Food-Contact Materials: One Evidence File, Two Rulebooks
The EU asks whether a material is safe, made under GMP and declared. FDA asks whether each migrating substance is authorised for the use. Keep both answers, separately.
In Short
- EU and US approvals are not interchangeable.
- Keep one evidence file per material and use.
- Review the file when supplier, formula or use changes.
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
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Packaging & Food-Contact Materials Guide
Every roll traced to its film, ink and adhesive lots.
Many converters sell the same film or tray in the EU and the US. The two systems ask different questions, so one certificate rarely covers both. This guide compares Regulation (EC) No 1935/2004 and its plastics and GMP measures with FDA's routes for food contact substances. Sources checked 3 Oct 2026; other markets have their own rules.
The EU asks: safe, made under GMP, declared
Article 3 of 1935/2004 requires materials to be made under good manufacturing practice so they do not transfer constituents in quantities that could endanger health or unacceptably change the food. Specific measures, such as 10/2011 for plastics, add positive lists and declarations.
More on the EU asks: safe, made under GMP, declared
Regulation 2023/2006 sets GMP with a documented quality assurance system, and Article 17 of 1935/2004 requires traceability at all stages.
Why one certificate rarely covers both
A substance listed in 21 CFR 177 may not be on the EU Union list, and an EU declaration does not establish FDA status. Keep the two answers separate, each tied to the material, revision and intended use.
Same material, two questions
| EU | US | |
|---|---|---|
| Core question | Safe, made under GMP, declared? | Each migrating substance authorised for the use? |
| Key texts | 1935/2004, 2023/2006, 10/2011 for plastics | 21 CFR 170–178, FCNs |
| Customer document | Declaration of compliance where required | Guaranty or compliance statement |
- Core question
- EU
- Safe, made under GMP, declared?
- US
- Each migrating substance authorised for the use?
- Key texts
- EU
- 1935/2004, 2023/2006, 10/2011 for plastics
- US
- 21 CFR 170–178, FCNs
- Customer document
- EU
- Declaration of compliance where required
- US
- Guaranty or compliance statement
One evidence file per material and use
For each grade, keep the supplier, revision, intended foods and conditions, EU declaration and supporting tests, US authorisation route and any guaranty, and the lots covered. Review it when a supplier, formulation or use changes.
One evidence file per material and use
Recycled Content and Changing Rules
Recycled plastics have their own EU regulation, 2022/1616, and FDA has guidance on recycled plastics in food packaging. EU rules keep changing, for example through Regulation (EU) 2025/351.
More on recycled Content and Changing Rules
Check consolidated texts and the Commission's legislation page before relying on a summary.
Questions
Is FDA clearance enough to sell in the EU?
No. The EU asks different questions, including the Union list for plastics and a declaration of compliance. Check each market separately.
Is an EU declaration of compliance enough for the US?
No. FDA status depends on authorisation of each migrating substance for the intended use.
Do non-plastic materials have rules too?
Yes. In the EU, 1935/2004 and 2023/2006 apply to all covered materials, and some materials have specific or national measures. In the US, the same substance-by-substance approach applies.
What can V5 keep for food-contact evidence?
Supplier declarations and documents by revision, supplier qualification, change control, customer specifications and lot trace. Your team decides compliance.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
EU 10/2011 Plastics Food Contact: Union List, Migration Limits and the Declaration of Compliance
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