The European Commission recently announced the revision of the EU Plastics in Contact with Food Regulation (EU No 10/2011) by issuing Regulation (EU) 2023/1627. The list of authorized substances in Annex I has been expanded, and di - 2 - ethylhexyl cyclohexane - 1,2 - dicarboxylate (DEHCH) has been officially included.
The background of this revision is based on the scientific assessment of DEHCH issued by the European Food Safety Authority (EFSA) on December 11, 2019. EFSA evaluated the use of DEHCH as a plasticizer in polyvinyl chloride (PVC). It was found that when in contact with aqueous, acidic, and low - alcohol foods and stored at room temperature or lower for a long time, the maximum use concentration can reach 25% by mass.
In 2020, EFSA further pointed out that DEHCH does not raise concerns in terms of genotoxicity. In the repeated - dose toxicity study of it, no adverse reactions were found even when the daily test dose reached 1000 mg/kg body weight. However, considering the possible uncertainty of the accumulation of this substance in the human body, the revision stipulates that its migration amount shall not exceed 0.05 mg/kg of food.
To ensure the rights and interests of relevant enterprises and the public, this revised regulation came into force on August 31, 2023. All relevant enterprises and institutions must pay attention to and comply with it.
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