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.

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.

The long subtitle of this paper, appearing in the first issue of the EJRR – a publication which fills a serious gap in the scholarly literature of the old continent – identifies what I take to be the key terms of the current debate on risk regulation. It is impossible to understand the evolution of risk regulation over the last three decades in Europe and the United States without having a good grasp of how these concepts, and their corresponding practices, interact. How, for example, does a particular institutional design affect the way scientific uncertainties are resolved? What decision rules are appropriate in situations of high scientific uncertainty? Which constitutional principles facilitate policy learning and accountability in the regulation of risk?

The title of our new section inevitably evokes a most basic question: What are lifestyle risks? While it is not that simple to define this broad term, in this editorial we aim at introducing the EJRR readership to this fascinating emerging area of risk studies. We shall attempt to describe the nature of lifestyle risks by identifying their main features and by raising some of the fundamental questions that are inherent to any discussion on this topic.

The Society for Risk Analysis (SRA) has kindly authorised the EJRR to publish the comments of SRA Past Presidents on the Deepwater Horizon oil spill. Going beyond news media accounts, these comments offer a first hand analysis of the effects of the oil spill on the field of risk analysis and risk regulation. Following the call for a moratorium on deep-sea drilling in Europe by Gunther Oettinger, the European Commissioner for Energy, the publication of these comments seems particularly timely. (AA)

This paper focuses on those parts of the regulatory environment that are designed to encourage scientific and technological innovation. Patent law is the obvious example; but tax law can also signal encouragement for particular activities. The key question is whether regulators will, or should, withhold tax incentives where there are some, but not universal, moral reservations about an innovation. In order to earth this question, three recent cases at the ECJ, two involving the controversial practice of cord-blood banking, are examined. Insofar as these cases offer any evidence of the prevailing regulatory approach, it seems to be similar to that found in patent law – that is, moral reservations do not count against the applicability of a tax exemption so long as they are not universally recognised.

The Commission has proposed to legitimise the renationalization of the cultivation of GMOs (Genetically Modified Organisms) accepting the request of a group of Member States who raised concerns at the Environment Council of June 2009 regarding the EU-wide decisions on GMO2 cultivation.

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.

As a volcano refugee in Frankfurt, it was rather interesting to see a slow motion regulatory science disaster taking place. On April 14 2010 the Icelandic volcano Eyjafjallajökull erupted sending millions of tons of ash into the upper atmosphere. The ash cloud, blown by the prevailing winds, moved down over northern Europe. European air traffic authorities, following well established and widely published safety protocols, began shutting down the air transport system due to the well known hazard of volcano ash. The shutdown lasted 6 days and soon became an unequal political contest between airline money on the one side and regulatory science on the other. In a classic case of shooting the messenger bringing bad news the responsible airline parties tried to shift the blame for shutdown to the regulators, while nervous governments quailed before the bullying of the airline executives.

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.

“After a reform is before another reform.” This paraphrasing of a famous saying from the world of football seems to be a very fitting way to describe the status quo of the European policy on genetically modified organisms (GMOs).

Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level has triggered the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects, and would such competition lead to desirable outcomes? In this paper I will first show that, due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs. I will then contrast these findings with EU pharmaceutical law and show that it tends to avoid competition. Also, in practice, competition among agencies is still exceptional for European pharmaceutical regulation. Finally, I conclude these findings and hint at the limits of the desired process for further coherence. Although a move towards even greater convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Article 5 (1, 2) EU read in conjunction with the areas of shared competence and the competence to support, coordinate and supplement.

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe's regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU's trade partners). By considering the discussion on animal cloning in the broader context of EU's regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.

This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards.

The European Union tried to establish a “coexistence” policy for the cultivation and processing of GM and non-GM products after the political agreement that put an end to the 1999-2004 moratorium.

Comparative risk assessments in the chemical safety field sometimes adopt a lofty view of the purposes of legislation. This personal essay is not lofty, and it is not just another professor's comparison of the purposes of the European Union's REACH with American regulatory programmes. I write today as an individual, as the last active remaining participant of the small group of industry players in 1975–76 who helped to negotiate the details of the 1976 US Toxic Substances Control Act (“TSCA”). As advocates for industry we won the key arguments over the law's terms and conditions, but the decades since have not shown TSCA to be a triumph for anyone.

Hazard is the potential of something to cause harm; risk is the likelihood of harm occurring. Chemicals regulation is largely focused on minimising risks associated with chemicals — and rightly so. However, in the EU the hazard classification of individual chemicals can impact significantly the regulation of products containing those chemicals, regardless of the actual risks that the products may pose to human health or the environment. This can lead to undesirable consequences, such as restrictions on the use of safe products, substitution towards less safe products, and disincentives to innovate. Such hazard-based regulation tends to be at odds with World Trade Organization rules and has raised significant concern with EU trading partners. This journal is an ideal forum for discussing how the EU can move towards a better and more coordinated legal framework for the regulation of chemicals.