In the EU, materials intended to come into contact with food must comply with strict regulations. To ensure a high level of food safety in Europe, all food contact materials and articles (FCM&A) must comply with Regulation (EC) No 1935/2004 (known as the Framework Regulation) on materials and articles intended to come into contact with food. Additionally, all FCM&A must be manufactured in accordance with Good Manufacturing Practices (GMP, Commission Regulation (EC) No 2023/2006).
Plastic materials, including bioplastics, must additionally comply with the harmonised Commission Regulation (EU) No 10/2011 (known as the Plastics Regulation), which lays down even stricter and more specific requirements for FCM&A. This regulation includes a list of permitted substances (including additives1, monomers, etc.) which may be used in the production of food contact materials. Each and every plastic component, whether part of a multi-layer product or not, must comply with the regulation. Among the compliance checks are composition checks of the plastic components of multi-component and multi-layer materials, and specific aspects related to migration, such as test conditions and migration limits2 of substances. The Plastics Regulation has been updated and revised several times since its adoption. Only risk-assessed3 and permitted substances listed in the Regulation are legally allowed to be used to produce plastic food contact materials and articles.