FDA-compliant rubber materials
Rubber parts that touch food, beverages or the equipment that handles them are usually specified as FDA compliant. For rubber articles meant for repeated use, the U.S. Food and Drug Administration rule is 21 CFR 177.2600.
The rule lists the polymers and additives a compound may contain. It also limits how much can be extracted from the finished rubber by water and by n-hexane, which stands in for fatty foods.
What FDA compliant means
FDA does not approve or register individual rubber compounds or parts. "FDA compliant" or "FDA grade" means the compound is made only from ingredients the regulation permits and meets its extraction limits. The compound maker documents this, and we provide certificates of compliance on request.
Choosing an FDA-compliant elastomer
FDA grades are made in several elastomers. Choose by the food, the temperature and the cleaning:
- Silicone: wide temperature swings, such as ovens, hot fill and freezers.
- EPDM: hot water, steam and many cleaning chemicals. Not for fats and oils.
- Nitrile (NBR): fats, oils and greasy foods.
- Viton™ / FKM: oils and fats at high temperature; check caustic cleaners and steam.
What we make for food and beverage contact
We extrude, mold and die cut parts from compounds that meet FDA 21 CFR 177.2600, including silicone parts and manway gaskets for food, dairy and beverage tanks. NSF compounds are available. Certificates of compliance are available on request, and every lot is traceable from source material to finished part.
What to tell us
- The food, beverage or fluid the part touches
- The temperature in service and during cleaning
- The cleaning and sanitizing method and chemicals
- The regulation or standard on your drawing
- The documentation you need with the shipment
Questions we hear
- Does FDA approve rubber parts?
- No. FDA does not approve individual rubber compounds or parts. An FDA-compliant compound is made from ingredients listed in 21 CFR 177.2600 and meets its extraction limits.
- Which rubber is best for food contact?
- It depends on the food, the temperature and the cleaning. Silicone suits wide temperature swings, EPDM suits hot water and steam, and nitrile or FKM suits fats and oils. Send us the conditions and we will recommend a compound.
Request a quote
Send us a drawing, a sample part or a rough sketch. We will review it, recommend the right material and process, and give you a firm ship date with your quote.
Viton™ is a trademark of The Chemours Company.