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Re‐assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materials

2025-06-10Artigo científico Acesso aberto
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datacite.subject.fosCiências Médicas::Ciências da Saúde
datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorEFSA Panel on Food Contact Materials (FCM)
dc.contributor.authorClaude, Lambré
dc.contributor.authorCrebelli, Riccardo
dc.contributor.authorSilva, Maria Da
dc.contributor.authorGrob, Konrad
dc.contributor.authorLampi, Evgenia
dc.contributor.authorMilana, Maria Rosaria
dc.contributor.authorPronk, Marja
dc.contributor.authorŠčetar, Mario
dc.contributor.authorTheodoridis, Georgios
dc.contributor.authorVan Hoeck, Els
dc.contributor.authorWaegeneers, Nadia
dc.contributor.authorBolognesi, Claudia
dc.contributor.authorConsiglio, Emma Di
dc.contributor.authorMengelers, Marcel
dc.contributor.authorAl Harraq, Zainab
dc.contributor.authorPilar, Irene Muñoz
dc.contributor.authorRainieri, Sandra
dc.contributor.authorRivière, Gilles
dc.date.accessioned2026-01-05T14:04:33Z
dc.date.available2026-01-05T14:04:33Z
dc.date.issued2025-06-10
dc.description.abstractThe EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re‐evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non‐genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.eng
dc.identifier.citationEFSA J. 2025 Jun 10;23(6):e9473. doi: 10.2903/j.efsa.2025.9473. eCollection 2025 Jun
dc.identifier.doi10.2903/j.efsa.2025.9473
dc.identifier.eissn1831-4732
dc.identifier.pmid40496253
dc.identifier.urihttp://hdl.handle.net/10400.18/10659
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9473
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectCAS No 100- 42-5
dc.subjectFood Contact Materials
dc.subjectGenotoxicity
dc.subjectOral Exposure
dc.subjectSafety Assessment
dc.subjectStyrene
dc.subjectGenotoxicidade Ambiental
dc.titleRe‐assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materialseng
dc.typejournal article
dcterms.referenceshttps://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2025.9473&file=efs29473-sup-0001-AnnexA.pdf
dcterms.referenceshttps://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2025.9473&file=efs29473-sup-0002-AnnexB.pdf
dcterms.referenceshttps://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903%2Fj.efsa.2025.9473&file=efs29473-sup-0003-AnnexC.pdf
dspace.entity.typePublication
oaire.citation.issue6
oaire.citation.startPagee9473
oaire.citation.titleEFSA Journal
oaire.citation.volume23
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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