Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2-ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 μg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90-day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2-ethylhexyl) ester (DEHP). Assuming that impurities migrate pro-rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.