FDA Compliant O-Rings

FDA O-Rings

Compliant Food and Drug Administration 

FDA-approved rubber is specially formulated to meet the requirements of the United States Food and Drug Administration.  Although the jurisdiction of the FDA is restricted to the United States, FDA regulations are commonly adopted as international control standards.   

The FDA code regarding the use of FDA-approved rubber states, “Rubber articles intended for repeated use may be safely used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.” This was taken from the FDA site Code of Federal Regulation Title 21 (FDA 21 CFR 177.2600 see below).  Through its Codes of Federal Regulations, the FDA manages a list of materials and chemicals approved for contact with foods.

FDA does not ‘approve’ products according to CFR 21.177.2600 (see below).  It is the responsibility of the manufacturer of the finished FDA rubber product to demonstrate compliance related to the material itself by issuing an FDA certificate.

It is also important to note that while a component may be made from an FDA rubber material suitable for food contact it does not mean or certify that the part is technically suitable for its intended application.  There are different classes of rubber articles for dry foods, aqueous foods, and fatty foods.

Rocket Seals can work with our manufacturers to supply you with the FDA product your application requires.  If you need certification or any other documents, let us know at the time the order is placed. 

FDA CFR 21.177.2600

The Food and Drug Administration is the US Federal Agency responsible for ensuring that food is 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 manages a list of materials and chemicals 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 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 the manufacturer of the finished FDA rubber product to demonstrate compliance by issuing an FDA certificate. It is also important to note that whilst a component may be made from an FDA rubber material that is suitable for food contact; this does not mean that the part is technically suitable for its intended application. For more information visit https://www.accessdata.fda.gov

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