¹ For the purposes of this review, I refer to GE or GEOs in the subsequent discussion as reflecting the book’s approach. The sole exception herein is when discussing the EU’s approach to new genomic or breeding technologies, where it is necessary to distinguish between the core genetically modified organism (GMO) regime and the legal developments arising regarding these new technologies.

² In other words, a pure or abstract version, helpful for analysis, but unlikely to be in existence in this form in practice.

³ GC Leonelli, Transnational Narratives and Regulation of GMO Risks (Oxford, Hart Publishing 2021) p 1.

⁴ ibid, 16.

⁵ Socially acceptable risks are fundamental to the determination of whether the product or process is “sufficiently safe” and thereby to the counter-hegemonic narrative, as seen at ibid, 12.

⁶ ibid, 14–15.

⁷ ibid, 2. Similarly, ibid, 30.

⁸ ibid, 9, 51–54,

⁹ PC Jessup, Transnational Law, Storrs Lectures in Jurisprudence at Yale Law School (New Haven, CT, Yale University Press 1956).

¹⁰ Eg P Zumbansen, “The Incurable Constitutional Itch: Transnational Private Regulatory Governance and the Woes of Legitimacy” in M Helfand (ed.), Negotiating State and Non-State Law. The Challenge of Global and Local and Legal Pluralism (Cambridge, Cambridge University Press 2015).

¹¹ Eg GC Leonelli, “The Postmodern Normative Anxiety of Transnational Legal Studies” in P Zumbansen (ed.), The Oxford Handbook of Transnational Law (Oxford, Oxford University Press 2021).

¹² In particular, the potential “opt out” for Member States regarding GMO cultivation is a rare example of partial de-harmonisation in the EU, where progressive harmonisation is the norm – even if not “proper de-harmonisation”, as noted by Leonelli, supra, note 3, 174.

¹³ ibid, 10.

¹⁴ ibid, 138–44. However, as Leonelli rightly points out in the subsequent pages, there is a significant disconnect between the regime’s treatment of OLFs (and scientific uncertainty) on paper and how they are considered in practice.

¹⁵ Eg ibid, 164.

¹⁶ Eg ibid, 173.

¹⁷ ibid, 172–75. See similarly regarding the fragmentation of the authorisation system: L Petetin, “Managing novel food technologies and Member States’ interests: shifting more powers towards the Member States?” in M Varju (ed.), Between Compliance and Particularlism: Member State Interests and European Union Law (Berlin, Springer 2019). See, however, the current proposals noted in the final paragraph of this review.

¹⁸ Eg D Vogel, The Politics of Precaution: Regulating Health, Safety and Environmental Risks in Europe and the United States (Princeton, NJ, Princeton University Press 2012).

¹⁹ Eg M Weimer, “Applying Precaution in EU Authorisation of Genetically Modified Products – Challenges and Suggestions for Reform” (2010) 16 European Law Journal 624; M Weimer, “Risk Regulation and Deliberation in EU Administrative Governance – GMO Regulation and its Reform” (2015) 21 European Law Journal 622.

²⁰ Eg JB Wiener, “Whose Precaution After All? A Comment on the Comparison and Evolution of Risk Regulatory Systems” (2003) 12 Duke Journal of Comparative and International Law 207; JB Wiener et al (eds), The Reality of Precaution. Comparing Risk Regulation in the United States and Europe (Abingdon, Routledge 2011).

²¹ Eg see Leonelli, supra, note 3, 13 and GC Leonelli, “Transatlantic Divergencies in the Regulation of Uncertain Risks: Co-Production, Normative Frames and Ideal Evidence-Based and Socially Acceptable Risk Approaches” (2022) 23 German Law Journal 769, at 777.

²² D Vogel, “Ships Passing in the Night: GMOS and the Politics of Risk Regulation in Europe and the United States”, INSEAD: Centre for the Management of Environmental Resources Working Paper 2002 https://sites.insead.edu/facultyresearch/research/doc.cfm?did=975.

²³ Although, even in the GE context, this is a clear oversimplification, as demonstrated by Leonelli’s examination of the opt-out system and the variations across and within the EU.

²⁴ See supra, note 21.

²⁵ Leonelli raises this very issue regarding the approach to the pandemic and vaccine hesitance, conspiracy theorists, etc., in a subsequent journal article: Leonelli, supra, note 21, 798–99.

²⁶ Leonelli, supra, note 3, 35, 277.

²⁷ Yet, see the final paragraph below regarding very recent EU legislative proposals.

²⁸ Eg Leonelli, supra, note 3, 274–75.

²⁹ M Dobbs, “Co-existence of GMOs in the EU – A Veritable Choice for Whom?” in M Cardwell and J McMahon (eds), Research Handbook on EU Agriculture Law (Cheltenham, Edward Elgar 2015).

³⁰ Eg AG Léger, in his Opinion of 3 March 2005 in Case C-132/03, Ministero della Salute v Coordinamento delle Associazioni per la Difesa dell’Ambiente e dei Diritti degli Utenti e dei Consumatori (Codacons) [2005] ECR I-416 at paras 81–82, indicated that the reasonable consumer might expect slight impurities or foreign substances in food, especially as the “contamination of the environment by GMOs is a well known phenomenon”.

³¹ EC – Measures Affecting the Approval and Marketing of Biotech Products, Panel Report (adopted 21 November 2006) WT/DS291, WT/DS292, WT/DS293.

³² Note, however, the developments regarding the related “new genomic techniques” below.

³³ Eg M Dobbs, “Genetically Modified Crops, Agricultural Sustainability and National Opt-Outs – Enclosure as the Loophole?” (2017) 54(4) Common Market Law Review 1093–122.

³⁴ Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625, COM(2023) 411 final, p 8 in the Explanatory Memorandum mentions patenting as an issue of concern for stakeholders.

³⁵ Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625, COM(2023) 411 final.

³⁶ Leonelli, supra, note 3, 127–29.

³⁷ Case C-528/16, Confédération Paysanne and Others v Premier Ministre and Ministre de l’Agriculture, de l’Agroalimentaire et de la Forêt, EU:C:2018:583.

³⁸ The Commission claims that this does not roll back on their approach to GMOs, as it considers GMOs and outputs from NGTs to be distinct: eg see the Commission’s FAQs on the new proposal https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568, where the response to Q14 includes the line that “[t]he new rules concern NGTs only, which are distinct from GMOs”. However, that is from only one perspective, and there remain considerable similarities and overlaps where one might expect similar regulatory regimes and references to elements such as the precautionary principle.