FDA 21 CFR 177.1520: What Your Supplier Must Provide

What the section actually says

Note what it does not say: there is no "FDA certificate" for a food container. FDA does not pre-approve individual products. Compliance is the manufacturer's declaration based on the regulation and test data.

What to request from a supplier

1. Resin declaration — the grade used, with the resin maker's statement that it is suitable for food contact under 177.1520
2. Additive list — including colour masterbatch and any anti-fog agent
3. Extraction test report — from an accredited lab, on the finished article
4. Statement of compliance in your company's name, if you are the importer

The three common failures

• Masterbatch not covered. The resin is compliant; the black or white masterbatch is not listed. Ask for the masterbatch declaration separately.
• Recycled content unverified. Post-consumer PP requires a separate regulatory pathway in most markets.
• Wrong test conditions. Extraction conditions must match the real use — fatty food, hot fill and long storage need different conditions from dry ambient.

"FDA approved" is the wrong phrase

If a supplier's website says "FDA approved", that is a signal, not a credential. The correct phrasing is "compliant with 21 CFR 177.1520" or "made from FDA-compliant food-grade resin". A supplier who knows the difference is a supplier who has been through a real audit.

FAQ

Do I need FDA registration as an exporter? Food-contact articles are not food; the facility registration requirement applies to food facilities. Check with your customs broker for your specific case.

Is a US agent required? For food-contact substances notifications, sometimes. For standard PP containers, usually not.

Does EU compliance imply FDA compliance? No. Different positive lists, different limits. Both need checking.

Next step

Tell us the food type and use conditions. We will confirm which extraction conditions apply and what documentation to request.

Related reading

• EU Regulation (EC) 1935/2004 & (EU) 10/2011 Explained for Plastic Food Containers
• EU 10/2011 Declaration of Conformity for PP Containers
• Germany VerpackG and France Triman: EPR Registration for Food Packaging

Models covered on this site: 750 ml PF-RG750 · 950 ml PF-GG950 · 1000 ml PF-SQ1000S · see all models in this category.