Scientific Opinion on the safety assessment of the substance, 5‐norbornene‐2, 3‐dicarboxylic anhydride, CAS No 826‐62‐0, for use in food contact materials

Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the risk assessment of 5-norbornene-2, 3-dicarboxylic anhydride CAS 826-62-0, FCM substance No 978, for a co-monomer in polyester based coatings for metal cans. Based on the residual content of the substance in the final coating, the calculated worst case migration of the two isomers of the substance and their hydrolysis products was 27 µg/kg food. From the same experiment the overall migration was 24 mg/kg food. LMWF was found to make up 8.8 mg/kg food, out of this the LMWF which contains the substance was 1.54 mg/kg food. Based on negative results from two in vivo genotoxicity tests, the Panel considered that the substance and the LMWF oligomers containing the substance moieties are non-genotoxic. The systemic toxicity of the substance-containing LMWF oligomers was assessed in a subchronic oral rat study. The comparison between the NOAEL, derived from this study and a daily intake gives a large margin of safety. The CEF Panel concluded that the substance 5-norbornene-2, 3-dicarboxylic anhydride is not of a safety concern for the consumer if it is used as a co-monomer in polyester based can coatings at levels of up to 18.3 weight % of the final dry coating, in contact with all food excluding beverages, at sterilization conditions and long term contact. Migration of the substance and its hydrolysis products should in total not exceed 50 µg/kg food.