Full text

Turn on search term navigation

© 2024. This work is published under http://creativecommons.org/licenses/by-nd/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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.

Details

Title
Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283
Author
Turck, Dominique; Bohn, Torsten; Castenmiller, Jacqueline; de Henauw, Stefaan; Hirsch‐Ernst, Karen Ildico; Maciuk, Alexandre; Mangelsdorf, Inge; McArdle, Harry J.; Naska, Androniki; Pentieva, Kristina; Siani, Alfonso; Thies, Frank; Tsabouri, Sophia; Vinceti, Marco; Aguilera Gómez, Margarita; Cubadda, Francesco; Frenzel, Thomas; Heinonen, Marina; Neuhäuser‐Berthold, Monika; Peláez, Carmen; Poulsen, Morten; Prieto Maradona, Miguel; Schlatter, Josef Rudolf; Siskos, Alexandros; van Loveren, Henk; Ackerl, Reinhard; Albert, Océane; Azzollini, Domenico; Fernández Dumont, Antonio; Gelbmann, Wolfgang; Germini, Andrea; Glymenaki, Maria; Kass, Georges E. N.; Kouloura, Eirini; Laganaro, Marcello; Matijevic, Leonard; Mendes, Vânia; Noriega Fernández, Estefanía; Nuin Garciarena, Irene; Precup, Gabriela; Roldán Torres, Ruth; Rossi, Annamaria; Turla, Emanuela; Valtueña Martinez, Silvia; Ververis, Ermolaos; Knutsen, Helle Katrine
Section
GUIDANCE
Publication year
2024
Publication date
Sep 1, 2024
Publisher
John Wiley & Sons, Inc.
ISSN
18314732
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3111075855
Copyright
© 2024. This work is published under http://creativecommons.org/licenses/by-nd/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.