Guide to FDA Sanitary Grade Rubber Parts for Food, Pharma and Cosmetic Industries

FDA sanitary grade rubber parts refers to materials that meet safety standards for contact with food, pharmaceutical, or cosmetic products, without releasing any harmful substance into the final product. The most common options are food-grade silicone, FDA-certified EPDM, and in some cases sanitary-grade NBR. Choosing the wrong material in these industries not only risks contaminating the product but can also cause the product to fail sanitary audits. Below, we review the selection criteria and the differences between common grades.

This article is part of the Comprehensive Guide to Rubber Seals; to learn about the basic types of O-rings, read the parent guide.

Table of Contents

• What Does FDA Sanitary Grade Mean?
• Common Sanitary Grade Materials
• Summary Technical Specifications Table
• What's the Difference Between Food, Pharmaceutical and Cosmetic Grade?
• Key Points When Ordering Sanitary Grade Parts
• Common Mistakes
• Frequently Asked Questions

What Does FDA Sanitary Grade Mean?

The U.S. Food and Drug Administration (FDA) has defined, under 21 CFR 177.2600, the requirements for elastomers that come into repeated or permanent contact with food. This standard sets limits on the type of fillers, pigments, and additives allowed in a compound's formulation, to ensure no hazardous migrating substance passes from the part into the food product. Holding a certificate of compliance with this standard is the primary requirement for using a rubber part on a food or pharmaceutical production line.

Common Sanitary Grade Materials

Food-grade silicone: Due to its chemical inertness, high heat resistance, and lack of taste or odor transfer, it is the most widely used option in food and pharmaceutical industries, especially in equipment subject to frequent Steam Cleaning/CIP.

FDA-certified EPDM: Thanks to its excellent resistance to hot water, steam, and alkaline detergents, it is used in industrial food-line washing equipment as well as in some pharmaceutical applications that require higher chemical resistance.

Sanitary-grade NBR: In cases where a part also contacts edible oils in addition to food (such as vegetable oil production lines), FDA-certified sanitary-grade NBR is a suitable option, although it is less widely available and less varied than silicone.

Summary Technical Specifications Table

What's the Difference Between Food, Pharmaceutical and Cosmetic Grade?

Although all three groups are evaluated against FDA standards, the strictness level differs between them: food grade is typically assessed under 21 CFR 177.2600, while pharmaceutical grade often also needs to comply with additional standards such as USP Class VI (which examines the part's biological toxicity in direct contact with the human body). Cosmetic grade usually falls between the two, and depending on the final product type, may require both certifications.

Key Points When Ordering Sanitary Grade Parts

• Always request a written, documented FDA or USP Class VI certificate from the supplier — not just a verbal claim of being "food grade."
• Note that a part's color (especially in silicone) can indicate the type of pigment used; even unauthorized pigments in a food-grade silicone base can cause problems.
• For equipment subject to steam sterilization (autoclave), always match the material's heat resistance to the actual sterilization process temperature.

Common Mistakes

• Assuming that "silicone" is always food grade by default, while ordinary industrial silicone lacks FDA certification and should not be used in contact with food.
• Ignoring the difference between food grade and pharmaceutical grade (USP Class VI) in pharmaceutical projects that require stricter compliance.
• Using sanitary-grade EPDM in lines that contact edible oils, without accounting for this material's weakness against oil.

Frequently Asked Questions

Sources & References

This guide was prepared based on FDA standard 21 CFR 177.2600, USP Class VI (the biological toxicity evaluation standard for polymers used in pharmaceutical applications), and ASTM D2000.

Summary

For most food and pharmaceutical applications involving water, steam, and detergents, food-grade silicone is the default, reliable choice. For high-temperature industrial washing lines, FDA-grade EPDM is a cost-effective alternative. But if the part also contacts edible oils, sanitary-grade NBR should be used instead. In all cases, obtaining a written FDA/USP certificate from the supplier is essential. If you're not sure which grade fits your project, our technical team is ready to provide a free consultation and price quote.