ArticleEFSA journal. European Food Safety Authority2025
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.
Article in EFSA journal. European Food Safety Authority, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- 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.EFSA journal. European Food Safety Authority · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.