TY - JOUR

T1 - Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/22831 (Revision 1)2

AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser-Berthold, Monika

AU - Nowicka, Grazyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Siani, Alfonso

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Engel, Karl Heinz

AU - Marchelli, Rosangela

AU - Pöting, Annette

AU - Poulsen, Morten

AU - Salminen, Seppo

AU - Schlatter, Josef

AU - Arcella, Davide

AU - Gelbmann, Wolfgang

AU - de Sesmaisons-Lecarré, Agnès

AU - Verhagen, Hans

AU - van Loveren, Hendrik

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Products

PY - 2021/3/26

Y1 - 2021/3/26

N2 - Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate 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 should be discussed in relation to the anticipated intakes 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. This guidance was originally adopted in 2016. It has been revised to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.

AB - Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate 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 should be discussed in relation to the anticipated intakes 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. This guidance was originally adopted in 2016. It has been revised to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.

KW - Authorisation

KW - Guidance

KW - Novel foods

KW - Safety

KW - Toxicity

KW - Traditional foods

UR - http://www.scopus.com/inward/record.url?scp=85103412769&partnerID=8YFLogxK

U2 - 10.2903/j.efsa.2021.6555

DO - 10.2903/j.efsa.2021.6555

M3 - Journal article

C2 - 33791039

AN - SCOPUS:85103412769

VL - 19

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 3

M1 - 6555

ER -