Engineered Living Materials (ELMs) have emerged as one of the most promising and conceptually disruptive technological developments at the intersection of biotechnology, materials science, and engineering. Over the past decade, they have attracted growing attention from researchers, policymakers, and funding bodies, culminating in high-profile recognition such as recognition among the Top 10 Emerging Technologies of 2025 by the World Economic Forum by the OECD in its forecasting as a foundational technological development that will reach maturity in the next 5-10 years. Within the European Union, the European Innovation Council has explicitly identified ELMs as a strategic priority, supporting their development through targeted funding initiatives aimed at positioning Europe at the forefront of this still-nascent technological domain. At the same time, ELMs challenge the conceptual and institutional foundations of existing regulatory frameworks. By integrating living cells into functional materials, ELMs blur traditional distinctions between products and processes, organisms and objects, and biological and industrial systems. Many ELMs rely on genetic engineering, often through new genomic techniques such as CRISPR-based mutagenesis, placing them squarely within the scope of European Union legislation governing genetically modified organisms (GMOs) and genetically modified microorganisms (GMMs). These regulatory regimes, however, were largely designed in the late 1990s and early 2000s with agricultural biotechnology and food safety in mind. The central question addressed in this study is therefore whether the current EU regulatory framework is capable of accommodating ELMs in a way that ensures safety while also fostering innovation and investment. The book adopts an interdisciplinary methodology to assess how this regulatory framework interacts with the development of ELMs. Doctrinal legal analysis is used to map the scope, structure, and internal logic of EU legislation governing GMOs, GMMs, food law, medicinal products, and environmental release. This is complemented by an economic analysis based on real options theory, which examines how regulatory uncertainty, approval delays, and compliance costs affect incentives to invest in ELM-related innovation. By combining these approaches, the authors aim to move beyond abstract legal interpretation and to assess how regulation operates in action, particularly from the perspective of innovators and investors.

Offers a guide to placing on the market of ELMs Presents the first assessment of EU ELM regulation Deals with the economic assessment of investments in ELMs

Autorentext

Kai P. Purnhagen is Full Professor and Director of the Research Center for German and European Food Law at the University of Bayreuth. He works in EU Law, International Economic Law and the interdisciplinary and comparative analysis of law, with emphasis on innovations in food markets. He studied law at the Justus-Liebig-University Gießen. He continued as LL.M. Fellow at the University of Wisconsin-Madison, before he obtained a PhD at the European University Institute in Florence. He undertook a Post-doc at the University of Amsterdam and at the Ludwig-Maximilians-University Munich, before he was appointed Assistant and Associate Professor in Law at Wageningen University. Justus Wesseler is the chair of the agricultural economics and rural policy group at Wageningen University. He graduated with a degree in agricultural, environmental, and natural resource economics from the University of Göttingen. His research is on bioeconomy economics and policy, including value chains and regulatory economics. He focuses on the contribution of the circular bioeconomy towards sustainable development.

Inhalt

Introduction.- Terminology and Methodology.- GMOs and GMMs Regulation in the EU.- Application of GMOs and GMMs Legislative Framework to ELMs.- Ethical Considerations.- Economics.- Regulatory Options.- Conclusion.