When I first started producing silicone hoses for food and beverage equipment, a customer asked, “Is your silicone FDA grade?” That question changed how I viewed material safety — because in industries that touch food or skin, certification isn’t optional.
FDA grade silicone refers to silicone rubber that meets the U.S. Food and Drug Administration (FDA) requirements for safety, purity, and non-toxicity under 21 CFR 177.2600, making it safe for food contact and medical use.
Understanding what “FDA grade” means helps buyers and engineers ensure that every seal, tube, or gasket complies with strict safety standards for human contact and processing environments.
What does FDA grade mean for silicone rubber?
Many people think FDA approval is a label you can print on packaging, but it’s much more specific than that.
FDA grade silicone must meet the chemical extraction limits set by the FDA — meaning no harmful substances migrate into food, water, or human tissue during use.
The relevant regulation is FDA 21 CFR 177.26001, which defines what rubber articles may contact food safely. This standard covers both raw material composition and post-curing cleanliness.
Key Requirements of FDA 21 CFR 177.2600
| Requirement | Description |
|---|---|
| Composition | Made from approved silicone polymers2, catalysts, and fillers |
| Extraction Limits | Low volatile and non-volatile residue when tested in solvents |
| Post-Curing | Heated at high temperature to remove unreacted chemicals |
| Color Additives | Must be FDA-approved pigments (usually translucent or white) |
At Julong Rubber, we strictly control each step — from raw material selection to post-curing3 — to ensure no peroxide residues remain. This guarantees both purity and stability for food-grade customers.
How is FDA grade silicone tested and certified?
Testing goes beyond visual inspection. Each batch must pass migration and extraction tests4 that simulate real contact with food and water.
FDA testing for silicone measures how much residue (extractables) migrates into liquids like water, n-hexane, or ethanol under elevated temperatures.
Samples are soaked in these liquids, then the weight of extracted material is measured. The limits are extremely low — often under 0.5 mg/in² for water and under 1.0 mg/in² for solvents.
Common FDA Silicone Tests
| Test Type | Purpose | Result Criteria |
|---|---|---|
| Water Extraction | Detects leaching into aqueous food | ≤ 0.5 mg/in² residue |
| n-Hexane Extraction | Detects migration into oily food | ≤ 1.0 mg/in² residue |
| Odor & Taste Test | Ensures neutrality | No perceptible odor/taste |
| Post-Cure Stability | Confirms removal of volatiles | Weight loss < 1% |
These evaluations are often verified by third-party laboratories following FDA and ISO 109935 methods. Once certified, manufacturers can provide a Declaration of Compliance6 confirming that the silicone meets the standard.
What are the main applications of FDA grade silicone?
FDA grade silicone is widely used in industries where hygiene, chemical neutrality7, and heat resistance8 are critical.
FDA grade silicone is used for seals, gaskets, tubing, and molds in food processing, beverage dispensing, medical, and pharmaceutical equipment.
Typical Applications
| Industry | Product Example | Function |
|---|---|---|
| Food & Beverage9 | Coffee machine gaskets, dairy hoses, baking molds | Safe for direct food contact |
| Medical & Pharmaceutical | Catheters, peristaltic pump tubing, vial seals | Biocompatible and sterilizable |
| Water Purification | Seals and O-rings in filters | Prevents taste and odor contamination |
| Packaging Machinery | Sealing profiles and conveyor pads | Clean, non-staining contact surfaces |
One of our clients in France switched to FDA silicone gaskets in their beverage lines. They noticed that after months of operation, the silicone still looked new — no odor, no yellowing, and no cracking.
How is FDA grade silicone different from ordinary silicone?
Not all silicone rubber is created equal. Standard industrial silicone may look similar but can contain catalysts or fillers that are not approved for food or medical use.
FDA grade silicone differs from ordinary silicone in purity, curing method, and allowable additives, ensuring it’s safe for human contact.
Comparison Table: FDA Grade vs Ordinary Silicone Rubber
| Property | FDA Grade Silicone | Ordinary Silicone |
|---|---|---|
| Purity | Ultra-pure, free of harmful additives | May contain unapproved fillers |
| Curing System | Platinum-cured (preferred) or peroxide-cured with full post-bake | Often peroxide-cured without post-bake |
| Color Options | Natural translucent or FDA-approved pigments | Any industrial colorants |
| Odor / Taste | None | Possible chemical odor |
| Safety Certification | Meets FDA 21 CFR 177.2600, LFGB | Not certified |
| Applications | Food, medical, water | Industrial, automotive |
Platinum-cured silicone is often chosen for higher purity and clarity. It releases no by-products and shows excellent mechanical stability — making it perfect for medical tubing and baking molds.
What standards besides FDA apply to food-grade silicone?
Global customers often ask if FDA alone is enough. In most cases, it’s part of a family of hygiene standards.
Other relevant certifications include LFGB (Germany), EU 1935/2004 (Europe), and ISO 10993 (medical biocompatibility).
International Compliance Overview
| Standard | Region | Scope |
|---|---|---|
| FDA 21 CFR 177.2600 | United States | Food contact safety |
| LFGB10 § 30/31 | Germany / EU | Food utensil and packaging approval |
| EU 1935/2004 | European Union | Overall migration and traceability |
| ISO 10993 | Global | Biological evaluation of medical materials |
When we export silicone gaskets to Germany or the Netherlands, clients often require both FDA and LFGB compliance. Our laboratory provides dual certification reports to cover both U.S. and EU markets.
Why choose FDA grade silicone for your project?
In industries where hygiene defines quality, FDA silicone provides confidence and compliance. It’s not just a material — it’s a safety guarantee.
FDA grade silicone ensures your final product meets food or medical safety laws, reduces contamination risk, and builds customer trust through certified material transparency.
At Julong Rubber, we specialize in custom-molded and extruded FDA silicone parts — from hoses to gaskets — all produced under ISO 9001 quality management. Each batch can be traced by lot number and material certificate.
Conclusion
FDA grade silicone means purity, safety, and reliability. Whether it touches food, drink, or skin, it guarantees performance without compromise.
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Understanding this regulation is crucial for ensuring food safety compliance in rubber articles. ↩
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Explore the role of silicone polymers in creating safe food contact materials. ↩
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Understanding post-curing is crucial for ensuring the safety and quality of silicone products in food and medical applications. ↩
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Learn about the testing processes that ensure silicone safety for food contact. ↩
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Discover how ISO 10993 ensures the safety of medical materials. ↩
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Find out how this declaration ensures that silicone meets safety standards. ↩
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Understanding chemical neutrality is key to ensuring safe food contact. ↩
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Learn why heat resistance is critical for silicone used in food and medical applications. ↩
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Explore this resource to understand how FDA grade silicone enhances safety and quality in food and beverage products. ↩
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Learn about LFGB standards and their importance for food contact materials in Europe. ↩
