Risk Regulation In The Internal Market

This book offers a topical inquiry into the legal and political limits of EU regulation in the field of risk and new technologies surrounded by techno-scientific complexity, uncertainty, and societal contestation. It uses agricultural biotechnology as a paradigmatic example to illustrate the complex intertwinement between environmental, public health, economic and social concerns in risk regulation. Weimer analyses the drawbacks of the EU approach to agricultural biotechnology showing that its reductionism, i.e. the narrow understanding of GMO risks as well as the exclusion of broader societal concerns related to environmental and social sustainability, has undermined both the legitimacy and effectiveness of EU regulation in this area. Resistance to this approach however has also triggered legal innovations prompting us to re-think EU internal market law, including the way in which it manages the tensions between unity and diversity, and between social and economic concerns. This text offers fresh and original insights into how far the EU can go in harmonizing regulatory approaches to risk. At the same time, it proposes new ways of re-thinking EU risk regulation to make it more responsive to different perspectives on risk and technology. A unique feature of this book is that it contributes to various strains of scholarship including risk regulation, internal market law, public administration, and studies of governance and regulation, as well as connecting these themes to broader debates about the legitimacy of European integration and new ways of differentiated integration. As a result it assists in re-imagining the EU internal market and its regulation as a site of diversity.

This book demonstrates how the Thalidomide catastrophe of the 1960s and the BSE crisis of the 1990s led to regulatory regimes for pharmaceuticals and foodstuffs in Europe. However, the developmental paths of these regimes differ – and so does the efficiency and legitimacy of regulatory policy-making.

This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.

'At times when so much attention is devoted to the constitutional architecture of the European Union via Treaty amendments or supplements in the aftermath of the Euro-crisis, the core business of European market building through harmonization is all too often neglected. It deserves strong recognition that Isidora Maleti forcefully brings Art. 114 TFEU back to the agenda. Her competent study provides new insights into the major competence rule which still forms the back bone of European Integration. The constant strive of the EU for embarking on non-trade policies against the half-hearted resistance of the Member States deserves indeed a major study, spelling out the details of the rather complex article. Her comprehensive analysis detects the amazing potential of Art. 114 TFEU as a tool to co-ordinate differences in the understanding of what might be a "high level of protection" and it allows for new ways of co-operation between the EU and the Member States. This finding, which is backed through the analysis of the ECJ case law and the notification procedure of Art. 114 TFEU fits into the overall debate on constitutional pluralism which stays away from a hierarchical understanding of the relationship between the EU legal order and the Member States.' – Hans Micklitz, European University Institute, Italy 'This book is essential reading for anyone seeking an up-to-date and critical understanding of the success of the European Union's approach to market harmonisation.' – Veerle Heyvaert, London School of Economics, UK 'Despite all the buzz around the single currency, the heart of the EU edifice remains the internal market. Isidora Maleti 's book is an outstanding contribution of original scholarship that makes this edifice look more solid than ever. By exploring the theory and practice of the archetype legal basis for EU regulatory action, this book dispels the ubiquitous claim that national derogations from European standards are reflective of a weak integration process and convincingly argues that national regulatory differentiation may instead provide opportunities for reflexive learning and risk prevention. The law and policy of harmonisation is European internal market's scholarship at its best and ought to be essential reading to all scholars interested in the dynamics of EU integration.' – Alberto Alemanno, HEC Paris, France and Editor, European Journal of Risk Regulation This innovative book explores the constitutional compromise between the European Union's legislative competence and member states' regulatory autonomy, and analyses the reconciliation of economic integration and welfare protection within the European internal market. It does so through the original lens of article 114 TFEU, the law-making clause underlying the European harmonisation process. Focusing on a critical provision and the controversial derogation mechanism contained therein, the book discusses contemporary, universally fundamental topics, such as risk assessment and related responsibility allocation within the constraints of complex legal frameworks, the preservation of regional regulatory autonomy against the background of centralised legislative norms, and the interaction of economic integration with policy interests like consumer, environmental and health protection. Highlighting the collaborative rather than adversarial value of national deviations from common European measures, the study not only complements the literature available on 'negative integration' of the internal market, but also challenges traditionally accepted axioms, revealing opportunities for risk prevention and legitimacy enhancement stemming from diverse European and national regulatory standards. This detailed book will be of wide international appeal to academics, practitioners, students, judges, policy-makers and officials working within the European Union and government representatives of individual member states, as well as anyone more generally interested in the dynamics of EU integration.

This book takes a completely new and innovative approach to analysing the development of EU law. Within the framework of different important areas of EU law, such as the internal market, consumer protection law, social law, investment law, environment law, migration law, legal translation and terminology, it examines the Union’s approach to the regulation and management of legal risks. Over the years, the Union has come to a point where it is becoming increasingly difficult to justify its authority to regulate in various areas of law. In managing legal risks deriving from the diversity of Member States’ laws, which create barriers to trade and hinder the Union’s economy, the Union itself has actually produced new legal risks that now have to be addressed. This failure on the part of EU institutions to manage legal risks has contributed to legal uncertainty for actors operating on the internal market. This book intends to contribute to the Union’s smoother functioning and continuing development by proposing effective concrete solutions for managing the legal risks distorting the development of various areas of EU law. It pursues an innovative and effective approach to identify legal risks, their causes at the EU level and their impacts on the functioning of the Union and its Member States. By presenting new approaches in this context, the first book on legal risk management in the EU will actively promote the improvement of the EU lawmaking process and the application of EU law in practice.

This book offers a topical inquiry into the legal and political limits of EU regulation in the field of risk and new technologies surrounded by techno-scientific complexity, uncertainty, and societal contestation. It uses agricultural biotechnology as a paradigmatic example to illustrate the complex intertwinement between environmental, public health, economic and social concerns in risk regulation. Weimer analyses the drawbacks of the EU approach to agricultural biotechnology showing that its reductionism, i.e. the narrow understanding of GMO risks as well as the exclusion of broader societal concerns related to environmental and social sustainability, has undermined both the legitimacy and effectiveness of EU regulation in this area. Resistance to this approach however has also triggered legal innovations prompting us to re-think EU internal market law, including the way in which it manages the tensions between unity and diversity, and between social and economic concerns. This text offers fresh and original insights into how far the EU can go in harmonizing regulatory approaches to risk. At the same time, it proposes new ways of re-thinking EU risk regulation to make it more responsive to different perspectives on risk and technology. A unique feature of this book is that it contributes to various strains of scholarship including risk regulation, internal market law, public administration, and studies of governance and regulation, as well as connecting these themes to broader debates about the legitimacy of European integration and new ways of differentiated integration. As a result it assists in re-imagining the EU internal market and its regulation as a site of diversity.

Animal cloning, nanotechnology, and genetic modifications are all examples of recent controversies around food regulation where scientific evidence occupies a central position. This book provides a fresh perspective on EU scientific food safety governance by offering a legal insight into risk analysis and the precautionary principle, positioned as general principles of EU food law. To explain what the science-based requirement means in EU multi-level governance, this book places these principles in the legislative dynamics of the EU internal market and the meta-framework of the international trade regime established by the WTO. Numerous examples of the case-law of European Courts show implications of risk analysis and science-based food law for EU and national decision makers, as well as food businesses. This book focuses on the crucial aspects of the risk analysis methodology. It redefines the precautionary principle and clarifies its scope of application. It analyses the extent to which non-scientific factors, such as consumers' risk perception, local traditions or ethical considerations, can be taken into account at national and EU level. This book argues that, compared to EU institutions, the autonomy allocated to national authorities is much more limited, which raises questions about the legitimacy of food safety governance in the EU.

This book examines the increasing role of the legal method of systematisation in European Union (EU) law. It argues that the legal method of systematisation that has been developed in a welfare-state context is increasingly used as a regulative tool to functionally integrate the market. The book uses the example of EU product regulation as a reference to illustrate the impact of systematisation on EU law. It draws conclusions from this phenomenon and redefines the current place and origin of systematisation in the EU legal system. It puts forward and demonstrates two main arguments. First, in certain sectors such as in EU product safety law, the quality of EU law changes from a sector-specific and reactive field of law to an increasingly coherent legal system at European level. Therefore, instead of punctual market intervention, it increasingly governs whole market areas. By doing so, it challenges and often fully replaces the respective welfare-based legal systems in the Member States for the benefit of the ideal of a market-driven EU legal system. Second, at European level, the ideal is in development. This illustrates the change of the function of Statecraft from nation-states to market-states.​