European Commission authorises the use of DEHCH in food contact materials

On 11 August 2023 the European Commission published an amendment, Regulation (EU) 2023/1627, to Annex I of Regulation (EU) No 10/2011 (the Food Contact Plastics Regulation) in the Official Journal of the European Union.

The amendment grants authorisation for the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) in the production of plastic food contact materials (FCMs) and will come into force on 31 August 2023.

In the amendment DEHCH is added Annex I of Regulation No 10/2011 which establishes a Union list of authorised substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into contact with food.

The authorisation follows a safety assessment adopted by the Panel on Food Contact Materials, Enzymes, and Processing Aids (CEP) under the European Food Safety Authority (EFSA) in December 2019 on the use of DEHCH as a plasticiser in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact with refrigerated or frozen aqueous, acidic and low-alcohol foods.

Based on a scientific study the CEP concluded that DEHCH does not raise genotoxicity concerns and that no adverse effects were observed in the toxicity studies. The CEP, however, expressed an uncertainty regarding the potential for accumulation of the substance in humans. It was therefore concluded that the migration of the substance should not exceed 0.05 mg/kg food and that it should only be used in PVC in contact with foods, for which simulants A (10 % ethanol) and B (3 % acetic acid) are assigned, at room temperature or below.