Safety assessment of the substance 1,3-benzenedicarboxamide, 5-[[[cis-4-(1,1-dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[cis-4-(1-methylethyl)cyclohexyl]- for use in food contact materials.

The EFSA Panel on Food Contact Materials assessed the safety of the 1,3-benzenedicarboxamide, 5-[[[cis-4-(1,1-dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[cis-4-(1-methylethyl)cyclohexyl]-, to be used as a clarifying agent in polypropylene at up to 0.08% w/w. The final articles are intended for contact with all types of food except foods containing more than 10% ethanol, infant formula or mineral water intended to be used to reconstitute infant formula. They are intended for long-term storage at room temperature and below, including hot fill and heating conditions. The migration of the substance was below the limit of quantification of 0.05 mg/kg food in 10% ethanol, with values estimated up to 0.031 mg/kg in olive oil. The migration of the trans isomers can be estimated up to 0.0006 mg/kg food. The total mass transfer of all impurities was individually below 0.05 mg/kg food. The Panel excluded genotoxicity concerns for the substance based on in vitro studies. Trans isomers and relevant impurities were assessed using in silico and literature data and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 0.08% w/w in polypropylene homo- and co-polymers, and the manufactured materials and articles are: (i) for single and repeated use, in contact up to and above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2^((T - 70)/10) min; and (ii) are used in contact with all types of food, excluding beverages with an ethanol content above 10%, infant formula, including reconstituted infant formula and human milk.