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Update of the safety assessment of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amines (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with food

2025-02-10Journal article Open access
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dc.contributor.authorEFSA Panel on Food Contact Materials (FCM)
dc.contributor.authorLambré, Claude
dc.contributor.authorCrebelli, Riccardo
dc.contributor.authorSilva, Maria Joao
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.authorCariou, Ronan
dc.contributor.authorCastle, Laurence
dc.contributor.authorDi Consiglio, Emma
dc.contributor.authorFranz, Roland
dc.contributor.authorWölfle, Detlef
dc.contributor.authorAl Harraq, Zainab
dc.contributor.authorBarthélémy, Eric
dc.contributor.authorComandella, Daniele
dc.contributor.authorFontán-Vela, Julia
dc.contributor.authorHalamoda, Blanka
dc.contributor.authorRivière, Gilles
dc.date.accessioned2025-11-10T15:58:00Z
dc.date.available2025-11-10T15:58:00Z
dc.date.issued2025-02-10
dc.description.abstractThe European Commission asked EFSA to review whether the authorisation of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO‐coco, PFAEO‐oleyl, PFAEO‐HT, PFAEO‐T and PFAO‐C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.eng
dc.identifier.citationEFSA J. 2025 Feb 10;23(2):e9104. doi: 10.2903/j.efsa.2025.9104. eCollection 2025 Feb
dc.identifier.doi10.2903/j.efsa.2025.9104
dc.identifier.eissn1831-4732
dc.identifier.pmid39931182
dc.identifier.urihttp://hdl.handle.net/10400.18/10582
dc.language.isoeng
dc.peerreviewedyes
dc.publisherWiley
dc.relation.hasversionhttps://www.efsa.europa.eu/en/efsajournal/pub/9104
dc.relation.ispartofEFSA Journal
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectN‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19)
dc.subjectN‐bis(2‐hydroxyethyl)alkyl(C8‐N
dc.subjectN-bis(2‐Hydroxyethyl)Alkylamine
dc.subjectEnvironmental Genotoxicity
dc.subjectGenotoxocidade Ambiental
dc.titleUpdate of the safety assessment of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amines (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with foodeng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue2
oaire.citation.startPagee9104
oaire.citation.titleEFSA Journal
oaire.citation.volume23
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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