FDA O-Rings and Seals

FDA O-ring & Seal Materials:

The Food and Drug Administration (FDA) has established a list of rubber compounding ingredients which tests have indicated are neither toxic nor carcinogenic. Rubber compounds produced entirely from those ingredients and which also pass the FDA extraction tests are said to "meet the FDA requirements". The FDA does not approve rubber compounds. It is the responsibility of the manufacturer to compound food grade materials from the FDA list of ingredients and establish whether they pass the necessary extraction requirements.

What Is FDA Compliant, Approved?

FDA 21 CFR 177.2600 lists approved chemicals for rubber compounds, which helps provide compounds that are safe for food contact and are odorless and tasteless. These materials must also be able to withstand the harsh environments of food applications, including extreme temperatures, chemicals, water and steam.

The FDA provides two categories for individual food types with rubber compatibility. The Class I category designates foods, including edible oils, butter, milk and milk based products and cooking oils. Rubber compounds that meet these requirements are also compliant with foods in Class II. The second category, Class II, pertains to foods that do not contain edible oils or milk products. Water, soft drinks, alcoholic beverages and other aqueous solutions are typical Class II environments.

FDA Nitrile (NBR) Compounds:

Brand Compound Number Datasheet Hardness (Shore A) Low Temp High Temp Color
Engineered Seal Products ESP-N8018 PDF 70 +- 5 -- -- Black
Parker N1220-70 PDF 70 +- 5 -- -- Black
Freudenberg 75 NBR 430 75 +- 5 -4 212 Black
Freudenberg 70 NBR 438 PDF 70 +- 5 -13 212 Black
Freudenberg 80 NBR 217383 80 +- 5 -13 212 Black
Freudenberg 85 NBR 436 PDF 85 +- 5 -13 212 Black
Freudenberg 90 NBR 433 90 +- 5 -4 212 Black

FDA Ethylene Propylene (EPDM) Compounds:

Brand Compound Number Datasheet Hardness (Shore A) Low Temp High Temp Color
Engineered Seal Products ESP-E8061 PDF 70 +- 5 -- -- Black
Parker E1028-70 PDF 70 +- 5 -- -- Black
Parker E3609-70 PDF 70 +- 5 -- -- Black
Freudenberg 60 EPDM 217952 60 +- 5 -40 302 Black
Freudenberg 68 EPDM 290 68 +- 5 -40 302 Black
Freudenberg 70 EPDM 291 PDF 70 +- 5 -40 302 Black
Freudenberg 70 EPDM 382 70 +- 5 -40 302 Black
Freudenberg 70 EPDM 391 PDF 70 +- 5 -40 302 Black
Freudenberg 70 EPDM 38596 70 +- 5 -40 302 Black
Freudenberg 70 EPDM 217937 70 +- 5 -40 302 Black
Freudenberg 75 EPDM 386 75 +- 5 -40 302 Black
Freudenberg 75 EPDM 253356 75 +- 5 -22 284 Black
Freudenberg 85 EPDM 292 85 +- 5 -40 302 Black
Freudenberg 85 EPDM 302 85 +- 5 -40 302 Black
Freudenberg 85 EPDM 387 85 +- 5 -40 302 Black
Freudenberg 85 EPDM 389 85 +- 5 -40 302 Black

FDA Silicone (VMQ) Compounds:

Brand Compound Number Datasheet Hardness (Shore A) Low Temp High Temp Color
Engineered Seal Products ESP-S8000 PDF 70 +- 5 -- -- Rust
Parker S1538-55 PDF 55 +- 5 -- -- Translucent
Parker S0317-60 55 +- 5 -- -- Rust
Parker S1138-70 70 +- 5 -- -- Rust
Freudenberg 60 VMQ 117117 60 +- 5 -58 392 Transparent
Freudenberg 70 VMQ 117055 PDF 70 +- 5 -58 392 Transparent
Freudenberg 76 VMQ 176643 76 +- 5 -40 392 Red
Freudenberg 78 VMQ 166898 PDF 78 +- 5 -40 392 Grey

FDA Fluorocarbon (FKM) Compounds:

Brand Compound Number Datasheet Hardness (Shore A) Low Temp High Temp Color
Parker V0680-70 PDF 70 +- 5 -- -- Red
Parker V1274-80 PDF 80 +- 5 -- -- Black
Freudenberg 75 FKM 38269 PDF 75 +- 5 -13 392 Black

FDA Perflouorinated (FFKM) Compounds:

Brand Compound Number Datasheet Hardness (Shore A) Low Temp High Temp Color
Parker FF200-75 PDF 75 +- 5 -- -- Black
Parker FF350-75 PDF 75 +- 5 -- -- White
Parker FF500-75 PDF 75 +- 5 -- -- Black
Freudenberg 75 Simriz® 494 PDF 75 +- 5 5 446 Black
Freudenberg 75 Simriz® 38581 75 +- 5 5 446 White

*Compounds comply with 21 CFR 177.2600 for ingredient guidelines, water, and hexane extraction limits listed in paragraph (e). However, the FDA has not addressed the use of perfluoroelasomer polymers in CFR 177.2600.