restrictions on grounds of health and environmental protection could thus far only be justified on a strict scientific basis, a variety of risk perceptions and evaluations are now made acceptable. The article explores what grounds may justify cultivation restrictions beyond those identified in a concrete environmental risk assessment. Two categories are suggested: general environmental concerns weighing systemic effects and uncertainty, and trans-environmental concerns such as the use-value of genetically modified plants, the avoidance of costs resulting from policies of coexistence with conventional plants, the halting of agricultural industrialisation, and ethical considerations. It is further examined if cultivation restrictions based on such grounds are compatible with the EU rules of free movement of goods and relevant WTO agreements. The pertinent report of a WTO-Panel on genetically modified plants is scrutinized for this purpose and a dissenting interpretation developed.

This article addresses conceptional components of national strategies on critical infrastructure protection (CIP). In particular, it focuses on the Swiss CIP programme and its strategic components. As in other countries, Switzerland divides its national infrastructure into critical sectors, but rather distinctively it subdivides them into critical subsectors and even lists specific critical infrastructure objects in a classified inventory. The article stresses the importance of a pragmatic public private partnership in further strengthening the CI's resiliency, but also argues for a more explicit legal foundation to provide some clearer guidelines in this evolving field of collaboration.

This report analyzes the tobacco carve-out clause (as well as the negotiations that led to its adoption) included in the final text of the Trans-Pacific Partnership Agreement, which permits the TPP Parties to deny investors that challenge their tobacco control measures access to the investor-state dispute settlement mechanism. The report also discusses the potential advantages and disadvantages of such a solution.