Key takeaways
- Food contact is a regulated use needing a regulatory citation, not a "food-grade" claim — FDA 21 CFR 177 in the US, EU 10/2011 in Europe.
- Each polymer family has its own CFR sub-section (177.1520 olefins, 177.1640 polystyrene, 177.1500 polyamides, 177.1580 polycarbonates); the CoA should cite the exact one.
- EU 10/2011 uses a positive list plus migration limits (10 mg/dm² overall, plus substance-specific SMLs) tested against food simulants, and diverges from FDA on heavy metals, phthalates and recycled content.
- Verify on the CoA: the CFR sub-section, that all colourants/additives are FDA-listed, an EU migration statement if shipping to Europe, heavy-metal residuals, and any temperature or food-type restriction.
When a polymer is going into a food-contact application — a milk bottle, a microwave tray, a beverage cap liner — the buyer needs more than the producer’s word that it is "food-grade." They need a regulatory citation. In the United States that means FDA 21 CFR 177. In the EU it means EU 10/2011. The two frameworks are similar in spirit but not identical in their additive lists.
Each polymer family has its own sub-section: 177.1520 covers olefin polymers (PE, PP), 177.1640 covers polystyrene, 177.1500 covers polyamides, 177.1580 covers polycarbonates. Each section lists the polymer specification limits and the permitted additive substances.
A producer claiming compliance will reference the exact sub-section on the CoA — "complies with 21 CFR 177.1520" — and confirm that all additives in the formulation are also listed in the relevant FDA inventories (CFR 178 for indirect-contact substances). The Food Contact Notification (FCN) inventory is the running list of substances cleared since 2000.
EU 10/2011 sets a positive list of monomers and additives, plus migration limits. The migration limits are tested by simulating contact with food-mimicking solvents (acidic, fatty, alcoholic, dry) at controlled temperatures. The maximum overall migration is 10 mg/dm² of food-contact surface, and there are specific migration limits (SMLs) for individual substances.
EU and US frameworks usually overlap. They diverge most often on heavy-metal limits, on phthalate restrictions, and on the use of recycled content in food-contact polymers — the EU EFSA opinion process for recycled PE/PET is stricter than the FDA letter-of-no-objection route.
- Specific CFR sub-section cited (e.g. 177.1520 for olefins)
- Confirmation that all colourants and additives are FDA-listed for food contact
- EU 10/2011 statement with declared migration limits if shipping into Europe
- Heavy-metal residual content (lead, cadmium, mercury, chromium) below the food-contact threshold
- Any temperature or food-type restrictions — "hot fill up to 100 °C" vs "ambient only"
Food-contact compliance is one of the few quality checks that survives downstream all the way to the consumer. A failed audit at the brand owner’s site walks back through every customer in the chain. Read the CoA carefully; confirm the citation, not just the sentence.
Frequently asked
Questions on the desk
What makes a polymer FDA food-contact compliant?
Compliance with the relevant 21 CFR 177 sub-section for that polymer family, with every additive and colourant also listed in the FDA inventories (CFR 178 for indirect-contact substances, plus the Food Contact Notification inventory). A credible CoA cites the exact section, e.g. "complies with 21 CFR 177.1520."
What is the FDA regulation for food-contact plastics?
21 CFR 177, split by polymer family — 177.1520 for olefin polymers (PE, PP), 177.1640 for polystyrene, 177.1500 for polyamides, 177.1580 for polycarbonates — backed by CFR 178 for indirect substances and the FCN inventory of substances cleared since 2000.
How does EU food-contact regulation differ from the FDA's?
EU 10/2011 sets a positive list of monomers and additives plus migration limits (10 mg/dm² overall migration, with specific limits per substance) tested against food-mimicking solvents. It overlaps with the FDA framework but diverges most on heavy-metal limits, phthalate restrictions, and recycled content.
How do I verify a polymer is food-contact safe?
Confirm the specific CFR sub-section is cited on the CoA — not just the word "food-grade" — check that all additives are FDA-listed, that heavy-metal residuals are below the food-contact threshold, and note any temperature or food-type restriction (e.g. hot-fill to 100 °C vs ambient only).
General market commentary from the OmniaStrata desk, provided for information only. It is not legal, financial, tax, or trading advice, and it is not an offer or a commitment to any terms. Figures such as price ranges, spreads, financing costs, and credit periods are illustrative market context, not OmniaStrata's rates or terms. Actual contract terms — including price, payment instrument, credit, insurance, and Incoterms — are agreed in writing on a per-transaction basis and at OmniaStrata's discretion. Market conditions change; figures reflect the publication date.