“FDA approved” is a phrase you’ll see a lot, but the FDA doesn’t approve resins one by one. A resin is compliant when its composition meets the conditions in the food-contact regulations for its intended use. Here’s what that means in practice.
The regulations
U.S. food-contact rules are in Title 21 of the Code of Federal Regulations (21 CFR), mainly Parts 174–178. Common sections for resins include:
| Polymer | Common 21 CFR section |
|---|---|
| Olefin polymers (PE, PP) | 177.1520 |
| Nylon | 177.1500 |
| Polycarbonate | 177.1580 |
| PET | 177.1630 |
| Polystyrene and HIPS | 177.1640 |
| Acetal (POM copolymer) | 177.2470 |
Each section has its own limits and conditions of use (temperature, food type). Always confirm against the producer’s compliance letter.
Documents to ask for
- A food-contact compliance letter from the producer for the specific grade, stating the regulation and any limits.
- A COA for the lot.
- If you sell into Europe, a separate EU 10/2011 declaration. For drinking water parts, check whether NSF/ANSI 61 applies.
Common traps
- Colorants and additives must be compliant too. A compliant resin with a non-compliant concentrate isn’t a compliant part.
- Recycled content needs its own clearance (usually an FDA no-objection letter for the recycling process).
- Conditions of use matter: a grade cleared for room-temperature use may not be cleared for hot fill or microwave.
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