Contextual comparative remarks on a sustainable European regulatory model for synthetic biology in agri-food area

Synthetic biology contributes to implement food security and global environmental sustainability notwithstanding the problems of limited knowledge in the uncertainty assessment. Concerns focused not only on how to manage «technological risks» which, unlike simple risks (e.g. car accidents), not be calculated according to traditional technocratic models, namely as a statistically foreseeable function of probability. Worries also regard how to consider public perceptions and food culture for the acceptance of a specific model of food governance. Thus law and regulation can successfully respond and adapt to biotech progress integrating both legal and non-legal tools (e.g. nudging mechanisms; education). To address these challenges, the current analysis restrains to European law to investigate the interplay of different regulatory models (product-directed regulation vs. process-based one) and different approaches (precautionary vs. substantial equivalence principles) inherent in the agri-food biotechnology stringent legislation at the light of the European Court of Justice jurisprudence. Findings will lead to express some critical remarks toward the factors that prevent the development of an appropriate regulatory environment in a critical area that has undergone by several legitimacy crisis, and where contextualization proved being pivotal in transplanting legal models. For this purpose, from a methodological point of view, the analysis aims at developing a contextual approach that seeks to engage with real-world issues and takes a practical perspective, following the path of contemporary comparative legal scholarship. Finally, the comparison offers some food for thought toward the «sustainable ingredients» of a successful regulatory model promoting biotech foods respectful of traditions and vice-versa. These will be some preliminary key attitudes for designing an effective and socially desirable biotech regulation, coherent to balance the EU innovation goal and cultural food policy.