EU Regulation of GMOs

EU Regulation of GMOs

Law and Decision Making for a New Technology

Biotechnology Regulation series

Maria Lee

This book explores the EU’s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts.

Chapter 4: Living with GMOs (1): Coexistence, Liability and Labelling

Maria Lee

Subjects: environment, biotechnology, environmental law, law - academic, biotechnology and pharmaceutical law, environmental law, european law, regulation and governance


INTRODUCTION The regulatory story of GMOs does not begin or end with authorisation.1 GMOs are cultivated and marketed in a particular legal context, and that context provides the social conditions for the development of the technology. The suitability of the rules applying to GMOs after authorisation is likely to feed into the acceptability of authorisation, and indeed authorisation decisions are incomplete if they are not made in the context of a reasonably predictable post-authorisation framework. But at the moment, that framework is difficult to pin down. This chapter examines three important and interrelated aspects of the legal environment in which GMOs will be grown and sold in the EU: coexistence, liability and labelling. Chapter 5 continues this theme, examining the application of patent law to GMOs. It is common to see these questions presented as if they were purely technical legal issues, amenable to incremental development and neutral application by experts. In fact, they are subject to profoundly political choices, determining the distribution of costs, benefits, risks and uncertainties. As such they should be the subject of normative debate in exactly the same way as any other part of the regulatory framework. Total isolation of GM material, certainly once agricultural biotechnology is widespread in the EU, is impossible. There will inevitably be some level of mixing between GM and non-GM material, through a variety of means, including natural cross-pollination by wind or insects, the survival of GM ‘volunteers’, and mixing by farm machinery, or in storage, distribution or processing. Those...

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