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Reā€evaluation of pullulan (E 1204) as a food additive and new application for its extension of use

2025-03-12Journal 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.authorFrutos Fernandez, Maria Jose
dc.contributor.authorAquilina, Gabriele
dc.contributor.authorBastos, Maria Lourdes
dc.contributor.authorBoon, Polly
dc.contributor.authorFallico, Biagio
dc.contributor.authorFitzgerald, Reginald
dc.contributor.authorGrasl-Kraupp, Bettina
dc.contributor.authorGundert-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.authorBarat Baviera, JosƩ 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.authorWƶlfle, Detlef
dc.contributor.authorAguilera Entrena, Jaime
dc.contributor.authorGagliardi, Gabriele
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMedrano-Padial, ConcepciĆ³n
dc.contributor.authorLunardi, Simone
dc.contributor.authorRincon, Ana Maria
dc.contributor.authorSmeraldi, Camilla
dc.contributor.authorTard, Alexandra
dc.contributor.authorRuggeri, Laura
dc.date.accessioned2025-10-27T16:01:46Z
dc.date.available2025-10-27T16:01:46Z
dc.date.issued2025-03-12
dc.descriptionEFSA FAF Panel members: Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald Fitzgerald, Maria Jose Frutos Fernandez, Bettina Graslā€Kraupp, Ursula Gundertā€Remy, Rainer GĆ¼rtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales, Sabina Passamonti and Laurence Castle.
dc.descriptionHenriqueta Louro - INSA
dc.description.abstractThe present opinion deals with the reā€evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a foodā€grade hydrolysed starch with nonā€genetically modified Aureobasidium pullulans ā– ā– ā– ā– ā– . Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal isoā€amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels.eng
dc.identifier.citationEFSA J. 2025 Mar 12;23(3):e9267. doi: 10.2903/j.efsa.2025.9267. eCollection 2025 Mar
dc.identifier.doi10.2903/j.efsa.2025.9267
dc.identifier.eissn1831-4732
dc.identifier.pmid40078887
dc.identifier.urihttp://hdl.handle.net/10400.18/10571
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9267
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectPullulan (E 1204)
dc.subjectFood Additive
dc.subjectSafety
dc.subjectEnvironmental Genotoxicity
dc.subjectGenotoxicidade Ambiental
dc.titleReā€evaluation of pullulan (E 1204) as a food additive and new application for its extension of useeng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue3
oaire.citation.startPagee9267
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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