EU Regulation (EU) No 10/2011 — Plastic Materials and Articles Intended to Come into Contact with Food

EU Regulation (EU) No 10/2011 — Plastic Materials and Articles Intended to Come into Contact with Food

Record: plastics-polymer-cert-021 (Plastics/Polymer, license regulation). Issuing body: European Commission.

1. What it is, who issues and enforces it

Regulation (EU) No 10/2011 is the EU's specific measure for plastic food-contact materials (FCMs), made under the framework Regulation (EC) No 1935/2004. It establishes the Union list of authorized monomers, other starting substances, additives, and polymer production aids — only listed substances may be used in plastic FCMs, subject to restrictions. It is a regulation (directly applicable); enforcement is by member-state food-safety authorities (with RASFF rapid alerts for non-compliant FCMs).

2. Scope, triggers, thresholds

Applies to plastic materials and articles (including printed surfaces, coatings, and multi-material multilayers' plastic layers) intended to contact food. Core mechanics:

• Union list (Annex I): ~1,000 authorized substances, each with restrictions (specific migration limits — SMLs — in mg/kg food, maximum residual content — QM — limits, or use restrictions).
• Overall migration limit (OML): 10 mg/dm² (60 mg/kg) for all substances migrating from the plastic.
• SMLs for individual substances (e.g., heavy metals, primary aromatic amines — non-detectable at 0.01 mg/kg for PAAs).
• Behind-barrier rules: non-listed substances may be used in layers behind a functional barrier if migration does not exceed 0.01 mg/kg and they are not CMR/mutagenic.
• Declaration of Compliance (DoC): every business operator placing plastic FCMs on the market must issue a DoC (Annex IV content) to its customer, supported by documentation (migration testing, calculations, modeling).

3. Key compliance obligations

1. Union-list verification of every monomer, additive, and processing aid in the formulation against current Annex I restrictions.
2. Migration testing per the regulated simulants, times, and temperatures (Annex III/V) — or validated modeling — demonstrating OML and SML compliance under worst-case foreseeable use.
3. DoC issuance down the supply chain (converter → distributor → food packer), each tier relying on the upstream DoC plus its own process evidence.
4. GMP (Regulation (EC) No 2023/2006): manufacturing under good manufacturing practice with QA/QC systems.
5. Change control and re-verification on formulation, supplier, or process changes.

4. Penalties and consequences

National food-law penalties: fines (commonly tens of thousands of euros per offence; higher for corporate/food-safety endangerment), product withdrawal/recall orders, RASFF notifications that effectively blacklist a supplier across the EU, and criminal liability in serious cases. Commercially, loss of DoC credibility ends a converter's food-packaging business.

5. Version and live changes (checked 2026-09-30)

• Regulation 10/2011 is amended frequently (15+ amendments) — new authorized substances, revised SMLs, updated testing rules. Always verify the consolidated version; the Union list changes.
• Bisphenol A: the EU has moved to effectively ban BPA in food-contact materials (Regulation (EU) 2024/3190, applying with phase-in) — plastic FCM formulators must confirm BPA-free compliance; this is the highest-profile recent change.
• Recycled plastics: Regulation (EU) 2022/528 on recycled plastic FCMs imposes authorization of recycling processes and recyclate quality requirements — post-consumer recyclate in food contact is a regulated process, not just a material choice.
• PPWR interaction: the Packaging and Packaging Waste Regulation (see PPWR brief) layers recyclability and substance requirements over FCM rules — both apply.

6. Related certifications

• RJG Master Molder I/II (Plastics flagship) — molders of food-contact articles own the DoC for their conversion step and the GMP discipline on the shop floor.
• ISO 13485 — adjacent QMS rigor; medical-device packaging often sits at the food/pharma boundary.
• No EU-FCM-specific individual certification; competence is regulatory-affairs and migration-testing practice.

7. Honest flags

• The Union list is a positive list — absence means prohibition (behind a functional barrier excepted). This is stricter than the US system and the most common US-to-EU compliance failure.
• BPA and recycled-plastics rules are recent and phased — verify current applicability dates rather than relying on older summaries.

Record: plastics-polymer-cert-021.

Original ETS reference writing, verified against public sources on 2026-09-30. Thin sourcing is flagged inline. Not legal advice — confirm current editions with the issuing body.