On August 10, 2023, the European Commission revised the regulations governing plastic food contact materials (FCM) within the European Union, permitting the utilization of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH; CAS 84731-70-4) as an additive in PVC film, up to a concentration of 25% by weight (w/w; weight per weight) for items that come in contact with food at room temperature or colder. The revised regulations list DEHCH as an approved substance in Annex I. These amendments are set to become effective on the twentieth day following their publication in the European Union’s Official Journal.
This decision follows an assessment carried out by the European Food Safety Authority’s (EFSA) panel on food contact materials, enzymes, and processing aids (CEP), which evaluated the safety of PVC film containing up to 25% w/w DEHCH in contact with aqueous, acidic, and low-alcohol foods intended for long-term storage at or below room temperature.
In a report issued in the EFSA Journal in 2020, the CEP indicated that DEHCH did not raise concerns about genotoxicity. However, the assessment did highlight some uncertainties regarding the potential accumulation of DEHCH in the human body.
The European Commission, taking into account the EFSA’s findings, determined that DEHCH would not pose a safety risk “when used in PVC film that comes into contact with foods for which simulants A (10% ethanol) and B (3% acetic acid) are designated.” The regulations specify that the migration of DEHCH should not exceed 0.050 mg/kg of food.
On July 11, 2023, the Commission published updates to the plastic FCM regulations, which included modifications to existing authorizations and specific migration limits for certain uses of phthalates such as DBP, BBP, DEHP, and DINP (FPF reported).
Reference
European Commission (August 10, 2023) “Commission Regulation (EU) 2023/1627 of 10 August 2023 amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079).”
Read more
Eline Schaart (August 17, 2023) “European Commission rules DEHCH safe for use in food packaging.” Chemical Watch
