FDA Standard

About FDA

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 compound 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.