Ever more risky service activities are carried out across borders, creating spillovers and externalities. At the same time, if freedom to provide services is legally enabled, states can cooperate in multiple ways to mitigate the potential risks accruing from crossborder activities. Global Administrative Law Scholarship distinguishes five types of administrative regulation: “administration by formal international organizations; administrations based on collective action by transnational networks of governmental officials; distributed administration conducted by national regulators under treaty regimes, mutual recognition arrangements or cooperative standards; administration by hybrid intergovernmental–private arrangements; and administration by private institutions with regulatory functions. In practice many of these layers overlap or combine […]”. In the area of risky cross–border service provision, the EU has moved from a more decentralised version of networks and mutual recognition characterised by coordination and minimum harmonization of rules and standards to a more centralized commandand–control system with European authorities and supervision.

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

This article aims to analyse liability issues as a further means to regulate risks, in case the precautionary measures of the delivered safety system fail. Through liability, the risk that cannot be prevented can be transferred onto those parties who are in the best position to spread them. The allocation of liability thus works as an incentive to the correct functioning of the preventive measures. Liability rules appear to be a key legal remedy which can ensure both tort reparation and a fair and efficient distribution of burdens in a legal order. In this vein, air traffic management (ATM) is addressed as a case study, which shows the main issues and the gaps that liability rules face when dealing with the trade off between risk and safety as conveyed by technology.

After having clarified the nature of the relations between risk and liability on the one hand, and automation and liability on the other hand, this article analyses liability issues in the framework of ATM by approaching this topic in a comparative way between the National Airspace System (NAS) of the United States of America (USA) and the Single European Sky (SES) of the European Union (EU).

In May 2011, the illegal use of the plasticizer di(2-ethylhexyl) phthalate in clouding agents for use in foods and beverages was reported in Taiwan. This food scandal has caused shock and panic among the majority of Taiwanese people and has attracted international attention raising once again concern regarding the contamination of food by chemical toxic compounds. However, although these accidents cause a lot of concern, it is worth remembering that governments throughout the world are intensifying their efforts to improve food safety. In Europe in particular, food policy is based on high safety standards, aimed to protect and promote consumers’ health. EU legislation specifies that food containing a level of contaminants that is unacceptable from a public health viewpoint, cannot be put on the market.

Currently, one of the great challenges in food safety is the control of risks associated with mixtures of contaminants, which are constantly changing. Food may be contaminated by chemical substances through production practices, packaging, transport, or storage. The contamination might also result from environmental pollution through contaminated air, water, soil, and accumulation in the food chain. Among the most prominent groups of emerging food contaminants, those from industrial sources (perfluorinated compounds (PFCs), polybrominated biphenyls (PBBs) and, partially, nanomaterials) cause particular concern. Many of these can be associated with severe damage to human health, for example some are suspected to be cancer promoters. Other compounds have been associated with endocrine disruptor effects, or can be accumulated and biomagnified through the food chain.

This article discusses the legal remedies available for Competent Authorities, patients and healthcare professionals to prevent harmful incidents involving medical devices. It outlines a theoretical framework for ex-ante and ex-post regulation of medical devices. It then focuses on certain aspects of ex-post regulation. Participation by Competent Authorities with a supervisory role, healthcare professionals and patients in ex-post regulatory legal processes is analysed in the light of the current European Union legal framework and the revised framework proposed by the European Commission. It also discusses whether the proposed new legal framework enables the Competent Authorities, patients and healthcare professionals to prevent the harm caused by unsafe medical devices. Ex-ante regulation might prevent the entrance on the market of unsafe devices whereas ex-post regulation might dismiss the unsafe devices. The contribution concludes by suggesting a number of improvements to the supervisory system of medical devices in Europe.

EU agencies, such as the European Food Safety Authority (EFSA), are usually created in an environment that is replete with other organizations, not only other European bodies and member state agencies, but also international organizations and third country agencies. Through their interactionwith EUagencies, these international organizations and third country agencies may affect policies, policymaking processes, institutions and behaviour in the EU and its member states. But EU agencies do not necessarily serve as passive channels for the interaction between international organizations and third country agencies, on the one hand, and the EU institutions, on the other hand. They often seem to play an active role as policy entrepreneurs,making use of the opportunities offered by the policies and policymaking processes of these organizations and agencies to influence institutions and behaviour in the EU and its member states. The above raises the question of what international role EFSA actually has performed: has it, despite the formal-legal restrictions put in place by the EU institutions, been able to act relatively autonomously at the international level? In order to address this question, this article examines EFSA's international relations, notably those with international organizations and third country agencies in its field of action. It adopts a dynamic perspective, describing these relations throughout the agency's development. The article demonstrates that EFSA has developed a considerable international role, despite the relatively limited scope of action allowed by its legal framework, and shows that this development has been driven by both functional needs and strategic motives.

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.

Early initiation of gambling has been argued to be closely correlated with placing players at higher risk of developing problem gambling behaviour in the future. The vast majority of jurisdictions, including Great Britain, attempts to eliminate minors’ access to gambling by making it illegal and by requiring gambling providers to adopt strict age-verification procedures. Despite those measures minors continue to successfully access gambling. This paper demonstrates that British legal framework suffers from many statutory loopholes. It considers weaknesses in the regulatory offences as well as enforcement deficiencies. It further highlights how the differences between black letter law, political rhetoric and practical application undermine the strength of the prohibition of gambling by minors.

This paper argues that the EU Regulation of credit rating agencies is concurrently pursuing two objectives that conflict with and would undermine each other. One is the objective of enhancing rating accuracy, and the other is the objective of restoring market discipline in the wholesale investment markets for credit ratings as information goods. The Regulation places more emphasis on regulating for rating accuracy which has the effect of instituting a form of product regulation for credit ratings, raising the public interest profile of credit ratings. This paper argues that this is undesirable and is contrary to policy-makers’ endeavours to enhance market discipline for rating quality and the private accountability of credit rating agencies. EU policy-makers would eventually need to confront the underlying conflicting objectives in the Regulation so that a normatively coherent and consistent regulatory regime can be designed and implemented.

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.