On May 24, 2017 the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) published a scientific opinion on the safety assessment of 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester (TDCM, CAS 23985-75-3) to be used as a co-monomer in the manufacture of polyester layers, which are not intended to come in direct contact with food (FPF reported). “The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs,” the CEF Panel explained, with contact conditions including sterilization followed by long-term storage at room temperature. TDCM is not expected to thermally degrade during manufacture of the middle polyester layer and of the multilayer articles. Further, total mass transfer of TDCM from a polyester monolayer was calculated to be up to 0.032 mg/kg food. The CEF Panel does not consider TDCM to be genotoxic according to three in vitro genotoxicity tests. Also, the CEF Panel found no indication of genotoxicity for migrating TDCM-related oligomers (mainly TDCM dimers), their oxidation products, and other TDCM-related reaction products. Therefore, the CEF Panel concluded that TDCM is safe for consumers if used as described. The CEF Panel noted that “the migration of the sum of the substance [TDCM] and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food.”
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CEF (May 24, 2017). “Safety assessment of the substance 1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester for use in food contact materials.”
