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EU: New food additive authorised in food contact plastic materials

AUGUST 2023 - ELECTRICAL AND ELECTRONICS, HARDLINES, TOYS AND CHILDREN'S PRODUCTS

On 10 August 2023, the European Commission adopted Regulation (EU) 2023/1627¹ which amends Annex I to Food Contact Plastic Regulation (EU) No 10/2011. The amendment authorises the use of the substance, bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH, FCM No. 1079), as a food additive in polyvinyl chloride (PVC) in accordance with the conditions of use set out in the regulation.

DEHCH is a plasticizer that is used in a variety of food contact materials, such as food packaging, bottles, and utensils. The Commission's decision to authorise the use of DEHCH was based on a risk assessment carried out by the European Food Safety Authority (EFSA)² in 2019. EFSA concluded that this substance does not raise a genotoxicity concern and is safe for use in food contact materials when used under the intended conditions. A specific migration limit for the substance was set at 0.05 mg/kg food.

This new amendment to Annex I will enter into force on the twentieth day following its publication in the Official Journal of the European Union (OJEU) (i.e., 31 August 2023).

In Annex I to Regulation (EU) No 10/2011, the entry of Table 1 is inserted by the following:

[1] Commission Regulation (EU) 2023/1627

[2] EFSA’s assessment of FCM No. 1079, adopted 11 December 2019

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