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

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Monaco, Alessandro ; Purnhagen, Kai:
Risk Triggers as Innovation Triggers? : Risk analysis and innovation´s promotion under the Novel Food Regulation.
In: European Food and Feed Law Review. (2022) . - S. 219-227.
ISSN 2190-8214

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Abstract

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.