Scientific Opinion on the safety assessment of the substance, N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide, CAS No 42774-15-2, for use in food contact materials
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and ProcessingAids (CEF) deals with the risk assessment of N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide, CASNo 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 andpolyethylene (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 conditionsrepresenting the intended use. The results show migration less than 5 mg/kg. Comparison between thechromatograms of solvent extracts of films of PA, PET and two multilayer structures of PP and PE containingEVOH, each with and without the substance as reference films, do not show significant differences. Based onnegative results from five in vitro genotoxicity tests, the Panel concluded that the substance does not raise aconcern related to genotoxicity. Based on the [removed for confidentiality reasons] at the highest dose levels in asubchronic and subacute studies an overall 'No Observed Adverse Effect Level' NOAEL is set to [removed for confidentiality reasons] mg/kg bw..Based on a consideration of the structure of the molecule along with the low log Pow value of 1.12, thesubstance does not give rise to concern for accumulation in man. The CEF Panel concluded that the substanceN,N'-Bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide is not a safety concern for the consumer if used as anadditive in plastics and its migration does not exceed 5 mg/kg food.
The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. Data on purity and migration as well as toxicological data have been provided under the established confidentiality agreements and they are redacted awaiting the decision of the Commission.