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FDA Registration for Color Additives

Color additives for food use must be FDA-approved. Facilities manufacturing food color additives must register with FDA. FDA food facility registration is required for all domestic and foreign color additives manufacturers selling in the United States.

FSMA CompliantBiennial RenewalForeign Facilities WelcomeSince 2009

FDA Requirements for Color Additives

Food color additive manufacturers must ensure their colors are listed in 21 CFR Parts 73–74 (approved for food use).

  • FDA Food Facility Registration — biennial renewal required
  • US FDA Agent — mandatory for all foreign food facilities
  • DUNS / UFI Number — required for all FDA food registrations
  • FSMA compliance — Preventive Controls or Produce Safety rule
  • Biennial renewal October 1–December 31 of even-numbered years

Commonly Found Color Additives on Food Products Are

  • Annatto Extract
  • Beta-carotene
  • Caramel Color
  • Carmine
  • Citrus Red No. 2
  • Cochineal Extract
  • FD & C Blue No. 1
  • FD & C Blue No. 2
  • FD & C Green No. 3
  • FD & C Red No. 3
  • FD & C Red No. 40
  • FD & C Yellow Nos. 5
  • FD & C Yellow Nos. 6
  • Fruit and Vegetable Juices
  • Grape Skin Extract
  • Orange B
  • Paprika Oleoresin
  • Saffron

Frequently Asked Questions

Common questions about food color additives FDA registration.
FDA lists approved colors in 21 CFR Part 73 (exempt from certification) and Part 74 (subject to batch certification).
Yes. Facilities manufacturing color additives for food use must register with FDA.

Ready to Register Your Color Additives Facility?

LMG handles FDA food facility registration, US FDA Agent service, and FSMA compliance for color additives manufacturers worldwide.

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