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How Is Food Grade Silicone Evaluated as an FDA-approved Material?
Oct 18, 2018

Food grade silicone rubber is often used in food processing, packaging and preparation applications. It can also be found in laboratory and medical environments. In such applications, it is crucial that every item that makes contact with the rubber is left unaffected. Although silicone is inherently non-toxic, only a specially formulated grade of the elastomer is fit for use with consumable products. As a result, food grade silicone was developed for use with consumables.

The food packaging and handling industry is a very serious business that involves the overall health and well being of an entire nation. The Food and Drug Administration (FDA) is tasked with regulating any and all materials that have to do with food. They have exacting standards of what can be allowed as food grade gaskets and seals for packaging purposes. The FDA has a method of approving anything as FDA-approved rubber.

FDA-approved silicone is often accompanied with a seemingly cryptic code: 21CFR177.2600. This code indicates where to find the guidelines for a food grade silicone rubber in the Code of Federal Regulations (CFR). The CFR is a collection of written rules and regulations pertaining to anything from agriculture to wildlife and fisheries. Title 21 is specifically set aside for the Food and Drug Administration and addresses regulations for mostly everything related to food and drugs: color additives, prescription drug advertising, and cosmetic labeling to name a few. It is here where you can find the federal guidelines for FDA-approved rubber in general.

The rules and regulations of FDA-approved silicone rubber are found in Section 177.2600 Title 21 of the CFR. This section specifically refers to elastomers such as food grade silicone being used around consumables and sets the following general rule:

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. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=177.2600)

The document goes on to outline the list of elastomers (e.g., styrene-butadiene, chloroprene) that must meet the specifications of food and medical applications. The rules stress that the rubber material is “finished;” meaning that the rubber is cured and will not contaminate any items that make contact the food grade silicone. Medical and food applications must use the FDA-approved silicone materials to avoid any health safety risks to the public. There is an emphasis on rubbers being suitable for repeated use, meaning it shouldn’t harbor contaminants just as it shouldn’t give them off. Food grade gaskets and seals should be able to function for long periods of time without falling prey to harmful contaminating agents, or degradation, no matter what type of product the food may be.

Silicone is the ideal elastomer to use as FDA-approved rubber. As noted above, the material is not susceptible to harmful microbial agents and other contaminants. However, one of its prime qualities is temperature resistance. It is a unique feature that is especially important when the elastomer is used as food grade silicone. Some applications in food handling require very cold temperatures. Silicone is able to withstand temperatures well below the freezing point. FDA-approved silicone can operate in temperatures ranging from -103° F and 450° F.

Another crucial, and somewhat obvious, importance is that the food grade silicone be an unmarking marking. The appearance of the elastomer is usually pure white, which makes it great for food contact. White does not rub off or stain on anything. Any FDA-approved rubber has to be a non-marking material. Luckily, silicone food grade gaskets step in to fill this requirement.

FDA officials inspect food grade silicone during the manufacturing of a product, but elastomers may be inspected post-production as well. The regulations governing FDA-approved silicone are set up to ensure the safety of the public’s health by setting guidelines for manufacturers to follow and inspectors and consumers to enforce. The code 21CFR177.2600 is like a stamp of approval for elastomers like neoprene, SBR and silicone. Medical, food and laboratory applications can work without second guessing the integrity of their workstation and the safety of American citizens.