FDA-approved silicone rubber sheet is a food-contact grade of silicone rubber tested and compliant with FDA guidelines for repeated contact with food, pharmaceutical and medical products. Duratuf’s version, FoodSafeSI60 Pro, holds up across a -30°C to +180°C range while staying non-toxic and non-reactive, which is why EHS teams and food and pharma engineering leads specify it for gaskets, seals and equipment linings that touch consumables directly.
Where FDA-Approved Silicone Rubber Sheet is Used?
Food & Beverage Processing
- Gaskets, seals, and conveyor belt components in equipment that contacts edible product directly
- Reduces contamination risk in wash-down environments that need frequent cleaning cycles
Pharmaceutical Manufacturing
- Container and drug-contact surface linings in formulation and packaging lines
- Suited to processes requiring sterilization and validated contamination control
Healthcare & Medical Devices
- Tubing and seals in equipment needing hypoallergenic, biocompatible material
- Tolerates repeated autoclaving without degrading
Industrial Equipment & Cleanroom Use
- Vibration dampening pads and sealing components in food and pharma production machinery
- Specified in cleanroom assemblies where general-purpose rubber compounds aren’t food-contact rated
Key Properties of FDA-Approved Silicone Rubber Sheet
Food-grade composition
Free of BPA, phthalates and other additives that can migrate out of general-purpose rubber compounds under heat or repeated use.
High purity, non-reactive
Resists leaching, which keeps contamination risk low across repeated contact cycles rather than just on first use.
Temperature resilience
FoodSafeSI60 Pro is rated -30°C to +180°C, covering both cold storage and sterilization or autoclave cycles in the same material.
Where silicone is the wrong choice
Silicone’s tradeoff is lower tensile strength and poor resistance to fuels and oils compared to NBR or EPDM. Specify it for food-contact and temperature performance, not for abrasion-heavy or oil-exposed applications. Use FoodSafeNBR60 Pro or FoodSafeEPDM60 Pro instead where oil resistance matters more than temperature range.
Why FDA Compliance Matters for Procurement and EHS Teams?
For plant and EHS teams
Unplanned downtime from a contamination event costs more than the material itself. A compliant sheet removes one variable from HACCP reviews and food-safety audits, since the base material is already documented rather than something your team has to justify case by case.
For OEMs and distributors
Sourcing FDA-compliant sheet means the compliance documentation carries through to your own customers’ audits. It’s also a smaller share of the market than general-purpose silicone, which is a real differentiator against suppliers who only stock non-food-grade rubber.
Duratuf FoodSafeSI60 Pro: Full Specification
| Parameter | Specified | Observed |
| Polymer | Silicone (SI), 100% | N/A |
| Colour | White / Translucent | N/A |
| S.G. (± 0.05) | 1.30 | 1.30 |
| Hardness (Shore A) | 60° | 60° |
| Tensile Strength (MPa) | 5.0 | 5.3 |
| Elongation at Break (%) | 350% | 368% |
| Recommended Use Temp. | -30°C to +180°C | N/A |
| Standard Thickness | 2–12mm (custom 1–60mm) | N/A |
| Standard Width / Length | 1.2m / 10m roll | N/A |
| Compliance | FDA (cert. ECI/2508/2236), REACH, RoHS, CE | N/A |
Looking for a different thickness, width or finish? Contact Duratuf for a quote.
FDA-Approved Silicone vs Other Duratuf Food-Grade Rubber Sheets
All four food-grade grades below meet FDA compliance, but the base polymer changes what each one is actually good for. Silicone isn’t automatically the right pick just because it’s the widest temperature range; check the “not recommended for” column before you specify it.
| Product | Polymer | Temp Range | Best For | Not Recommended For |
| FoodSafeNR60 Pro | NR/SBR | -10°C to +70°C | General food-contact mats and flooring where abrasion resistance also matters | Oil exposure or steam sterilization |
| FoodSafeNBR60 Pro | NBR | -10°C to +90°C | Food-contact areas with oil or grease exposure, e.g. fryers, oil-handling lines | Outdoor UV/ozone exposure, steam sterilization |
| FoodSafeEPDM60 Pro | EPDM | -10°C to +110°C | Wash-down and steam-cleaned equipment, UV/ozone exposure | Oil, fuel, or grease contact |
| FoodSafeSI60 Pro | Silicone | -30°C to +180°C | Widest temperature swings, cold storage through autoclave/sterilization cycles | Oil or fuel exposure, abrasion-heavy contact |
How to Specify FDA-Approved Silicone Rubber Sheet?
Best for:
- Applications that swing between cold storage and sterilization in the same cycle
- Direct food or drug contact requiring a non-reactive, non-leaching material
- Medical equipment needing hypoallergenic, biocompatible material
Not recommended for:
- Oil, fuel or grease-exposed environments (specify FoodSafeNBR60 Pro instead)
- Abrasion-heavy or load-bearing contact where tensile strength matters more than temperature range
Questions to ask before you order:
- What thickness and surface finish do you need? Plain (P+P) is standard; textured finishes are available for grip
- Do you need FDA documentation or a Certificate of Analysis with every batch, or only at first order?
- What’s your sterilization method (steam autoclave, chemical, UV)? This affects which thickness we’d recommend
Do you need a custom width or length beyond the standard 1.2m x 10m roll?
