Regulation of Biotechnological Risks in a Multi-Level System

This book offers an in-depth analysis of the EU regulation of genome edited plants and its compatibility with WTO law and the Comprehensive Economic Trade Agreement (CETA). It analyses in detail whether the EU authorisation procedures, labelling requirements and the EU's opt-out mechanism and its application to genome edited plants are compatible with the EU's obligations under the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), the Agreement on Technical Barriers to Trade (TBT Agreement), the General Agreement on Tariffs and Trade (GATT) and CETA. Based on this analysis, the EU Commission's proposal for a new regulation on plants produced by certain new genomic techniques is discussed. Also, the book provides suggestions to further improve the EU Commission's proposal. The book's analysis is not only relevant for legal researchers in the field of biotechnology and international economic law, but also discusses regulatory aspects that are highly relevant for the scientific and industrial sector involved in biotechnology.

Elisabeth Anna Lümkea Andersen graduated in law from the University of Freiburg in 2018. Already during her studies, she focused on public international law and the interrelations of science and law especially in the field of German and international patent law. From 2018 to 2022, she has been a legal researcher at the Centre for Integrative Biological Signalling Studies, Cluster of Excellence, University of Freiburg. Her research focused on international and EU biotechnology law and its interactions with WTO law and CETA as well as public international law. For her PhD thesis which she realised as part of the CIBSS project, she especially focused on the regulation of genome editing techniques and its application to plants in EU law, WTO law and CETA, also examining the EU Commission's plans to adopt new regulations in this field.