© 2018

EU Policy-Making on GMOs

The False Promise of Proceduralism

  • Provides a thorough analysis of the development and operation of European risk governance of GMOs

  • Highlights the shortcomings, dynamics and contradictions of the EU’s regulatory framework

  • Offers a long-needed but also timely account of the GMO 'problem' by bringing together its historical development, institutional features, conceptual assumptions and operational practice

  • Examines the efficacy of the Deliberate Release Directive in its current institutional form

  • Will appeal to actors involved in the design and analysis of risk regulatory frameworks in Europe


Table of contents

  1. Front Matter
    Pages i-xv
  2. Mihalis Kritikos
    Pages 1-27
  3. Mihalis Kritikos
    Pages 301-332
  4. Back Matter
    Pages 333-341

About this book


‘A critical analysis of the complex scientific, legal, and ethical challenges faced by the decision-making bodies of the European Union in governing the planting of GM crops. It is a fascinating case-study of the politics of risk management in Europe.’
David Vogel, University of California, Berkeley, USA

 ‘This book will command the attention of policy-makers and academics not just in this field but of that of wider EU risk regulation. It is a must-read.’

—Damian Chalmers, the National University of Singapore and the London School of Economics and Political Science, UK

 ‘A masterful analysis of how existing institutions shape the regulation of new technologies.’

—Calestous Juma, Harvard University, USA


This book examines the development and implementation of the EU’s legislative framework on the commercial release of GMO products as a case study of social regulation operating within a predominantly technical framework. The analysis and findings are based on an extensive documentary analysis and interviews with regulators, risk assessors, public interest groups and biotechnology experts. It argues that in the case of the EU biotechnology framework, the particular institutional settings created for the formulation and interpretation of its provisions have been of decisive importance in elaborating a proceduralised ‘science-based’ prior authorization scheme as the preferred framework for granting commercial permits. This interdisciplinary work will appeal to EU lawyers, decision-makers and risk managers as well as academics working in the fields of EU studies, politics, law, risk governance, sociology of science/risk and technology assessment.


Mihalis Kritikos is Research Fellow at the Law, Science, Technology and Society research group at the Faculty of Law and Criminology, and Associate Researcher at the Institute of European Studies, Vrije Universiteit Brussels (VUB), Belgium, and a Fellow at Athens Public International Law Center (PIL), Greece. 

This book is based on a PhD thesis that was awarded the 2008 UACES Prize for Best Thesis in European Studies in Europe and with the EPEES 1st Prize for Best Thesis by a Greek Researcher (2004-2008).


genetically modified organisms GMO EU policy-making GMO authorisation procedure in the EU European Commission GMO science democracy dichotomy agricultural biotechnology genetic engineering GMO biosafety research GMO environmental risks EU legal framework on genetic engineering European agricultural biotechnology licensing GMOs public health and the environment agricultural biotechnology regulatory affairs EU regulatory governance Directive 2001/18/EC EU legislative framework historical institutionalism proceduralism in the European Commission deliberate release directive

Authors and affiliations

  1. 1.LawVrije Universiteit BrusselBrusselsBelgium

About the authors

Mihalis Kritikos is Research Fellow at the Law, Science, Technology and Society research group at the Faculty of Law and Criminology, and Associate Researcher at the Institute of European Studies, Vrije Universiteit Brussels (VUB), Belgium, and a Fellow at Athens Public International Law Center (PIL), School of Law, University of Athens.

Bibliographic information

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“This book provides a detailed and rigorous analysis of a topical area that straddles law and science. Its institutional focus sheds new light on the EU’s regulation and management of biotechnology. Theoretically informed and with a keen interest in practice, this insightful study should be read by lawyers, policy-makers, and scientists.” (Panos Koutrakos, Professor of EU Law and Jean Monnet Professor of EU Law, City, University of London, UK)

“This fascinating and compelling volume explores the transnational regulation of technological risks with a focus upon the European Union’s evolving framework for the governance of genetically modified organisms. The volume offers a clear-sighted and critical account of this framework and offers sensitive and insightful proposals for reform to assist in transcending the science–democracy divide.” (Joanne Scott Professor of European Law, University College London (UCL), UK)

“This close-up study of the inner workings of the European Commission when dealing with the uncertain technological and environmental risk of agricultural GMOs is revealing and gives rise to a result that may be disturbing to some: when a public administration accords experts a special role as advisers, the political nature of expertise and the intertwining of facts and values come to light. And when administrations are not reflexive about this, the politics around science-based decision-making may become intractable. Kritikos delivers a strong argument that institutions matter for delivering outcomes. He elaborates this instructively for the EC’s Deliberate Release Directive.” (Arthur Petersen Department of Science, Technology, Engineering and Public Policy (STEaPP), University College London (UCL), UK)

“Hardly any topic has been so controversial and confusing for the public as the regulation of genetically engineered organisms. The book by Mihalis Kritikos sheds light into this complex situation: He succeeds in proving both a comprehensive and comprehensible analysis of transnational regulation and points to the ambiguities and conflicts but also the legal basis surrounding the debate. The author has to be congratulated for such a thorough, unbiased and still critical report of the regulatory reality. The book is a must for anyone interested in the regulatory debate on contested technologies.” (Ortwin Renn Chair of Environmental Sociology and Technology Assessment, University of Stuttgart and Director of Stuttgart Research Center for Risk, Germany)

“Kritikos’s book is a timely analysis of the dilemma raised by regulatory strategies for the release of genetically modified organisms. The author criticises with good arguments the dominant focus on science-based decisions. He develops instead the creative potential of concepts of “risk management” and “proceduralisation” that still play a minor role in regulatory practice. This is a line of argumentation that is extremely helpful for both practitioners and scholars working on regulatory policies.” (Karl-Heinz Ladeur University of Hamburg, Germany)

“This excellent book provides well-researched and carefully argued insights into the governance of Genetically Modified Organisms in the EU. With a clearly written style, the book gives a dispassionate and solid historical account of the difficulties to balance very different interests and perspectives, and the challenges of current expert-driven institutional practices in EU authorizations.” (Susana Borrás Copenhagen Business School, Denmark)

“The last two decades of EU regulations on genetically modified organisms offer a unique window into the tensions at the heart of European institutions. Mihail Kritikos takes us deep into the dilemmas of policy-makers confronting complex technological objects and unexpected political challenges. In addition to its clear-eyed analysis of the limitations of proceduralism, this is a book full of advice on how regulatory bodies can address controversial technologies in a reflexive and socially responsive way.” (Javier Lezaun Institute for Science, Innovation and Society,University of Oxford, UK)

“Kritikos provides a well written and thorough analysis of the development and operation of European risk governance of GMOs. The focus is on institutional and organisational conditions implemented for the deliberate release framework for GMOs. It describes the challenges emerged related to scientific uncertainties and disagreements, the importance of acknowledging local conditions as natural habitats and different agricultural systems, as well as necessity of including ethical and socio-economic considerations. The book is recommendable for risk assessors, risk managers and risk researchers within the GMO field and emerging technologies. It provides guidance on that risk governance need to move beyond an exclusive focus on expert-driven processes and “hard” scientific facts to provide socially and sustainable regulatory outcomes.” (Anne Ingeborg Myhr Director at GenØk, Centre for Biosafety, Norway)

“This book goes to the heart of how the European Union agreed rules on GMO crops.  Inside the ‘box’, the institutional setting matters: it favours scientific expertise and it leads the EU Commission into drawing false dichotomies, with consequences for the effectiveness and legitimacy of the licensing regime.  The analysis is high quality: showing empirical rigour and conceptual relevance.  It prompts a more critical reflection on the EU regulatory model, with implications that go beyond this sector.” (Prof Kevin Featherstone, AcSS, Head of the European Institute; Eleftherios Venizelos Professor of Contemporary Greek Studies and Professor of European Politics, LSE)

“Agri-food biotechnology is a segment of risk politics of exemplary practical and theoretical importance. The analyses offered are utmost care and in their discussion of the multi-faceted policy debates, legal and transdisciplinary discussion which have to cope with the intricacies of risk debates and the challenges of legitimate transnational, in particular European governance. It arrives at a time in which emotion trumps deliberation, facts are discounted, expertise and practical reason meet with contempt. In that sense it is untimely and outdated. Precisely for the same reason it to be welcomed and praised. This study explains the complexity of our products and their regulatory domestication. It represents the type of argumentation which is at risk and deserves to be defended.” (Christian Joerges, Professor of Law and Society, Hertie School of Governance, Berlin)

“This book is a masterful analysis of how existing institutions shape the regulation of new technologies. Its lessons are relevant for many other fields beyond agricultural biotechnology. Its scholarly rigor and originality are matched by its practical utility for policy makers. I highly recommend for anyone perplexed by the European Union's complex biosafety regime.” (Professor Calestous Juma, FRS, Belfer Center for Science and International Affairs, Harvard Kennedy School, Cambridge, USA)

“Dr. Kritikos has written the most detailed and rigorous account to date that unravels the European Union’s approach to developing a framework on behalf of the EU federation of 28 nations, for regulating genetically engineered crops, which the author rightly describes as “neither linear nor without contradictions.” (Sheldon Krimsky, Lenore Stern Professor of Humanities and Social Sciences, Tufts University)