The European Commission has issued Commission Regulation (EU) 2023/1627, amending Annex I to Regulation (EU) No 10/2011. This amendment concerns the authorization of the substance bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (DEHCH), identified as FCM No 1079.
This decision follows a favorable scientific opinion by the European Food Safety Authority (EFSA), issued on December 11, 2019. The EFSA approved the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate as an additive (plasticizer) in poly(vinyl chloride) (PVC) at concentrations of up to 25% w/w. The substance can be used in contact with aqueous, acidic, and low-alcohol foods for long-term storage at room temperature or below, including refrigerated and frozen conditions. The EFSA found no genotoxicity concerns and observed no adverse effects up to the highest tested dose of 1,000 mg/kg body weight per day in repeated dose toxicity studies.
However, the EFSA noted some uncertainty regarding the potential for accumulation of the substance in humans. Consequently, it was recommended that the migration of the substance should not exceed 0.05 mg/kg food, and it should only be used in PVC intended for contact with foods for which simulants A (10% ethanol) and B (3% acetic acid) are assigned, at room temperature or below.
The amendment to Regulation (EU) No 10/2011 authorizes the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate in accordance with the EFSA's recommendations.
LINK TO: 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)