October 28
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Context of the book

The analysis of the book ‘Risk regulation in the internal market: Lessons from agricultural biotechnology’ by Maria Weimer (Oxford Studies in European Law, 2019) shall be inserted in the framework of the Anthropocene, where the increasing convergence between digital, biological, and physical technologies is creating new global risks and is exacerbating the existing ones. We live in a society of risks. In this context, there is a growing expectation that public regulators intervene to protect people from risks to health, safety, and the environment. However, risk regulators are facing two significant problems, which may undermine the effectiveness and legitimacy of their decisions. One the one hand, they have to overcome the epistemic problem of deciding in situations of incomplete, uncertain, and rapidly changing technoscientific knowledge. On the other hand, they have to meet the political challenge of adequately responding to the social, cultural, and value dimensions of technological innovations, ensuring that the regulation is socially acceptable.

Aims of the book

In this context, the book offers an in-depth inquiry into EU regulation of risks surrounded by technoscientific complexity, uncertainty, and societal contestation. To do so, the author uses the example of agricultural biotechnology, which is the use of genetic engineering or genetically modified organisms (GMO) in modern agriculture. This case study is of particular interest because, as the author underlines, agricultural biotechnology constitutes a wicked problem, due to the complex and intertwined issues arising from the use of this technology, which lies at the nexus between the modern food and agriculture system, environmental degradation, human health, and social justice. By using an interdisciplinary methodology (which combines legal analysis with insights from political science), the purpose of the book is to analyse the legal and political limits of EU regulation in the field of agricultural biotechnologies. By doing so, the book touches upon some fundamental questions about the relationship between, on the one hand, science, democratic politics, and law, and on the other hand, EU and national authority.

Structure of the book

The first chapter of the book lays the foundation for understanding risk regulation in general (Chapter 1). The second one provides an analysis of the evolution and challenges of EU risk regulation in the internal market (Chapter 2). Chapters 3 and 4 contain a critical assessment of the EU legal framework for GMO authorisation (Chapter 3) and its implementation in practice (Chapter 4). Chapters 5 and 6 focus on the law and governance of GMO post-authorisation, with a concluding section.

Findings of the book

The book brings to light the severe limitations encountered by EU regulation of GMOs. First, the EU struggles to adequately legitimise its decisions based on the narrow mandate contained in Article 114 TFEU. Indeed, the reference to the economic dimension of the risk – which is assessed and managed for the purpose and within the limits of the construction of the internal market – reduces the EU’s capacity to respond to the political, cultural, and value dimensions of risk and technology. Second, the Commission’s risk management of GMOs is characterised by the failure to achieve a balanced deliberative form of decision-making able to reconcile the scientific and political legitimacy.

To overcome these drawbacks, the book makes three proposals. At the legislative level, the book underlines the need for legislative reform that reinforces deliberation and cross-policy coordination in the field of EU risk regulation. At the administrative level, the book considers it appropriate to re-think the role of the Commission as the main administrative decision-maker. Indeed, the Commission, while being granted wide discretionary powers to take controversial decisions on risk and technology, lacks the necessary political authority to legitimise its choices. At the societal level, the book reveals the need for a broader societal debate about modern agriculture and food production that openly confronts questions of safety and sustainability.

Perspectives of the book

The book provides a rigorous, comprehensive, and original analysis of the limits of risk regulation in the EU internal market in relation to a recent and controversial case study, like agricultural biotechnology. From this perspective, the regulation of GMOs could be a source of inspiration for the management of other uncertain risks under EU law. Indeed, as the author underlines, risks issued from agricultural biotechnology share essential features with other uncertain risks, like nanotechnologies, chemicals, pesticides, and endocrine disruptors. As a potential perspective of this book, it could be interesting to understand if the limitations and drawbacks concerning EU regulation of GMOs also apply to the regulation of these other uncertain risks.


Alessandra Donati is Senior Research Fellow at the Max Planck Institute for procedural law in Luxembourg. She is a doctorate of law at the University Paris 1 – Pantheon Sorbonne, with a thesis on the precautionary principle under EU law, and an Attorney at law in Italy and France.


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