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The Annex I to Regulation (EU) No 10/2011 adds a new authorized substance Release Time:2023-08-18

On 11 August 2023, the European Union issued Directive(EU) 2023/1627 in its Official

Journal (OJ) to amend the Annex I of Directive (EU) No 10/2011, addition a new authorized substances.The Regulation enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The requirements of the new authorized substances:




Conditions of restriction



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

1. SML: 0.05mg/kg;

2. 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.

(Food simulants A, B are assigned for  contact with aqueous, acidic and low-alcohol foods)


DEHCH is used for the manufacture of plastic products, this substance can be found in products with material based on plastic food packaging and storage. But consumers do not have to worry about the safety of DEHCH when used under the expected conditions, based on a scientific study provided to the European Food Safety Authority, the European Food Safety 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.

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