{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T14:24:19Z","timestamp":1768314259341,"version":"3.49.0"},"reference-count":9,"publisher":"Wiley","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:p>Abstract The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the substances \u2018wax, rice bran, oxidised\u2019 and \u2018wax, rice bran, oxidised, calcium salt\u2019, used as additives up to 0.3% in polyethylene terephthalate (PET), polyamide (PA), thermoplastic polyurethane (TPU), polylactic acid (PLA) and poly(vinyl chloride) (PVC) in contact with all food types for long\u2010term storage at room temperature and below, after hot\u2010fill and\/or heating. The substances consist of the chemical classes wax esters, carboxylic acids, alcohols and calcium salts of acids, along with an unidentified organic fraction up to 5% w\/w. Migration into 10% ethanol and 4% acetic acid was below 0.012 mg\/kg for each chemical class, and about 0.001 mg\/kg for the unidentified fraction. In isooctane, migration was up to 0.297 mg\/kg food for wax esters, below 0.01 mg\/kg food for the other chemical classes and about 0.02 mg\/kg food for the unidentified fraction. The contact with dry food and food simulated by 20% ethanol were considered covered by the migration tests with aqueous simulants. Based on genotoxicity assays and compositional analyses, the constituents of the chemical classes did not raise a concern for genotoxicity. The potential migration of individual constituents or groups of chemically\u2010related compounds of the unidentified fraction would result in exposures below (for aqueous food) and above (for fatty food) the threshold of toxicological concern for genotoxic carcinogens. Therefore, the FCM Panel concluded that the substances are not of safety concern for the consumer, if used as additives up to 0.3% w\/w in PET, PLA and rigid PVC materials and articles intended for contact with all food types except for fatty foods, for long\u2010term storage at room temperature and below, including hot\u2010fill and\/or heating up to 100\u00b0C for up to 2 h.<\/jats:p>","DOI":"10.2903\/j.efsa.2024.8960","type":"journal-article","created":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T05:22:14Z","timestamp":1722835334000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety assessment of the substances \u2018wax, rice bran, oxidised\u2019 and \u2018wax, rice bran, oxidised, calcium salt\u2019 for use in 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":"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":"Eric","family":"Barth\u00e9l\u00e9my","sequence":"additional","affiliation":[]},{"given":"Daniele","family":"Comandella","sequence":"additional","affiliation":[]},{"given":"Gilles","family":"Rivi\u00e8re","sequence":"additional","affiliation":[]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2024.8960_ref1","doi-asserted-by":"crossref","unstructured":"EFSA (European Food Safety Authority) . 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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:\/\/ec.europa.eu\/food\/sites\/food\/files\/safety\/docs\/sci\u2010com_scf_out82_en.pdf"},{"key":"10.2903\/j.efsa.2024.8960_ref5","volume-title":"471: Bacterial reverse mutation test, OECD guidelines for the testing of chemicals, section\u00a04","author":"OECD (Organisation for Economic Co\u2010operation and Development)","year":"1997a"},{"key":"10.2903\/j.efsa.2024.8960_ref6","volume-title":"Test No 476: In\u00a0vitro mammalian cell gene mutation test","author":"OECD (Organisation for Economic Co\u2010operation and Development)","year":"1997b"},{"key":"10.2903\/j.efsa.2024.8960_ref7","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.2024.8960_ref8","unstructured":"OECD (Organisation for Economic Co\u2010operation and Development) (2016b), Test No. 474: Mammalian erythrocyte micronucleus test, OECD guidelines for the testing of chemicals, section\u00a04, OECD Publishing, . https:\/\/doi.org\/10.1787\/9789264264762\u2010en."},{"issue":"12","key":"10.2903\/j.efsa.2024.8960_ref9","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1007\/BF02636324","article-title":"Composition of waxes from crude rice bran oil","volume":"59","author":"Yoon","year":"1982","journal-title":"Journal of the American Oil Chemists' Society"}],"container-title":["EFSA Journal"],"original-title":[],"link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.2903\/j.efsa.2024.8960","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/onlinelibrary.wiley.com\/wol1\/doi\/10.2903\/j.efsa.2024.8960\/fullpdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T09:00:10Z","timestamp":1768294810000},"score":1,"resource":{"primary":{"URL":"http:\/\/doi.wiley.com\/10.2903\/j.efsa.2024.8960"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":9,"journal-issue":{"issue":"8"},"URL":"https:\/\/doi.org\/10.2903\/j.efsa.2024.8960","relation":{},"ISSN":["1831-4732","1831-4732"],"issn-type":[{"value":"1831-4732","type":"print"},{"value":"1831-4732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]}}}