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Re‐evaluation of neotame (E 961) as food additive

2025-07-04Journal article Open access
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dc.contributor.authorEFSA Panel on Food Additives and Flavourings (FAF)
dc.contributor.authorCastle, Laurence
dc.contributor.authorAndreassen, Monica
dc.contributor.authorAquilina, Gabriele
dc.contributor.authorBastos, Maria Lourdes
dc.contributor.authorBoon, Polly
dc.contributor.authorFallico, Biagio
dc.contributor.authorFitzGerald, Reginald
dc.contributor.authorFrutos-Fernandez, Maria Jose
dc.contributor.authorGrasl‐Kraupp, Bettina
dc.contributor.authorGundert‐Remy, Ursula
dc.contributor.authorGürtler, Rainer
dc.contributor.authorHoudeau, Eric
dc.contributor.authorKurek, Marcin
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorMorales, Patricia
dc.contributor.authorPassamonti, Sabina
dc.contributor.authorBatke, Monika
dc.contributor.authorBruzell, Ellen
dc.contributor.authorChipman, James
dc.contributor.authorCrebelli, Riccardo
dc.contributor.authorFortes, Cristina
dc.contributor.authorFürst, Peter
dc.contributor.authorGaffet, Eric
dc.contributor.authorKarlien, Cheyns
dc.contributor.authorHalldorsson, Thorhallur
dc.contributor.authorLeblanc, Jean‐Charles
dc.contributor.authorLindtner, Oliver
dc.contributor.authorLoeschner, Katrin
dc.contributor.authorMast, Jan
dc.contributor.authorMirat, Manuela
dc.contributor.authorMortensen, Alicja
dc.contributor.authorUndas, Anna
dc.contributor.authorWright, Matthew
dc.contributor.authorBarmaz, Stefania
dc.contributor.authorCivitella, Consuelo
dc.contributor.authorAbrahantes, Jose Cortiñas
dc.contributor.authorLe Gall, Pauline
dc.contributor.authorMazzoli, Elena
dc.contributor.authorMech, Agnieszka
dc.contributor.authorRasinger, Josef Daniel
dc.contributor.authorRincon, Ana
dc.contributor.authorRiolo, Francesca
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorZakidou, Panagiota
dc.contributor.authorLodi, Federica
dc.date.accessioned2025-11-13T12:26:53Z
dc.date.available2025-11-13T12:26:53Z
dc.date.issued2025-07-04
dc.description.abstractThe present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52‐week chronic and 104‐week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).eng
dc.identifier.citationEFSA J. 2025 Jul 4;23(7):e9480. doi: 10.2903/j.efsa.2025.9480. eCollection 2025 Jul
dc.identifier.doi10.2903/j.efsa.2025.9480
dc.identifier.eissn1831-4732
dc.identifier.eissn40626198
dc.identifier.pmid1831-4732
dc.identifier.urihttp://hdl.handle.net/10400.18/10605
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9480
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectNeotame
dc.subjectSafety Assessment
dc.subjectEnvironmental Genotoxicity
dc.subjectE961
dc.subjectFood Additive
dc.subjectRe-Evaluation
dc.subjectSweetener
dc.subjectGenotoxicidade Ambiental
dc.titleRe‐evaluation of neotame (E 961) as food additiveeng
dc.typejournal article
dcterms.referenceshttps://pmc.ncbi.nlm.nih.gov/articles/PMC12231243/#sec60
dspace.entity.typePublication
oaire.citation.issue7
oaire.citation.startPagee9480
oaire.citation.titleEFSA Journal
oaire.citation.volume23
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameLouro
person.givenNameHenriqueta
person.identifier157627
person.identifier.ciencia-id721D-2BB1-7DB1
person.identifier.orcid0000-0001-9744-7332
person.identifier.scopus-author-id6507971479
relation.isAuthorOfPublication2361a951-8b9a-4b90-92d6-f6384003a242
relation.isAuthorOfPublication.latestForDiscovery2361a951-8b9a-4b90-92d6-f6384003a242

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