Packaging that clears U.S. review without issue can still get flagged at the EU border — and the reverse happens just as often. The two systems don’t just use different paperwork; they’re built on different legal philosophies for deciding what’s safe to touch food.
This guide breaks down how the FDA and the EU actually approve food contact materials, where the documentation requirements diverge, and the mistakes that trip up compliance teams managing both markets at once.
Quick Answer
The FDA regulates food contact substances mainly through case-by-case Food Contact Notifications (FCNs) and GRAS (Generally Recognized as Safe) determinations — a substance-by-use clearance model. The EU runs on a framework regulation, EC 1935/2004, backed by material-specific rules like Regulation (EU) 10/2011 for plastics, which maintains an EU-wide authorized-substances list with defined migration limits. In short: the U.S. leans on notification and exemption; the EU leans on harmonized positive lists — though only for certain material types.
How the Two Systems Approve Materials
In the U.S., a company wanting to use a new food contact substance typically files an FCN under 21 CFR 170.100, submitting safety data for that specific substance and its intended use. The FDA has 120 days to object; if it doesn’t, the notifier can market the substance — but the clearance is tied to that notifier, that substance, and that use, not a public blanket approval. Substances can also skip FDA review entirely if they’re GRAS, or if they fall under the Threshold of Regulation exemption for substances present at very low dietary concentrations.
The EU takes a more centralized route. Regulation (EC) 1935/2004 sets the general safety principle that applies to all food contact materials, but detailed, harmonized rules only exist for a handful of material categories — most notably plastics under Regulation (EU) 10/2011. That regulation keeps a Union list of authorized monomers and additives, each with its own Specific Migration Limit (SML), plus an Overall Migration Limit (OML) of 10 mg per dm² of food contact surface (or 60 mg/kg of food for articles meant for infants and young children).
Where the Paperwork Diverges
The EU is far more document-driven. Under Article 15 of Regulation (EU) 10/2011, a written Declaration of Compliance (DoC) must be available at every marketing stage of the plastics supply chain — from raw material supplier through converter and brand owner — except at the retail stage itself: a retailer selling directly to the final consumer isn’t required to issue one. Business operators must also keep supporting documentation on file, such as migration test results or calculations, showing why the material complies, and make it available to enforcement authorities on request. Good manufacturing practice is a standalone legal requirement under Regulation (EC) 2023/2006, not just a recommendation.
The FDA has GMP expectations too (21 CFR 174.5), but U.S. practice relies more on supplier letters of guarantee and internal compliance files rather than a legally mandated DoC format. Another key gap: materials like paper and board, adhesives, inks, rubber, and coatings aren’t harmonized across the EU at all. They’re governed country by country — Germany leans on BfR recommendations, Italy has its own ministerial decree with a national positive list, and other member states have their own frameworks. A product compliant in one EU country for these materials isn’t automatically compliant in another.
Tips / Common Mistakes
Don’t assume an FDA clearance transfers to the EU, or vice versa — they’re legally separate systems with no mutual recognition. An FCN is also notifier-specific; a different company using the same substance generally needs its own FCN or must show it qualifies under an existing one.
Check the specific migration limit for each substance, not just the overall migration limit — a plastic can pass OML testing and still fail on an individual substance’s SML. If you’re shipping non-plastic materials (paper, inks, adhesives, rubber) into the EU, verify the national rules of the destination country rather than assuming an EU-wide standard exists. And build your Declaration of Compliance file before you ship to your direct business customer — EU buyers will often ask for it as a condition of the order — but remember a retailer selling straight to a consumer, per Article 15, isn’t the one required to issue it.
Explore more: More compliance guides for packaging teams.
FDA vs EU Food Contact Regulations FAQs
Does an FDA Food Contact Notification work in the EU?
No. FCNs are a U.S.-only mechanism under 21 CFR 170.100. Selling the same material in the EU requires compliance with EU rules — generally Regulation (EC) 1935/2004 and, for plastics, Regulation (EU) 10/2011 — regardless of U.S. clearance status.
What is the EU’s overall migration limit for plastics?
Under Regulation (EU) 10/2011, the overall migration limit is 10 mg per dm² of food contact surface, or 60 mg/kg of food for articles intended for infants and young children. Individual substances may also have their own, often stricter, specific migration limits.
Who has to issue a Declaration of Compliance under EU rules?
Under Article 15 of Regulation (EU) 10/2011, businesses at the marketing stages of the plastics supply chain — material suppliers, converters, and brand owners — must make a written Declaration of Compliance available to the next business down the chain. The regulation expressly excludes the retail stage: a retailer selling directly to the final consumer is not required to issue one.
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Photo by Trnava University on Unsplash.