Calcium Phosphate Color Additive Approval for Foods
Summary
The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
Compliance Requirements
- #1
The final order amends the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
Deadline: 2025-06-26(June 26, 2025)
Market Impacts
Calcium phosphate is now approved as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies, creating new formulation opportunities for manufacturers; Expansion of approved uses for calcium phosphate creates new market opportunities for ingredient suppliers and color additive manufacturers
Action Items
Update product formulations
Modify manufacturing recipes and formulations to include calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies as permitted under 21 CFR 73.80
Revise quality control procedures
Update quality control and assurance protocols to include testing and verification of calcium phosphate usage levels and compliance with the new color additive regulation
Update labeling and documentation
Revise product labels, technical documentation, and ingredient statements to reflect the use of calcium phosphate as a color additive in accordance with 21 CFR 73.80 requirements
Train production staff
Provide training to manufacturing and production personnel on the proper handling, measurement, and incorporation of calcium phosphate as a color additive in approved food products
Implement by effective date
Ensure all manufacturing processes, formulations, and quality control procedures incorporating calcium phosphate as a color additive are fully implemented and compliant by June 26, 2025
Validated Company Impacts
HORMEL FOODS CORP /DE/
Hormel Foods is a major food manufacturer that produces ready-to-eat chicken products through brands like Jennie-O Turkey Store, which directly aligns with the rule's focus on ready-to-eat chicken products. The company's extensive food manufacturing operations would be significantly affected by color additive regulations governing their product formulations. The FDA rule addresses food safety and color additive regulations for specific food products, which has no connection to the company's sole identified risk of cybersecurity attacks and IT interruptions. There is no overlap between food manufacturing compliance requirements and technology security risks.
HERSHEY CO
Hershey operates directly in the confectionery and snack manufacturing sectors targeted by this rule, specifically producing candy melts, coated candies, and other sugar-based products where calcium phosphate could be used as a color additive. As a major manufacturer of chocolate and confectionery products, the company would be directly affected by FDA color additive regulations governing these food categories. The FDA rule on calcium phosphate as a color additive primarily affects food formulation and ingredient sourcing, which does not align with any of the company's disclosed risk factors. The company's risks focus on financial pressures, supply chain disruptions, consumer demand shifts, labor constraints, and data integration - none of which are directly impacted by color additive regulatory changes.
SMITHFIELD FOODS INC
Smithfield Foods operates in the packaged meats segment, which includes ready-to-eat chicken products that are directly regulated by this FDA rule on calcium phosphate color additives. The company's focus on product innovation and packaged meat offerings aligns with the rule's requirements for food manufacturers using this specific color additive. The FDA rule addresses food safety and color additive regulations for specific food products, while the company's only identified risk factor relates to cybersecurity and technology disruptions. There is no overlap between the regulatory requirements for food manufacturing and the company's technology-focused risk profile.
TYSON FOODS, INC.
Tyson Foods operates a significant chicken segment and produces prepared foods, directly aligning with the rule's focus on ready-to-eat chicken products. As a major food manufacturer, they would be directly affected by color additive regulations governing their product formulations. The FDA rule addresses food safety and color additive regulations for specific food products, while the company's only identified risk is cybersecurity threats in technology. There is no overlap between the regulatory compliance risks associated with food additive safety and the company's cybersecurity risk profile.