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Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wares

dc.contributor.authorEFSA FAF Panel (EFSA Panel on Food Additives and Flavourings)
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.authorFernandez, Maria Jose Frutos
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.authorDourus, Antonios
dc.contributor.authorChipman, James
dc.contributor.authorCrebelli, Riccardo
dc.contributor.authorFürst, Peter
dc.contributor.authorHalldorsson, Thorhallur
dc.contributor.authorMirat, Manuela
dc.contributor.authorMortensen, Alicja
dc.contributor.authorWright, Matthew
dc.contributor.authorLindtner, Oliver
dc.contributor.authorBarmaz, Stefania
dc.contributor.authorCivitella, Consuelo
dc.contributor.authorHorvath, Zsuzsanna
dc.contributor.authorLevorato, Sara
dc.contributor.authorMazzoli, Elena
dc.contributor.authorRasinger, Josef Daniel
dc.contributor.authorRincon, Ana Maria
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorLodi, Federica
dc.date.accessioned2026-05-22T15:59:33Z
dc.date.available2026-05-22T15:59:33Z
dc.date.issued2026-02-17
dc.description.abstractThe present opinion deals with the re‐evaluation of sucralose (E 955) as food additive and with the safety of a proposed extension of use in food category (FC) 7.2 ‘Fine bakery wares’. Based on the available data, no safety concerns arose for genotoxicity of sucralose (E 955) and its impurities and degradation products. Based on the weight of evidence (WoE), the Panel considered the decrease in body weight observed in rats as the relevant endpoint for the derivation of a reference point (RP). The Panel performed a benchmark dose (BMD) analysis on the data from the longest study (combined chronic and carcinogenicity study) with a modified benchmark dose response to account for the poor palatability of sucralose. The resulting RP was 55 mg/kg bw per day (benchmark dose lower confidence limit; BMDL). The Panel considered it appropriate to derive chemical‐specific assessment factor for sucralose and concluded that there is no need to revise the current ADI of 15 mg/kg bw per day of sucralose (E 955) previously established by the Scientific Committee on Food. The exposure estimates considering the currently authorised uses did not exceed the ADI. Therefore, the Panel concluded that there is no safety concern at the reported uses and use levels of sucralose (E 955). The overall exposure did not increase substantially when considering the proposed extension of use. However, based on the available data and the identified uncertainties regarding the potential formation of chlorinated compounds under the wide range of baking processes that may be applicable for FC 7.2, the Panel could not conclude on the safety of the proposed extension of use of E 955 in this FC. The Panel issued recommendations to the European Commission, primarily to consider a revision of the EU specifications for sucralose.eng
dc.identifier.citationEFSA J. 2026 Feb 17;24(2):e9854. doi: 10.2903/j.efsa.2026.9854. eCollection 2026 Feb
dc.identifier.doi10.2903/j.efsa.2026.9854
dc.identifier.eissn1831-4732
dc.identifier.pmid41710869
dc.identifier.urihttp://hdl.handle.net/10400.18/11317
dc.language.isoeng
dc.peerreviewedno
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2026.9854
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectEnvironmental Genotoxicity
dc.subjectE 955
dc.subjectFood Additive
dc.subjectSucralose
dc.subjectSweetener
dc.subjectGenotoxicidade Ambiental
dc.titleRe‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery wareseng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue2
oaire.citation.startPagee9854
oaire.citation.titleEFSA Journal
oaire.citation.volume24
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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