Yesterday, the European Commission (EC) released draft text for the 18th amendment to the Plastics Regulation, (EU) No 10/2011 on the Public Consultations website of the European Commission. The draft amendment proposes additional requirements that represent a serious challenge to the continued compliance and marketing of plastic food-contact materials in Europe.  The amendment is open for comments until April 10, 2024. 

The European Commission (EC) announcement of the draft amendment indicates that the Regulation aims to increase quality control under the Plastics Regulation by: (1) ensuring alignment with other regulations, (2) introducing purity requirements for substances obtained from waste and natural materials; and (3) adapting migration testing of multi-layer materials and repeat testing.

Of central importance are new “quality control” requirements proposed in the amendment, which would amend Article 8 and add a new Article 3(a) to the Plastics Regulation. The proposed requirements would affect all substances, not only those obtained from waste or from natural origin. Should these amendments be adopted and incorporated into the Plastics Regulation, all starting materials used in the production of plastic materials and articles would be subjected to extremely severe purity requirements.  This amendment may create significant obstacles on the continued use of plastics in food-contact applications in Europe.