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Food and Drug Administration (FDA CFR 21) - FDA Rubber

The Food and Drug Administration is the US Federal Agency responsible for ensuring that foods are safe, 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 promulgates a list of materials and chemicals that are approved for contact with foodstuffs. FDA CFR 21.177.2600 paragraphs A to 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 moulded 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, then this claim must be supported with appropriate documentation such as a manufacurer's FDA 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.

PPE manufactures O-ringshygienic gaskets and custom-designed components from a range of FDA-compliant rubber materials, including NBREPDMSiliconeHNBRFKM, and FFKM.


Class of use for rubber articles
FDA requirement
Limit for extractives
Dry foods
Must be formulated and cured under
conditions of good manufacturing
practice as to be suitable for repeated use.
No specified test
Aqueous foods

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 
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.

More information:

IDEX - Sealing Solutions
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