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Risk Triggers as Innovation Triggers? Risk analysis and innovation's promotion under the Novel Food Regulation

Alessandro Monaco, Kai P. Purnhagen


Regulation (EU) No. 2283/2015 on novel foods (NFR) defines the legal framework applicable to the majority of food innovations in the European Union. Following a risk analysis approach, the NFR requires pre-market authorization for foods not available on the European market before 1997, to assess the potential threats to human health and consumers' interests. The NFR’s regulatory scope requires identification of certain factors which constitute a presumption of risk in innovative products and processes. We refer to such factors as “risk triggers”. This paper shows that 'Legal Novelty' and 'Unnaturalness' are the main risk triggers associated with novel foods, even though the link between 'Legal Novelty' and 'Unnaturalness' and a clear risk for consumers' interests, human health or the environment is not evident per se. Novel foods, compared to non-novel food products, are thus subject to additional regulatory requirements investigating their safety. Benefits derived from their market entry and adoption are therefore delayed, or even lost. As a consequence, the innovation process in the food sector, which we identify as an implicit objective of the NFR, is potentially hindered.

Alessandro Monaco, Lecturer, Junior Researcher and Ph.D. Candidate, University of Bayreuth Faculty VII. For Correspondence: <alessandro.monaco@uni-bayreuth.de>. Kai P. Purnhagen, Professor and Director at Research Centre for German and European Food Law, University of Bayreuth. For Correspondence: <kai.purnhagen@uni-bayreuth.de>. This research is funded by the Deutsche Forschungsgemeinschaft (DFG), grant agreement PU424/2-1 and by the Oberfrankenstiftung, grant agreement No. FP00535.

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