FDAFinal Rule

Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date

HealthcareAgriculture

Summary

The FDA is confirming that calcium phosphate, a white coloring ingredient used in foods, no longer needs special government testing and approval before manufacturers use it. This makes the approval process simpler and faster for food companies that want to use this common additive in products like baked goods and processed foods.

Key Points

  • 1Calcium phosphate is being exempted from FDA certification requirements, meaning it no longer needs pre-approval testing
  • 2This ingredient is used as a white colorant in various food products including baked goods, confections, and processed foods
  • 3The exemption applies because calcium phosphate is considered safe based on existing scientific evidence
  • 4Food manufacturers can now use this additive more easily without going through lengthy government approval processes
  • 5This change only affects the coloring use of calcium phosphate; other uses of this ingredient may still have different requirements

Impact Assessment

If you are a food manufacturer, this means you can use calcium phosphate as a white coloring ingredient without obtaining pre-market FDA certification, reducing approval timelines and costs.

Impact Level
Routine
Geographic Scope

National

Compliance Cost

Minimal

Who is Affected
ManufacturersConsumersSmall Businesses

Key Dates

Published

August 21, 2025

Regulatory Connections

Amends CFR Sections
21 CFR Part 73
Other Documents in This Rulemaking (FDA-2023-C-0544)

This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.