US vs. EU Food Contact: One Product, Two Frameworks¶

Q: Can I use one test report for both FDA and EU food contact compliance?

You can use the same laboratory and test specimens, but you will receive two separate reports — one against FDA guidance, one against EU 10/2011. The test conditions, limits, and compliance criteria differ between jurisdictions.

Q: Is a US Declaration of Compliance valid in the EU?

No. An FDA DoC citing 21 CFR has no legal standing in the EU. A separate EU DoC under Regulation (EC) 1935/2004 must be issued by the EU business operator with EU-specific regulatory citations.

Q: What is the fastest pathway to dual-market compliance for a new food contact material?

Commission dual migration testing early with both FDA and EU protocols. For new substances not on the EU positive list, the EFSA authorization process is the critical path, typically 12-18 months.

A food packaging product sold in both the United States and the European Union must satisfy two separate food contact regulatory regimes — and neither accepts the other's documentation. The FDA Declaration of Compliance cites 21 CFR regulations and Food Contact Notifications. The EU Declaration of Compliance cites Regulation (EC) 1935/2004 and material-specific measures like the Plastics Regulation (EU) 10/2011. The migration testing is similar but the test conditions, simulants, and limits differ. And a Declaration of Compliance valid in one market is not valid in the other.

This guide compares the two systems, identifies the key operational differences, and explains how to build dual-market food contact compliance without duplicating every test.

The Two Systems Side by Side¶

Aspect	US (FDA)	EU (EC 1935/2004)
Primary legislation	FFDCA, 21 CFR Parts 170-199	Regulation (EC) 1935/2004
Material-specific rules	21 CFR 175 (adhesives/coatings), 176 (paper), 177 (polymers), 178 (adjuvants)	Regulation (EU) 10/2011 (plastics), 1895/2005 (BADGE/BFDGE/NOGE), 282/2008 (recycled plastics), plus measures for ceramics, regenerated cellulose, active and intelligent materials
New substance clearance	Food Contact Notification (FCN) — proprietary to notifier, effective if FDA does not object within 120 days	EFSA evaluation → Commission authorization → listed in positive list (Annex I of 10/2011 for plastics)
GRAS pathway	Self-affirmed or FDA-notified GRAS determination	No GRAS equivalent — all substances must be on a positive list or individually authorized
GMP	FDA GMP for food packaging (21 CFR 110, applied indirectly)	Regulation (EC) 2023/2006 (specific to FCM GMP)
Declaration of Compliance	Industry standard (not codified in regulation, but effectively mandatory)	Mandated by Article 16 of 1935/2004 and Article 15 of 10/2011
Migration testing	FDA Guidance on migration testing	Specific migration limits (SML) defined in Annex I of 10/2011; testing per EU 10/2011
Enforcement	FDA facility inspections, CBP import holds	Member State competent authorities, RASFF alerts

Declaration of Compliance: Separate Documents, Separate Citations¶

Both systems require a Declaration of Compliance — but the content, structure, and legal references differ:

FDA Declaration of Compliance¶

Must include: - Identification of the material and all its components - The specific 21 CFR citation (e.g., "21 CFR § 177.1520 — Olefin polymers"), FCN number, or GRAS basis for each substance - The conditions of use under which the material is cleared (food types, temperature limits, contact duration) - Limitations or restrictions on use

The FDA does not prescribe a mandatory DoC format, but a DoC that fails to map each substance to its regulatory clearance is treated as inadequate during FDA inspections.

EU Declaration of Compliance¶

Must include (per Annex IV of 10/2011 for plastics): - Identity of the business operator issuing the DoC - Identity of the material or article - Date of the declaration - Confirmation of compliance with 1935/2004 and applicable material-specific measures - For plastics: information on authorized substances subject to restrictions or specifications, overall migration limit compliance, and specific migration limit compliance - For dual-use additives (substances also regulated as food additives): their identity and confirmation of compliance with applicable food additive regulations

The DoC must be renewed whenever substantial changes occur in production or when new scientific evidence becomes available, and supporting documentation must be made available to competent authorities upon request.

Migration Testing: The Hidden Cost Divergence¶

A food contact material that passes FDA migration testing does not automatically comply with EU migration limits — even when the same test conditions are used. The key differences:

Test conditions differ. FDA guidance specifies certain time-temperature combinations. EU 10/2011 specifies different test conditions based on the same intended contact conditions but with different selection logic and specific combinations not always aligned with FDA guidance.
Overall migration limit. EU 10/2011 specifies an overall migration limit of 10 mg/dm² of food contact surface area (60 mg/kg for some applications). The FDA does not have a codified overall migration limit — individual substances are evaluated based on their estimated daily intake (EDI) and cumulative dietary exposure.
Specific migration limits (SMLs). EU 10/2011 Annex I lists SMLs for every authorized substance. FDA clearance is use-specific, and the conditions of use defined in the clearance effectively determine the permissible migration.
Food simulants. Both systems use simulants (aqueous, acidic, alcoholic, fatty), but the specific simulants, test temperatures, and contact times differ between FDA guidance and EU 10/2011.

In practice, migration testing for dual-market compliance is typically performed as two separate test programs during the same laboratory session using the same test specimens — but with different test conditions applied and separate compliance assessments against the two sets of limits.

The Proprietary FCN Problem¶

A substance cleared by a Food Contact Notification in the US is cleared only for the FCN notifier and only for the uses specified in the notification. A downstream manufacturer relying on a supplier's FCN must have explicit authorization from the notifier — typically a letter of authorization.

The EU system avoids this problem through positive lists: once a substance is authorized and listed in Annex I of 10/2011, any manufacturer may use it for the approved applications. The EU positive list system is more transparent and more accessible for downstream manufacturers, but the authorization process through EFSA is longer and more resource-intensive than the FDA FCN process.

Regulatory Overlap: PFAS, BPA, and Emerging Substances¶

Both the US and the EU are addressing emerging food contact substance concerns:

Substance	US Status	EU Status
PFAS	FDA voluntary phase-out agreements for certain long-chain PFAS in food packaging. State-level bans (CA, NY, MN, etc.) on PFAS in food packaging.	EU considering PFAS restriction under REACH. Several Member States have national restrictions. Use in food contact declining under market pressure.
Bisphenol A (BPA)	BPA cleared for food contact use by FDA. Market-driven phase-out in baby bottles and infant formula packaging. CA Prop 65 listing.	BPA banned in baby bottles (EU 321/2011) and infant feeding articles. EFSA proposed a significantly lower tolerable daily intake in 2023, which could lead to further restrictions.
Phthalates	Limited FDA restrictions. Some phthalates cleared for food contact use subject to conditions. Consumer pressure driving phase-out.	Multiple phthalates restricted in food contact materials under Regulation (EU) 10/2011.

Dual-Market Compliance Strategy¶

Building food contact compliance for both the US and EU from a single set of raw material data is the most efficient approach:

Start with full material characterization. Identify every substance in your material — monomers, additives, processing aids, and impurities. This database is the foundation for both FDA and EU compliance.
Map each substance against both regulatory frameworks. For the FDA: 21 CFR citation, FCN number with authorization letter, or GRAS basis. For the EU: positive list entry in Annex I of 10/2011, specific SML, and any restrictions.
Commission dual migration testing. Provide your laboratory with both FDA and EU test protocols. The same test specimens can be used; separate test conditions and compliance assessments produce separate reports.
Issue separate Declarations of Compliance. The FDA DoC cites 21 CFR and FCN references and US conditions of use. The EU DoC cites 1935/2004 and 10/2011 and EU conditions of use. Both are generated from the same underlying material data.
Maintain both dossiers. FDA and EU competent authorities can request supporting documentation at any time. The data is largely the same, but the documentation must be structured and retrievable for the specific regulator making the request.

How Sustalium Supports Dual-Market Food Contact Compliance¶

Managing FDA and EU food contact documentation for the same product — two separate Declarations of Compliance, two sets of regulatory citations, two sets of migration test reports, and two sets of conditions of use — creates version control problems and documentation divergence if the two dossiers are maintained separately.

Sustalium centralizes dual-market food contact compliance:

Unified Substance Database — Enter your material composition once, including CAS numbers and substance functions. Sustalium maps each substance against both FDA (21 CFR citation or FCN number) and EU (positive list entry and SML) clearance pathways.
Dual DoC Generator — Generate the FDA Declaration of Compliance and the EU Declaration of Compliance from the same material data, with the correct regulatory citations, conditions of use, and structural format for each jurisdiction.
Migration Test Report Integration — Link both FDA and EU migration test reports to your material profile. When one standard or test report is updated, the change propagates to both dossiers.
Supplier Authorization Management — Track FCN authorization letters from your suppliers and link them to the products that rely on those authorizations — so when a supplier's authorization expires or a substance clearance is modified, you know which Declarations of Compliance are affected.

One Product, Two Market Dossiers, One Platform

Running separate FDA and EU food contact compliance programs for the same product doubles the overhead without adding safety. Build both dossiers from the same material data.

With Sustalium, build your dual-market food contact compliance dossier for just €10 per document.

Start Your Food Contact Compliance Now →

Frequently Asked Questions¶

Can I use one test report for both FDA and EU compliance?

You can use the same laboratory and the same test specimens, but you will receive two separate test reports — one against FDA guidance conditions and limits, one against EU 10/2011 conditions and limits. A single report covering both frameworks is not standard industry practice because the compliance criteria differ.

Is a US Declaration of Compliance valid in the EU?

No. An FDA DoC citing 21 CFR regulations has no legal standing in the EU. A separate EU Declaration of Compliance citing Regulation (EC) 1935/2004 and applicable material-specific measures must be issued by the EU business operator.

What is the fastest pathway to dual-market compliance for a new food contact material?

Commission dual migration testing early — providing your lab with both FDA and EU test protocols before testing begins. This avoids the cost of re-testing and allows the FDA and EU Declarations of Compliance to be prepared in parallel. For new substances not yet on the EU positive list, the EFSA authorization process is the critical path, typically taking 12-18 months.

Last updated: July 16, 2026