Most of us hear about the FDA approved drugs or other topics involving the agency frequently. What you often do not hear about is an FDA approved gasket. When a gasket is used in a food application, most of our customers want and should take comfort in knowing that the gasket that they are using has FDA-approved ingredients. There is a specification for this: FDA 21 CFR 177.2600
Information on the Standard:
The standard sets forth a percentage threshold for base elastomers, vulcanizing agents, retarders, accelerators, antioxidants, antidegradants, activators, plasticizers, fillers, emulsifiers, and other additives for being used in food grade applications. The standard furthermore sets forth that prior to use in the field, the gasketing material shall be cleansed thoroughly. There are also methods specified to test the elastomers so nothing seeps into the food, specifically fatty and aqueous foods. The FDA does not test elastomers and approve them, so it is the responsibility of the manufacturer of the material to issue a FDA-approved ingredients certificate for that material.
Many silicone rubber materials would fall underneath FDA 21 CFR 177.2600. Silicone Foam, Silicone Sponge, and Silicone Rubber materials are all available as FDA Gaskets. This is because silicone is odorless, tasteless, non-toxic, and chemically inert in most applications.
Products that are FDA 21 CFR 177.2600 Complaint for Gaskets
|Product||Manufacturer||Type of Material|
|HT-800(Medium)||Rogers Corporation||Silicone Foam|
|HT-820(Firm)||Rogers Corporation||Silicone Foam|
|HT-840(Very Firm)||Rogers Corporation||Silicone Foam|
|HT-870(Very-Soft)||Rogers Corporation||Silicone Foam|
|BF-1000(Very-Soft)||Rogers Corporation||Silicone Foam|
|F12 (Very-Soft)||Saint Gobain Performance Plastics||Silicone Foam|
|Sold Silicone Rubber||Various||Solid Silicone Rubber(40A, 50A, 60A, 70A durometer)|
|Silicone Sponge||Various||Silicone Sponge(Soft, Medium, Firm)|
We mention mostly silicone elastomers here because their availability is the widest and most comprehensive. However, there are a number of other elastomers that are used frequently for FDA Gasketing applications, including EPDM, fluoroelastomers, and others.
For more information on FDA approved ingredients gaskets or you believe you have an application that could utilize them, please contact firstname.lastname@example.org.
For more information on FDA 21 CFR 177.2600, please visit the FDA’s website.