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FDA CFR 21 177.2600- What is it and Why is it Important?

February 21, 2014
All of the Sanitary Gaskets We Provide are Made with FDA CFR 21 177.2600 Approved Material

All of the Sanitary Gaskets We Provide are Made with FDA CFR 21 177.2600 Approved Material

In the high purity process industry, certificates are not just pieces of paper that fill a binder. Consumers implicitly rely upon the standards put into place by governing agencies to protect the public’s health and well-being. When evaluating a new product, many of our customers immediately jump to USP Class VI approval tests.   One standard often overlooked, but usually published alongside USP Class VI, is FDA 21 CFR 177.2600.

To begin, the USA food and Drug Administration (FDA) places regulations on three different types of food additives- direct, secondary direct, and indirect food additives.

Direct food additives are components added directly to the food, such as a food coloring or dye.

Secondary direct food additives are components that are added as part of a treatment or process. These are substances whose functionality is required during the manufacture or processing of a food and are ordinarily removed from the final food.

Indirect food additives are substances that may come into contact with food but are not intended to be added directly to food. Examples of an indirect food additive are things like packing, containers, and food process equipment. The Federal legislation that covers indirect food additives and the most specific references to rubber and rubber products is CFR 21 FDA 177.2600, entitled “rubber articles intended for repeated use”.

CFR 21 FDA 177.2600 is essentially a list of permitted base elastomers, vulcanization materials, accelerators, retarders, activators, antioxidants, plasticizers, fillers, emulsifiers, and other additives. The list recognizes some materials as inherently safe, these are classified as GRAS, generally recognized as safe.

FDA 21 CFR 177.2600 also sets the product extraction limits for both aqueous and fatty foods. Extractables in fatty foods must be less than 20 milligrams/square inch after the sample is refluxed with hexane for seven hours and then just 1 mg/square inch for the next 2 hours. For aqueous foods, the criteria is 175 mg/square inch of extractables when refluxed with water for 7 hours and 3 mg/square inch for the next two.

FDA 21 CFR 177.2600 also stipulates that rubber products intended for repeated use in contact with food should be thoroughly cleansed prior to their first contact with food. Approved substances include acrylonitrile-butadiene copolymer (Buna), silicone, polytetrafluoroethylene, and ethylene propylene diene monomer.

Where is does FDA 21 CFR 177.2600 come into play in sanitary process equipment?  In a word, everywhere.  Every type of sanitary valve has an elastomer seal seat.  Every sanitary pump has o rings associated with the seal.  All sorts of sanitary ancillary equipment have a myriad of o rings, gaskets, etc.  And of course most systems have many sanitary clamp unions with sanitary gaskets.  We can assist you in locating elastomers that meet FDA 21 CFR 177.2600.  If you need help contact us.

So if you’re still awake after reading through all of this, you will now know what the long string of letters and numbers located next to “USP Class VI” means.  Stay tuned for hopefully more exciting, non-regulatory blog posts tackling more of your sanitary process questions.

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