Safety assessment of the substance (2E,2′E)‐2,4,8,10‐tetraoxaspiro[5.5]undecane‐3,9‐diylbis(2‐methylpropane‐2,1‐diyl) bis(2‐cyano‐3‐(3,4‐dimethoxyphenyl)acrylate for use in plastic food contact materials

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of (2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate, which is intended to be used as an additive at up to 0.75% w/w in polyethylene terephthalate (PET) single-use articles for contact with all types of food, for long-term storage at room temperature including hot fill and/or heating up to 100°C for a maximum of 2 h. Migration tests were carried out into the food simulants 3% acetic acid, 10% ethanol and olive oil, using PET samples containing the substance at the maximum intended level. The specific migration of the substance was up to 33 μg/kg food. The individual migration of its impurities was generally below the limits of quantification or not detected at the limits of detection, both in the few μg/kg food range, except for 3,4-dimethoxybenzaldehyde and spiroglycol in 10% ethanol (up to 45 and 46 μg/kg food, respectively). The specific migration of potential reaction or degradation products was below 50 μg/kg food. Genotoxicity studies demonstrated that the substance does not raise a concern. Impurities and the potential degradation or reaction products do not raise a concern for genotoxicity, based on genotoxicity studies, literature data or in silico assessment. The Panel concluded that the substance is not of safety concern for the consumers (i) if it is used as an additive at up to 0.75% w/w in PET intended for contact with all types of foods, except human milk, infant formula and water that could be used to reconstitute infant formula; (ii) if it is used for long-term storage at room temperature, including hot fill and/or heating conditions up to 100°C for a maximum of 2 h; and (iii) if the migration of its impurity 3,4-dimethoxybenzaldehyde does not exceed 50 μg/kg food.