{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T05:07:52Z","timestamp":1739250472687,"version":"3.37.0"},"reference-count":32,"publisher":"Wiley","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:p>Abstract\r\n The European Commission asked EFSA to review whether the authorisation of N,N\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)amine (FCM No 19) and N,N\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)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\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)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\u2009mg\/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)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\u2009mm 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\u2009mg\/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\u2010coco, PFAEO\u2010oleyl, PFAEO\u2010HT, PFAEO\u2010T and PFAO\u2010C18 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\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)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. \r\n<\/jats:p>","DOI":"10.2903\/j.efsa.2025.9104","type":"journal-article","created":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T10:02:36Z","timestamp":1739181756000},"source":"Crossref","is-referenced-by-count":0,"title":["Update of the safety assessment of N,N\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)amines (FCM No 19) and N,N\u2010bis(2\u2010hydroxyethyl)alkyl(C8\u2010C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with food"],"prefix":"10.2903","volume":"23","author":[{"name":"EFSA Panel on Food Contact Materials (FCM)","sequence":"first","affiliation":[]},{"given":"Claude","family":"Lambr\u00e9","sequence":"additional","affiliation":[]},{"given":"Riccardo","family":"Crebelli","sequence":"additional","affiliation":[]},{"given":"Maria","family":"da Silva","sequence":"additional","affiliation":[]},{"given":"Konrad","family":"Grob","sequence":"additional","affiliation":[]},{"given":"Evgenia","family":"Lampi","sequence":"additional","affiliation":[]},{"given":"Maria Rosaria","family":"Milana","sequence":"additional","affiliation":[]},{"given":"Marja","family":"Pronk","sequence":"additional","affiliation":[]},{"given":"Mario","family":"\u0160\u010detar","sequence":"additional","affiliation":[]},{"given":"Georgios","family":"Theodoridis","sequence":"additional","affiliation":[]},{"given":"Els","family":"Van Hoeck","sequence":"additional","affiliation":[]},{"given":"Nadia","family":"Waegeneers","sequence":"additional","affiliation":[]},{"given":"Claudia","family":"Bolognesi","sequence":"additional","affiliation":[]},{"given":"Ronan","family":"Cariou","sequence":"additional","affiliation":[]},{"given":"Laurence","family":"Castle","sequence":"additional","affiliation":[]},{"given":"Emma","family":"Di Consiglio","sequence":"additional","affiliation":[]},{"given":"Roland","family":"Franz","sequence":"additional","affiliation":[]},{"given":"Detlef","family":"W\u00f6lfle","sequence":"additional","affiliation":[]},{"given":"Zainab","family":"Al Harraq","sequence":"additional","affiliation":[]},{"given":"Eric","family":"Barth\u00e9l\u00e9my","sequence":"additional","affiliation":[]},{"given":"Daniele","family":"Comandella","sequence":"additional","affiliation":[]},{"given":"Julia Font\u00e1n","family":"Vela","sequence":"additional","affiliation":[]},{"given":"Blanka","family":"Halamoda","sequence":"additional","affiliation":[]},{"given":"Gilles","family":"Rivi\u00e8re","sequence":"additional","affiliation":[]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2025.9104_ref1","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2008). Note for Guidance for the preparation of an application for the safety assessment of a substance to be used in plastic food contact materials. EFSA Journal, 6(7), 21r. https:\/\/doi.org\/10.2903\/j.efsa.2008.21r","DOI":"10.2903\/j.efsa.2008.21r"},{"key":"10.2903\/j.efsa.2025.9104_ref2","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2009). Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessments carried out by EFSA. Part 2: General principles. EFSA Journal, 7(5), 1051. https:\/\/doi.org\/10.2903\/j.efsa.2009.1051","DOI":"10.2903\/j.efsa.2009.1051"},{"key":"10.2903\/j.efsa.2025.9104_ref3","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee , Hardy, A., Benford, D., Halldorsson, T., Jeger, M., Knutsen, H. K., More, S., Naegeli, H., Noteborn, H., Ockleford, C., Ricci, A., Rychen, G., Silano, V., Solecki, R., Turck, D., Younes, M., Aquilina, G., Crebelli, R., G\u00fcrtler, R., \u2026 Schlatter, J. (2017). Clarification of some aspects related to genotoxicity assessment. EFSA Journal, 15(12), 5113. https:\/\/doi.org\/10.2903\/j.efsa.2017.5113","DOI":"10.2903\/j.efsa.2017.5113"},{"key":"10.2903\/j.efsa.2025.9104_ref4","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee , More, S. J., Bampidis, V., Benford, D., Bragard, C., Halldorsson, T. I., Hern\u00e1ndez\u2010Jerez, A. F., Bennekou, S. H., Koutsoumanis, K., Lambr\u00e9, C., Machera, K., Mennes, W., Mullins, E., Nielsen, S. S., Schrenk, D., Turck, D., Younes, M., Aerts, M., Edler, L., \u2026 Schlatter, J. (2022). Guidance on the use of the benchmark dose approach in risk assessment. EFSA Journal, 20(10), 7584. https:\/\/doi.org\/10.2903\/j.efsa.2022.7584","DOI":"10.2903\/j.efsa.2022.7584"},{"key":"#cr-split#-10.2903\/j.efsa.2025.9104_ref5.1","unstructured":"European Commission . (1997). Reports of the scientific committee for food (thirty\u2010third series)"},{"key":"#cr-split#-10.2903\/j.efsa.2025.9104_ref5.2","unstructured":"first report of the scientific committee for food on certain additives used in the manufacture of plastic materials intended to come into contact with foodstuffs (opinions expressed until 3 May 1992). https:\/\/aei.pitt.edu\/40842\/1\/33rd_food.pdf"},{"key":"10.2903\/j.efsa.2025.9104_ref6","unstructured":"European Commission . (2001a). Guidelines of the scientific committee on food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. https:\/\/ec.europa.eu\/food\/sites\/food\/files\/safety\/docs\/sci\u2010com_scf_out82_en.pdf"},{"key":"10.2903\/j.efsa.2025.9104_ref7","unstructured":"European Commission . (2001b). Opinion of the scientific committee on food on the 13th additional list of monomers and additives for food contact materials. https:\/\/ec.europa.eu\/food\/system\/files\/2020\u201012\/sci\u2010com_scf_out86_en.pdf"},{"key":"10.2903\/j.efsa.2025.9104_ref8","unstructured":"Kaling, M. (2017). Determination of monoethanolamine and diethanolamine in rat urine and serum. Clariant Produkte (Deutschland) GmbH CLAS, R&D Analytics CIC. Study no. 16\u2010005211. Unpublished report."},{"key":"10.2903\/j.efsa.2025.9104_ref9","doi-asserted-by":"crossref","unstructured":"Lee, M. S., Kaling, M., Dierdof, I., & Kreiling, R. (2017). Assessment of systemic exposure to metabolically generated mono\u2010 and diethanolamine in rats treated with 2,2\u2032\u2010(C12\u201018 alkylimino)\u2010diethanol. Unpublished report.","DOI":"10.1016\/j.toxlet.2017.07.279"},{"issue":"7","key":"10.2903\/j.efsa.2025.9104_ref10","doi-asserted-by":"crossref","first-page":"733","DOI":"10.1080\/004982597240316","article-title":"Diethanolamine absorption, metabolism and disposition in rat and mouse following oral, intravenous and dermal administration","volume":"27","author":"Mathews","year":"1997","journal-title":"Xenobiotica"},{"key":"10.2903\/j.efsa.2025.9104_ref11","volume-title":"Test no. 474: Mammalian erythrocyte micronucleus test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1983"},{"key":"10.2903\/j.efsa.2025.9104_ref12","volume-title":"Test no. 102: Melting point\/melting range, OECD guidelines for the testing of chemicals, section\u00a01","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1995a"},{"key":"10.2903\/j.efsa.2025.9104_ref13","volume-title":"Test no. 103: Boiling point, OECD guidelines for the testing of chemicals, section\u00a01","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1995b"},{"key":"10.2903\/j.efsa.2025.9104_ref14","volume-title":"Test no. 105: Water solubility, OECD guidelines for the testing of chemicals, section\u00a01","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1995c"},{"key":"10.2903\/j.efsa.2025.9104_ref15","volume-title":"Test no. 421: Reproduction\/developmental toxicity screening test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1995d"},{"key":"10.2903\/j.efsa.2025.9104_ref16","volume-title":"Test no. 422: Combined repeated dose toxicity study with the reproduction\/developmental toxicity screening test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1996"},{"key":"10.2903\/j.efsa.2025.9104_ref17","volume-title":"Test no. 471: Bacterial reverse mutation test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1997a"},{"key":"10.2903\/j.efsa.2025.9104_ref18","volume-title":"Test no. 476: in\u00a0vitro mammalian cell gene mutation test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1997b"},{"key":"10.2903\/j.efsa.2025.9104_ref19","volume-title":"Test no. 473: In\u00a0vitro mammalian chromosome aberration test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1997c"},{"key":"10.2903\/j.efsa.2025.9104_ref20","volume-title":"Test no. 474: Mammalian erythrocyte micronucleus test","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1997d"},{"key":"10.2903\/j.efsa.2025.9104_ref21","volume-title":"Test no. 408: Repeated dose 90\u2010day oral toxicity study in rodents, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"1998"},{"key":"10.2903\/j.efsa.2025.9104_ref22","volume-title":"Test no. 414: Prenatal developmental toxicity study, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2001"},{"key":"10.2903\/j.efsa.2025.9104_ref23","volume-title":"Test no. 407: Repeated dose 28\u2010day oral toxicity study in rodents, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2008"},{"key":"10.2903\/j.efsa.2025.9104_ref24","volume-title":"Test no. 490: in\u00a0vitro mammalian cell gene mutation tests using the thymidine kinase gene, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2016a"},{"key":"10.2903\/j.efsa.2025.9104_ref25","volume-title":"Test no. 474: Mammalian erythrocyte micronucleus test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2016b"},{"key":"10.2903\/j.efsa.2025.9104_ref26","volume-title":"Test no. 422: Combined repeated dose toxicity study with the reproduction\/developmental toxicity screening test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2016c"},{"key":"10.2903\/j.efsa.2025.9104_ref27","volume-title":"Test no. 408: Repeated dose 90\u2010day oral toxicity study in rodents, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2018a"},{"key":"10.2903\/j.efsa.2025.9104_ref28","volume-title":"Test no. 443: Extended one\u2010generation reproductive toxicity study, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2018b"},{"key":"10.2903\/j.efsa.2025.9104_ref29","volume-title":"Test no. 414: Prenatal developmental toxicity study, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2018c"},{"key":"10.2903\/j.efsa.2025.9104_ref30","volume-title":"Test no. 487: In\u00a0vitro mammalian cell micronucleus test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development Testing Guidelines)","year":"2023"},{"key":"10.2903\/j.efsa.2025.9104_ref31","doi-asserted-by":"crossref","unstructured":"Pradeep, P., Judson, R., DeMarini, D. M., Keshava, N., Martin, T. M., Dean, J., Gibbons, C. F., Simha, A., Warren, S. H., Gwinn, M. R., & Patlewicz, G. (2021). Evaluation of existing QSAR models and structural alerts and development of new ensemble models for Genotoxicity using a newly compiled experimental dataset. Computational Toxicology, 18, 100167. https:\/\/doi.org\/10.1016\/j.comtox.2021.100167","DOI":"10.1016\/j.comtox.2021.100167"}],"container-title":["EFSA Journal"],"original-title":[],"link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.2903\/j.efsa.2025.9104","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/onlinelibrary.wiley.com\/wol1\/doi\/10.2903\/j.efsa.2025.9104\/fullpdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T10:02:49Z","timestamp":1739181769000},"score":1,"resource":{"primary":{"URL":"http:\/\/doi.wiley.com\/10.2903\/j.efsa.2025.9104"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2]]},"references-count":32,"journal-issue":{"issue":"2"},"URL":"https:\/\/doi.org\/10.2903\/j.efsa.2025.9104","relation":{},"ISSN":["1831-4732","1831-4732"],"issn-type":[{"value":"1831-4732","type":"print"},{"value":"1831-4732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2]]}}}