{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T13:38:56Z","timestamp":1786714736412,"version":"build-2736575974"},"reference-count":16,"publisher":"Wiley","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:p>Abstract The EFSA Panel on Food Contact Materials assessed the safety of the 1,3\u2010benzenedicarboxamide, 5\u2010[[[cis\u20104\u2010(1,1\u2010dimethylethyl)cyclohexyl]carbonyl]amino]\u2010N1,N3\u2010bis[cis\u20104\u2010(1\u2010methylethyl)cyclohexyl]\u2010, to be used as a clarifying agent in polypropylene at up to 0.08% w\/w. The final articles are intended for contact with all types of food except foods containing more than 10% ethanol, infant formula or mineral water intended to be used to reconstitute infant formula. They are intended for long\u2010term storage at room temperature and below, including hot fill and heating conditions. The migration of the substance was below the limit of quantification of 0.05 mg\/kg food in 10% ethanol, with values estimated up to 0.031 mg\/kg in olive oil. The migration of the trans isomers can be estimated up to 0.0006 mg\/kg food. The total mass transfer of all impurities was individually below 0.05 mg\/kg food. The Panel excluded genotoxicity concerns for the substance based on in\u00a0vitro studies. Trans isomers and relevant impurities were assessed using in silico and literature data and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 0.08% w\/w in polypropylene homo\u2010 and co\u2010polymers, and the manufactured materials and articles are: (i) for single and repeated use, in contact up to and above 6 months at room temperature and below, including hot\u2010fill conditions and\/or heating up to 70\u00b0C\u2009\u2264\u2009T\u2009\u2264\u2009100\u00b0C for maximum t\u2009=\u2009120\/2^((T\u2009\u2212\u200970)\/10) min; and (ii) are used in contact with all types of food, excluding beverages with an ethanol content above 10%, infant formula, including reconstituted infant formula and human milk.<\/jats:p>","DOI":"10.2903\/j.efsa.2026.10292","type":"journal-article","created":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T13:15:21Z","timestamp":1786713321000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety assessment of the substance 1,3\u2010benzenedicarboxamide, 5\u2010[[[cis\u20104\u2010(1,1\u2010dimethylethyl)cyclohexyl]carbonyl]amino]\u2010N1,N3\u2010bis[cis\u20104\u2010(1\u2010methylethyl)cyclohexyl]\u2010 for use in food contact materials"],"prefix":"10.2903","volume":"24","author":[{"name":"EFSA Panel on Food Contact Materials (FCM)","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude","family":"Lambr\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Crebelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Jo\u00e3o","family":"da Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konrad","family":"Grob","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ester","family":"Heath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evgenia","family":"Lampi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rosaria","family":"Milana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marja","family":"Pronk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"\u0160\u010detar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgios","family":"Theodoridis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Els","family":"Van Hoeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadia","family":"Waegeneers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronan","family":"Cariou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence","family":"Castle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Di Consiglio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland","family":"Franz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Barth\u00e9l\u00e9my","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remigio","family":"Marano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Rivi\u00e8re","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2026.10292_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.2026.10292_ref2","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2023a). Principles that could be applicable to the safety assessment of the use of mixtures of natural origin to manufacture food contact materials. EFSA Supporting Publications, 20(11), EN\u20108409. https:\/\/doi.org\/10.2903\/sp.efsa.2023.EN\u20108409","DOI":"10.2903\/sp.efsa.2023.EN-8409"},{"key":"10.2903\/j.efsa.2026.10292_ref3","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . (2023b). Harmonised approach for reporting reliability and relevance of genotoxicity studies. EFSA Supporting Publications, 20(9), EN\u20108270. https:\/\/doi.org\/10.2903\/sp.efsa.2023.EN\u20108270","DOI":"10.2903\/sp.efsa.2023.EN-8270"},{"key":"10.2903\/j.efsa.2026.10292_ref4","doi-asserted-by":"crossref","unstructured":"EFSA AFC Panel (EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food) . (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.2026.10292_ref5","doi-asserted-by":"crossref","unstructured":"EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids) . (2016). Scientific opinion on recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials. EFSA Journal, 14(1), 4357. https:\/\/doi.org\/10.2903\/j.efsa.2016.4357","DOI":"10.2903\/j.efsa.2016.4357"},{"key":"10.2903\/j.efsa.2026.10292_ref6","doi-asserted-by":"crossref","unstructured":"EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) . (2019). Scientific Opinion on the update of the risk assessment of \u2018wood flour and fibres, untreated\u2019 (FCM No 96) for use in food contact materials, and criteria for future applications of materials from plant origin as additives for plastic food contact materials. EFSA Journal, 17(11), 5902. https:\/\/doi.org\/10.2903\/j.efsa.2019.5902","DOI":"10.2903\/j.efsa.2019.5902"},{"key":"10.2903\/j.efsa.2026.10292_ref7","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee . (2011). Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA Journal, 9(9), 2379. https:\/\/doi.org\/10.2903\/j.efsa.2011.2379","DOI":"10.2903\/j.efsa.2011.2379"},{"key":"10.2903\/j.efsa.2026.10292_ref8","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee . (2017). Guidance on the risk assessment of substances present in food intended for infants below 16\u2009weeks of age. EFSA Journal, 15(5), 4849. https:\/\/doi.org\/10.2903\/j.efsa.2017.4849","DOI":"10.2903\/j.efsa.2017.4849"},{"key":"10.2903\/j.efsa.2026.10292_ref9","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee . (2021a). Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. EFSA Journal, 19(8), 6769. https:\/\/doi.org\/10.2903\/j.efsa.2021.6769","DOI":"10.2903\/j.efsa.2021.6769"},{"key":"10.2903\/j.efsa.2026.10292_ref10","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee . (2021b). Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: Human and animal health. EFSA Journal, 19(8), 6768. https:\/\/doi.org\/10.2903\/j.efsa.2021.6768","DOI":"10.2903\/j.efsa.2021.6768"},{"key":"10.2903\/j.efsa.2026.10292_ref11","doi-asserted-by":"crossref","unstructured":"EFSA Scientific Committee . (2025). Guidance on the use of read\u2010across for chemical safety assessment in food and feed. EFSA Journal, 23(7), e9586. https:\/\/doi.org\/10.2903\/j.efsa.2025.9586","DOI":"10.2903\/j.efsa.2025.9586"},{"key":"10.2903\/j.efsa.2026.10292_ref12","unstructured":"Joint Research Centre (JRC) . (2016). Technical guidelines for compliance testing in the framework of regulation (EU) no. 10\/2011 on plastic food contact materials. Draft for Stakeholder Consultation."},{"key":"10.2903\/j.efsa.2026.10292_ref13","volume-title":"Test No. 473: In\u00a0vitro mammalian chromosomal aberration test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development)","year":"2016a"},{"key":"10.2903\/j.efsa.2026.10292_ref14","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)","year":"2016b"},{"key":"10.2903\/j.efsa.2026.10292_ref15","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)","year":"2020"},{"key":"10.2903\/j.efsa.2026.10292_ref16","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)","year":"2023"}],"container-title":["EFSA Journal"],"original-title":[],"link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.2903\/j.efsa.2026.10292","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/onlinelibrary.wiley.com\/wol1\/doi\/10.2903\/j.efsa.2026.10292\/fullpdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T13:15:23Z","timestamp":1786713323000},"score":1,"resource":{"primary":{"URL":"http:\/\/doi.wiley.com\/10.2903\/j.efsa.2026.10292"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":16,"journal-issue":{"issue":"8"},"URL":"https:\/\/doi.org\/10.2903\/j.efsa.2026.10292","relation":{},"ISSN":["1831-4732","1831-4732"],"issn-type":[{"value":"1831-4732","type":"print"},{"value":"1831-4732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]}}}