Food contact compliance: FDA 21 CFR vs EU 10/2011
Buyers routinely ask whether a film is "food grade" and accept a certificate as the answer. The two major regimes do not work that way, and they do not work the same way as each other. Understanding the difference is what stops a shipment being rejected at import.
Two regimes, two logics
The United States works through 21 CFR: a substance used in a food-contact article must be either the subject of a regulation authorising that use, covered by a Food Contact Notification, or otherwise exempt. The focus is on the substance and its authorised conditions of use — the polymer, the additives, the temperature and food type it may contact.
The European Union works through Framework Regulation 1935/2004 and, for plastics, Regulation 10/2011. There is a Union list of authorised substances, plus migration limits: an overall migration limit for everything that transfers into food, and specific migration limits for individual substances. The focus is on what actually ends up in the food, demonstrated by testing under specified conditions.
That difference has a practical consequence. A US authorisation is largely about the material. An EU declaration is about the material in your application — because migration depends on the food type, the contact time and the temperature.
A one-line certificate saying "complies with EU food contact regulations" is not a declaration of compliance and will not satisfy an informed customer or an inspector.
What an EU declaration of compliance must actually say
A proper declaration identifies the material and the manufacturer, states the regulations complied with, and — the part usually missing — specifies the conditions of use for which compliance is declared: which food types, what maximum contact temperature, what contact duration. It confirms compliance with overall and specific migration limits, notes any substances subject to restriction, and is supported by migration test data available on request.
If a supplier's declaration does not name the food simulants and the test conditions, it has not told you the one thing you needed to know. A film that is compliant for dry solids at ambient temperature may not be compliant for fatty foods at elevated temperature, and the certificate can look identical.
This is the sharpest practical divergence between the regimes and the most common source of an unpleasant surprise late in a project.
Where recycled content complicates things
Mechanically recycled polyolefin is generally not authorised for direct food contact in the EU in the way recycled PET is. So a food-contact pack with recycled content normally has to place that content in a layer that does not touch the food, with a functional barrier in between. That is a structural design decision, not a specification note.
Which means: if you are simultaneously chasing a recycled-content target and a food-contact application, the structure has to be designed for both from the start. Retrofitting recycled content into a food-contact film late in a project is where programmes lose six months.
What to ask for, and in what order
- The declaration of compliance for the specific structure, not the resin — your pack is a multi-layer article, and compliance applies to the article.
- The stated conditions of use: food simulants, temperature, contact duration. Check they cover your product, not a generic case.
- Migration test reports from an accredited laboratory. These sit behind an NDA at most suppliers, including ours; certificates do not.
- Confirmation of the recycled-content position if there is any recycled material in the structure.
- Regional extras where relevant — Japan's Food Sanitation Act positive list, or the Gulf conformity schemes.
We hold FDA 21 CFR and EU 1935/2004 and 10/2011 documentation, BRC packaging certification, HACCP, GMP and ISO 22000, and we state the conditions of use with every food-contact declaration. See the full certification list.
Common questions
Is a "food grade" certificate enough for food contact packaging?
No. Under EU rules you need a declaration of compliance that states the conditions of use — food simulants, maximum contact temperature and duration — because migration depends on the application. A film compliant for dry solids at ambient temperature may not be compliant for fatty foods when hot.
Can I use recycled content in food-contact flexible packaging?
Generally not in the layer touching the food. Mechanically recycled polyolefin is not authorised for direct food contact in the EU the way recycled PET is, so the recycled content goes in an outer layer behind a functional barrier. The structure must be designed that way from the start.
Does a US FDA 21 CFR declaration cover me in the EU?
No. The two regimes work on different principles — 21 CFR authorises substances and their conditions of use, while EU 10/2011 additionally requires demonstrated compliance with overall and specific migration limits. You need documentation for each market you sell into.
Where to go next
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