DEHCH Added to Authorized Substances List for Food Contact Plastic Materials - Regulatory News - Food & Food Contact Materials

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On August 11, 2023, the European Commission published the Commission Regulation (EU) 2023/1627, amending Annex I to Regulation (EU) No 10/2011 by adding bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079) into the authorized substance list for food contact plastic materials.

Details are as follows:

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 polyvinyl chloride (PVC) at up to 25% weight by weight (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 bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH, CAS 84731-70-4, FCM No 1079), as an additive (plasticizer) in polyvinyl 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 EFSA, it 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 milligrams per kilograms (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.

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