For Southeast Asian exporters targeting the European market, understanding Regulation (EU) No 10/2011 is not optional—it's the gateway to accessing one of the world's most valuable food packaging markets. This regulation governs plastic materials and articles intended to come into contact with food, establishing strict safety standards that protect European consumers while creating clear compliance pathways for international suppliers.
The regulatory framework operates on three interconnected pillars: Framework Regulation (EC) No 1935/2004 establishes the overarching safety principle that all food contact materials (FCM) must be safe and inert; GMP Regulation (EC) No 2023/2006 mandates good manufacturing practices throughout the supply chain; and Plastics Regulation (EU) No 10/2011 provides specific technical requirements for plastic FCM including migration limits, positive lists of authorized substances, and documentation obligations [5].
What makes EU 10/2011 particularly challenging for Southeast Asian suppliers is its supply chain-wide accountability. Unlike some certification schemes where responsibility ends at the manufacturer, EU 10/2011 places compliance obligations on every operator in the supply chain—from raw material producers to importers introducing products to the EU market. This means a Vietnamese plastic container manufacturer, a Thai food packaging exporter, and a Malaysian film producer all share responsibility for ensuring their products meet EU standards before reaching European consumers.
The regulation's scope extends beyond finished products. It covers all plastic layers in multi-layer materials, intermediate products like adhesives and coatings, and even non-plastic components that may interact with plastic layers. This comprehensive approach ensures no compliance gaps exist where harmful substances could migrate into food.
EU 10/2011 Core Requirements at a Glance
| Requirement Type | What It Means | Who Is Responsible | Documentation Needed |
|---|---|---|---|
| Overall Migration Limit (OML) | Maximum 10 mg/dm² of substances migrating from material to food | Manufacturer + Importer | Test reports with simulant selection |
| Specific Migration Limit (SML) | Individual substance limits (default 0.01 mg/kg for non-authorized substances) | Manufacturer + Importer | Analytical test results per substance |
| Positive List Compliance | Only authorized monomers, additives, and production aids may be used | Raw Material Supplier + Manufacturer | Substance inventory with CAS numbers |
| Declaration of Compliance (DoC) | Written declaration confirming regulatory compliance | Company introducing product to EU market | 9-element DoC document per EU guidance [2] |
| NIAS Assessment | Risk evaluation of non-intentionally added substances | Manufacturer | Screening reports + risk assessment documentation |
| Good Manufacturing Practice | Quality management system throughout production | All operators in supply chain | GMP certificates, audit reports |

