Authorizing The Use of The Additive DEHCH In PVC Films
On 10 August 2023, the European Commission revised Commission Regulation (EU) 10/2011 authorizing the use of bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (DEHCH; CAS 84731-70-4; FCM 1079) as an additive in the manufacturing of polyvinyl chloride (PVC) films. The use of DEHCH is limited up to a concentration of 25% by weight (w/w) for materials that come in contact at or below room temperature with food. The revised regulation lists DEHCH as an authorized substance in Table 1 of Annex I.
This authorization follows the favorable scientific opinion adopted by the European Food Safety Authority (EFSA) on 11 December 2019. In the safety study reported by EFSA, the Authority concluded that, due to potential for accumulation of the substance in humans, the migration of the substance should not exceed 0.05 mg/kg food, and that the PVC applications containing the additive shall only become into contact with foods for which simulants A (10% ethanol) and B (3% acetic acid) are assigned.
| FCM 1079 | CAS 84731-70-4 | bis(2-ethylhexyl) cyclohexane-1,4- dicarboxylate (DEHCH) | Specific Migration Limit (SML) 0.05 mg/kg | Only to be used as an additive in PVC at up to 25% w/w in contact at or below room temperature with foods for which food simulants A or B are assigned in Table 2 of Annex III. |
The amendment took effect on 31 August 2023.
The previous amendment [Commission Regulation (EU) 2023/1442] to Regulation (EU) 10/2011 came into force on 01 August 2023, and with it, certain entries in the Annex I list of authorized substances permitted in the manufacturing of plastic food contact materials and articles were added, excluded, or modified.
How Can Intertek Help?
It can be challenging for companies developing and manufacturing plastic food contact materials to know and understand their regulatory obligations. Intertek’s experts have extensive experience with both the regulatory and technical aspects of Regulation (EU) 10/2011, and can assist with your material/product assessments to help you comply with this regulation.
Our services include:
- Reviewing bill of materials (BOM) and/or material formulations for compliance;
- Developing and conducting migration testing programs;
- Performing analytical and toxicological safety assessments for non-intentionally added substances (NIAS), per Article 19 of the Food Contact Plastics Regulation;
- Developing appropriate documentation and a Declaration of Compliance (DoC) for food contact materials; and
- Providing technical reviews of testing strategies to identify and mitigate risk.