How innovation-friendly is the EU Novel Food Regulation? The case of cellular agriculture

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Reinhardt, Tilman ; Monaco, Alessandro:
How innovation-friendly is the EU Novel Food Regulation? The case of cellular agriculture.
In: Future Foods. Bd. 11 (2025) . - 100574.
ISSN 2666-8335
DOI: https://doi.org/10.1016/j.fufo.2025.100574

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Abstract

The Novel Food Regulation provides the central legal framework for regulating food innovation in the European Union (EU). Its suitability for transformative innovation, such as cellular agriculture, has recently come under intense political and scientific scrutiny. This paper systematically analyzes how the Novel Food Regulation affects the development of cellular agriculture in the EU. It employs an original analytical framework that captures its influence on the functionality of the innovation system as well as the potential for “legal disruption” caused by technological development. It triangulates a detailed legal analysis with empirical data, collected through EFSA's stakeholder consultations, expert interviews, as well as an original stakeholder survey. Results show mixed effects of the regulation on the innovation system for cellular agriculture: whilst the transparent and robust procedures by EFSA contribute to knowledge diffusion and legitimation, the complex authorization process hampers entrepreneurial experimentation, resource mobilization and market formation. The regulation's narrow focus on food safety and the potential for political interference in the authorization process create a risk for “legal disruption”. We argue that the creation of well-designed “regulatory sandboxes” could facilitate the identification of solutions that actually contribute to food system sustainability and innovation, without compromising food safety.