Specification Grade Silicones

FDA Silicone and BgVV Silicone

ElastaPro makes FDA silicone and BgVV silicone materials that meet requirements from the U.S. Food and Drug Administration (FDA) and BgVV, the German Institute for Consumer Health and Protection. Choose these specification grade silicone materials in the solid silicone sheet or uncured silicone compound in the durometers, sizes, and colors that you need.

FDA Grade White Silicone and FDA Grade Silicone

ElastaPro makes FDA grade white silicone and FDA grade translucent silicone for food contact applications. Both materials are available in 30, 40, 50, 60, and 70 durometer. FDA grade white silicone is also available in 80 durometer.

FDA Silicone and BgVV Silicone Solid Sheet

FDA/BgVV solid silicone sheet arrives ready for die cutting and is between .010” to .500” thick and available in widths of up 60”.

FDA Silicone and BgVV Silicone Uncured Compound

FDA/BgVV uncured silicone compound arrives ready for curing.

What is FDA Silicone?

FDA silicone meets the requirements of CFR 177.2600, a regulation within the U.S. Code of Federal Regulations that specifies the requirements for rubber articles intended for repeated use or contact with food.  It outlines the types of rubber materials, additives, and manufacturing practices that are permitted to ensure the safety of these materials when used in food processing, packaging, and handling. 

What Does CFR 177.2600 Entail?

Scope: The regulation applies to rubber articles used in various food-related processes, including producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. 
Material Requirements: It specifies that rubber articles should be made from natural and synthetic polymers and approved adjuvant substances (additives). 
Compositional Limits: The regulation sets limits on the amounts of certain substances that can be used in the rubber articles, ensuring they are not present in amounts that could migrate into food. 
Good Manufacturing Practices (GMP): Rubber materials must be manufactured under GMP to ensure consistent quality and safety. 
Thorough Cleaning: Rubber articles must be thoroughly cleaned before their first use in contact with food. 
Specific Extraction Requirements: For rubber articles intended to contact fatty foods, the regulation includes specific extraction limits when tested with n-hexane. 
Examples of Approved Substances: The regulation lists various substances, including some elastomers like Buna (acrylonitrile-butadiene copolymer), silicone, and PTFE, as well as other additives. 

What is BgVV Silicone?

BgVV, or Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, was the German Federal Institute for Health Protection of Consumers and Veterinary Medicine. It has since been reorganized into the BfR (German Federal Institute for Risk Assessment) and the BVL (German Federal Office of Consumer Protection and Food Safety). 

BgVV was responsible for assessing the health risks of substances and materials, particularly in relation to food, consumer products, and veterinary medicine. Specifically, it provided recommendations and guidelines for food packaging materials, including those used for labels. For example, BgVV had recommendations regarding the suitability of substances and materials for use in food packaging.