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Safety evaluation of jagua (genipin‐glycine) blue as a food additive

2025-12-01Artigo científico Acesso aberto
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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.authorCivitella, Consuelo
dc.contributor.authorMech, Agnieszka
dc.contributor.authorMedrano-Padial, Concepción
dc.contributor.authorTard, Alexandra
dc.contributor.authorZakidou, Panagiota
dc.contributor.authorRugger, Laura
dc.date.accessioned2026-01-20T16:01:04Z
dc.date.available2026-01-20T16:01:04Z
dc.date.issued2025-12-01
dc.descriptionEFSA Panel on Food Additives and Flavourings (FAF) Members: Laurence Castle, Monica Andreassen, Gabriele Aquilina, Maria Lourdes Bastos, Polly Boon, Biagio Fallico, Reginald FitzGerald, Maria Jose Frutos Fernandez, Bettina Grasl-Kraupp, Ursula Gundert-Remy, Rainer Gürtler, Eric Houdeau, Marcin Kurek, Henriqueta Louro, Patricia Morales and Sabina Passamonti.
dc.description.abstractThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin‐glycine) blue as a new food additive. Jagua (genipin‐glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of Genipa americana L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue‐coloured polymer and minor colouring components. In vitro Caco‐2 cell permeability test demonstrated a low permeability of jagua (genipin‐glycine) blue, but repeated dose toxicity studies showed organs discoloration and green‐coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub‐chronic toxicity, genotoxicity studies and also a 12‐month toxicity study including in utero exposure. Jagua (genipin‐glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12‐month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin‐glycine) blue as a food additive at the proposed use and use levels.eng
dc.identifier.citationEFSA J. 2025 Dec 1;23(12):e9738. doi: 10.2903/j.efsa.2025.9738. eCollection 2025 Dec
dc.identifier.doi10.2903/j.efsa.2025.9738
dc.identifier.issn1831-4732
dc.identifier.issn1831-4732
dc.identifier.urihttp://hdl.handle.net/10400.18/10729
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9738
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/
dc.subjectGenipa Americana
dc.subjectBlue‐Coloured Polymer
dc.subjectFood Colour
dc.subjectGenipin
dc.subjectJagua Blue
dc.subjectEnvironmental Genotoxicity
dc.subjectGenotoxicidade Ambiental
dc.titleSafety evaluation of jagua (genipin‐glycine) blue as a food additiveeng
dc.typejournal article
dcterms.referenceshttps://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2025.9738&file=efs29738-sup-0001-Annex+A.xlsx
dspace.entity.typePublication
oaire.citation.issue12
oaire.citation.startPagee9738
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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