EU 10/2011 — plastics in food contact
The central European regulation for plastics in food contact — and how Rotogal proves compliance for every batch.
All plastic materials and articles intended to come — or likely to come — into contact with food, placed on the EU market.
Regulation (EU) No 10/2011 has been in force since 2011 and complements Framework Regulation (EC) No 1935/2004 for the specific case of plastics. It defines exhaustively which starting substances may be used and sets migration limits as well as test conditions.
For manufacturers like Rotogal that means every formulation is cross-checked against the so-called positive list (Annex I), migration tests run against defined food simulants, and a Declaration of Conformity (DoC) documents each batch.
Positive list of starting substances
Only monomers, additives and auxiliaries listed in Annex I are allowed — unlisted substances cannot be part of the formulation.
Overall migration limit (OML)
The overall migration limit is 10 mg per dm² of contact surface, or 60 mg per kg of food — substance-independent.
Specific migration limit (SML)
Individual substances have their own specific migration limits (SMLs), to be demonstrated via migration tests with the appropriate simulants.
Declaration of Conformity (DoC)
Every shipment must be accompanied by a written DoC — identifying substances, food types, temperature and time conditions.
Traceability
Raw-material batches and production lots must stay traceable across the whole chain.
Food-grade formulations
We only use polyethylene formulations whose components are fully referenced against Annex I.
Migration testing
Migration tests run in an accredited lab using simulants A/B/C/D1/D2, matched to the food category and service temperature.
Batch-level traceability
Every production batch is labelled and traceable for years — from raw pellets to finished part.
DoC with every delivery
Every Rotogal shipment ships with a product-specific Declaration of Conformity including all permitted use conditions.
Declaration of Conformity (DoC)
Product-specific, identifying material, permitted food categories, temperature and time window.
Migration test report
Overall and specific migration, accredited, with the simulants relevant to your application.
Formulation compliance statement
Confirms all additives and monomers are referenced against Annex I.
Batch / lot certificate
Traceability per production lot, incl. raw-material batch and production date.
Frequently asked questions
Does EU 10/2011 apply to reusable containers?
Yes — explicitly. The regulation does not distinguish between single-use and reusable. For reusable containers migration tests are run under repeated-use conditions (the 3rd migration test is typically the deciding one).
What do I have to check as a customer, as a minimum?
That the DoC covers the temperature and food categories that actually occur in your process. A generic "food contact" note is not enough — the category (aqueous, acidic, fatty, alcoholic), temperature and exposure time must be specified.
How often does Rotogal re-run migration testing?
Routinely every three years, and additionally after any relevant formulation or raw-material change. On customer request we provide project-specific re-testing for critical applications.
Are recycled content fractions covered?
For food contact we currently use certified virgin food-grade material. Mechanical recyclate is additionally regulated by EU 2022/1616 — we can integrate this on request and document the chain transparently.
Need evidence for your audit?
We'll send the full compliance pack for your chosen product on request — often the same day.
More standards
Please note: All information on this page – in particular dimensions, technical data, material properties and application recommendations – is provided for general guidance only and is non-binding. The exact specifications tailored to your specific application are agreed on a binding basis as part of the quotation and order process.
Got a project?
Tell us about your requirement — we typically come back with a first assessment within 24 hours.