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Reā€evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives

2024-11-15Journal article Open access
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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.authorGraslā€Kraupp, Bettina
dc.contributor.authorGundertā€Remy, Ursula
dc.contributor.authorGĆ¼rtler, 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.authorFĆ¼rst, Peter
dc.contributor.authorHalldorsson, Thorhallur
dc.contributor.authorLeBlanc, Jeanā€Charles
dc.contributor.authorMirat, Manuela
dc.contributor.authorLindtner, Oliver
dc.contributor.authorMortensen, Alicja
dc.contributor.authorNtzani, Evangelia
dc.contributor.authorShah, Romina
dc.contributor.authorWallace, Heather
dc.contributor.authorWright, Matthew
dc.contributor.authorBarmaz, Stefania
dc.contributor.authorCivitella, Consuelo
dc.contributor.authorGeorgelova, Petra
dc.contributor.authorLodi, Federica
dc.contributor.authorMazzoli, Elena
dc.contributor.authorRasinger, Josef
dc.contributor.authorMaria Rincon, Ana
dc.contributor.authorTard, Alexandra
dc.contributor.authorZakidou, Panagiota
dc.contributor.authorYounes, Maged
dc.contributor.authorEFSA Panel on Food Additives and Flavourings (FAF)
dc.date.accessioned2025-03-05T16:14:11Z
dc.date.available2025-03-05T16:14:11Z
dc.date.issued2024-11-15
dc.description.abstractThis opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The Panel considered the refined brand-loyal exposure assessment scenario the most appropriate exposure scenario for the risk assessment. The Panel noted that the P95 exposure estimates for chronic exposure to saccharins (E 954) were below the ADI. The Panel recommended the European Commission to consider the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEFSA J. 2024 Nov 15;22(11):e9044. doi: 10.2903/j.efsa.2024.9044. eCollection 2024 Nov
dc.identifier.doi10.2903/j.efsa.2024.9044pt_PT
dc.identifier.issn1831-4732
dc.identifier.pmid39553702
dc.identifier.urihttp://hdl.handle.net/10400.18/10411
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.9044
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectE 954pt_PT
dc.subjectFood Additivept_PT
dc.subjectPotassium and Calcium Saltspt_PT
dc.subjectSaccharin and its Sodiumpt_PT
dc.subjectSweetenerpt_PT
dc.subjectEnvironmental Genotoxicitypt_PT
dc.subjectGenotoxicidade Ambientalpt_PT
dc.titleReā€evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additivespt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue11pt_PT
oaire.citation.startPagee9044
oaire.citation.titleEFSA Journal
oaire.citation.volume22pt_PT
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
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication2361a951-8b9a-4b90-92d6-f6384003a242
relation.isAuthorOfPublication.latestForDiscovery2361a951-8b9a-4b90-92d6-f6384003a242

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