The EFSA panel delivers scientific opinion on the substance CAS No 42774-15-2 used as additive in food contact plastics materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide, CAS No 42774-15-2, FCM No 1051, for use as an additive in poly(ethylene terephthalate) (PET), in polyamide (PA) inner layer in multilayers, and in the ethylene vinyl alcohol (EVOH) layer in polypropylene (PP)/EVOH/PP and polyethylene (PE)/EVOH/PE laminates.

Migration tests for the substance were performed in food simulants: acetic acid 3 %, ethanol solutions (10, 20 and 50 %) and olive oil, at time/temperature testing conditions representing the intended use. The results show migration less than 5 mg/kg. Comparison between the chromatograms of solvent extracts of films of PA, PET and two multilayer structures of PP and PE containing EVOH, each with and without the substance as reference films, do not show significant differences.

Based on negative results from five in vitro genotoxicity tests, the Panel concluded that the substance does not raise a concern related to genotoxicity. Based on the at the highest dose levels in a subchronic and subacute studies an overall 'No Observed Adverse Effect Level' NOAEL is set to mg/kg bw.

Based on a consideration of the structure of the molecule along with the low log Pow value of 1.12, the substance does not give rise to concern for accumulation in man. The CEF Panel concluded that the substance N,N'-Bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide is not a safety concern for the consumer if used as an additive in plastics and its migration does not exceed 5 mg/kg food.