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

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Monaco, Alessandro:
Data Protection Under the Novel Food Regulation : Valuable Instrument or Barrier to Innovation? Insights from the Insect Sector.
In: European Food and Feed Law Review. Bd. 18 (3 Juli 2023) Heft 3 . - S. 172-178.
ISSN 2190-8214

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Abstract

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 An exclusive right to place novel foods on the market can be granted to the applicants if proprietary, unpublished data they provide to the EFSA are essential for the positive outcome of the authorization procedure.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.