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Food Facility Registration

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FOOD FACILITY REGISTRATION

The United States imports food, feeds, and beverages worth more than $147 billion.

Before you consider exporting cocoa beans, cocoa powder, cocoa butter, cocoa nibs, cocoa liquor, chocolate, coffee, tea, wine, beer, champagne, soft drink, vegetable oil, spice, rice, cheese, sugar, nuts and any other food products, you must first register your facility or establishment with the U.S. Food and Drug Administration (FDA).

When the FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the FDA may by order suspend the registration of a facility that:

  • Created, caused, or was otherwise responsible for such reasonable probability
  • Knew of, or had reason to know of, such reasonable probability, and packed, received, or held such food
FOOD FACILITY DEFINED

Food Facilities include:

  • Manufacturer, Processor
  • Warehouse, Holding Facility
  • Packer, Repacker
  • Labeler, Relabeler
  • Contract Sterilizer
  • Salvage Operator
  • Animal Food Manufacturer, Processor
  • Trading Company
  • Dietary Supplements Manufacturer, Processor, Exporter, Importer

Establishments that meet the definition of a primary production farm, secondary activities farm, retail food establishment, restaurant, or nonprofit food establishment, are not required to register.

Farm mixed-type facilities, must register.

U.S. AGENT REQUIREMENT

Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is required to appoint one as part of the registration process.

What a U.S. Agent is not?

  • Commercial Agent
  • Customs Broker
  • Initial Importer
  • Importer of Record
  • FSVP Importer
FDA U.S. Agent

Registered Facilities as of January 11, 2021

Domestic (U.S.) registrations: 80,935

Foreign registrations: 101,212

Total: 182,147

Here is the list of Foreign Registered Facilities by Country:

Country

Registered

Afghanistan31
Albania62
Algeria26
Andorra2
Anguilla1
Antigua and Barbuda3
Argentina1,307
Armenia126
Aruba4
Australia1,229
Austria523
Azerbaijan11
Bahamas29
Bahrain7
Bangladesh108
Barbados28
Belarus43
Belgium614
Belize26
Benin13
Bermuda3
Bhutan4
Bolivia103
Bosnia and Herzegovina50
Botswana1
Brazil1,956
Brunei Darussalam4
Bulgaria299
Burkina Faso7
Burma1
Burundi11
Cambodia36
Cameroon39
Canada5,270
Cape Verde18
Cayman Islands4
Chad3
Chile1,335
China8,183
Colombia1,282
Comoros5
Congo2
Congo (DRC)14
Costa Rica507
Cote d’Ivoire80
Croatia169
Curacao4
Cyprus59
Czech Republic181
Denmark260
Djibouti2
Dominica2
Dominican Republic400
East Timor1
Ecuador909
Egypt308
El Salvador203
Estonia45
Ethiopia216
Falkland Islands (Malvinas)5
Faroe Islands26
Fiji100
Finland83
France9,526
French Guiana2
French Polynesia15
Gambia3
Georgia148
Germany1,986
Ghana118
Greece1,034
Greenland47
Grenada26
Guadeloupe7
Guatemala583
Guinea18
Guinea-Bissau2
Guyana58
Haiti57
Honduras306
Hong Kong Sar412
Hungary224
Iceland152
India3,710
Indonesia867
Iran26
Iraq38
Ireland257
Israel507
Italy8,881
Jamaica189
Japan10,078
Jersey1
Jordan141
Kazakhstan17
Kenya216
Kiribati2
Korea2
Korea (south)3,324
Kosovo9
Kuwait7
Kyrgyzstan10
Lao10
Latvia82
Lebanon141
Lesotho2
Liberia12
Liechtenstein3
Lithuania127
Luxembourg15
Macao Sar8
Macedonia72
Madagascar94
Malawi31
Malaysia552
Maldives16
Mali8
Malta8
Marshall Islands6
Martinique13
Mauritania5
Mauritius31
Mexico6,571
Micronesia5
Moldova69
Monaco9
Mongolia15
Montenegro2
Morocco299
Mozambique20
Myanmar135
Namibia11
Nepal65
Netherlands848
New Caledonia2
New Zealand1,074
Nicaragua228
Nigeria305
Northern Mariana Islands3
Norway359
Oman27
Pakistan310
Palau1
Palestinian Territory27
Panama135
Papua New Guinea44
Paraguay99
Peru1,033
Philippines611
Poland796
Portugal887
Puerto Rico3
Qatar2
Reunion21
Romania117
Russia1,140
Rwanda39
Saint Barthelemy1
Saint Helena, Ascension3
Saint Kitts and Nevis4
Saint Lucia17
Saint Martin1
Saint Vincent & Grenadines11
Samoa11
San Marino5
Sao Tome and Principe1
Saudi Arabia58
Senegal39
Serbia210
Seychelles5
Sierra Leone20
Singapore190
Sint Maarten1
Slovakia81
Slovenia186
Solomon Islands2
Somalia2
South Africa891
Spain4,206
Sri Lanka306
Sudan24
Suriname19
Swaziland10
Sweden157
Switzerland337
Syria58
Taiwan1,672
Tajikistan2
Tanzania73
Thailand1,218
Timor-Leste5
Togo18
Tonga8
Trinidad and Tobago83
Tunisia137
Turkey1,208
Turkmenistan2
Turks and Caicos Islands2
Uganda71
Ukraine459
United Arab Emirates173
United Kingdom1,465
U. S. Minor Outlying Islands1
Uruguay118
Uzbekistan24
Vanuatu8
Venezuela160
Viet Nam1,436
Virgin Islands6
Virgin Islands, U.S.2
West Bank3
Yemen37
Zambia21
Zimbabwe7
TOTAL101,212

Registered Food Facilities as of December 15, 2021
Domestic (U.S.) registrations: 93,284
Foreign registrations: 127,302
Total: 220,586

FDA & CANADIAN FOOD INSPECTION AGENCY (CFIA)

Canada’s three largest cities, Toronto, Montreal and Vancouver account for 75% of national economic activity and population. Approximately 90% of Canadians live within 100 miles of the U.S. border.

Nearly $130 million in food and agricultural products cross the U.S-Canada border every day.

The United States-Mexico-Canada agreement (USMCA) entered into force on July 1st, 2020.

However, Canadian food companies must register with the United States Food and Drug Administration (U.S. FDA).

Ready to join businesses around the world?
You could click on the link below for additional information.

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