Open AccessGuidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation ( EU ) 2015/2283 1 (Revision 1) 2
Author(s) -
NDA Allergies,
Turck Dominique,
Bresson JeanLouis,
Burlingame Barbara,
Dean Tara,
FairweatherTait Susan,
Hein Marina,
HirschErnst Karen Ildico,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
NeuhäuserBerthold Monika,
Nowicka Grazyna,
Pentieva Kristina,
Sanz Yolanda,
Siani Alfonso,
Sjödin Anders,
Stern Martin,
Tomé Daniel,
Vinceti Marco,
Willatts Peter,
Engel KarlHeinz,
Marchelli Rosangela,
Pöting Annette,
Poulsen Morten,
Salminen Seppo,
Schlatter Josef,
Arcella Davide,
Gelbmann Wolfgang,
SesmaisonsLecarré Agnès,
Verhagen Hans,
Loveren Hendrik
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6555
Subject(s) - food safety , authorization , context (archaeology) , european commission , risk analysis (engineering) , business , food contact materials , table (database) , computer science , food packaging , process management , microbiology and biotechnology , european union , computer security , database , food science , biology , economic policy , paleontology
Endorsement date 21 January 2021 Implementation date 27 March 2021Following 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 beenrevised to informapplicants 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.