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Safety evaluation of d‐α‐tocopheryl polyethylene glycol‐1000 succinate (Vitamin E TPGS) as a food additive

2025-07-11Journal article Open access
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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.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.authorLeblanc, Jean‐Charles
dc.contributor.authorMoldeus, Peter
dc.contributor.authorWaalkens‐Berendsen, Ine
dc.contributor.authorWölfle, Detlef
dc.contributor.authorConsuelo, Civitella
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMedrano‐Padial, Concepción
dc.contributor.authorRincon, Ana Maria
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorRuggeri, Laura
dc.date.accessioned2025-11-10T13:36:12Z
dc.date.available2025-11-10T13:36:12Z
dc.date.issued2025-07-11
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of d‐α‐tocopheryl polyethylene glycol‐1000 succinate (Vitamin E TPGS) as a new food additive to be used in several food categories as emulsifier. In 2007, the EFSA AFC Panel assessed TPGS as a source of tocopherol intended to be used in foods for particular nutritional uses. The Panel considered the AFC Panel assessment relevant for the present new food additive. Compositional data showed that the proposed food additive is composed of Vitamin E TPGS monoesters (< 82% w/w of the whole preparation) and diesters (<20% w/w of the whole preparation). Data on the hydrolysis of Vitamin E TPGS showed that the ester bond between d‐α‐tocopherol and succinic acid is stable under the tested conditions, as no increase in free d‐α‐tocopherol was observed. Vitamin E TPGS is poorly absorbed and does not represent a source of Vitamin E in the healthy population. Vitamin E TPGS does not raise a concern with respect to genotoxicity and no adverse effects on reproductive and developmental parameters were observed up to 1000 mg TPGS/kg bw per day, the highest dose tested and identified as a reference point. Due to the limitations in the available data (e.g. in reporting), the Panel decided to use an MOE approach instead of deriving an ADI. The Panel considered the calculated MOEs sufficient. Based on the available data, the Panel concluded that the use of Vitamin E TPGS as a new food additive does not raise a safety concern at the proposed use and use levels.eng
dc.identifier.citationEFSA Journal. 2025 Aug;23(8):e9605. doi:10.2903/j.efsa.2025.9605
dc.identifier.doi10.2903/j.efsa.2025.9605
dc.identifier.eissn1831-4732
dc.identifier.urihttp://hdl.handle.net/10400.18/10574
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectEnvironmental Genotoxicity
dc.subjectd‐α‐tocopheryl Polyethylene Glycol‐1000 Succinate
dc.subjectVitamin E TPGS
dc.subjectFoods for Special Medical Purposes
dc.subjectEmulsifier
dc.subjectFood Supplements
dc.subjectGenotoxicidade Ambiental
dc.titleSafety evaluation of d‐α‐tocopheryl polyethylene glycol‐1000 succinate (Vitamin E TPGS) as a food additiveeng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue8
oaire.citation.startPagee9605
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

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