Repository logo
 
Publication

Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)

2025-05-14Journal article Open access
Simple item page
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.authorUrsula Gundert‐Remy
dc.contributor.authorGundert-Remy, Ursula
dc.contributor.authorHoudeau, Eric
dc.contributor.authorKurek, Marcin
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorMorales, Patricia
dc.contributor.authorPassamonti, Sabina
dc.contributor.authorBarat-Baviera, José Manuel
dc.contributor.authorDegen, Gisela
dc.contributor.authorGott, David
dc.contributor.authorHerman, Lieve
dc.contributor.authorLeblanc, Jean-Charles
dc.contributor.authorMoldeus, Peter
dc.contributor.authorWaalkens-Berendsen, Ine
dc.contributor.authorWölfle, Detlef
dc.contributor.authorConsuelo, Civitella
dc.contributor.authorDino, Borana
dc.contributor.authorLunardi, Simone
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMultari, Salvatore
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorRuggeri, Laura
dc.date.accessioned2025-11-12T16:34:46Z
dc.date.available2025-11-12T16:34:46Z
dc.date.issued2025-05-14
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme‐catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain K. phaffii CGMCC 7539. The final product is composed mostly of rebaudioside M (> 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from K. phaffii CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain K. phaffii CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme‐catalysed bioconversion.eng
dc.identifier.citationEFSA J. 2025 May 14;23(5):e9396. doi: 10.2903/j.efsa.2025.9396. eCollection 2025 May
dc.identifier.doi10.2903/j.efsa.2025.9396
dc.identifier.issn1831-4732
dc.identifier.pmid40371316
dc.identifier.urihttp://hdl.handle.net/10400.18/10600
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9396
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectRebaudioside M
dc.subjectEnvironmental Genotoxicity
dc.subjectSafety Assessment
dc.subjectEnzyme-Catalysed Bioconversion
dc.subjectKomagaetella Phaffi
dc.subjectStevia
dc.subjectSteviol Glycosides
dc.subjectGenotoxicidade Ambiental
dc.titleSafety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)eng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue5
oaire.citation.startPagee9396
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

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
2025 EFSA Journal - 2025 - - Safety of the proposed amendment of the specifications of the food additive E960c i or E960c ii.pdf
Size:
285.52 KB
Format:
Adobe Portable Document Format
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
4.03 KB
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

DGH - Artigos em revistas internacionais
INSA - Artigos em revistas internacionais