Scientific Opinion on the safety evaluation of the substance, 1,3,5‐tris(2,2‐dimethylpropanamido)benzene, CAS No. 745070‐61‐5, 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 evaluation of the additive 1,3,5-tris(2,2-dimethylpropanamido)benzene with the CAS No. 745070-61-5, the Ref. No 95420, the FCM Substance No 784, for use as a nucleating agent/clarifier at a maximum use level of 250 mg/kg in polyprolylene (PP). Final articles are intended to be used in contact with all type of foods for short term contact (1 hour) at temperatures up to 100 ºC and/or for long term storage at ambient temperature or below. Specific migration of the substance into 3 % acetic acid, 10 % ethanol and olive oil, was measured to be up to 48 µg/kg, 79 µg/kg and 94 µg/kg, respectively. In vitro and in vivo genotoxicity tests showed no evidence for a genotoxic potential of the substance. A 90-day dietary toxicity study in Wistar rats showed no effects at any dose and the NOAEL was considered to be 961 mg/kg bw/day in males and 1104 mg/kg bw/day in females or higher. Therefore, the CEF Panel concluded that the substance 1,3,5-tris(2,2-dimethylpropanamido)benzene does not raise a safety concern for the consumer if it is used in polyolefins and the migration does not exceed 5 mg/kg food.