FDA O-Rings

Sealing Solutions for Human and Food Contact

food

Marco Rubber manufactures FDA O-rings, FDA gaskets, FDA rubber seals and custom-designed components from a range of FDA compliant rubber materials, including FDA Buna-N, FDA EPDM, FDA Silicone, FDA Viton®, FDA Kalrez® and Markez® FFKM.

FDA O-Rings Compliant Food and Drug Administration FDA CFR 21.177.2600

The Food and Drug Administration is the US Federal Agency responsible for ensuring that food safety, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. Although the jurisdiction of the FDA is restricted to the United States, FDA regulations are commonly adopted as international control standards. Through its Codes of Federal Regulations the FDA manages a list of materials and chemicals that are approved for contact with foods.

FDA CFR 21.177.2600 paragraphs A through D describe the relevant regulations for ‘Rubber articles intended for repeated use’. This lists the ingredients, and any quantitative limits, that may be used in a rubber compounds for molded products intended for repeated use in all stages of food manufacture, preparation and transportation.

FDA CFR 21.177.2600 paragraphs E and F also specify limits on extractible products if the FDA rubber seal is to be used in contact with aqueous or fatty foods. The regulation specifies extraction test limits in water and n-hexane. It is important to note that for an FDA rubber material to be compliant to these requirements, and then this claim must be supported with appropriate documentation such as a manufacturer’s FDA Compliance Certificate.

FDA does not ‘approve’ products to CFR 21.177.2600. It is for the manufacturer of the finished FDA rubber product to demonstrate compliance by issuing a FDA certificate. It is also important to note that whilst a component may be made from a FDA rubber material that is suitable for food contact; this does not mean that the part is technically suitable for its intended application.

CLASS OF USE FOR RUBBER ARTICLES

CFR21.177.2600

FDA REQUIREMENT FDA REQUIREMENT

LIMIT FOR EXTRACTIVES

Dry foods 
(A-D)

Must be formulated and cured under 
conditions of good manufacturing 
practice as to be suitable for repeated use.

No specified test

Aqueous foods 
(A-E)

Must meet extraction test criteria 
(distilled water at reflux temperature).

First 7 hours: Not exceeding 20mg per square inch. 
Next 2 hours: Not exceeding 20mg per square inch.

Fatty foods 
(A-F)

Must meet extraction test criteria 
(n-hexane at reflux temperature).

>First 7 hours: Not exceeding 175mg per square inch. 
Next 2 hours: Not exceeding 4mg per square inch.

O-Ring Pile Colors

Popular Compounds

Contact us for help selecting from these and the many more available.

CPD#MATERIALDUROMETER (SHORE A)COLORLOW TEMP (F)HIGH TEMP (F)FDA*USP CLASS VI**NSF61USDA 3AMETAL DETECTABLE
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E1000EPDM70Black-65300checkmarkcheckmark
Peroxide cured EPDM, Different Durometer , KTW, WRAS standards available
E1074EPDM70White-65300checkmarkcheckmarkcheckmark
Wide range of compliance
E1080EPDM70Black-40250checkmarkcheckmarkcheckmark
Wide range of compliance
E1097EPDM70Black-65300checkmarkcheckmarkcheckmark
Formulated for Chloramine Resistance. Can be manufactured in custom shapes with minimal setup charge.
B1002NBR70Black-30250checkmark
Available in many durometers and colors
B1039NBR70White-30250checkmark
Available in many durometers and colors
B1058NBR70Black-30250checkmarkcheckmark
KTW, WRAS and other standards available.
B1105NBR70Black-30250checkmarkcheckmark
Metal detectable for contamination detection sensors(additional colors available)
S1000VMQ70Orange-75400checkmark
Available in many durometers and colors
S1020VMQ70Clear Translucent-75400checkmark
Clear Translucent, available in many durometer and color choices.
S1037VMQ70Clear Translucent-75400checkmarkcheckmark
Clean room manufactured, platinum cured (specific base materials and cleanroom packaging options available)
S1083VMQ70Clear Translucent-65400checkmarkcheckmark
Commercial manufactured, platinum cured (cleanroom manufacturing and packaging options available)
S1146VMQ70White-75480checkmarkcheckmark
Cleanroom manufactured, Lower cost than clear
V1039FKM75White-15437checkmarkcheckmark
Cleanroom manufacturing and packaging options available
V1118FKM70White-15437checkmarkcheckmarkcheckmark
Steam Resistant Terpolymer, Also available in black
V1148FKM70Black-15392checkmarkcheckmark
Metal detectable for contamination detection(additional colors available)
Z1416FFKM75Black-5610checkmark
FDA compliant, higher temperature resistance, wide chemical compatibility. Compare to Kalrez® 6230, Kalrez® LS222
Z1703FFKM75Black5525checkmarkcheckmark
Greater temperate resistance range. Compare to Kalrez® 6230, Kalrez® LS222
Z1400FFKM75Black-5635
Highest temperature FFKM with best long term compression set resistance up to 335ºC, short exposures up to 350ºC, low outgassing, and high purity. A wide range of chemical, acid, and solvent resistances. Compare to Kalrez® 7075, Kalrez® 4079, Kalrez® 8900
Z1318FFKM75White5500checkmarkcheckmark
USP Class VI and FDA compliant white FFKM with wide range compatibility. Compare to Kalrez® 6221, Kalrez® LS205, Chemraz® 625

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*FDA compliance per 21 CFR 177.2600 parts A-D, E&F approved compounds available upon request. **USP <87> and USP <88> approved compounds available upon request.
The temperature ranges presented above are approximations for dry air service only and should not be used to determine design specifications or end-use temperature limits. Actual temperature range of a compound in an end-use application is highly dependent on part type, hardware configuration, applied forces, chemical media, pressure and thermal cycling effects, and other factors. The most practical way of determining an end-use temperature range is testing in the actual application conditions. Consult a Marco Engineer for more details.