Federal Register #FDA-2025-C-3543

FDA Revokes Authorization for Orange B Color Additive in Food Casings

This notice announces a regulatory action by the Food and Drug Administration (FDA) regarding food color additives: - Government Buyer: - Food and Drug Administration (FDA), Office of Premarket Additive Safety, Human Foods Program, Department of Health and Human Services - Regulatory Action: - FDA is revoking the regulation that permitted the use of Orange B as a color additive for frankfurter and sausage casings - The revocation is due to the abandonment of Orange B's use (no batch certifications since 1978) - After the effective date, Orange B can no longer be used in food products, and any remaining lots will be considered uncertified and their use will result in adulterated food - Products Mentioned: - Orange B Color Additive (Part Number: 74.250) - No OEMs or vendors are named, as this is not a procurement or solicitation for products or services - Notable Requirements: - This is a regulatory change impacting food manufacturers and processors, not a request for goods or services - The action is part of FDA's ongoing review to remove obsolete food additive regulations

Description

The Food and Drug Administration (FDA) is issuing an order to revoke the regulation that allows the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. The authorized use of Orange B has been abandoned, and the regulation is considered outdated and unnecessary. The FDA is revoking the authorized use in food of Orange B. The order is effective September 8, 2026, and objections must be submitted by August 24, 2026.

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