United States

No agreement yet · Strong coverage · Compiled 2026-07-05

28 screening rules

Labeling: 12 rules — 9 blocking, 2 conditional, 1 advisory
Additives: 5 rules — 4 blocking, 0 conditional, 1 advisory
Contaminants & residue limits: 4 rules — 4 blocking, 0 conditional, 0 advisory
Import & registration: 7 rules — 5 blocking, 2 conditional, 0 advisory

Market profile

Main food law: FDCA (COMPS) + FSMA 2011
Labeling regulation: 21 CFR 101 (2024 ed.) + FDA Labeling Guide
Import requirements: 21 CFR Part 1 FSVP + FDA import portal
National standards body: None — all federal law free

Certificates required

US FDA food facility registration — Mandatory (Applies to: Facilities manufacturing/packing/holding food for US)
US FDA prior notice — Mandatory (Applies to: Every food shipment)
Veterinary health certificate (products of animal origin) — Mandatory (Applies to: Meat, poultry, egg products (FSIS-eligible countries); some dairy)
Phytosanitary certificate (IPPC / ePhyto) — Mandatory (Applies to: Fresh fruit & vegetables and other APHIS-regulated plant products)
USDA NOP organic certificate & NOP Import Certificate — Mandatory (Applies to: Products labelled organic)
SQF (Safe Quality Food) Food Safety Code — Commonly requested (Applies to: Retail/foodservice suppliers)
FSSC 22000 — Commonly requested (Applies to: Manufacturers)
BRCGS Food Safety — Commonly requested (Applies to: Manufacturers)
PrimusGFS — Commonly requested (Applies to: Fresh produce)
CanadaGAP — Commonly requested (Applies to: Fresh produce)
BAP (Best Aquaculture Practices) — Commonly requested (Applies to: Farmed seafood)
Kosher certificate (Letter of Certification) — Commonly requested (Applies to: Ingredients & packaged foods)
Non-GMO Project Verified — Commonly requested (Applies to: Retail packaged foods)
GFCO gluten-free certification — Commonly requested (Applies to: Gluten-free claims)
Fairtrade certificate — Commonly requested (Applies to: Coffee, cocoa, bananas)

Import and export

Documents to import

Commercial invoice — Issued by: Exporter/seller — Mandatory
Packing list — Issued by: Exporter/seller — Mandatory
Bill of lading / airway bill — Issued by: Carrier — Mandatory
Customs declaration — Issued by: CBP (entry CBP 3461/7501 via ACE) — Mandatory
Certificate of origin (incl. preferential forms) — Issued by: Exporting country chamber/authority — Conditional
FDA food facility registration (foreign manufacturer/packer/holder) — Issued by: FDA (FURLS) — Mandatory
FDA Prior Notice of imported food — Issued by: FDA — Mandatory

Documents to export

Commercial invoice — Issued by: Exporter/seller — Mandatory
Packing list — Issued by: Exporter/seller — Mandatory
Bill of lading / airway bill — Issued by: Carrier — Mandatory
Customs declaration — Issued by: CBP (entry CBP 3461/7501 via ACE) — Mandatory
Certificate of origin (non-preferential and FTA forms) — Issued by: Exporter self-certifies; chambers of commerce for non-preferential — Conditional

Government fees

FDA food facility registration (Import) — 0 USD
FDA prior notice (Import) — 0 USD
Merchandise Processing Fee (formal entry) (Import) — 0.3464% (min 33.58, max 651.50)
Merchandise Processing Fee (informal entry, automated) (Import) — 2.69 USD
Harbor Maintenance Fee (Import) — Not confirmed — check with the authority
FDA reinspection / recall fees (FSMA) (Import) — Not confirmed — check with the authority
Customs bond premium (Import) — Not confirmed — check with the authority
VAT/GST on imported food (Import) — Not confirmed — check with the authority
APHIS phytosanitary certificate fee (Export) — Not confirmed — check with the authority
FDA export certificate fee (Export) — Not confirmed — check with the authority

Customs single window: CBP ACE; FDA PNSI/FURLS

Customs duties are not included.

A fee without a confirmed amount is listed by name only.

Official sources

Federal Food, Drug, and Cosmetic Act — compiled text (govinfo COMPS-973) (2025) Open the source
FDA Food Safety Modernization Act (FSMA), Public Law 111-353 (2011) Open the source
21 CFR Parts 100-169 (incl. Part 101 Food Labeling) — 2024 annual edition (2024) Open the source
21 CFR Parts 1-99 (incl. Part 1 Subpart L FSVP, facility registration, prior notice) — 2024 annual edition (2024) Open the source
FDA Food Labeling Guide (Guidance for Industry) (2013) Open the source
FDA — Importing Food Products into the United States (portal) (2026) Open the source
USDA FSIS — Importing Meat, Poultry & Egg Products (portal) (2026) Open the source

Reference documents

21 CFR Parts 1-99 (incl. FSVP; registration) (2024) Open the source
21 CFR Parts 100-169 (incl. Part 101 Food Labeling) (2024) Open the source
FDA Food Labeling Guide (2013) Open the source
FDA Food Safety Modernization Act (FSMA) PL 111-353 (2011) Open the source
FDA — Importing Food Products into the United States (current) Open the source
Federal Food Drug and Cosmetic Act (COMPS-973) (current) Open the source
USDA FSIS — Importing Meat Poultry and Egg Products (current) Open the source

Guidance compiled from published sources — not legal clearance. Confirm the requirements with the destination regulator or a licensed advisor before shipping.

Screening guidance based on published standards — not legal clearance. Requirements marked "needs verification" are directional hints; confirm with the destination regulator or a licensed advisor before shipping.