FDA O-Rings for Human and Food Contact Rubber Seals

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.


Popular Compounds

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

CPD# MATERIAL DUROMETER (SHORE A) COLOR LOW TEMP (F) HIGH TEMP (F) FDA* USP CLASS VI** NSF61 USDA 3A METAL DETECTABLE
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E1000 EPDM 70 Black -65 300 checkmark checkmark
Peroxide cured EPDM, Different Durometer , KTW, WRAS standards available
E1074 EPDM 70 White -65 300 checkmark checkmark checkmark
Wide range of compliance
E1080 EPDM 70 Black -40 250 checkmark checkmark checkmark
Wide range of compliance
E1097 EPDM 70 Black -65 300 checkmark checkmark checkmark
Formulated for Chloramine Resistance. Can be manufactured in custom shapes with minimal setup charge.
B1002 NBR 70 Black -30 250 checkmark
Available in many durometers and colors
B1039 NBR 70 White -30 250 checkmark
Available in many durometers and colors
B1058 NBR 70 Black -30 250 checkmark checkmark
KTW, WRAS and other standards available.
B1105 NBR 70 Black -30 250 checkmark checkmark
Metal detectable for contamination detection sensors(additional colors available)
S1000 VMQ 70 Orange -75 400 checkmark
Available in many durometers and colors
S1020 VMQ 70 Clear Translucent -75 400 checkmark
Clear Translucent, available in many durometer and color choices.
S1037 VMQ 70 Clear Translucent -75 400 checkmark checkmark
Clean room manufactured, platinum cured (specific base materials and cleanroom packaging options available)
S1083 VMQ 70 Clear Translucent -65 400 checkmark checkmark
Commercial manufactured, platinum cured (cleanroom manufacturing and packaging options available)
S1146 VMQ 70 White -75 480 checkmark checkmark
Cleanroom manufactured, Lower cost than clear
V1039 FKM 75 White -15 437 checkmark checkmark
Cleanroom manufacturing and packaging options available
V1118 FKM 70 White -15 437 checkmark checkmark checkmark
Steam Resistant Terpolymer, Also available in black
V1148 FKM 70 Black -15 392 checkmark checkmark
Metal detectable for contamination detection(additional colors available)
Z1204 FFKM 75 Black 20 450 checkmark checkmark
Least expensive for standard sizes  Alternative to Kalrez® 6230
Z1409 FFKM 75 Black -4 500 checkmark
Greater temperate resistance range, Alternative to Kalrez® 6230
Z1318 FFKM 75 White 5 500 checkmark checkmark checkmark
Least expensive for standard sizes Alternative to Kalrez® 6221
Z1305 FFKM 80 White 5 590 checkmark checkmark checkmark
Greater temperate resistance range,  Alternative to Kalrez® 6221

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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.

New Customer Hotline: 800-775-6525

Existing Customer Specialist: 800-775-6525 or repeat customers

Marco Rubber & Plastics
PO Box 1150
Seabrook, NH 03874

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