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.

This book, coordinated and supervised by Prof. Vincenzo Salvatore, is part of the output of the workshop organized by the Università dell’Insubria in Varese in November 2010 which gathered legal and economic scholars and experts of EU Institutions with the aim of presenting and discussing present problems and future challenges of the EU agencies. The diverse set of perspectives contained in the book contributes significantly to rethink the role and nature of the EU agency institutional model, by pointing out some of the most relevant legal issues such as the delegation of powers and the lack of homogeneity of the model, which reflect features and peculiarities of the EU integration process.

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 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.

There has been an increasing interest in making legal decision-making and scholarship scientific or inter-disciplinary, without there being any interrogation of how or why this should be done. This has resulted in polarised views of the importance of science on one hand, and the primacy of democracy on the other. Such polarisation is not helpful primarily because both ‘science’ and ‘democracy’ remain unintelligible to those who do not have access to the particular epistemology that supports their usage. In this article, I seek to reconceptualise the conflict between democracy and science as the association of legal decision-makers and scholars with expert inquiry. I further conceptualise such association as a process that involves normative reductionism of testimonial exchange. Despite a claim to ‘a culture of justification’ in legal systems such as the European Union, the process of normative reductionism is essentially arbitrary. I seek to articulate a framework where this process may be approached in a disciplined manner, concentrating on the role of mediation and moderation of expert knowledge.

This article analyses the role played by standards of protection in the regulation of catastrophic risks. It examines how to protect people against the occurrence of catastrophic events, considering that the related risk is highly uncertain and difficult to predict using rational methodologies. In this perspective, the article focuses on environmental risks and terrorist threats affecting common goods – namely environment and security – areas where any damage is susceptible to producing ruinous effects and huge casualties. Both natural and man-made disasters are capable of altering the normal legal relations that States are institutionally to ensure to their citizens. Therefore, the severity of the consequences of catastrophic events cannot be ignored, despite the low probability of their occurrence. However, in the absence of emergencies, exceptional measures may be adopted as a means of altering the legal framework, and thus the enjoyment, of fundamental freedoms and priorities in the allocation of public resources. No precautionary approach can escape from rational reflections about the opportunity-cost of any action, the cost-benefit analysis of countermeasures and the proportionality of every regulatory decision. In order to understand how to face those “low probability – high cost” risks, the article considers a specific method of regulating risks by resorting to standards of protection. By using thresholds of alarm, public administrations can decide upon best-fit countermeasures that will correspond to specific risk characterisations. To this end, the article analyses the administrative process of formulating standards and how they enable uncertain risks to be managed, thus promoting the development of a sound and accountable administration.

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).

Web-based financial intermediation on a peer-to-peer (P2P) basis will eventually prevail as an economically superior form of organisation compared to the traditional banking business model. P2P lending is the most popular type of crowdfunding, whereby an internet platform collects small amounts of funds from individuals in a crowd to finance collectively a larger loan to individuals or businesses. Unlike a commercial bank, the platform does not take risks through its own contractual positions. Whereas banks accumulate risks by taking positions on their balance sheet, platforms decentralise the risks by spreading them to their users. The emergence of financial platform businesses challenges legislators and regulators in several respects: the “easy way” of modifying existing finance and banking laws is inadequate; the internal organisation and knowledge of staff is not well suited to regulating crowdfunding; and capital mediation by crowdfunding platforms requires a different regulatory approach than banking. Finally, there is no doubt that P2P lending platforms will in the long run need a dedicated, single European regulatory framework.

The debate as to whether chemicals should be regulated according to hazard or risk is once again under the spotlight, this time commented by Ragnar Lofstedt, PhD, Professor and Director of the Kings Centre for Risk Management at Kings College in London. He takes the reader through the history of risk assessment and chemical control, presents two interesting current case studies and sheds light on the influence of politics on the implementation of regulation.

Professor Lofstedt's assumption that two different methods of assessment exist is not a complete statement. In fact this is a confusing way to describe the scientific and political processes involved in regulation. It is not a choice between two methods, but rather a balance between political ambition and scientific facts within one method. Examples can be found where science has been more influential than policy on the actual regulatory decision, and vice versa.

The closure of part of European airspace as a result of the eruption of the Eyjafjallajokull volcano constitutes “extraordinary circumstances” which does not release air carriers from their obligation, in the event of cancellation of a flight, to provide passengers care and assistance (author's headnote).

Technological innovations are crucial drivers of economic, social, and environmental progress. While innovations lead the evolution of our societies and permeate all domains of human life, they also pose significant risks both to humans and the environment. Law and regulation are expected to enable innovation, while at the same time protecting society from unintended consequences. However, assessing new technological risks confronts deep uncertainty and limited knowledge. In contrast to simple risks (e.g. car accidents), technological risks (such as risks stemming from new health technologies, nanotechnology, biotechnology, or robotics as discussed in this special issue) cannot be calculated according to traditional technocratic models, namely as a statistically foreseeable function of probability and effects. It is widely recognised that regulating new and emerging technologies is challenging for law due to problems of uncertainty and limited knowledge in the assessment and management of technological risks. To address this challenge it is crucial to study the ways in which law and regulation can successfully respond and adapt to technological progress.