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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 at the national and European levels. 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.The book is based on a PhD thesis that was awarded with the 2008 UACES Prize for the Best Thesis in European Studies in Europe and with the EPEES 1st Prize for the Best Thesis written by a Greek Researcher between 2004 and 2008.