FDA Gaskets

Most of us hear about the FDA (Food and Drug Administration) in the news frequently, hearing about a new drug that was recently approved, or hearing about new FDA food safety rules. What you often do not hear about is an FDA approved gasket. When a gasket is used in a food application, most of our customers want — and should take comfort in knowing — that the gasket that they are using has FDA-approved ingredients. Since there are hundreds of ingredients that may be used when compounding rubber, it is a good idea to limit the use and, if used, the percentage of the ingredients when in contact with food.

Luckily, the FDA has already outlined a standard for this; FDA 21 CFR 177.2600 (Title 21, Chapter 1, Subchapter B, Part 177, Section 177.2600). This specification is a standard set forth by the FDA that lists approved ingredients for rubber products. The standard is set forth to ensure that the rubber is “used safely in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting and holding food.” The standard sets forth a percentage threshold for base elastomers, vulcanizing agents, retarders, accelerators, antioxidants, antidegradants, activators, plasticizers, fillers, emulsifiers, and other additives for being used in food grade applications. The specification outlines that these materials are for repeated use. The standard furthermore sets forth that prior to use in the field, the gasketing material shall be cleansed thoroughly. There are also methods specified to test the elastomers so nothing seeps into the food, specifically fatty and aqueous foods. These methods set forth extraction methods, as well as what fluid this extraction takes place in (n-hexane and water), for testing the rubber products. The FDA does not test elastomers and approve them, so it is the responsibility of the manufacturer of the material to issue a FDA-approved ingredients certificate for that material.

NEDC is able to provide FDA approved ingredient materials that make gaskets, o-rings, waterjet cut gaskets, die cut gaskets, and cord stock. FDA-approved rubbers are often supplied as white (of course, this is not always the case, just like fluorosilicone isn’t always blue.) There are many types of gasketing material that can be compounded to be FDA compliant; some of the typical materials are nitrile, DuPont’s Viton, EPDM, and of course silicone. NEDC also stocks many gasketing materials that are FDA ingredient compliant with FDA 21 CFR 177.2600. One important caveat to take notice of, is that FDA 21 CFR 177.2600 graded rubber is entirely different than “medical grade” rubber, and the two should not be confused. Albeit, it is possible for a particular elastomer to be both “medical grade” and FDA 21 CFR 177.2600 compliant, but the medical grade would need a classification. For any further questions concerning NEDC’s FDA approved gaskets, please contact sales@nedc.com.

For more information on FDA 21 CFR 177.2600, please visit the FDA’s website.

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