Selling a plastic food packaging product into the European Union requires more than a good recipe and a food-safe label. Regulation (EU) No 10/2011 is the binding document that governs every plastic material intended for food contact, and the evidence bar it sets is high. Any supplier producing, converting, or importing plastic food contact materials needs a compliance dossier rooted in migration testing and toxicological evaluation. This guide explains what EU 10/2011 food contact materials compliance actually requires in 2026 and how to design migration studies that reviewers accept without revision.
What EU 10/2011 food contact materials regulation covers
Regulation 10/2011 sets out a positive list of monomers, additives, and polymer production aids authorised for use in plastics intended to come into contact with food. Every substance used in EU 10/2011 food contact materials must appear on the Union List of Authorised Substances (Annex I) or fall within one of the permitted categories of non-listed substances with appropriate risk assessment. Anything outside that framework is non-compliant by default.
The regulation applies to single-layer and multi-layer plastic articles, plastic layers within multi-material articles, and coatings. It does not cover paper, metal, glass, rubber, or active and intelligent materials, those have their own frameworks, though EU 10/2011 principles often inform them.
Specific Migration Limits and the Overall Migration Limit
Specific Migration Limits (SMLs)
Each authorised substance on the Union List carries a Specific Migration Limit expressed in mg of substance per kg of food (mg/kg). The SML is the ceiling on how much of that substance can migrate into food from the EU 10/2011 food contact materials article under realistic use conditions. SMLs are derived from toxicological evaluation, usually a Tolerable Daily Intake divided by a conventional consumption assumption (17 g of packaging exposed to 1 kg of food per day).
Overall Migration Limit (OML)
The OML is a single 10 mg/dm² ceiling on the total migration from any plastic surface, regardless of composition. It is effectively a proxy for consumer-exposure control when non-listed substances migrate at low levels. Every compliance dossier must demonstrate OML adherence for the intended food simulant and conditions of use.
Migration testing workflow for EU 10/2011 food contact materials
Step 1: Select food simulants
Annex III of EU 10/2011 assigns food simulants to food categories: 10% ethanol for aqueous and acidic foods, 3% acetic acid for acidic foods below pH 4.5, 50% ethanol for high-alcohol content foods, vegetable oil or Tenax for fatty foods. Multi-simulant testing is the norm for versatile packaging intended across food categories.
Step 2: Define time and temperature conditions
Annex V maps real-world storage and heating to standardised laboratory conditions. Testing at 70°C for 2 hours mimics short-term hot-fill use; 40°C for 10 days covers long-term room-temperature storage. The contact conditions chosen must envelope the most aggressive intended use.
Step 3: Perform OML and SML measurements
OML is a gravimetric determination, simulant is evaporated and the non-volatile residue weighed. SML determinations are target-substance specific and typically use LC-MS/MS or GC-MS with validated methods per ISO 17025. The limit of quantification must be at least 10% of the SML to be considered fit for purpose.
Step 4: Toxicologically evaluate non-listed migrants
Non-intentionally added substances (NIAS) and degradation products will show up in any thorough migration study. Each must be identified and evaluated against the Threshold of Toxicological Concern (TTC) or compound-specific data. The EFSA scientific opinion on NIAS is the reference document for the evaluation methodology. Our Read-Across Assessment method is commonly applied when a NIAS lacks published tox data.
Declaration of Compliance and the supporting dossier
Every batch of EU 10/2011 food contact materials placed on the market must be accompanied by a Declaration of Compliance (DoC) signed by the business operator. The DoC names the intended food categories, conditions of use, SML-relevant substances, and restrictions passed down the supply chain. The supporting dossier behind the DoC contains migration test reports, analytical method validation, toxicological evaluations for NIAS, and a documented risk assessment.
The supporting dossier is not a public document, but Directorate-General SANTE and national control authorities can demand it. A weak or incomplete dossier is the most common reason compliant-on-paper products get withdrawn from shelves.
Common pitfalls in EU 10/2011 food contact materials dossiers
Pitfall 1: Treating recycled content as equivalent to virgin. Recycled plastic under EU 2022/1616 has additional decontamination demonstration requirements stacked on top of EU 10/2011. A dossier that ignores the recycling pathway is incomplete.
Pitfall 2: Missing the NIAS evaluation. Unintentional migrants are assumed to exist. A dossier without a documented NIAS risk assessment, even a negative one, will be challenged.
Pitfall 3: Using a single food simulant. A packaging product described as “for general food contact” needs migration testing in all relevant simulant categories, not the most convenient one.
Pitfall 4: Reporting OML above authorised temperature. Testing at 40°C when intended use is hot-fill invalidates the dossier. Simulant choice and temperature choice must both reflect worst-case intended use.
Pitfall 5: Ignoring dual-use authorisations. Many substances have SMLs that differ for food versus non-food use. Using the lower limit only in the wrong context is a compliance failure.
Emerging issues in EU 10/2011 food contact materials
The 2026 policy landscape is in active flux. EFSA continues to issue scientific opinions that tighten SMLs for bisphenols, phthalates, and per- and polyfluoroalkyl substances. The Commission’s proposed FCM revision, expected to consolidate the framework across plastic and non-plastic materials, will reshape compliance dossiers over the next three years. Suppliers who anticipate the revision, documenting NIAS, applying structure-based hazard screening, archiving data in machine-readable formats, will transition far more cheaply than those who wait.
For the chemistry-to-risk translation that sits behind SML derivations, our guide to chemical compounds and their effects provides the conceptual foundation. Verified compound data feeds every risk assessment we deliver, our Toxicology Monographs cover over 7,200 substances including most plastic migrants and typical NIAS.
How ToxLibrary supports your FCM programme
If your team is building an EU 10/2011 food contact materials dossier, responding to a Declaration of Compliance challenge, or planning for the coming FCM revision, we can help. Our toxicologists have delivered SML derivations, NIAS evaluations, and multi-simulant migration interpretations for suppliers serving EU food categories from beverages to chocolate to baby food. Reach out, a defensible compliance file costs far less than a batch recall.
