the genotoxicity studies carried out on FCM No 768 and evaluated two new bac-

Overview

This source page is a mechanical bulk-ingest record for a PDF in the methylmercury infant-formula research pull. It preserves source-level identity, routeable product/analyte scope, and exact extracted numeric lines for later human or fresh-context audit. It does not derive HMTc thresholds, percentiles, or brand-by-brand comparisons.

Key numbers

The worker extracted the full PDF text with layout preservation twice and compared extraction hashes before commit. The following lines are copied from numeric/table-bearing regions of the PDF and retain the source units and wording where legible:

Safety assessment of the substance amines, di-C14-C20-alkyl,
assessed the safety of amines, di-C14-C18-alkyl, oxidised, renamed by the Panel
as amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil. The sub-
No 768. The vegetable-sourced substance is intended to be used at up to 0.1% w/w
was tested from polyethylene samples in 10% ethanol and 3% acetic acid for 2 h
were detected to migrate at detection limits (LoD) in the range 0.003–0.029 mg/
kg. The LoD of authorised carboxylic acids was 0.35 mg/kg. The Panel reassessed
the genotoxicity studies carried out on FCM No 768 and evaluated two new bac-
the consumers if it is used as an additive at 0.1% w/w in the manufacture of poly-
amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, FCM substance No 1092, FCM
substance No 768, food contact materials, plastic, safety assessment, tallow
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
EFSA Journal. 2024;22:e8769. efsa.onlinelibrary.wiley.com/journal/1831-4732 | 1 of 13
SAFETY ASSESSMENT OF THE SUBSTANCE AMINES, DI-C14-C20-ALKYL, OXIDISED, FROM HYDROGENATED VEGETABLE OIL, FOR USE IN
2 of 13 | FOOD CONTACT MATERIALS
3.1. Non-toxicological data��5
3.1.2. Physical and chemical properties��6
3.1.3. Residual content and specific migration of the substance��7
3.2. Toxicological data��7
3.2.1.1. Oxidised bis(hydrogenated tallow alkyl) amines��8
3.2.1.1.1. Bacterial reverse mutation test.��8
3.2.1.1.2. In vitro mammalian cell gene mutation test��8
3.2.1.1.3. In vitro mammalian chromosomal aberration test��9
3.2.1.2. Amines, di-C14-C20-alkyl��9
3.2.1.2.1. In vitro mammalian chromosomal aberration test��9
3.2.1.3. Nitrones, di-C14-C20-alkyl��9
3.2.1.3.1. Bacterial reverse mutation test��9
3.2.1.3.2. In vitro mammalian chromosomal aberration test�� 10
3.2.1.4. Oximes, C14-C20-alkyl�� 10
3.2.1.4.1. Bacterial reverse mutation test�� 10
3.2.1.4.2. In vitro mammalian chromosomal aberration test�� 10
3.2.1.6. C14-C20 alkyl aldehydes��11
Documentation as provided to EFSA�� 12
SAFETY ASSESSMENT OF THE SUBSTANCE AMINES, DI-C14-C20-ALKYL, OXIDISED, FROM HYDROGENATED VEGETABLE OIL, FOR USE IN
FOOD CONTACT MATERIALS | 3 of 13
Food Safety Authority (EFSA)‘s opinion on its safety is required. This procedure has been established in Articles 8, 9 and 10
of Regulation (EC) No 1935/20041 of the European Parliament and of the Council of 27 October 2004 on materials and arti-
und Lebensmittelsicherheit, BVL), requesting the safety evaluation of the substance amines, di-C14-C18-alkyl, oxidised,
FCM substance No 1092, with the CAS number 1801863-42-2. The request has been registered in EFSA’s register of received
questions under the number EFSA-Q -2021-00555. The dossier was submitted by BASF SE.
According to Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles
Materials (EFSA CEF Panel, 2008) and the ‘Administrative guidance for the preparation of applications on substances to be

Methods (brief)

was tested from polyethylene samples in 10% ethanol and 3% acetic acid for 2 h
were detected to migrate at detection limits (LoD) in the range 0.003–0.029 mg/
kg. The LoD of authorised carboxylic acids was 0.35 mg/kg. The Panel reassessed
to be below the limit of detection (LoD) of 20 μg/L. The solubility can be anticipated to be marginally higher in real circum-
The residual contents12 of all the components in the test samples, except for the tert-alkyl-N-oxides, were determined by
LoD of 10 mg/kg polymer. For all the other components, the individual residual amounts in the polymer samples were in
accordance with the transformation chemistry of the substance. The total nitrogen determinations in the test samples
density polyethylene (LDPE), high-density polyethylene and polypropylene samples in contact with 10% ethanol (food
quantification (LoQ) ranging from 0.14 to 0.73 mg/kg.
Considering such high LoQ, the Panel requested second migration tests, which were carried out using an analytical
tunable ultraviolet (UV) detector; stearic acid by high-pressure liquid chromatography coupled with mass spectrometry
(HPLC/MS). The migration tests were performed using the maximum intended use level of 0.1% w/w of the substance
in LDPE samples, again using simulants A and B. More severe contact conditions were applied: 2 h at 100°C followed by
100°C). None of the components were detected to migrate at LoD of 0.008 mg/kg for hydroxylamines, 0.025 mg/kg for
The migration of the components of the substance other than carboxylic acids was not detected at the LoD (in the range
The solubility in water of all the substance components was below the LoD of 20 μg/L at room temperature. No migration
of the substance components other than carboxylic acids was detected at the LoD (3–29 μg/kg). C14-, C16-, C18-, C20-car-
LoD limit of detection

Implications

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Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.

Commit	Date	Change	Description
3171d06	2026-08-02	major	1 section added
bc84bfc	2026-08-02	major	6 sections added; narrative text revised