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Everything You Wanted to Know About FDA Approved Rubber!
Oct 18, 2018

FDA approved rubber is specially formulated silicone to meet the requirements of the United States Food and Drug Administration. While the Food and Drug Administration (FDA) has regulatory authority in the United States, many have adopted the standards set forth by them and follow these standards in their own countries. The FDA code regarding the use of FDA approved rubber states that: “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.” The latter was taken from the FDA site Code of Federal Regulation Title 21 (FDA 21 CFR 177.2600).

FDA silicone rubber, or simply FDA rubber, is compliant with Code of Federal Regulations Title 21 (FDA 21 CFR 177.2600) an FDA regulation that covers materials for use with consumables such as food and beverages. However, food-safe silicone can also be found in use in the cosmetics and pharmaceutical industries. It should be noted that FDA approved rubber should not be confused with commercial grade or medical and pharmaceutical grade rubbers that are respectively made to less or more stringent specifications.

Any FDA rubber must be compliant to official regulations and certified for use with and during food production. Many compounds are certified for this including Neoprene, Nitrile, and EPDM. Silicone, however, is the most commonly used compound because of its good resistance to a variety of chemicals and temperature extremes. Silicone can normally handle temperatures up to 450 degrees Fahrenheit. This signature feature of FDA silicone rubber is especially recommended since foods, while cooking, see elevated temperatures. It does not degrade or boil in such conditions. At the same time, some foods are stored and packaged in very low temperatures that may go below freezing. Food-safe silicone is well suited for cold situations because it can survive in temperatures that reach below -100 degrees Fahrenheit. The body material of the silicone FDA approved rubber will not crack or become brittle in the face of extreme cold.

Silicone FDA approved rubber is typically white in color for aesthetic reasons. The color black signifies industrial use while grays and whites are more neutral and are generally preferred for domestic or commercial purposes. A big reason for this is due to the aesthetic considerations of various settings and applications. Sometimes a black colored part can make an item look unappealing or too industrial. White is a neutral color that lends itself well to sensitive food and medicine related applications.

FDA rubber is commonly used in applications that involve the production, packing, processing, preparing, or holding of food, beverages, or consumables to preserve the quality of these products and to prevent them from being contaminated by exposure to foreign elements. FDA silicone rubber does not allow for harmful contaminants to gather on it. As a result, FDA approved rubber is commonly used in the fabrication of gaskets, seals, tubing, conveyor belts, or counter top matting and can be found in commercial kitchens, food processing plants, pharmaceutical processing, and the cosmetics industry. FDA approved rubber is a solid, industrial-grade sheet rubber that can be used in wet or dry applications, and has a smooth surface that makes it very easy to clean. As an added bonus, the food-safe silicone material offers a very good level of abrasion resistance. FDA approved rubber is overall very clean, free from impurities, and has no contaminants so it does not give a taste or odor to consumables that may come in contact with it.

FDA rubber that is certified to Title 21 (FDA 21 CFR 177.2600) must be used in these applications because the risk of product contamination when not using this type of rubber rises significantly. Regular contact with some foods or liquids can lead to the development of acids and chemicals that could affect the quality of food and possibly lead to food poisoning. Since FDA approved rubber is considered non-toxic and is a non-marking material, it is the perfect elastomer to use for food-related applications