This paper analyzes the problems of EU risk regulation of agricultural biotechnology through the lens of deliberative theories of EU law and governance, such as deliberative supranationalism and experimentalist governance. Previous research had suggested that the GMO issue is not conductive to deliberation in both Council of Ministers and comitology because of its high politicisation. This paper argues that another equally salient factor is the scientification of the EU authorization process. Scientification stands for the Commission’s overreliance on regulatory science, and therefore on epistemic legitimacy as the sole basis for risk management. Given the deadlock of comitology in this field, scientification is exacerbated by a reversion to top-down regulation by the Commission. As a result, political responsibility for GMO authorisations gets lost. Through an in-depth analysis of both legal rules and institutional practices this contribution reframes the problem of GMO regulation as one of a precarious co-production between scientification and politicisation. It shows that both processes are mutually accelerative ultimately leading to a break down of dialog at EU level. This contradicts the assumption that deliberation is fostered by technocratic ‘behind closed door’ decision-making. In the GMO case the top-down imposition of epistemic authority has only increased politicisation contributing to the de-legitimation of all EU institutions involved in GMO regulation (i.e. European Food Safety Authority, Commission, comitology committees, and Council of Ministers).

This paper explores how far experimentalist features of the EU’s internal food safety governance regime are being extended to the Union’s external governance of food safety. Hence, it analyses whether and how far the Union’s engagement with both third countries and global institutions displays features of experimentalism. Our analysis shows that while the EU constitutes a powerful global standard setter in the field of food safety, its unilateral role is to some extent mitigated by both its cooperative engagement with third countries at the bilateral level and by its embeddedness within multilateral global governance institutions, such as the WTO and the Codex Alimentarius Commission. Furthermore, our analysis of two crucial institutional mechanisms of EU’s external food safety governance, namely the EU Food and Veterinary Office (FVO) and the EU Rapid Alert System for Food and Feed (RASFF) shows that both are designed, and often function well as reflexive institutions with strong features of de-centralised implementation, reporting and peer review, as well as learning and recursive revision of rules. Both FVO and RASFF provide important opportunities for third countries to participate in the Union’s internal governance and rule-making processes. However, reviewing the performance of both institutions in previous food crisis situations, the analysis also reveals some important shortcomings in their practical functioning as experimentalist tools, which calls for the further improvement of these mechanisms.

Against a backdrop of rapidly evolving crisis management in the European financial and sovereign debt crisis this essay aims both to explore and to re-consider the role of law in the EU integration process: What did law accomplish? Where did it fail? What is law going to endure? What kind of future can it envisage? The essay traces back the evolution of the law-politics relationship in both EU legal scholarship and practice from the foundational period of ‘integration-through-law’ to the advent of ‘new governance’ in the EU, and finally to the current deep transformations of EU law in new economic governance and the financial crisis. The centrality of law as ‘both the object and the agent’ of European integration, and the legal enshrinement of EU’s economic constitution has recently neglected the weight of ‘the social’ in the societies of post-war Europe, a failure which was to become detrimental to both domestic social stability and the legitimacy of integration. Attempts to cure Europe’s social deficit by re-conceptualising the notion of law as new governance have widened the theoretical perspective of EU legal scholarship. Yet new governance has not delivered more social democracy and justice in Europe in practical terms, and continues to suffer from the methodological problems of its ‘definition-by-contrast.’ These problems re-emerge in current new economic governance, which Europe’s crisis management is generating. This hybrid arrangement of hard and soft law instruments has, to date, been economically unsuccessful and socially disastrous, especially in the South of Europe. Equally disquieting, the notion of democratic law (either in traditional or experimentalist understandings) has been replaced by a praxis of authoritarian executive managerialism. The essay concludes by sketching out an alternative understanding of law-mediated legitimacy in the integration process, namely ‘conflicts-law constitutionalism’. This approach stresses the normative value of conflicts and pluralism in the process of European integration. Instead of ‘ever more Europe’ it aims to secure the existing democratic credentials of EU law, namely its ability to correct the democratic deficit of the Member States while respecting their constitutional integrity.

Reality is complex, and often does not lend itself to generalization or simplifying explanations. Yet at the same time, explaining reality often requires the shaping of notions and concepts of it through generalization and the reduction of complexity. This tension between complexity and particularity on the one hand and generalization and the search for abstracting explanatory patterns on the other is beautifully illustrated by two recently released publications on precaution and risk regulation in the United States and Europe, namely “The Politics of Precaution” by David Vogel and “The Reality of Precaution” edited by Jonathan Wiener, Michael Rogers, James Hammitt, and Peter Sand. This essay first reviews both books in isolation, and then juxtaposes them, while discussing their relation, relative merits and achievements.

This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory frameworks for scientific innovations in the EU, especially in the area of food safety. It presents a nebulous combination of challenges to devising effective regulation: scientific uncertainty about risks to human health and the environment; strong international trade interest in the free circulation of ‘cloned foods’ on the EU market; and other concerns (e.g. ethics) as well as societal resistance and negative consumer preferences that affect the legitimacy of regulatory approaches. This mix of circumstances has hampered the establishment of new legal rules for animal cloning under the EU Novel Foods legal framework. The analysis of this paper reveals that the establishment of viable EU legal rules in this area has been afflicted with problems due to the complexity and multi-sectoral nature of animal cloning regulation. Moreover, strong pressure from the international trade market and international trade rules has resulted in persistent institutional disagreement over animal cloning. This indicates that legal and political pressure from EU’s external trade partners hampers the willingness and ability of the EU to establish precautionary and responsive risk frameworks.

This paper analyzes the Commission proposal to grant EU Member States more freedom to restrict or ban the cultivation of GMOs on their territory. It argues that this new "flexible" approach to GMO cultivation not only raises concerns from the point of view of EU internal market law, but also is unlikely to solve the problem of Member States’ opposition to the authorisation of new GMOs in the comitology system as reformed following the Lisbon Treaty. The paper concludes that the Commission proposal should mainly be seen as a strategic policy choice. In return for its flexibility the Commission hopes to facilitate the GMO authorisation process at EU level. At the same time it wants to shift the legal and political responsibility for GMO restrictions on to the Member States. Rather than resolving the current problems of GMO regulation, this situation demonstrates once again a political “ping pong” game, in which political leaders at both EU and national level do not feel very comfortable having the final say on whether or not to cultivate GM crops in Europe.

This article endeavours to examine concrete challenges that arise with regard to implementation of the precautionary principle in the field of European Union regulation of genetically modified organisms (GMOs). Developed by the European courts into a general legal principle, precaution requires EU regulators to strike a balance between scientific and political legitimacy when taking decisions on risk-entailing products. Following this understanding, the current GMO legislation creates precautionary governance structures that allow for a broad input into the authorisation process, not only of scientific, but also of ‘other legitimate factors’. At the same time, it can be criticised for narrowly defining precaution as a decision rule, which, if applied correctly, will lead the decision maker to the ‘right’ decision. It is argued that this misconception is one of the reasons why, in the current authorization practice, the EU institutions fail to apply the principle in a balanced way, falling into the extremes of either purely science-based decision making or a highly politicised precautionary rhetoric. The paper suggests that in order not to be paralysing, precaution should be understood as a procedural principle that provides for precautionary governance, thus enabling regulators to make appropriate risk choices

After genetically modified organisms and nanotechnology, EU food regulators are currently facing the challenge of choosing an appropriate policy approach towards animal cloning for food supply. While different regulatory options are being discussed, the ultimate choice of the EU is likely to have ramifications for EU’s compliance with the international legal trade order of the WTO. In this paper I take the EU policy debate as a starting point to outline the main legal issues that future EU regulation on animal cloning could raise with regard to the most pertinent WTO Agreements, the GATT, the SPS Agreement, and the TBT Agreement. I argue that any future legal assessment of EU policy in this area should pay particular attention to the thorough delineation between the scopes of application of these agreements, since the choice of the applicable WTO regime will directly impact on the extent to which the EU enjoys regulatory autonomy to pursue its policy choice. In the light of the recent Panel report in EC-Biotech the applicability of the SPS Agreement also to future EU measures on animal cloning appears likely thereby resulting in strong constraints on EU policy choice. This appears problematic seeing that strong criticism is voiced against the extensive interpretation of the concept of an SPS measure, as undertaken by the Panel in EC-Biotech; and that doubts persist as to whether potential risks related to animal cloning can, in fact, be characterized as sanitary and phytosanitary risks.

This book addresses the question of how to constitutionalize, thus rendering democratically legitimate, post-national administrative governance in the field of EU regulation of genetically modified organisms (GMOs). It does so in an innovative way by exploring the potential of a novel approach to EU constitutionalism, namely of European conflicts-law, to ensure the democratic legitimacy of EU administrative governance in this field. At the same time it employs governance as an analytical framework to analyse the functioning of the GMO regulatory regime in the Union including its on-going reform. The term administrative governance is being used as referring to a system of administrative action, in which EU administrative actors implement EU law in cooperation with national administrations, as well as with scientific and private experts. Hence, the main added value of this book is that it offers a new way of thinking about the democratic legitimacy of administrative risk governance in the EU by bringing together three major academic debates, namely on EU constitutionalism, governance, and risk regulation. In this way, it offers fresh insights for a broad audience of academics, policy-makers, and practitioners working in these fields.