Safety assessment of diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate for use in a food contact material

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Claude Lambré; José Manuel Barat Baviera; Claudia Bolognesi; Andrew Chesson; Pier Sandro Cocconcelli; Riccardo Crebelli; David Michael Gott; Konrad Grob; Evgenia Lampi; Marcel Mengelers; Alicja Mortensen; Inger-Lise Steffensen; Christina Tlustos; Henk Van Loveren; Laurence Vernis; Holger Zorn; Laurence Castle; Emma Di Consiglio; Roland Franz; Nicole Hellwig; Maria Rosaria Milana; Stefan Merkel; Eric Barthélémy; Daniele Comandella; Gilles Rivière

doi:10.2903/j.efsa.2022.7172

Safety assessment of diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate for use in a food contact material

EFSA J. 2022 Mar 9;20(3):e07172. doi: 10.2903/j.efsa.2022.7172. eCollection 2022 Mar.

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate, FCM substance No. 1007, which is intended to be used in the polymerisation reaction to make poly(ethylene 2,5-furandicarboxylate) (PEF) plastic. The substance is intended to become a component of the backbone of the polymer and has an antioxidant function that provides thermal stability to the polyester during heat processing. The resulting plastic is intended to be used in contact with all types of food under any condition of time and temperature. A PEF sample made using 0.1% w/w of the substance (which is the maximum intended use) was used in a comprehensive set of migration tests with food simulants. The migration of the substance was below the quantification limits estimated around 10 µg/kg. Solvent extraction tests showed no presence of impurities or breakdown products of the substance. The toxicological data provided are the same as those submitted by the same applicant and previously evaluated. The resulting assessment and conclusions are considered still valid by the CEP Panel. Therefore, the CEP Panel concluded that the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate does not raise a safety concern for the consumer if used at up to 0.1% w/w (based on the weight of the polymer) in the polymerisation to make PEF intended for contact with all types of foods under any contact conditions.

Keywords: CAS No. 976‐56‐7; FCM substance No. 1007; diethyl[[3,5‐bis(1,1‐dimethylethyl)‐4‐hydroxyphenyl]methyl] phosphonate; food contact materials; safety assessment.