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FDA Compliant Seals (Food & Drug Administration)

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 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 extractable 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 manufacturer'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.

Please consult individual material datasheets for details of FDA compliance.

FDA seals, gaskets and rubber components from PPE

PPE manufactures food-grade gaskets and seals including O-rings, hygienic gaskets and custom-designed components from a range of over 40 FDA-compliant rubber material grades:-

FDA Class Elastomer Material
Class A-D (dry foods) EPDM - often used in the food and beverage industry, it is ideal for temperature ranges between -40°C and 150°C.
NBR - Nitrile rubber offers temperature resistance between -40°C and 120°C. PPE offers metal detectable grades of NBR that are FDA compliant.
Silicone - PPE’s VMQ material grades offer thermal stability and low toxicity. Ideal for temperature ranges between -60°C and 250°C.
FKM - Fluorocarbon seals offer high chemical resistance and a large working temperature range from -20°C to 200°C.
Class A-E (aqueous foods) EPDM - Datasheets
Class A-F (fatty foods) FFKM (Perlast®) - Perfluoroelastomers offer near universal chemical resistance and a large temperature range -15°C and 320°C.
Metal detectable elastomers (Detectaseal®) - This range includes EPDM, Nitrile and FKM seals.
More information
FKM - Datasheets
Silicone - Datasheets
EPDM - Datasheets

How can we help?  Looking for FDA compliant rubber seals and sealing components? Contact us to discuss your FDA seal requirements with our experts.

Documents Download
Document Description Download
Certificate FDA (A - D) Download File
Cetificate FDA (A - E) Download File
Certificate FDA (A - F) Download File
Certificate FDA FFKM Download File
Certificate ADI-free Download File
Certificate ADI-free FFKM Download File
Brochure Food, Pharma & Life-sciences Download File
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