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Author: Alessandro Monaco

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Data Protection Under the Novel Food Regulation: Valuable Instrument or Barrier to Innovation? Insights from the Insect Sector journal article

Alessandro Monaco

European Food and Feed Law Review, Volume 18 (2023), Issue 3, Page 172 - 178

The data protection clause under Regulation (EU) No 2283/2015 on novel foods (NFR) is the instrument chosen by the legislator to reward innovators for their efforts in obtaining a novel food authorization in the European Union. Authorizations under the NFR are in principle horizontal. An exclusive right to place novel foods on the market can be granted to the applicants if proprietary, unpublished data they provide to the EFSA are essential for the positive outcome of the authorization procedure. The article hypothesizes the potential impact of data protection in the novel foods sector. Insights from the insect industry, considered the first real test for the NFR and the data protection clause, are used to provide a valuable case study.

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

Alessandro Monaco, Kai P. Purnhagen

European Food and Feed Law Review, Volume 17 (2022), Issue 3, Page 219 - 227

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.

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