On October 17, 2019, the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEP Panel) published a scientific opinion assessing the safety of the substance trimellitic acid, tris (2-ethylhexyl) ester (also called tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, CAS 3319-31-1) for use in food contact materials. Specifically, the substance is “intended to be used as a plasticizer 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.”
The substance was found to migrate “up to 165 µg/kg food from wrap films and was not detected in food simulant in contact with tubing.” It “does not raise concern for genotoxicity” based on the “three reported in vitro genotoxicity studies.” Based on a 90-day oral toxicity study, the CEP Panel could derive the lowest no observed effect level (NOAEL) of 225 mg/kg body weight (bw) per day. Further, the data on “toxicokinetic and metabolism . . . does not give rise to concern for accumulation in humans.” In addition, the Panel reported that “the substance does not cause developmental effects as induced by phthalic acid, bis(2-ethylhexyl) ester” (DEHP; CAS 117-81-7) and that the “estimated migration” of impurities “does not raise a safety concern” when “assuming that impurities migrate pro-rata to a migration of the substance up to 5 mg/kg food.”
Therefore, the Panel concluded “that the substance does not raise a 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.” It is specified that “overall, the use of the substances does not raise a safety concern if its migration does not exceed 5 mg/kg food.” However, “due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.”
EFSA CEP Panel (2019). “Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials.” EFSA Journal 17: e05864.