(1)

Commission Regulation (EU) No 10/2011 (2) lays down specific rules as regards plastic materials and articles intended to come into contact with food. In particular, Annex I to that Regulation 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.

(2)

On 11 December 2019, the European Food Safety Authority (‘the Authority’) adopted a favourable scientific opinion (3) on the use of the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (‘DEHCH’, CAS No 84731-70-4, FCM No 1079), as an additive (plasticiser) in poly(vinyl chloride) (PVC) 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, and the substance 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.

(3)

Therefore, it is appropriate to authorise the substance bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate.

(4)

Regulation (EU) No 10/2011 should be amended accordingly.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,