Guide
EU 10/2011: The Plastics Food-Contact Regulation, Decoded
Commission Regulation (EU) No 10/2011 is the lex specialis for plastic materials and articles intended to come into contact with food, sitting under the Framework Regulation (EC) 1935/2004 and the GMP Regulation (EC) 2023/2006. It establishes the Union List of authorised monomers and additives (Annex I), Specific Migration Limits (SML) and the 10 mg/dm² Overall Migration Limit (OML), the food simulants and migration test conditions (Annex III, V), Non-Intentionally Added Substances (NIAS) risk management, and the Declaration of Compliance with its mandatory supporting documentation (Annex IV). This guide walks the structure, the recurring audit findings, and a practical path to a defensible 10/2011 file.
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The Union List and the substance status check
Annex I lists every authorised monomer and additive with its FCM substance number, CAS number, SML (or "no migration detectable"), and use restrictions. A substance not on the Union List cannot be intentionally added to a food-contact plastic placed on the EU market, with narrow exceptions (polymerisation aids, NIAS, dual-use additives covered by other authorisations). The recurring finding is a colourant or stabiliser supplied with US clearance that has no Union List entry and therefore no EU defence.
SML, OML, food simulants and migration testing
Annex III defines food simulants A–E mapped to food types; Annex V defines migration test conditions (time and temperature). The OML of 10 mg/dm² applies regardless of composition; substance-level SMLs apply where listed. Migration testing must reflect the most severe foreseeable conditions of use — a film cleared only at 40 °C for 10 days has no defence when the customer uses it for hot-fill at 80 °C. The 2023 update to Annex II (restrictions on lead, antimony, arsenic, mercury, barium, cobalt, copper, iron, lithium, manganese, nickel, zinc as Specific Migration Limits) is now bedded in and shows up in supplier qualification audits.
NIAS, risk assessment and the 2023 PFAS direction
Article 19 places the manufacturer under a duty to assess NIAS — impurities of authorised substances, reaction intermediates, decomposition products — for compliance with Article 3 of the Framework Regulation, even where no SML is set. The European Commission proposal to restrict PFAS as a class under REACH, and EFSA's tolerable weekly intake for PFOS/PFOA/PFNA/PFHxS, have moved fluorinated processing aids and grease-proofing chemistry into mandatory NIAS scope. A NIAS file that exists only as a one-line risk statement no longer survives serious technical scrutiny.
The Declaration of Compliance and supporting documentation
Annex IV specifies the Declaration of Compliance content: identity and address of the business operator, identity of the material, date, confirmation of compliance with 10/2011 and 1935/2004, adequate information on substances subject to restriction, specifications on use, the food types and time/temperature conditions, the highest food-to-surface ratio for which compliance has been verified, and barrier function (if applicable). The supporting documentation must be available to competent authorities on request and must contain the test conditions, calculation, results and any reasoning. A DoC issued without the supporting documentation in inspection-ready form is the modal finding in EU competent-authority audits.
A 60-day readiness path
Days 1–15: substance-level Union List status check across every grade and additive; flag non-authorised substances. Days 16–35: migration test plan refresh to current Annex III/V; SML/OML calculation for each grade in each customer use-condition. Days 36–50: NIAS assessment for each grade including PFAS and oligomers; refresh DoCs against Annex IV. Days 51–60: GMP audit against EC 2023/2006 (documented system, change control, raw material specifications, record retention); freeze the baseline for inspection.
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Frequently asked
Does 10/2011 cover recycled plastics?
No — recycled plastics are covered by Regulation (EU) 2022/1616, which sets out authorised recycling technologies, the EFSA evaluation route, and the operating conditions for recyclers. A grade containing recycled content must satisfy both 10/2011 and 2022/1616.
How does 10/2011 differ from 21 CFR 177?
10/2011 is a substance-level positive list with SMLs and a 10 mg/dm² OML; 21 CFR 177 is a polymer-class listing supplemented by FCNs and TORs without a unified positive list. Suppliers serving both markets maintain parallel files.
Is a single DoC sufficient for the supply chain?
Each business operator in the supply chain — resin maker, converter, brand owner — issues its own DoC for its output, drawing on the upstream DoC. A converter cannot rely on the resin maker's DoC alone if it adds colourants, additives or laminations of its own.
What about multi-material multi-layer (MMML) structures?
MMML structures (e.g. plastic with paper or metal foil) are partly outside 10/2011; the plastic layers must still comply with 10/2011 if they contact food or are separated from food by a functional barrier. EU work on a dedicated MMML measure is ongoing — track Commission communications.
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