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Safety evaluation of curdlan as a food additive

2024-09-09Journal article Open access
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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.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.authorCivitella, Consuelo
dc.contributor.authorEntrena, Jaime Aguilera
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMultari, Salvatore
dc.contributor.authorRuggeri, Laura
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorVermeiren, Sam
dc.contributor.authorCastle, Laurence
dc.contributor.authorEFSA FAF Panel (EFSA Panel on Food Additives and Flavourings)
dc.date.accessioned2025-03-06T11:21:04Z
dc.date.available2025-03-06T11:21:04Z
dc.date.issued2024-09-09
dc.descriptionEFSA Panel on Food Additives and Flavourings (FAF) Members: Henriqueta Louro, Departamento de Genética Humana, INSA.
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β-1,3-linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK-u. The toxicological dataset consisted of sub-chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well-tolerated with no overt organ-specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three-generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment-related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break-down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEFSA J. 2024 Sep 9;22(9):e8985. doi: 10.2903/j.efsa.2024.8985. eCollection 2024 Sep
dc.identifier.doi10.2903/j.efsa.2024.8985pt_PT
dc.identifier.issn1831-4732
dc.identifier.pmid39253337
dc.identifier.urihttp://hdl.handle.net/10400.18/10414
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWiley-VCH Verlag
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8985
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectCurdlanpt_PT
dc.subjectCAS number 54724‐00‐4
dc.subjectINS No.: 424
dc.subjectRhizobium radiobacter biovar 1
dc.subjectGut microbiota
dc.subjectStabiliser
dc.subjectβ‐1,3‐glucan
dc.subjectFood Additivept_PT
dc.subjectFood Safetypt_PT
dc.subjectEnvironmental Genotoxicitypt_PT
dc.subjectGenotoxicidade Ambientalpt_PT
dc.titleSafety evaluation of curdlan as a food additivept_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue9pt_PT
oaire.citation.startPagee8985
oaire.citation.titleEFSA Journal
oaire.citation.volume22pt_PT
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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