Safety assessment of the substance bis(2‐ethylhexyl)cyclohexane‐1,4‐dicarboxylate, for use in food contact materials
Meta data
Competing interests: Roland Franz declared that Fraunhofer institute at which he was employed provides advisory services to private business operators active in the sector on food contact materials. In line with EFSA's Policy on Independence and the Decision of the Executive Director on Competing Interest Management, a waiver was granted to Roland Franz regarding his participation to the EFSA's Working Group on Food Contact Materials (FCM WG) in accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management. Pursuant to Article 21(6) of the above‐mentioned Decision, the involvement of Roland Franz is authorised as member in the FCM WG, allowing him to take part in the discussions and in the drafting phase of the scientific output, but he is not allowed to be, or act as, a chairman, a vice‐chairman or rapporteur of the working group.
Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information has been provided under confidentiality and it is redacted awaiting the decision of the Commission: cis/trans ratio and manufacture details of the substance, percentage of residual impurity, tested concentrations of the in vitro mammalian cell gene mutation test, details of the study report on the toxicokinetic testing.
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.