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Safety assessment of the substances ‘wax, rice bran, oxidised’ and ‘wax, rice bran, oxidised, calcium salt’ for use in food contact materials

2024-08-05Journal article Open access
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dc.contributor.authorEFSA Panel on Food Contact Materials
dc.contributor.authorLambré, C.
dc.contributor.authorCrebelli, R.
dc.contributor.authorSilva, Maria Joao
dc.contributor.authorGrob, K.
dc.contributor.authorLampi, E.
dc.contributor.authorMilana, M.R.
dc.contributor.authorPronk, M.
dc.contributor.authorŠčetar, M.
dc.contributor.authorTheodoridis, G.
dc.contributor.authorVan Hoeck, E.
dc.contributor.authorWaegeneers, N.
dc.contributor.authorBolognesi, C.
dc.contributor.authorCariou, R.
dc.contributor.authorCastle, L.
dc.contributor.authorDi Consiglio, E.
dc.contributor.authorFranz, R.
dc.contributor.authorBarthélémy, E.
dc.contributor.authorComandella, D.
dc.contributor.authorRivière, G.
dc.date.accessioned2025-01-29T13:02:02Z
dc.date.available2025-01-29T13:02:02Z
dc.date.issued2024-08-05
dc.description.abstractThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the substances ‘wax, rice bran, oxidised’ and ‘wax, rice bran, oxidised, calcium salt’, used as additives up to 0.3% in polyethylene terephthalate (PET), polyamide (PA), thermoplastic polyurethane (TPU), polylactic acid (PLA) and poly(vinyl chloride) (PVC) in contact with all food types for long‐term storage at room temperature and below, after hot‐fill and/or heating. The substances consist of the chemical classes wax esters, carboxylic acids, alcohols and calcium salts of acids, along with an unidentified organic fraction up to w/w. Migration into 10% ethanol and 4% acetic acid was below 0.012 mg/kg for each chemical class, and about 0.001 mg/kg for the unidentified fraction. In isooctane, migration was up to 0.297 mg/kg food for wax esters, below 0.01 mg/kg food for the other chemical classes and about 0.02 mg/kg food for the unidentified fraction. The contact with dry food and food simulated by 20% ethanol were considered covered by the migration tests with aqueous simulants. Based on genotoxicity assays and compositional analyses, the constituents of the chemical classes did not raise a concern for genotoxicity. The potential migration of individual constituents or groups of chemically‐related compounds of the unidentified fraction would result in exposures below (for aqueous food) and above (for fatty food) the threshold of toxicological concern for genotoxic carcinogens. Therefore, the FCM Panel concluded that the substances are not of safety concern for the consumer, if used as additives up to 0.3% w/w in PET, PLA and rigid PVC materials and articles intended for contact with all food types except for fatty foods, for long‐term storage at room temperature and below, including hot‐fill and/or heating up to 100°C for up to 2 h.eng
dc.identifier.citationEFSA J. 2024 Aug 5;22(8):e8960. doi: 10.2903/j.efsa.2024.8960
dc.identifier.doi10.2903/j.efsa.2024.8960
dc.identifier.issn1831-4732
dc.identifier.urihttp://hdl.handle.net/10400.18/10318
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://onlinelibrary.wiley.com/resolve/doi?DOI=10.2903/j.efsa.2024.8960
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectFood Contact Materials
dc.subjectSafety Assessment
dc.subjectWax Rice Bran
dc.subjectEnvironmental Genotoxicity
dc.subjectGenotoxicidade Ambiental
dc.titleSafety assessment of the substances ‘wax, rice bran, oxidised’ and ‘wax, rice bran, oxidised, calcium salt’ for use in food contact materialseng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue8
oaire.citation.startPagee8960
oaire.citation.titleEFSA journal
oaire.citation.volume22
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameSilva
person.givenNameMaria Joao
person.identifier.ciencia-id7710-643D-97A3
person.identifier.orcid0000-0002-6060-0716
person.identifier.scopus-author-id55944437600
relation.isAuthorOfPublicationa7763685-7c34-468d-b958-9dd0aca66db4
relation.isAuthorOfPublication.latestForDiscoverya7763685-7c34-468d-b958-9dd0aca66db4

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