EU Plastics Regulation 10/2011 Explained

Regulation (EU) No 10/2011 — Plastic Food Contact Materials

Plastic packaging for the EU market lives under one detailed rulebook: Regulation 10/2011. It lists exactly which substances may be used in plastic food-contact materials, sets migration limits, and prescribes how compliance is tested. If you make or buy plastic food packaging for Europe, this is your specification.

Key provisions

• Positive list: only authorized monomers, additives, and aids (in the Union list) may be used — with restrictions and specifications per substance.
• Migration limits: overall migration limit (OML) of 10 mg/dm², plus specific migration limits (SMLs) for individual substances.
• Testing rules: prescribed simulants (ethanol, acetic acid, olive oil substitutes), time-temperature conditions matched to real use, and rules for repeated-use articles.
• Declaration of compliance: required at each supply-chain stage, with supporting documentation (test reports, calculations).
• Scope notes: covers plastics including coatings and adhesives in plastic multilayers; printed surfaces have their own considerations.

Why it matters

10/2011 turns packaging buying into a technical exercise: the declaration of compliance must reference the regulation, state the food types and conditions covered, and be backed by test data. Generic “food grade” claims don’t cut it. The common failures: declarations that don’t match actual use conditions (hot-fill, long storage, fatty foods need the right simulant data), and suppliers who can’t produce the supporting file. Audit your packaging suppliers like ingredient suppliers — because chemically, they are.

The plastic functional barrier

The regulation’s functional-barrier concept is pragmatic genius: a layer that prevents migration from outer (possibly non-compliant, e.g., recycled) layers reaching food lets manufacturers use recycled content safely. But the barrier must actually function — demonstrated by testing or modeling, not assumed. This provision is what makes recycled PET in food bottles legally viable in the EU: the recycled core sits behind virgin functional barriers. Enforcement focuses on whether the barrier claim is substantiated. As recycled-content mandates grow, the functional barrier moves from niche provision to mainstream compliance strategy — and the testing burden grows with it.

Sources: EUR-Lex (official EU law); EFSA.

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