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

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Competing interests: R. Franz declared that Fraunhofer institute at which he is employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA’s Policy on Independence (https://www.efsa.europa.eu/sites/default/files/corporate_publications/f…) and the Decision of the Executive Director on Competing Interest Management (https://www.efsa.europa.eu/sites/default/files/corporate_publications/f…), a waiver was granted to R. Franz regarding his participation to the EFSA’s Working Group on Food Contact Materials (FCM WG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of R. Franz is authorised as member in the FCM WG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.

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.