FDA Approved O-Rings

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, 3A, & NSF?

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.

NSF 51 Food & Beverage Information NSF 61 Drinking Water - Irrigation Information

FDA Nitrile (NBR) Compounds:

General NBR Information

Brand	Material	Duro	Industry Material Specification
Engineered Seal Products	ESP-N0417	70	FDA CFR 21 177.2600
Engineered Seal Products	ESP-N1001	70	FDA CFR 21 177.2600
Engineered Seal Products	ESP-N6012	90	FDA CFR 21 177.2600
Engineered Seal Products	ESP-N8018	70	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class II, EC1935/2004, NSF 61
Engineered Seal Products	ESP-N6018	70	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III
Parker	N1220-70	70	N1220-70 is an NSF 51 approved material exhibiting typical physical properties. N1220-70 also meets FDA requirements.
Freudenberg	75 NBR 430	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class II
Freudenberg	70 NBR 438	70	3A Sanitary Standard 18 Class II
Freudenberg	85 NBR 436	85	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class II
Freudenberg	90 NBR 433	90	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class II

FDA Ethylene Propylene (EPDM) Compounds:

General EPDM Information

Brand	Material	Datasheet	Duro	Industry Material Specification
Engineered Seal Products	ESP-E1060	--	70	FDA CFR 21 177.2600
Engineered Seal Products	ESP-E8002	--	70	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class IV
Engineered Seal Products	ESP-E8003	--	70	USP Class VI, FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III
Engineered Seal Products	ESP-E8004	--	70	FDA CFR 21 177.2600
Engineered Seal Products	ESP-E8005	--	80	FDA CFR 21 177.2600
Engineered Seal Products	ESP-E8061	--	70	FDA CFR 21 177.2600, 6, 3A Sanitary Standard 18 Class, 2011/65/EU, NSF/ANSI 61
Engineered Seal Products	ESP-E8062	--	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III
Engineered Seal Products	ESP-E8063	--	80	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III
Engineered Seal Products	ESP-E8064	--	85	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III
Parker	E1028-70		70	FDA CFR 21 177.2600
Parker	E3609-70		70	FDA CFR 21 177.2600, 3A Sanitary Class VI
Freudenberg	60 EPDM 217952		60	FDA CFR 21 177.2600, 3A Sanitary Class VI
Freudenberg	70 EPDM 291		70	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III, NSF 51, NSF 61
Freudenberg	70 EPDM 382		70	FDA CFR 21 177.2600
Freudenberg	70 EPDM 391		70	FDA CFR 21 177.2600
Freudenberg	70 EPDM 38596		70	FDA CFR 21 177.2600
Freudenberg	70 EPDM 217937		70	FDA CFR 21 177.2600
Freudenberg	75 EPDM 386		75	FDA CFR 21 177.2600
Freudenberg	75 EPDM 253356		75	FDA CFR 21 177.2600
Freudenberg	85 EPDM 292		85	FDA CFR 21 177.2600
Freudenberg	85 EPDM 302		85	FDA CFR 21 177.2600

FDA Silicone (VMQ) Compounds:

General VMQ Information

Brand	Material	Datasheet	Duro	Industry Material Specification
Engineered Seal Products	ESP-S8000	--	70	FDA CFR 21 177.2600, 3A Sanitary Standard Class IV
Parker	S1538-55	--	55	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class IV
Parker	S0317-60	--	55	FDA CFR 21 177.2600, 3A Sanitary Class VI
Parker	S1138-70	--	70	FDA CFR 21 177.2600, 3A Sanitary Class VI
Freudenberg	60 VMQ 117117	--	60	FDA CFR 21 177.2600
Freudenberg	70 VMQ 117055	--	70	FDA CFR 21 177.2600, 3A Sanitary Standard Class I
Freudenberg	76 VMQ 176643	--	76	FDA CFR 21 177.2600
Freudenberg	78 VMQ 166898	--	78	FDA CFR 21 177.2600

FDA Fluorocarbon (FKM) Compounds:

General FKM Information

Brand	Material	Datasheet	Duro	Industry Material Specification
Engineered Seal Products	ESP-V1021	--	80	FDA CFR 21 177.2600
Engineered Seal Products	ESP-V1101	--	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class II, NSF51/NSF61
Engineered Seal Products	ESP-V6100	--	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class I, 3A D4.6 meets Class II requirements
Engineered Seal Products	ESP-V8028	--	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class III, NSF 61
Engineered Seal Products	ESP-V8029	--	70	FDA CFR 21 177.2600, NSF 61
Engineered Seal Products	ESP-V8038	--	75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class I, NSF 61
Engineered Seal Products	ESP-V6020	--	80	FDA CFR 21 177.2600
Parker	V0680-70		70	FDA CFR 21 177.2600, 3A Sanitary Class VI, NSF 51
Parker	V1274-80		80	FDA CFR 21 177.2600, 3A Sanitary Class VI
Freudenberg	75 FKM 38269		75	FDA CFR 21 177.2600, 3A Sanitary Standard 18 Class I
Freudenberg	75 FKM 239961		75	FDA CFR 21 177.2600

FDA Perflouorinated (FFKM) Compounds:

General FFKM Information

Brand	Material	Datasheet	Duro	Industry Material Specification
Parker	FF200-75	--	75	FDA CFR 21 177.2600
Parker	FF350-75	--	75	FDA CFR 21 177.2600
Parker	FF500-75	--	75	FDA CFR 21 177.2600
Freudenberg	75 Simriz® 494	--	75	FDA CFR 21 177.2600
Freudenberg	75 Simriz® 38581	--	75	FDA CFR 21 177.2600

*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.

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