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 7: Conclusions

Maria Lee

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


Three main themes have dominated this book. First, the regulation of GMOs needs to capture factors beyond the almost overwhelming risk rubric, raising in turn questions about the relative roles of the public and of experts in regulation. Whilst important insights on the complexity of decision making in areas of high technological complexity have now been absorbed into the mainstream, actually making this meaningful is proving difficult. Secondly, GMOs force us to consider the appropriate level of authority for decision making, in a context of increasingly globalised scrutiny of domestic regulation. And thirdly, the ‘regulation’ of agricultural biotechnology by no means begins and ends with the procedure for the authorisation of a GMO. Overemphasis of the authorisation process can distract from the distribution of very significant responsibilities, costs and benefits in other areas of law. Realistically, regulation stretches both forwards and backwards from authorisation, and we cannot afford to ignore the legal context in which GMOs exist. These three themes compel the addition of governance questions to the list of possible concerns about GMOs – as well as health, environmental, social, political and ethical concerns, close reflection on the ways in which decisions are taken leaves room for disquiet. The regulation of GMOs is about far more than science, risk and safety. Safety and environmental protection are enormously important and very complex, but so may be the way a technology distributes risk, benefit and power, globally and locally. And new technologies are almost by definition tied up with profound uncertainties that...

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