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Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a–d) and the modification of the acceptable daily intake (ADI) for steviol

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.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.authorRuggeri, Laura
dc.contributor.authorTard, Alexandra
dc.contributor.authorDino, Borana
dc.contributor.authorVermeiren, Sam
dc.contributor.authorEFSA Panel on Food Additives and Flavourings (FAF)
dc.date.accessioned2025-03-05T16:21:37Z
dc.date.available2025-03-05T16:21:37Z
dc.date.issued2024-11-04
dc.description.abstractThe EFSA Panel on Food Additive and Flavourings (FAF Panel) evaluated the safety of proposed changes to the currently permitted uses of the food additive steviol glycosides (E 960a-d) and of a proposed modification of the current acceptable daily intake (ADI) from 4 mg/kg body weight (bw) per day to 6 or 16 mg/kg bw per day, expressed as steviol equivalents. Currently, steviol glycosides (E 960a-d) are authorised in the EU in 32 different food categories (FCs). An extension of use was proposed for four new uses within FC 7.2 'Fine bakery wares'. In addition, an increase of the maximum permitted levels (MPLs) for FC 14.1.3 'Fruit nectars' and for three uses within FC 14.1.4 'Flavoured drinks' was requested. Consequently, the Panel updated the exposure estimates using the protocol for assessing exposure to sweeteners, developed to consider the specificities related to consumers' exposure to this functional class of food additives. Considering the proposed extension of use and increase of the MPLs, together with the currently authorised uses (at the MPLs) of E 960a-d, the highest 95th percentiles of exposure are 4.1 and 6.9 mg/kg bw per day for infants and toddlers, respectively. Based on the currently available absorption, distribution, metabolism and excretion (ADME) dataset for steviol glycosides (E 960a-d), the Panel concluded that that there is insufficient justification to increase the current ADI of 4 mg/kg bw per day, expressed as steviol equivalents. With respect to the proposed extension of use and increase of the MPLs, the Panel concluded that the calculated, conservative, dietary exposure would result in an increased exceedance of the ADI for toddlers at the 95th percentile.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEFSA J. 2024 Nov 4;22(11):e9045. doi: 10.2903/j.efsa.2024.9045. eCollection 2024 Nov.
dc.identifier.doi10.2903/j.efsa.2024.9045pt_PT
dc.identifier.eissn1831-4732
dc.identifier.pmid39502654
dc.identifier.urihttp://hdl.handle.net/10400.18/10412
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.9045
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectE960pt_PT
dc.subjectFood Additivept_PT
dc.subjectSteviol Glycosidespt_PT
dc.subjectEnvironmental Genotoxicitypt_PT
dc.subjectGenotoxicidade Ambientalpt_PT
dc.titleScientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a–d) and the modification of the acceptable daily intake (ADI) for steviolpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue11pt_PT
oaire.citation.startPagee9045
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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