{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T05:11:49Z","timestamp":1734412309812,"version":"3.30.2"},"reference-count":14,"publisher":"Wiley","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:p>Abstract\r\n The EFSA Panel on Food Contact Materials assessed the safety of 2,2\u2032\u2010oxydiethylamine, which is intended to be used at up to 14% w\/w as a monomer along with adipic acid and caprolactam to make polyamide thin films intended for single use, in contact with all types of food under all conditions of time and temperature. Specific migration of 2,2\u2032\u2010oxydiethylamine was tested from a polyamide film in water and was below the limit of quantification (LOQ) of 0.015 mg\/kg. Migration of impurities has been estimated pro\u2010rata. Migrating oligomers were identified and semi\u2010quantified in 10% ethanol, 3% acetic acid and olive oil. Considering the measured migration and the virtual presence at the LOQ of the oligomers below 1000 Da containing the substance, the estimated migration of these oligomers would be 1.042 mg\/kg. Genotoxicity studies were performed on the substance and on 1\u2010oxa\u20104,11,18\u2010triazacycloeicosane\u20105,10,17\u2010trione and 1\u2010oxa\u20104,11,18,25\u2010tetraazacycloheptacosane\u20105,10,17,24\u2010tetraone. (Q)SAR analyses were provided on the oligomers of higher molecular masses. Based on these data, the Panel excluded genotoxicity concerns for the substance and its oligomers. From a 90\u2010day toxicity study on the 1\u2010oxa\u20104,11,18\u2010triazacycloeicosane\u20105,10,17\u2010trione, the Panel identified a NOAEL of 1040 mg\/kg bw per day. Based on their physico\u2010chemical properties and experimental data, the Panel considered the potential for accumulation in humans of the oligomers containing the substance of no concern. The Panel concluded that the substance is not of safety concern for the consumer if it is used as a comonomer with 99.6% minimum purity at up to 14% w\/w to manufacture polyamide films (maximum thickness: 25 \u03bcm) and intended to be used in contact with all types of foods, except infant formula and human milk, at all time and temperature conditions. The migrations of the substance and of the oligomers below 1000 Da containing the substance should not exceed 0.05 and 5 mg\/kg food, respectively. \r\n<\/jats:p>","DOI":"10.2903\/j.efsa.2024.9105","type":"journal-article","created":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T14:02:26Z","timestamp":1734357746000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety assessment of the substance 2,2\u2032\u2010oxydiethylamine for use in plastic food contact materials"],"prefix":"10.2903","volume":"22","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":"de 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":"Eric","family":"Barth\u00e9l\u00e9my","sequence":"additional","affiliation":[]},{"given":"Remigio","family":"Marano","sequence":"additional","affiliation":[]},{"given":"Gilles","family":"Rivi\u00e8re","sequence":"additional","affiliation":[]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2024.9105_ref1","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.2024.9105_ref2","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2021). Administrative guidance for the preparation of applications on substances to be used in plastic food contact materials. EFSA Supporting Publications, 18, EN\u20106514. https:\/\/doi.org\/10.2903\/sp.efsa.2021.EN\u20106514","DOI":"10.2903\/sp.efsa.2021.EN-6514"},{"key":"10.2903\/j.efsa.2024.9105_ref3","unstructured":"EFSA (European Food Safety Authority) . (2023). Harmonised approach for reporting reliability and relevance of genotoxicity studies. EFSA Supporting Publications, EN\u20108270. https:\/\/doi.org\/10.2903\/sp.efsa.2023.EN\u20108270"},{"key":"10.2903\/j.efsa.2024.9105_ref4","doi-asserted-by":"crossref","unstructured":"EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food) . (2017). Scientific Opinion on the re\u2010evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives. EFSA Journal, 15(6), 4786. https:\/\/doi.org\/10.2903\/j.efsa.2017.4786","DOI":"10.2903\/j.efsa.2017.4786"},{"key":"10.2903\/j.efsa.2024.9105_ref5","doi-asserted-by":"crossref","unstructured":"EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids) . (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. 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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:\/\/food.ec.europa.eu\/system\/files\/2020\u201012\/sci\u2010com_scf_out82_en.pdf"},{"key":"10.2903\/j.efsa.2024.9105_ref9","unstructured":"OECD (Organisation for Economic Co\u2010operation and Development) . (2008). Test No. 407: Repeated dose 28\u2010day oral toxicity study in rodents, OECD Guidelines for the testing of chemicals, section\u00a04, OECD Publishing, Paris. https:\/\/doi.org\/10.1787\/9789264070684\u2010en"},{"key":"10.2903\/j.efsa.2024.9105_ref10","unstructured":"OECD (Organisation for Economic Co\u2010operation and Development) . (2016). 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