Commission Regulation (EC) No 2023/2006, adopted December 22, 2006, established EU good manufacturing practice (GMP) requirements for all materials and articles intended to contact food—including plastic film, paper, board, and printed laminates used in flexible packaging. Although application began August 1, 2008, converters and ink suppliers spent 2007 implementing documented quality-assurance and quality-control systems ahead of the deadline.
The regulation applies across manufacture, processing, and distribution up to—but excluding—starting-substance production. For printers, Annex rules require that inks applied to the non-food-contact side be formulated and applied so substances do not transfer to the food-contact side. Printed materials must be handled and stored to prevent set-off migration, and printed surfaces must not directly contact food.
GMP definitions cover quality assurance systems, quality control verification, and corrective actions when conformity fails. Flexible packaging plants combining extrusion, printing, lamination, and slitting had to map which process steps fell under GMP documentation versus existing ISO or BRC schemes. EU Regulation (EC) No 1935/2004 remained the overarching framework requiring materials not endanger health or alter food composition or organoleptic properties.
Industry associations advised converters to revise supplier specifications for lamination adhesives, inks, and substrates simultaneously, because GMP audits would examine entire structures—not isolated layers. Printers running solvent flexo, gravure, and UV lines sought written declarations from ink makers on photoinitiator selection after benzophenone migration surveys and the Nestlé ITX incident.
By mid-2007, major European flexible packaging groups scheduled SOP updates for reel storage, quarantine of printed web, and segregation of food versus non-food jobs on shared presses. The August 2008 enforcement date made 2007 a pivotal planning year for any converter exporting printed film or pouches into EU food markets.