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Re‐evaluation of acesulfame K (E 950) as food additive

2025-04-30Journal 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.authorCheyns, Karlien
dc.contributor.authorCrebelli, Riccardo
dc.contributor.authorFortes, Cristina
dc.contributor.authorFürst, Peter
dc.contributor.authorHalldorsson, Thorhallur
dc.contributor.authorLeblanc, Jean-Charles
dc.contributor.authorMirat, Manuela
dc.contributor.authorLindtner, Oliver
dc.contributor.authorMortensen, Alicja
dc.contributor.authorBarmaz, Stefania
dc.contributor.authorWright, Matthew
dc.contributor.authorCivitella, Consuelo
dc.contributor.authorLe Gall, Pauline
dc.contributor.authorMazzoli, Elena
dc.contributor.authorRasinger, Josef Daniel
dc.contributor.authorRincon, Ana
dc.contributor.authorTard, Alexandra
dc.contributor.authorLodi, Federica
dc.date.accessioned2025-11-12T16:20:52Z
dc.date.available2025-11-12T16:20:52Z
dc.date.issued2025-04-30
dc.description.abstractThe present opinion deals with the re‐evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6‐methyl‐1,2,3‐oxathiazin‐4(3H)‐one‐2,2‐dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5‐chloro‐acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).eng
dc.identifier.citationEFSA J. 2025 Apr 30;23(4):e9317. doi: 10.2903/j.efsa.2025.9317. eCollection 2025 Apr
dc.identifier.doi10.2903/j.efsa.2025.9317
dc.identifier.eissn1831-4732
dc.identifier.pmid40309404
dc.identifier.urihttp://hdl.handle.net/10400.18/10599
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9317
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectAcesulfame K (E950)
dc.subjectSafety Assessment
dc.subjectEnvironmental Genotoxicity
dc.subjectFood Additive
dc.subjectRe‐Evaluation
dc.subjectSweetener
dc.subjectGenotoxicidade Ambiental
dc.titleRe‐evaluation of acesulfame K (E 950) as food additiveeng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue4
oaire.citation.startPagee9317
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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