FDA Food Contact Compliance: U.S. Importer's Guide

Any packaging in contact with food sold in the United States must comply with U.S. Food and Drug Administration (FDA) regulations under 21 CFR (Code of Federal Regulations). For importers of bagasse and molded fiber packaging, the specific requirements differ from those for plastic packaging, and the documentation burden falls on the importer, not the manufacturer.

The regulatory framework

FDA food-contact compliance operates through three pathways:

1. Generally Recognized as Safe (GRAS) status: Materials with long-established safe use (paper, certain plastics, standard glass) are GRAS by default
2. Food Contact Notification (FCN): A submission process for new food-contact substances. Once accepted, the substance is added to FDA’s Food Contact Substance database
3. Food Additive Petition: The most rigorous pathway, used for substances requiring formal FDA review

Bagasse and other molded fiber materials derived from food-grade agricultural inputs (sugarcane, wheat straw, rice husk) are typically classified under the 21 CFR 176.170 (“components of paper and paperboard in contact with aqueous and fatty foods”) regulation. This places bagasse in the GRAS-equivalent paper category.

What 21 CFR 176.170 covers

21 CFR 176.170 establishes that paper and paperboard intended for food contact must:

• Be made from materials of suitable grade for the intended use
• Contain only permitted components (specified in the regulation’s substance list)
• Not transfer constituents to food in amounts exceeding specified limits
• Be manufactured under good manufacturing practices (GMP)

Documentation buyers should request

For FDA compliance, importers should obtain from suppliers:

1. Letter of Compliance: Statement from the manufacturer confirming the product meets 21 CFR 176.170 (or applicable section) for the intended food-contact use
2. Material composition declaration: Listing all components and their percentages
3. Migration test results: Lab analysis showing migration levels are within FDA limits for relevant food simulants (water, oil, acidic, ethanol)
4. Independent third-party test reports: SGS, Intertek, or similar lab confirmation
5. Manufacturer GMP certification: BRCGS, ISO 22000, or equivalent

Migration testing requirements

Migration testing measures whether substances from packaging transfer to food at concerning levels. FDA-recognised food simulants:

• Aqueous food: Distilled water at 40°C / 24 hours
• Acidic food: 3% acetic acid solution
• Fatty food: n-Heptane or other approved fat-mimic
• Alcoholic food: 10-95% ethanol depending on application

Bagasse molded fiber plates and bowls typically pass migration testing comfortably for aqueous, acidic, and fatty food simulants; its inert plant-fiber composition does not release significant chemical residues. PFAS-related concerns (see below) require explicit testing.

The PFAS consideration

PFAS (per- and polyfluoroalkyl substances) have been used in molded fiber food packaging as grease-resistance additives. The FDA, several U.S. states (California AB 1200, Maine LD 1503, others), and the EU have moved to ban PFAS in food contact materials.

A compliant bagasse supplier must:

• Use PFAS-free formulations explicitly
• Provide independent test results confirming PFAS levels below detection limits
• Update material composition declarations to reflect PFAS-free status

Buyers should request a PFAS declaration as part of standard supplier documentation, regardless of state.

FDA inspection at port of entry

FDA inspects imported food-contact materials at U.S. ports. Common reasons for detention:

• Missing or invalid Letter of Compliance
• Migration test results expired or not covering the specific SKU
• PFAS testing absent or inadequate
• Material composition declaration inconsistent with shipment manifest

Importers should pre-clear documentation with their customs broker and have current Letter of Compliance and migration test reports available before goods arrive at port.

Multi-market documentation strategy

For chains importing into the U.S. and other markets, hold the following documentation set as standard:

• FDA 21 CFR 176.170 Letter of Compliance (U.S.)
• EN 13432 compostability certificate (EU and UK)
• ASTM D6400 / BPI certificate (U.S. compostability)
• FSSAI registration (if importing from India to other markets)
• BRCGS Packaging Materials A or A+ (universal)
• Third-party lab test reports (SGS, Intertek)
• PFAS-free declaration
• Sedex SMETA audit (ESG)

Ecofy’s FDA position

Ecofy’s bagasse molded fiber FDA-compliant plates, bowls, and compostable food trays meet 21 CFR 176.170 for aqueous, fatty, acidic, and alcoholic food simulants. We provide Letter of Compliance, migration test reports (SGS / Intertek), PFAS-free declaration, and BRCGS A+ Letter of Conformity with every shipment to U.S. customers. Our QR-coded shipment documentation allows customs brokers to verify all certificates digitally, reducing port-of-entry friction.