On August 11, 2023, the European Commission released the Commission Regulation (EU) 2023/1627, 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).
Details of bis (2-ethylhexyl) cyclohexane-1,4-dicarboxylate are listed in the following table:
| FCM substance No. | CAS No. | Substance name |
SML [mg/kg] |
Restrictions and specifications |
| 1079 | 84731-70-4 | bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH) | 0.05 |
Only to be used as an additive in poly(vinyl chloride) (PVC) at up to 25 % w/w in contact at room temperature or below with foods for which food simulants A or B are assigned in Table 2 of Annex III. |
Background:
On December 11, 2019, the European Food Safety Authority (EFSA) published a favorable scientific opinion on the use of the substance bis (2-ethylhexyl) cyclohexane-1,4-dicarboxylate (DEHCH, CAS 84731-70-4, FCM No 1079), as an additive (plasticiser) in poly (vinyl chloride) at 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).
Furthermore, based on a scientific study provided to the Authority, the Authority concluded that the substance does not raise a genotoxicity concern and noted that 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. However, given uncertainty on the potential for accumulation of the substance in humans, it concluded that the migration of the substance should not exceed 0.05 mg/kg food.
(EU) 2023/1627 shall enter into force from August 31, 2023.
