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

Autor: Turck D, Bohn T, Castenmiller J, de Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera Gómez M, Cubadda F, Frenzel T, Heinonen M, Neuhäuser-Berthold M, Peláez C, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Ackerl R, Albert O, Azzollini D, Fernández Dumont A, Gelbmann W, Germini A, Glymenaki M, Kass GEN, Kouloura E, Laganaro M, Matijevic L, Mendes V, Noriega Fernández E, Nuin Garciarena I, Precup G, Roldán Torres R, Rossi A, Turla E, Valtueña Martinez S, Ververis E, Knutsen HK
Jazyk: angličtina
Zdroj: EFSA journal. European Food Safety Authority [EFSA J] 2024 Sep 30; Vol. 22 (9), pp. e8961. Date of Electronic Publication: 2024 Sep 30 (Print Publication: 2024).
DOI: 10.2903/j.efsa.2024.8961
Abstrakt: 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.
Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.
(© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
Databáze: MEDLINE
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