FDA Silicone

FDA‑compliant silicone is a high‑purity elastomer formulated to meet the material safety requirements of 21 CFR 177.2600, the U.S. Food & Drug Administration regulation governing rubber articles intended for repeated food contact.

These materials are used in food processing equipment, beverage systems, dairy operations, pharmaceutical manufacturing, and hygienic sealing applications where cleanliness, durability, and regulatory compliance are essential.

SSP manufactures FDA‑compliant silicone materials with tight control over extractables, cure chemistry, and physical properties, ensuring consistent performance in demanding sanitary environments. Keep reading to learn more and contact us for a quote. 

What Makes a Silicone “FDA‑Compliant”?

A silicone elastomer is considered FDA‑compliant when it meets the requirements of 21 CFR 177.2600, which limits:

• Extractables in water and n‑hexane

• Volatile content

• Cure system byproducts

• Ingredients used in compounding

FDA compliance applies to the material, not the finished part — meaning the silicone formulation must meet the regulation before molding, extrusion, or fabrication.

Key Characteristics of FDA‑Compliant Silicone

• High‑purity base polymer

• Platinum‑cure or peroxide‑cure systems suitable for food contact

• Low extractables and leachables

• Odorless and tasteless

• Resistant to cleaning chemicals and sanitizers

• Wide operating temperature range (–60°C to +200°C typical)

FDA Silicone vs. Medical‑Grade Silicone

These terms are often confused, but they serve different regulatory needs.

Applications of FDA‑Compliant Silicone

FDA silicone is used across industries where sanitation, durability, and regulatory compliance are critical.

Food & Beverage Processing

• Pump and valve seals

• Transfer tubing

• Oven and freezer gaskets

• Bottling and filling equipment

• Dairy processing components

Pharmaceutical & Biotech Manufacturing

• Peristaltic pump tubing

• Sanitary gaskets

• Fluid‑handling seals

• Cleanroom equipment components

Consumer & Household Products

• Food‑safe bakeware

• Beverage dispensing systems

• Water filtration components

Performance Advantages of FDA Silicone

FDA‑compliant silicone offers a combination of mechanical, thermal, and chemical properties ideal for hygienic environments.

Mechanical Properties

• Flexible across wide temperature ranges

• Excellent compression set resistance

• High tear strength options available

Thermal Performance

• Suitable for both hot and cold processing

• Stable under repeated sterilization cycles

• Resistant to thermal aging

Chemical Resistance

• Compatible with CIP/SIP cleaning chemicals

• Resistant to oils, fats, and mild acids

• Non‑reactive with food products

Available Forms of FDA Silicone

SSP can supply FDA‑compliant silicone in multiple formats:

• Solid silicone sheet

• Extruded profiles and cords

• Molded gaskets and seals

• Custom shapes and die‑cut parts

• Tubing and hose

Durometers typically range from 30–80 Shore A, depending on application requirements.

Comparison: FDA Silicone vs. General‑Purpose Silicone

A high‑value table for engineers and procurement teams:

Does FDA silicone require a specific cure system?

Both platinum‑cure and peroxide‑cure systems can be FDA‑compliant, provided they meet extractables limits.

Is FDA silicone safe for repeated food contact?

Yes — 21 CFR 177.2600 specifically covers repeated‑use food contact applications.

Can FDA silicone be used in high‑temperature food processing?

Most FDA silicones operate from –60°C to +200°C, with specialty grades available for higher temperatures.

Is FDA silicone resistant to cleaning chemicals?

Yes — it withstands common sanitizers, detergents, and CIP/SIP processes.

Does FDA compliance apply to the material or the finished part?

Compliance applies to the material formulation, not the final geometry.