Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Monika Neuhäuser-Berthold, Carmen PeláezMorten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Reinhard Ackerl, Océane Albert, Domenico Azzollini, Antonio Fernández Dumont, Wolfgang Gelbmann, Andrea Germini, Maria Glymenaki, Georges E.N. Kass, Eirini Kouloura, Marcello Laganaro, Leonard Matijevic, Vânia Mendes, Estefanía Noriega Fernández, Irene Nuin Garciarena, Gabriela Precup, Ruth Roldán Torres, Annamaria Rossi, Emanuela Turla, Silvia Valtueña Martinez, Ermolaos Ververis, Helle Katrine Knutsen, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

Research output: Contribution to journalArticleResearch

2 Citations (Scopus)

Abstract

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use.

Original languageEnglish
Article numbere8961
Pages (from-to)e8961
JournalEFSA Journal
Volume22
Issue number9
DOIs
Publication statusPublished - 30 Sept 2024

Keywords

  • authorisation
  • EFSA guidance
  • food innovation
  • food safety
  • hazard characterisation
  • hazard identification
  • novel foods
  • risk assessment

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