Full definition
Elastomer compounds that comply with FDA 21 CFR 177.2600 (Rubber articles intended for repeated use in contact with food), meaning all ingredients (polymer, curing agents, fillers, plasticizers, colorants) are listed in the FDA-approved ingredient lists and the finished product passes extraction tests. Key requirements: no carbon black (replaced with white fillers — silica, TiO₂, CaCO₃), no aromatic process oils (replaced with paraffinic or ester oils), no staining antioxidants (phenolic types only), and no heavy metals above limits. Common FDA-compliant elastomers: silicone VMQ (most widely used food-grade material — inherently non-toxic, odorless, tasteless), white EPDM (for water/steam/beverage contact), white NBR (for edible oils/fats contact), white FKM (for aggressive food chemicals), and white NR (for food conveyor belts). Testing: FDA extraction protocol using water, 8% ethanol, and n-heptane at specified temperatures. Also requires organoleptic testing (taste and odor transfer). Additional regulations: EU (EC) 1935/2004, BfR (German), and 3-A Sanitary Standards for dairy. Applications: food processing conveyor belts, seals in beverage filling equipment, dairy pump gaskets, bakery oven door seals, and pharmaceutical manufacturing seals.