Specialty Silicone Products (SSP) makes FDA silicone materials for food contact and medical applications. SSP’s SSP2390 series of FDA silicones also meet USP Class VI and RoHS requirements. All SSP2390 materials are platinum-cured for low levels of extractables, potentially harmful substances that could leach out of a material.
What is FDA Silicone?
FDA silicone refers to a type of food grade silicone that meets safety and quality standards set by the U.S. Food and Drug Administration (FDA). It must comply with FDA 21 CFR 177.26000, a U.S. regulation for rubber articles intended for repeated use in food contact.
FDA silicone is designed and formulated for use in applications that involve contact with food and beverages; however, these materials are also used in medical devices and equipment, and by the pharmaceutical industry. Other standards, such as USP Class VI, may also apply.
What is FDA 21 CFR 177.2600?
FDA 21 CFR 177.2600 specifies the requirements for rubber articles intended for repeated use that come into contact with food. This regulation ensures that such materials are safe for human use and do not transfer harmful substances to food.
What are Some Key Features of FDA Silicone?
FDA silicone offers these important features.
Biocompatibilitye: Safe for use in medical and food-contact applications.
Non-toxic & Odorless: Won’t leach harmful substances.
Heat Resistant: Can typically withstand temperatures from -60°C to 230°C (-76°F to 446°F), sometimes higher.
Flexible & Durable: Maintains elasticity and integrity over time.
Non-reactive: Chemically inert, so it won’t interact with the contents it touches.
Easy to Sterilize: Can be cleaned with steam, boiling, or certain chemicals.
What is FDA Silicone Used for?
FDA silicone is used for for food, medical, and pharmaceutical applications. Here are some examples:
- Food-grade tubing and seals
- Baby bottle nipples and pacifiers
- Bakeware and kitchen utensils
- Medical tubing, implants, and gaskets
- Pharmaceutical manufacturing components
Who Makes FDA Silicone?
Specialty Silicone Products makes FDA silicone at our Made in USA manufacturing facility in Ballston Spa, New York in accordance with our ISO 9001:2015 certified Quality Management System (QMS)
SSP2390 silicone meets FDA 21 CFR 177.2600 requirements from the U.S. Food and Drug Administration (FDA). This FDA silicone is safe for rubber articles for repeated use that come into contact with food.
Why Use SSP2390 FDA Silicones?
SSP2390 FDA silicones are high-purity elastomers. Because they are platinum-cured, these materials have stronger physical properties and lower shrinkage values than peroxide cured compounds.
SSP ships these silicones platinum pre-catalyzed and ready for use. Choose moldable compounds, sheet stock, or rolls from .005″ to .250″ thick. Among its many advantages, SSP2390 is available in a range of durometer-based grades (10 to 80 Shore A).
How are Food Grade Silicone Sheets Made?
Food grade silicone sheets can be made through calendering, a process that’s shown in the video below.
Are All Food Grade Silicones FDA Silicones?
Not necessarily. Some countries, such as Canada, generally refer to FDA standards when defining food grade standards. Other, such as the member nations of the European Union, follow different standards, including Restriction of Hazardous Substances (RoHS).
When deciding which type of silicone you need, make sure to check all of the requirements. In some cases, it may not be enough to use an FDA approved materials. For example, the terms “food grade silicone” includes materials that meet NSF 51 and NSF 61 standards. NSF International is not a regulatory agency, but the FDA and food equipment manufacturers refer to its published standards.
