Safety assessment of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate, for use in food contact materials

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the additive bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH), food contact materials (FCM) substance No 1079, which is intended to be used as plasticizer in poly(vinyl chloride) (PVC) film sat up to 25% w/w in contact with aqueous, acidic and low-alcohol foods for long-term storage at room temperature or below (refrigerated and frozen). The films are not intended for use in reheating food. Under the tested conditions, the substance migrated up to 0.034 mg/kg from samples of PVC films manufactured with 25% w/w DEHCH. Based on the reported in vitro and in vivo genotoxicity studies, the Panel concluded that the substance does not raise a concern for genotoxicity. Based on the provided toxicokinetic study, the Panel concluded that there is uncertainty on the potential for accumulation of the substance in humans. No adverse effects were observed up to the highest tested dose of 1,000 mg/kg body weight (bw) per day in repeated dose toxicity studies. Nevertheless, these data do not remove the uncertainty on the potential for accumulation in humans. Therefore, the CEP Panel concluded that the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate is not of safety concern for the consumer, if it is used in poly(vinyl chloride) (PVC) in contact with foods for which simulants A (10% ethanol) and B (3% acetic acid) are assigned, for long-term storage at room temperature or below. The migration of the substance should not exceed 0.050 mg/kg food.