If you sell plastic packaging, tableware or components into the European Union, Regulation (EC) No 10/2011 on food contact materials is the rulebook your product is measured against. It is not a single test but a framework: a positive list of authorised substances, substance-specific and overall migration limits, and a mandatory Declaration of Compliance that travels with the product. This guide breaks down EU food contact regulation 10/2011 into the parts that matter to importers and exporters, and explains what to verify in supplier documentation before goods ship.
EU Food Contact Regulation 10/2011: Scope and Definitions
The regulation applies to plastic materials and articles intended to touch food, including layers, multi-material multi-layer structures, gaskets, lids and the plastic carrier of coatings and adhesives. It also incorporates good manufacturing practice requirements through Regulation (EC) 2023/2006. Notably, printing inks, varnishes and certain recycling processes sit outside 10/2011 and are handled separately, which matters because a compliant plastic layer can be undermined by a non-compliant surface print.
The Union List and Migration Limits
Compliance starts from the Union list of authorised monomers, additives and starting substances. A substance that is not on the list cannot be used in EU food contact plastic unless it qualifies under a specific derogation. Three limit systems then apply:
- Specific migration limits (SML) - substance-by-substance caps expressed in mg/kg of food or food simulant, some set at zero or at the limit of detection.
- Overall migration limit (OML) - 10 mg/dm2 of surface area, or 60 mg/kg of food for containers and for articles where surface area cannot be estimated.
- Dual-use additives - substances authorised as food additives are restricted to the lower of their food-additive level and their SML.
Migration Testing and the Declaration of Compliance
Verification is done by migration testing with food simulants - A for aqueous foods, B for acidic, C for alcoholic, D1 for milk, D2 for oil and E for dry foods - under standardised time and temperature conditions that reflect the intended use: ten days at 40 degrees Celsius for long-term ambient storage, two hours at 100 degrees for hot-fill, and so on. The output feeds the Declaration of Compliance, which must state the substances used, the relevant migration data, the conditions of use the article is compliant for, and for multi-layer materials which function each layer performs. A Declaration that omits the conditions of use is incomplete: the same tray can be compliant for frozen storage and non-compliant for microwave reheating.
What Buyers Should Require from Suppliers
- Declaration of Compliance under Regulation 10/2011 naming the substances and the compliant use conditions.
- GMP statement under Regulation 2023/2006 for the production site.
- Migration test reports from an accredited laboratory, with simulants, time and temperature stated.
- Identity of the resin and additive suppliers, plus a change-notification commitment.
- For recycled content, evidence of authorisation of the recycling process under (EU) 2022/1616 where food contact is claimed.
Adjacent Rules Worth Knowing
Beyond 10/2011, several national and EU rules interact with it. Germany's LFGB and BfR recommendations add testing traditions that many buyers treat as a baseline, France and Italy maintain specific measures for certain materials and uses, and the EU Packaging and Packaging Waste Regulation is pushing recycled-content and recyclability requirements that will change what compliant means over the life of a product line. For a wider map of how the EU and US regimes differ, our EU and US plastics compliance guide compares REACH, RoHS, FDA and packaging rules side by side, and the overview of food contact plastics basics places 10/2011 in context. Recycled-content specifics are covered in our analysis of recycled plastic market trends, and manufacturers with documented EU programmes can be shortlisted through our supplier directory.
Related product categories
The materials and part types discussed above are grouped in our sourcing directory:
