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.

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.

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.

A medical device is intended to alleviate a medical condition or to substitute a body function. The use of medical devices entails risks, first and foremost for patients who usually lack the necessary information, time and ability for informed decisions. Based on this, societies choose to regulate these products. Government involvement in medical device regulation seems to be more pronounced and centralised in the US than it is in the EU, where the system involves privatised elements. A consultation, initiated by the European Commission in 2008, proposed at its centre the introduction of a European medical device agency. By this the European system would follow the US benchmark. This research discusses some fundamental questions pertaining to the risk concept in medical devices, namely how risks are currently being addressed in the two most important regulatory systems of the US and the EU, and how the European system might be adjusted in the future.

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.

Alfalfa is one of the most important legumes used in agriculture and the fourth most cultivated plant behind corn, soybeans and wheat in the US. It has been grown in almost all federal states, occupies 9 million hectares and is primarily used in feed for dairy cows and beef cattle. US consumers also eat GM alfalfa as sprouts in salads and other foods. Roundup Ready alfalfa was developed by the agrobiotechnology firms Monsanto and Forage Genetics. It was originally approved in June 2005 for commercial sale by the US Department of Agriculture (USDA). Alfalfa is designed to tolerate the leading active substance in Monsanto’s trademark Roundup herbicide, glyphosate. It is also the first genetically modified perennial crop to be commercialized. As a result, its cultivation poses special environmental, agricultural and economic risks.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals' health and safety, inter alia.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

This section discusses issues related to risk communication across a range of publicly perceived high-risk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.

This section aims at updating readers on the latest developments of risk-related aspects of food law at EU level, giving information on legislation and case law on various matters, such as food safety, new diseases, animal health and welfare and food labelling.

The recent Romanian outbreak of subtype H5N1 of the highly pathogenic avian influenza (HPAI) virus, the first detected case of H5N1 avian influenza in Europe in 2010, has reinvigorated the debate concerning risks related to the spread of avian influenza in the European Union.

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.

The manufacturer of a substance that is used safely and, in more than 99.9% of cases, used as an intermediate (and thereforeis exempted from the authorisation procedure) is deemed to have no legal grounds for claiming the suspension of the inclusion of that substance in the Candidate List for lack of urgency. Its mere inclusion should not automatically result in any significant damages to the manufacturer, neither should the Candidate List serve as a regulatory blacklist (official headnote).

Under Section II of the Rules of Conduct for the DSU, the institutional affiliation of experts may be considered as an element that casts doubts on their impartiality and independence. Under Articles 5.1 and 5.7 of the SPS Agreement, the level of protection that a particular country is ready to tolerate may inform risk assessment and have an impact on the determination of insufficiency of scientific evidence. In a situation in which there is sufficient scientific evidence for performance of risk assessment in one of the international standard setting-organizations, one may still find insufficiency as provided by Article 5.7 if new data puts into question the relationship between the relevant scientific evidence and the conclusions in relation to risk, thereby not permitting the performance of a sufficiently objective assessment of risk (authors’ headnote).

1. The concept of ‘monomer substances’ in Article 6 (3) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, relates only to reacted monomers which are integrated in polymers (official headnote).

2. Article 6 (3) of Regulation (EC) No. 1907/2006 infringes neither the principle of proportionality nor the principle of equal treatment (author's headnote).

The Austrian Umweltsenat is a court or tribunal for the purposes of Article 234 EC. The Environmental Impact Assessment (EIA) Directive is to be interpreted as meaning that a Member State has to subject a transboundary project to environmental impact assessment (EIA) even if the size of the project on its own territory does not reach the threshold for an assessment as defined in Annex I of the EIA Directive but the threshold is exceeded when parts of the project that are located in another State are taken into account (author’s headnote).

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at [email protected].