Scientific Opinion on the safety assessment of the substance, furan-2,5-dicarboxylic acid, CAS No 3238-40-2, for use in food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the substance furan-2,5-dicarboxylic acid (FDCA) with CAS No 3238-40-2 and FCM substance No 01031, for use as a monomer with ethylene glycol to produce polyethylene furanoate (PEF) polymer. Final articles are intended to be used in contact with all types of foodstuffs and storage under any condition of time and temperature. Based on the residual content in the plastic, specific migration of the substance was calculated to be up to 0.12 mg/kg food when assuming total mass transfer. Concerning the migration of oligomers, the sum of all species that had a low molecular weight, contained the FDCA unit, and migrated into food simulants under test conditions of 10 days at 60 °C, was estimated to be up to 0.060 mg/kg food as derived from the migration into 20 % ethanol, which was considered representative and still conservative for the intended use. Based on three negative in vitro tests, the Panel considered that there is no concern with respect to genotoxicity. From a 90-day oral toxicity study in rat, it was concluded that the NOAEL was 300 mg FDCA/kg bw/day. The substance does not raise concern for accumulation in man. The Panel concluded that the substance furan-2,5-dicarboxylic acid does not raise a safety concern for the consumer when used as a monomer in the production of polyethylene furanoate (PEF) polymer and the migration of the substance itself does not exceed 5 mg/kg food. However, considering the lack of data demonstrating that the migrating oligomers and reaction products are hydrolysed in vivo back to their starting substances, the CEF Panel furthermore concluded that migration of oligomers less than 1000 Da should not exceed 50 µg/kg food (expressed as FDCA).