Evidence map›Paper›PMID 39351446›Full record

ArticleEFSA journal. European Food Safety Authority2024

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

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen Ildico Hirsch-Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska and 37 more

Abstract read
In one paragraph

Article in EFSA journal. European Food Safety Authority, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

47 authors.

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan de Henauw
Karen Ildico Hirsch-Ernst
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Kristina Pentieva
Alfonso Siani
Frank Thies
Sophia Tsabouri
Marco Vinceti
Margarita Aguilera Gómez
Francesco Cubadda
Thomas Frenzel
Marina Heinonen
Monika Neuhäuser-Berthold
Carmen Peláez
Morten Poulsen
Miguel Prieto Maradona
Josef Rudolf Schlatter
Alexandros Siskos
Henk van Loveren
Reinhard Ackerl
Océane Albert
Domenico Azzollini
Antonio Fernández Dumont
Wolfgang Gelbmann
Andrea Germini
Maria Glymenaki
Georges E N Kass
Eirini Kouloura
Marcello Laganaro
Leonard Matijevic
Vânia Mendes
Estefanía Noriega Fernández
Irene Nuin Garciarena
Gabriela Precup
Ruth Roldán Torres
Annamaria Rossi
Emanuela Turla
Silvia Valtueña Martinez
Ermolaos Ververis
Helle Katrine Knutsen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

authorisationEFSA guidancefood innovationfood safetyhazard characterisationhazard identificationnovel foodsrisk assessment

Identifiers

PMID39351446
PMCPMC11440143

What OpenQuestion holds

Textmetadata
LicenceCC BY-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.