Scientific Opinion on the safety assessment of the substance, 2,2,4,4‐tetramethylcyclobutane‐1, 3‐diol (TMCD), CAS No 3010‐96‐6, for use in food contact materials

Abstract

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety re-evaluation of 2,2,4,4-tetramethylcyclobutane with the CAS No 3010-96-6, the Ref. No 25187 and the FCM substance No 881 for use as monomer in the manufacture of polyesters. Final articles are intended to be used in contact with non-fatty foods for long time storage at room temperature or below and hot fill. This application represents an extension for single use excluding fatty foods. Migration of the substance, reaction products related to the manufacturing process and oligomers from two typical polyester samples into 3 % acetic acid and 10 % ethanol was considered. Migration of the substance was found to be up to 2 µg/kg in food simulants. Migration of the reaction products was in the range from 1 to 40 µg/kg. Migration of each oligomer containing the substance moiety is estimated to be approximately 10 µg/kg food. The substance was previously evaluated and considered non-genotoxic. No genotoxicity is anticipated for the reaction products and oligomeric species. Therefore the CEF Panel concluded that for single uses, the substance 2,2,4,4-tetramethylcyclobutane-1, 3-diol is not of safety concern for the consumer if the substance is used as co-monomer in the production of polyesters at use levels up to 35 mol % of the diol component, in contact with all food types other than spirits and highly fatty foods simulated by D2, for long time storage at room temperature or below and hot fill.