EU Regulation 10/2011 (plastic food contact)

Regulation (EU) No 10/2011, often called the Plastics Implementation Measure (PIM), sets the EU rules for plastic materials and articles intended to come into contact with food. Turkish food contact legislation is largely aligned with it.

Where it fits

Framework Regulation (EC) 1935/2004 sets the general rule that materials must not transfer substances to food in amounts that endanger health or unacceptably change the food. Regulation (EC) 2023/2006 covers good manufacturing practice. 10/2011 adds the detailed rules for plastics and has been amended many times.

Key elements

• Union list of authorised monomers, additives and other starting substances
• Overall migration limit of 10 mg/dm² (60 mg/kg food in certain cases, such as infant food)
• Specific migration limits for individual substances
• Food simulants and standard test conditions
• Declaration of compliance through the supply chain
• Functional barrier concept for layers behind a barrier such as foil

Relevance to flexible packaging

All-plastic multi-layer laminates fall within scope; in multi-material structures with paper or foil, specific provisions apply to the plastic layers. Inks and adhesives are not plastics but are considered in migration assessment. If you sell into the EU, ask for an up-to-date declaration of compliance covering your food type, contact time and temperature.