FDA Registration for Food Additives
Food additive manufacturers must register with FDA. All food additives must be FDA-approved or GRAS. FDA food facility registration is required for all domestic and foreign food additives manufacturers selling in the United States.
FSMA CompliantBiennial RenewalForeign Facilities WelcomeSince 2009
FDA Requirements for Food Additives
Manufacturers must ensure food additives have FDA approval (food additive petition) or GRAS status before use in food products sold in the USA.
- 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
Examples of Food Additives
- Anticaking Agents and Free-Flow Agents
- Antimicrobial Agents
- Antioxidants
- Curing and Pickling Agents
- Dough Strengtheners
- Drying Agents
- Emulsifiers and Emulsifier Salts
- Enzymes
- Firming Agents
- Flavor Enhancers
- Flavoring Agents and Adjuvants
- Flour Treating Agents
- Formulation Aids
- Fumigants
- Humectants
- Antidusting Agents
- Leavening Agents
- Lubricants and Release Agents
- Non-Nutritive Sweeteners
- Oxidizing and Reducing Agents
- pH Control Agents
- Processing Aids
- Propellants and Aerating Agents
- Sequestrants
- Solvents and Vehicles
- Stabilizers and Thickeners
- Surface-Active Agents
- Surface-Finishing Agents
- Synergists
- Texturizers
These are not a complete list of food additives that may require FDA facility registration.
Frequently Asked Questions
Common questions about Food Additives FDA registration.
What makes a substance a food additive?
A food additive is any substance that may become a food component or otherwise affecting the characteristics of food.
How do I get FDA approval for a new food additive?
New food additives require a food additive petition demonstrating safety to FDA.
Ready to Register Your Food Additives Facility?
LMG handles FDA food facility registration, US FDA Agent service, and FSMA compliance for food additives manufacturers worldwide.
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