FDA 21 CFR 177.2600 Silicone Rubber For Food Contact Applications
What Is FDA 21 CFR 177.2600?
FDA 21 CFR 177.2600 is a U.S. Food and Drug Administration regulation for rubber articles intended for repeated food contact use. It is commonly referenced for silicone rubber materials used in food processing, beverage handling, packaging equipment, dairy systems, bakery equipment, and other food contact environments.
For manufacturers supplying silicone rubber components into food grade applications, FDA 21 CFR 177.2600 supports material selection for products such as custom gaskets, seals, O-rings, tubing, extruded profiles, and silicone sheet materials.
These components may come into direct or indirect contact with food during processing, transfer, sealing, packaging, or equipment operation.
Food industry buyers may also reference NSF 51 compounds, solid FDA grade white silicone, metal detectable silicone, and X-ray detectable silicone when selecting materials for food processing environments.
We offer customized gaskets for food grade applications and can also reverse engineer silicone and rubber components from samples, drawings, or application requirements to support replacement parts and specialized food contact components.
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Key Features Of FDA 21 CFR 177.2600 Silicone Rubber
FDA Referenced Material
Commonly selected for food processing, packaging, beverage, bakery, and dairy equipment.
Food Contact Use
Suitable for rubber and silicone components used in repeated food contact applications.
Custom Product Forms
Available as gaskets, seals, O-rings, tubing, extruded profiles, and silicone sheet.
Food Grade Options
Can be supplied with related options such as NSF 51, metal detectable silicone, and X-ray detectable silicone.
Custom Manufacturing Support
We can manufacture customized gaskets and reverse engineer silicone parts for food industry applications.
Product Applications For FDA 21 CFR 177.2600 Silicone Rubber
Silicone Gaskets: Used for sealing food processing and packaging equipment.
Customized Gaskets: Manufactured to meet specific food industry sealing and performance requirements.
Silicone Seals: Suitable for equipment requiring dependable sealing in food contact environments.
O-Rings: Used in food processing systems, pumps, valves, and fluid handling equipment.
Extruded Profiles: Applied for sealing, edge protection, and enclosure applications.
- Silicone Tubing: Commonly used for food and beverage transfer applications.
- Silicone Sheeting: Used for fabricated parts, liners, and custom-cut components.
Requirements Under FDA 21 CFR 177.2600
FDA 21 CFR 177.2600 establishes requirements for rubber materials intended for repeated food contact use. The regulation includes extraction testing requirements and material limitations designed to support food contact applications.
Materials developed for FDA 21 CFR 177.2600 applications are commonly selected for food processing equipment, beverage systems, packaging machinery, bakery equipment, and other environments where rubber or silicone components may come into contact with food products.
Compliance requirements can vary depending on the compound formulation, application conditions, operating temperatures, and end-use environment.
Buyers may also specify additional requirements such as NSF 51, metal detectable silicone, or other food industry standards based on the application.
FDA 21 CFR 177.2600 Compliance Overview
| Category : | Details: |
| Regulation | FDA 21 CFR 177.2600 |
| Industry Focus | Food Processing And Food Contact Applications |
| Covers | Rubber Articles Intended For Repeated Food Contact Use |
| Common Products | Gaskets, Seals, O-Rings, Tubing, Profiles, Sheeting |
| Typical Industries | Food Processing, Beverage, Dairy, Bakery, Packaging |
| Related Standards | NSF 51, USP Class VI, ISO 10993 |
| Not A | Material Grade Or Physical Property Specification |
Performance Characteristics Of FDA 21 CFR 177.2600 Silicone Rubber
FDA 21 CFR 177.2600 silicone rubber materials are commonly selected for applications requiring:
- Temperature resistance.
- Flexibility across varying operating conditions.
- Long-term sealing performance.
- Durability in food processing environments.
- Resistance to moisture and cleaning processes.
- Consistent performance in repeated-use applications.
Product Forms Available Under FDA 21 CFR 177.2600
FDA 21 CFR 177.2600 silicone rubber materials can be manufactured in a variety of product forms to support food processing, packaging, and food contact applications.
Silicone strips.
Customized gaskets.
Silicone seals.
Extruded profiles.
Silicone tubing.
Elastostar Rubber Corporation provides custom manufacturing capabilities for food grade silicone components and can support projects from prototype-to-production.
We also offer reverse engineering services for existing silicone and rubber components requiring replacement or redesign.
Related Food Grade Standards And Compliance Options
FDA 21 CFR 177.2600 is commonly specified for food contact silicone and rubber components, but some applications may require additional standards or material requirements depending on the operating environment.
- NSF 51: Commonly referenced for food equipment materials used in commercial food processing and preparation environments.
- Metal Detectable Silicone: Used in food manufacturing systems where material detection capabilities are required.
- X-Ray Detectable Silicone: Selected for applications where X-ray detection systems form part of the contamination control process.
- USP Class VI Section 87 And 88: May be specified for certain medical, pharmaceutical, and specialized processing applications.
- ISO 10993: Often referenced for biocompatibility evaluation of materials used in healthcare-related applications.
These requirements may be used independently or alongside FDA 21 CFR 177.2600, depending on the product design, regulatory requirements, and end-use application.
Related Industry Standards And Grade Options
Different industries may require specific material standards, compliance requirements, or quality systems based on the application.
Food: FDA 21 CFR 177.2600, NSF 51, metal detectable silicone, X-ray detectable silicone, and commercial FDA grade silicone.
Pharma And Medical: USP Class VI Section 87 And 88 and ISO 10993 materials for medical and pharmaceutical applications.
Aerospace: ZZ-R-765, and A-A-59588 silicone rubber requirements for aerospace, military, and defense projects.
Automotive: IATF quality management requirements for automotive rubber and silicone components.
General Industrial: ISO 9000 quality management practices for industrial sealing and fabricated rubber products.
Flame Resistant Applications: UL 94 V-0 and flame retardant silicone materials for specialty and safety-focused applications.
Why FDA 21 CFR 177.2600 Matters To Food Industry Buyers
For food industry buyers, FDA 21 CFR 177.2600 provides a recognized framework for selecting silicone rubber materials intended for repeated food contact use.
It helps support material selection for components used throughout food processing, packaging, handling, and manufacturing operations.
This is especially important in food production environments where closed cell silicone gaskets, seals, O-rings, tubing, and other components must perform reliably while meeting food contact requirements.
FDA 21 CFR 177.2600 For Food Processing And Food Contact Applications
FDA 21 CFR 177.2600 is commonly referenced across food processing operations where silicone and rubber components may come into direct or indirect contact with food products.
The regulation is frequently specified for sealing components used in processing equipment, packaging systems, transfer equipment, and food handling machinery.
At Elastostar Rubber Corporation, we manufacture customized gaskets, seals, O-rings, tubing, extruded profiles, and molded silicone components for food grade applications.
We also provide reverse engineering services and custom manufacturing support for replacement parts, new equipment designs, and prototype-to-production requirements.
Why Choose Elastostar Rubber Corporation For FDA 21 CFR 177.2600 Requirements?
Elastostar Rubber Corporation is a custom manufacturer of food grade silicone and rubber products for applications where quality, consistency, and compliance matter.
With extensive custom manufacturing capabilities and Made in USA production, we support food processing, packaging, beverage, bakery, and other food contact industries.
We manufacture customized gaskets, seals, O-rings, silicone tubing, extruded profiles, sheeting, and molded silicone components for food grade applications.
Our team can also reverse engineer existing silicone rubber parts from samples, drawings, or application requirements to support replacement components and custom product development.
From prototype-to-production, We helps customers convert material requirements into dependable finished product.
