If you export food packaging to both Europe and the United States, two regulations will define your compliance work: EU Regulation (EU) No 10/2011 and the US FDA 21 CFR. Understanding how EU 10/2011 vs FDA 21 CFR differ is not an academic exercise — it determines which materials you can use, which tests you must run, and which documents your customers will request. Get it wrong, and a container of perfectly good pouches can sit at the port while customs and buyers demand paperwork you do not have. In this guide we break down the practical differences between the two systems. For a broader overview of the two markets, see our earlier comparison of US vs EU packaging requirements.
What Each Regulation Governs
EU Regulation (EU) No 10/2011 is the framework regulation for plastic materials and articles intended to come into contact with food. It works as a positive list: only substances listed in its Annex I may be used in food-contact plastics, and each substance carries a specific migration limit (SML) expressed in milligrams per kilogram of food simulant. A global migration limit (OML) of 10 mg per square decimeter also applies. FDA 21 CFR works differently. It is a collection of regulations — most importantly 21 CFR 174, 175, 176 and 177 — that manage food contact substances through the food additive framework. A substance is compliant when it meets the conditions described in the relevant section, including any limits on temperature, food type and contact time.
Scope and Regulatory Logic
The two systems differ in their core logic. The EU regulation is article-based: it applies to plastic materials and articles, including each plastic layer in a multilayer structure, and requires a compliance assessment of the finished article. The FDA approach is substance-based: what matters is whether each substance used is authorized for the intended conditions of use, regardless of the structure it ends up in. In practice, this means the same multilayer film must undergo an overall compliance evaluation for Europe, while for the United States the focus is on confirming each component against the applicable 21 CFR section.
Substance Lists and Limits
Annex I of Regulation (EU) No 10/2011 lists permitted monomers, additives and polymer production aids, each with its own SML. FDA 21 CFR expresses restrictions differently — for example “not to exceed 0.05 mg/kg” or “for use only with aqueous foods” — and many entries include temperature and use-condition caveats. A common real-world problem: an ink or adhesive is fully compliant in China and Europe, but one component is absent from the FDA lists, or its authorized temperature range is lower than your retort process requires. The safe approach is to select materials by working backwards from the target market at the design stage, not after the film is already printed.
Migration Testing Differences
Migration testing sits at the heart of both systems, but the details differ. The EU regulation defines a fixed set of food simulants (water, 3% acetic acid, 10% ethanol, olive oil and others), test time and temperature combinations, and refers to the EN 1186 series of test methods. The FDA framework relies on the simulants and conditions in 21 CFR 176.170 and FDA-endorsed testing guidance. One detail exporters often miss: Europe requires verification of the finished article and coverage of every food-contact surface, while the United States emphasizes substance-level authorization. Laboratory reports are not interchangeable — always tell the lab which market you are targeting before testing begins.
Documentation and Declarations
Article 15 of Regulation (EU) No 10/2011 requires a Declaration of Compliance to be passed down the supply chain, supported by test reports and calculation data that must be kept for ten years. The EU also requires labeling such as the food contact symbol and instructions for use where needed. The FDA does not prescribe a specific declaration format, but companies must keep adequate evidence of compliance for inspection. If you sell into both markets, building your documentation system around the stricter EU requirements means the US evidence chain is largely covered as well. For more on the European regulatory landscape, read our EU PPWR regulation guide and the 2026 European packaging regulation trends.
How to Comply with Both Systems
For companies serving both markets, a practical strategy is to follow the stricter requirement in each area: choose substances that appear on both the EU positive list and the FDA lists, run migration tests under the more demanding conditions, and build an EU-style documentation system. The extra testing and paperwork cost at the front end is small compared with a rejected shipment or a lost customer. When in doubt, ask your material supplier for their EU and FDA compliance statements in writing before you commit to a structure.
Summary
EU 10/2011 and FDA 21 CFR embody two different regulatory philosophies: an article-based positive list system versus a substance-based authorization system. Exporters do not need to become regulation lawyers, but they do need to handle selection, testing and documentation according to the target market. If you are developing food packaging for export, contact OMOpack — our team is familiar with both the EU and US food-contact frameworks and can review your structure for compliance risks. Visit OMOpack.com for more packaging knowledge and industry insights.
