Importing food packaging into the EU runs on a different legal framework than the US does, and treating an FDA-compliant tray as automatically EU-ready is one of the most common (and costly) assumptions a buyer can make. The two systems share a similar goal — packaging shouldn't transfer harmful substances into food — but they're built differently, documented differently, and a customs or market-surveillance check in an EU member state will ask for EU-specific paperwork that an FDA letter doesn't cover. This guide walks through what the EU framework actually requires, what documentation a factory should hand you, and how it compares to the US approach we cover in our FDA food-contact compliance guide.
The EU Legal Framework, in Plain Terms
Three regulations sit on top of each other. Framework Regulation (EC) 1935/2004 sets the general principle: any material or article intended to contact food must not transfer its components into that food in quantities that could endanger health, change food composition unacceptably, or affect taste and smell. Regulation (EU) No 10/2011, the "Plastics Regulation," is the one that actually governs plastic packaging specifically — it maintains a positive list of authorized monomers and additives, sets overall and specific migration limits, and defines the testing methodology. Regulation (EC) 2023/2006 on Good Manufacturing Practice (GMP) covers how the factory itself must be run — traceability, quality assurance and documented process control — rather than what the material is made of.
On top of these EU-wide rules, several member states layer their own additional requirements. Italy and France, in particular, have historically applied stricter national rules on certain plastics and additives, and some countries require the Declaration of Compliance to be provided in the local language rather than English. If you're importing into a specific EU country rather than the bloc generally, it's worth confirming there's no additional national requirement before your first shipment.
Migration Testing: What It Actually Measures
Migration testing is the technical core of EU compliance, and it works differently from a simple pass/fail material certificate. Testers place the packaging in contact with food simulants — standardized substitutes that mimic aqueous, acidic, alcoholic or fatty foods — under time and temperature conditions matched to how the product will actually be used (a microwave-reheated meal is tested differently from a refrigerated salad container). Two limits apply: the Overall Migration Limit (OML), capped at 10mg per dm² of contact surface, which measures total substance transfer regardless of what it is, and Specific Migration Limits (SMLs) for individual substances on the EU's positive list, each with its own maximum. A material can pass the overall limit while still failing on one specific substance, so a compliant packaging line needs both tests run, not just one.
The Declaration of Compliance (DoC)
Every batch of plastic food-contact packaging placed on the EU market needs a Declaration of Compliance — a document the manufacturer or importer issues stating the material meets Regulation 10/2011. A proper DoC identifies the specific materials and articles it covers, confirms compliance with the overall and specific migration limits, states the food types and conditions of use the compliance was tested against (a tray tested for cold, dry food isn't automatically cleared for hot, fatty food), and names the person responsible for issuing it along with a reference to the supporting test documentation. A DoC that's generic boilerplate with no SKU-specific detail is a warning sign — EU market surveillance authorities can and do ask importers to produce the underlying test data behind a DoC, not just the declaration itself.
How This Differs from the US (FDA) Approach
Both systems authorize substances rather than certifying finished products, but the mechanics diverge in ways that matter for a buyer sourcing internationally. The FDA framework is substance-authorization-based with less emphasis on formal per-batch declarations; the EU framework requires an actual DoC document per batch, tied to specific migration test data, and layers a formal GMP regulation on top that has no direct FDA equivalent. If you're supplying both markets from the same tooling and resin, don't assume one certificate covers both — request both a US food-contact statement and an EU DoC with matching migration reports, and confirm the same resin and colorant combination was actually used for both tests. A resin substitution between test runs invalidates the comparison even if the tray looks identical.
REACH: The Chemicals Layer Behind the Packaging Regulation
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) sits alongside the food-contact rules and restricts or requires authorization for certain hazardous substances across all products sold in the EU, not just food packaging. For plastic packaging, the practical REACH concern is usually additives and colorants — confirm with your supplier that no Substances of Very High Concern (SVHC) above the REACH threshold are present in the resin or pigment system, and ask for a REACH statement alongside the DoC. This is a separate document from the DoC — one covers food-contact migration, the other covers restricted chemical substances more broadly — and EU customers increasingly expect both.
What to Request Before Your First EU Order
- A Declaration of Compliance under Regulation (EU) 10/2011, specific to the SKU and the food type/conditions you'll actually use it for.
- Migration test reports (overall and specific limits) from an accredited third-party lab, matched to the resin and colorant actually used in production.
- A REACH statement confirming no restricted SVHCs above threshold.
- Batch traceability records so a non-conformance can be traced back to a specific production run.
- Confirmation of which national requirements apply if you're importing into a specific member state rather than the EU generally.
Our Factory's Certifications
We manufacture under ISO 9001:2015 (quality management system) and BRCGS Packaging (the Global Standard for Packaging Materials, widely recognized by EU retailers and brand owners for supplier qualification), with SGS third-party test reports available per SKU on request. These are the certifications our factory actually holds — we don't want to send you chasing documentation we can't produce, so ask us directly about EU 10/2011 DoCs and migration reports for the specific SKUs you're sourcing.
Buyer FAQ
Does an FDA compliance letter cover EU sales too?
What's the difference between the Overall Migration Limit and Specific Migration Limits?
Do I need a new Declaration of Compliance for every order, or just once?
Is REACH the same thing as EU food-contact compliance?
Do EU member states have additional national rules beyond the EU-wide regulations?
How do I verify a supplier's EU compliance claims are real?
Sourcing for the EU market?
Tell us the SKUs and the member states you're shipping to — we'll confirm what documentation we can provide for your first order.
Related Guides
FDA Compliance Guide
The US-side documentation checklist — read alongside this EU guide.
Read the guide →
Factory & QC
See the production floor and quality-control process behind these certifications.
Learn more →