On August 11, 2023, the European Union issued Directive (EU) 2023/1627 in its Official Journal (OJ), amending Annex I of Directive (EU) No 10/2011 by adding an authorized new substance, bis (2-ethylhexyl) cyclohexane-1,4-dicarboxylate (DEHCH). The amendment will take effect on August 31, 2023.

Add authorized substances

Substance: bis (2-ethylhexyl) cyclohexane-1,4-dicarboxylate (DEHCH)

CAS NO: 84731-70-4

FCM No: 1079

SML (mg/kg): 0.05

Restriction requirement: Additives used only for polyvinyl chloride (PVC) shall not exceed 25% when in contact with food simulants A or B specified in Table 2 of Annex II at or below room temperature.

Revision background

On December 11, 2019, the European Food Safety Agency (EFSA) issued a positive scientific opinion on the use of diethylhexyl cyclohexanedicarboxylate (DEHCH) as an additive (plasticizer) in polyvinyl chloride (PVC). In contact with water-based, acidic, and low alcohol foods, and under long-term storage at room temperature or lower temperatures (refrigerated and frozen), its maximum usage concentration can reach 25% mass ratio.

In addition, according to the opinion released by EFSA in 2020, this substance does not raise concerns regarding genotoxicity. No adverse reactions were observed in the repeated administration toxicity study with a daily maximum test dose of 1000 mg/kg body weight (bw). However, given the uncertainty regarding the accumulation of this substance in the human body, it is stipulated that its migration amount should not exceed 0.05 mg/kg of food.