EU 10/2011: what a plastics declaration must stand on
Regulation 10/2011 sets which substances may be used in food-contact plastics, how much may migrate, and what the declaration of compliance must contain.
In Short
- Starting substances come from the Union list.
- Overall migration: 10 mg per dm² of surface.
- Declare at every stage except retail; renew on change.
The Packaging & Food-Contact Materials Guide
Every roll traced to its film, ink and adhesive lots.
- Which rules apply
- Evidence for the use
- Hold, decide, trace
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UltimateFree guide
The Packaging & Food-Contact Materials Guide
Every roll traced to its film, ink and adhesive lots.
Commission Regulation (EU) No 10/2011 is the specific measure for plastic food-contact materials under the framework Regulation (EC) No 1935/2004, with good manufacturing practice in Regulation (EC) No 2023/2006. It has been amended many times, including by Regulation (EU) 2025/351, so read the current consolidated text. We read the original texts on EUR-Lex on 3 Oct 2026.
The Union List
Annex I lists the monomers, additives and other starting substances authorised for plastics, with any restrictions and specific migration limits. Article 19 says substances not on the list, such as impurities and reaction products, are assessed using internationally recognised risk assessment principles.
Migration Limits
Article 11 sets specific migration limits in Annex I, in mg of substance per kg of food. Article 12 sets an overall migration limit of 10 mg of total constituents per dm² of food contact surface, with a different basis for materials intended for infants and young children.
What each limit measures
| Limit | Basis | Where |
|---|---|---|
| Specific migration limit | mg of a substance per kg of food | Article 11, Annex I |
| Overall migration limit | 10 mg of total constituents per dm² of surface | Article 12 |
- Specific migration limit
- Basis
- mg of a substance per kg of food
- Where
- Article 11, Annex I
- Overall migration limit
- Basis
- 10 mg of total constituents per dm² of surface
- Where
- Article 12
More on migration Limits
Test conditions and food simulants are set out in the annexes.
The Declaration of Compliance
Article 15 requires a written declaration at marketing stages other than retail, for plastic materials, intermediate products and the substances used to make them. It must contain the Annex IV information and let the customer identify what it covers.
A declaration you can stand behind
Article 15 and Annex IV.
More on the Declaration of Compliance
It must be renewed when substantial changes in composition or production change migration, or when new scientific data becomes available.
Supporting Documents
Article 16 requires documentation showing compliance, including test conditions and results, calculations or other analysis, available to national authorities on request. Regulation 2023/2006 asks for a documented quality assurance system (Article 5) and documentation of specifications, formulae and processing (Article 7).
Traceability
Article 17 of 1935/2004 requires traceability at all stages, so you can identify the businesses you received materials from and supplied them to. Link each declaration to the lots it covers.
Questions
Does 10/2011 apply to paper, metal or glass?
No. It covers plastic materials and articles. Other materials fall under 1935/2004 and any specific EU or national measures.
What is the overall migration limit?
10 mg of total constituents per dm² of food contact surface (Article 12), with a different basis for materials intended for infants and young children.
Who must issue a declaration of compliance?
The business operator, at marketing stages other than retail, for plastics, intermediate products and starting substances (Article 15 and Annex IV).
Does V5 test migration or issue declarations?
No. V5 keeps supplier declarations and test reports by revision, supplier qualification, change control and lot trace. Your team and laboratories decide compliance.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Food-Contact Materials in the EU and US: One Evidence File, Two Systems
EU Packaging and Packaging Waste Regulation (PPWR) 2025/40 Readiness
FCM Migration Testing Readiness Guide (EU 10/2011 & FDA)
FDA Food-Contact Polymers (21 CFR 177): Clearance Routes, FCNs and Conditions of Use
Bisphenols and Phthalates in Plastics: EU 2024/3190, FDA Abandoned Uses and CPSC Limits
Recycled Plastics for Food Contact: EU 2022/1616 and FDA's Recycling Guidance