Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Food Standards Agency, United Kingdom, for safety assessment of the substance furan-2,5-dicarboxylic acid (FDSA) following a corresponding application from YXY Technologies B.V., The Netherlands.
FDCA is a monomer intended to manufacture PEF polymer with ethylene glycol as co-monomer. The PEF polymer is intended to be used in contact with all types of foodstuffs and storage under any condition of time and temperature.
Specific migration was estimated based on an assumption of 100 % mass transfer of the residual content of FDCA in PEF polymer and this provided an estimate of 0.12 mg/kg food. Overall migration was performed with 3 % acetic acid, 10, 20, 50 and 95 % ethanol and iso-octane food simulants for 10 days at 60 °C. All results were below the limit of detection of 6 mg/kg food. Concerning the migration of oligomers, using the same test conditions, the sum of all migrating species that had a low molecular weight and contained the FDCA unit was estimated to be 1.5 mg/kg food (into 95 % ethanol), 0.54
(50 % ethanol), 0.060 (20 % ethanol), 0.021 (10 % ethanol) and 0.011 mg/kg (3 % acetic acid). Due to swelling effects that are known to occur when polyesters are in contact with higher ethanol levels the migration values from the 95% and 50% ethanol tests were considered as too severe and the 20 % ethanol test was taken as more representative and still conservative for the intended use. The substance did not induce gene mutations in bacteria and mammalian cells, and did not induce chromosomal aberrations in human peripheral lymphocytes. 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 rats, a NOAEL of 300 mg FDCA/kg bw/day was derived based on a reduction of body weight and effects on adrenal glands.
Therefore the CEF Panel concluded that the substance furan-2,5-dicarboxylic acid (FDCA) does not raise a safety concern for the consumer when the substance is 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 the oligomers less than 1000 Da should not exceed 50 µg/kg food (expressed as FDCA).