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 Nudge (2008) Richard Thaler and Cass Sunstein suggested that public policy–makers arrange decision–making contexts in ways to promote behaviour change in the interest of individual citizens as well as that of society. However, in the public sphere and Academia alike widespread discussions have appeared concerning the public acceptability of nudgebased behavioural policy. Thaler and Sunstein's own position is that the anti–nudge position is a literal non–starter, because citizens are always influenced by the decision making context anyway, and nudging is liberty preserving and acceptable if guided by Libertarian Paternalism and Rawls’ publicity principle. A persistent and central tenet in the criticism disputing the acceptability of the approach is that nudging works by manipulating citizens’ choices. In this paper, we argue that both lines of argumentation are seriously flawed. We show how the anti–nudge position is not a literal non–starter due to the responsibilities that accrue on policy–makers by the intentional intervention in citizens’ life, how nudging is not essentially liberty preserving and why the approach is not necessarily acceptable even if satisfying Rawls’ publicity principle. We then use the psychological dual process theory underlying the approach as well as an epistemic transparency criterion identified by Thaler and Sunstein themselves to show that nudging is not necessarily about “manipulation”, nor necessarily about influencing “choice”. The result is a framework identifying four types of nudges that may be used to provide a central component for more nuanced normative considerations as well as a basis for policy recommendations.

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.

At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

Private scientific organizations exert a great deal of influence in the regulation of some technological risks. The high level of expertise of their members is arguably a good reason for them to participate in making and monitoring risk regulations, in order to adjust these to scientific progress. Nevertheless, there are also sound reasons why governments shouldn’t uncritically follow the views expressed by such organizations. Taking the role played by the International Commission on Non–Ionizing Radiation Protection in the regulation of electromagnetic fields as an illustrative example, this paper shows that private scientific organizations such as these are structurally less well suited than democratic authorities when it comes to managing those risks.

In this article a synthesis of formal models for the economic interpretation of the precautionary principle is presented, with their virtualities, limitations and measures to overcome them.

The concept of precaution has great relevance in environmental regulation in the European Union. On the one hand, and despite the somewhat vague nature of legislation, the interpretation of the precautionary principle has seen recent progress with the development of some economic models and their application. There is, however, a need for a regulatory framework for the implementation of this principle in environmental decision-making, i.e., to clarify concepts and management procedures that are appropriate to the nature of environmental risks.

It is therefore important to know the most relevant economic approaches and models with the aim of identifying their contribution to the debate on precaution in the context of environmental risk management and discuss their practical relevance in public decision-making.

Over a decade ago I was involved in a group project that focused on developing a regulatory model concerning the implementation of the precautionary principle in the EU. The project involved a number of workshops and in those workshops I used to joke about the fact that while there were many different frameworks being produced to represent risk regulation, these diagrams basically fell into two different categories. In the first category there were those diagrams that characterised risk regulation as a linear process involving usually a scientific process of risk assessment and then political processes of risk management and risk communication. In the second category there were those diagrams that had lots of looping arrows going all over the place that represented the fact that risk regulation was an iterative process that constantly involved many scientific, socio-political and other inputs.

Behind my joking was a sense of hope. The linear diagrams did have their minimalist appeal, but the messy diagrams captured much of the reality of this area of regulatory practice.

The three Directives concerning medical devices are currently under revision and a long process that started with a consultation in 2008 seems to be nearing its conclusion with two Regulation proposals in the pipeline and at the time of writing under discussion in the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI Committee). In this article we examine if the proposed Regulation for medical devices will deliver on the promises. We will focus on what we know to be the hot topics for industry. Since the article is forward- looking about draft legislation currently in the legislative process, it is by necessity speculative on points and the proposals may have changed by the time this article is printed.

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles–based approach, contrasting this with traditional rule–based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Research in lifestyle risks is becoming more and more important, particularly with reference to what is generally known as “unhealthy diets”. The Law is now firmly established as a prominent instrument of Public Health. There are several distinctive methods of legal intervention targeted at counteracting overweight and promoting healthier lifestyles. In this paper we examine several measures that have been adopted and discuss whether Law should foster healthy diets. Our purpose is to examine the threats of falling into a paternalistic attitude when devising any regulatory intervention aimed at promoting a healthier lifestyle.

Harmonization is an essential instrument of international risk governance. It is the process through which disparities among national regulatory standards are ironed out, producing uniform outcomes that all participants in a regime can accept and that facilitate the free exchange of regulated goods in commerce. Contrary to conventional belief, however, harmonization requires not only technical but also political cooperation, since standards themselves are not direct mirrors of reality but are co-produced responses to technoscientific and political uncertainty. Attempts to harmonize standards across national borders therefore pit alternative political cultures and their systems of public reasoning against one another. Put differently, harmonization calls into question the underlying models of subsidiarity that provide the foundation for robust international regimes. This paper examines three models of epistemic subsidiarity – coexistence, cosmopolitanism, and constitutionalism – and discusses each scheme's capacity to protect a nation's fundamental political commitments while advancing the goals of international risk governance.

Although scholars have described and commented on the European New Approach to standardisation principles, they have paid much less attention to the ways in which this innovative process and its follow-on, i.e. the Global Approach, have been implemented. In many cases, this comes through the day-to-day activity of a very specific population of European experts, the notified bodies. Notified bodies, whose role it is to certify that products, for a given sector, comply with the essential safety requirements set out in the corresponding directive, originate from the Member States, but also compete against each other within a European certification market. This article examines the technical and political difficulties encountered by the Commission and the Member States in ensuring both the independence and the competences of these certifiers. It describes and questions the organisational architecture devised in response to these problems.

Member States wishing to cultivate genetically modified organisms (GMOs) have always been a minority in the EU. Only eight out of twenty-seven have experienced transgenic agriculture. Throughout the years, the opposition to this form of farming has become a genuinely transnational phenomenon given that many regions of different European countries declared themselves GMO-free. Moreover, Member States such as Austria, Luxembourg, Greece, Poland and, most recently, Hungary officially banned transgenic agriculture within their borders altogether. France and Germany suspended the cultivation of GM maize MON 810, respectively in 2008 and 2009.

In addition, the EU has previously authorized only two GM crops: GM maize MON 810 (authorization renewed in 2008) and GM potato EH92-527-1 (2010), known as the ‘Amflora potato.’ The cautious approach towards transgenic farming is also witnessed by the long and contested process of renewal of the permit to cultivate GM maize MON 810 and the issue of the authorization for the Amflora potato.

The Transatlantic Trade and Investment Partnership (“TTIP”) has been hailed as an opportunity for the world's two largest consumer markets to expand inter- regional trade, investment and jobs, and to secure greater regulatory convergence that could considerably reduce costly and market-distorting extra-territorial non-tariff regulatory trade barriers. As fears of potential adverse effects on the World Trade Organization’s multilateral trading system have abated after the Doha round stalled, the initiation of the TTIP has been welcomed by the business communities on both sides of the Atlantic.

Notwithstanding the anticipated benefits, questions arise with respect to both the way the negotiations are conducted and the topics covered. The TTIP negotiating mandate covers three main elements: (i) market access, (ii) regulatory convergence, and (iii) trade rules addressing shared global challenges.

This study focuses on the role of the discount rate in cost–benefit analysis (CBA) of regulation, providing a systematic investigation into regulatory practice vis–à–vis the existing economic theories. In the first part, a quick survey of the main economic literature on the social discount rate (SDR) is presented. In the second part, the current institutional practice is investigated, firstly comparing the recommendations on discounting issued by institutional actors in the US (Office of Management Budget, Environmental Protection Agency) and the EU (Commission), and secondly examining the SDRs adopted in two samples of CBAs selected among Regulatory Impact Analyses of US EPA and Impact Assessments of EU Directorate–General for the Environment. A gap exists between economic theory and institutional practice in the selection of the SDR. Regulatory decisions which are based on CBA reflect the most workable economic literature on discounting rather than the most theoretically consistent one, thus yielding less reliable and less robust results. Scholars who aim at improving the quality of rule–making and at fostering the application of CBA in regulatory decisions should improve the “operational validity” of their research, thus providing practitioners with methods that are both consistent and workable.