STEMA · TECHNICAL INSIGHTS

FDA-Compliant O-Rings and Food Contact Seals – What Documentation Is Needed?

Understand FDA food-contact O-ring claims, 21 CFR 177.2600, 177.1550 and EU 1935/2004 for seals and gaskets.

FDA-compliant does not automatically mean FDA-approved. Food-contact suitability depends on the exact formulation, intended conditions of use and supporting documentation.

21 CFR 177.2600 addresses certain rubber articles intended for repeated use; 21 CFR 177.1550 concerns specified perfluorocarbon resins. European food-contact requirements also need assessment.

Food-contact compliance is compound-specific

Ask for the exact formulation's declaration of compliance and applicable use limitations. FDA 21 CFR 177.2600 and 177.1550 address different material categories. EU 1935/2004 and applicable EU or national requirements must also be considered.

USP Class VI and FDA food-contact compliance are not interchangeable. STEMA can check available documentation for a proposed compound on request.

Find suitable seals at STEMA

Explore relevant products or send us your operating conditions for material selection.

General technical guidance, not approval for a specific application. Confirm material grade, dimensions and suitability for actual operating conditions.

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