TY - JOUR
T1 - Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - de Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Aguilera Gómez, Margarita
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Neuhäuser-Berthold, Monika
AU - Peláez, Carmen
AU - Poulsen, Morten
AU - Prieto Maradona, Miguel
AU - Schlatter, Josef Rudolf
AU - Siskos, Alexandros
AU - van Loveren, Henk
AU - Ackerl, Reinhard
AU - Albert, Océane
AU - Azzollini, Domenico
AU - Fernández Dumont, Antonio
AU - Gelbmann, Wolfgang
AU - Germini, Andrea
AU - Glymenaki, Maria
AU - Kass, Georges E.N.
AU - Kouloura, Eirini
AU - Laganaro, Marcello
AU - Matijevic, Leonard
AU - Mendes, Vânia
AU - Noriega Fernández, Estefanía
AU - Nuin Garciarena, Irene
AU - Precup, Gabriela
AU - Roldán Torres, Ruth
AU - Rossi, Annamaria
AU - Turla, Emanuela
AU - Valtueña Martinez, Silvia
AU - Ververis, Ermolaos
AU - Knutsen, Helle Katrine
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - © 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
PY - 2024/9/30
Y1 - 2024/9/30
N2 - 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.
AB - 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.
KW - authorisation
KW - EFSA guidance
KW - food innovation
KW - food safety
KW - hazard characterisation
KW - hazard identification
KW - novel foods
KW - risk assessment
UR - http://www.scopus.com/inward/record.url?scp=85205551196&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/39351446/
U2 - 10.2903/j.efsa.2024.8961
DO - 10.2903/j.efsa.2024.8961
M3 - Article
C2 - 39351446
AN - SCOPUS:85205551196
SN - 1831-4732
VL - 22
SP - e8961
JO - EFSA Journal
JF - EFSA Journal
IS - 9
M1 - e8961
ER -