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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 Name

Number of Registrations

Afghanistan 31
Albania 62
Algeria 26
Andorra 2
Anguilla 1
Antigua and Barbuda 3
Argentina 1,307
Armenia 126
Aruba 4
Australia 1,229
Austria 523
Azerbaijan 11
Bahamas 29
Bahrain 7
Bangladesh 108
Barbados 28
Belarus 43
Belgium 614
Belize 26
Benin 13
Bermuda 3
Bhutan 4
Bolivia 103
Bosnia and Herzegovina 50
Botswana 1
Brazil 1,956
Brunei Darussalam 4
Bulgaria 299
Burkina Faso 7
Burma 1
Burundi 11
Cambodia 36
Cameroon 39
Canada 5,270
Cape Verde 18
Cayman Islands 4
Chad 3
Chile 1,335
China 8,183
Colombia 1,282
Comoros 5
Congo 2
Congo (DRC) 14
Costa Rica 507
Cote d’Ivoire 80
Croatia 169
Curacao 4
Cyprus 59
Czech Republic 181
Denmark 260
Djibouti 2
Dominica 2
Dominican Republic 400
East Timor 1
Ecuador 909
Egypt 308
El Salvador 203
Estonia 45
Ethiopia 216
Falkland Islands (Malvinas) 5
Faroe Islands 26
Fiji 100
Finland 83
France 9,526
French Guiana 2
French Polynesia 15
Gambia 3
Georgia 148
Germany 1,986
Ghana 118
Greece 1,034
Greenland 47
Grenada 26
Guadeloupe 7
Guatemala 583
Guinea 18
Guinea-Bissau 2
Guyana 58
Haiti 57
Honduras 306
Hong Kong Sar 412
Hungary 224
Iceland 152
India 3,710
Indonesia 867
Iran 26
Iraq 38
Ireland 257
Israel 507
Italy 8,881
Jamaica 189
Japan 10,078
Jersey 1
Jordan 141
Kazakhstan 17
Kenya 216
Kiribati 2
Korea 2
Korea (south) 3,324
Kosovo 9
Kuwait 7
Kyrgyzstan 10
Lao 10
Latvia 82
Lebanon 141
Lesotho 2
Liberia 12
Liechtenstein 3
Lithuania 127
Luxembourg 15
Macao Sar 8
Macedonia 72
Madagascar 94
Malawi 31
Malaysia 552
Maldives 16
Mali 8
Malta 8
Marshall Islands 6
Martinique 13
Mauritania 5
Mauritius 31
Mexico 6,571
Micronesia 5
Moldova 69
Monaco 9
Mongolia 15
Montenegro 2
Morocco 299
Mozambique 20
Myanmar 135
Namibia 11
Nepal 65
Netherlands 848
New Caledonia 2
New Zealand 1,074
Nicaragua 228
Nigeria 305
Northern Mariana Islands 3
Norway 359
Oman 27
Pakistan 310
Palau 1
Palestinian Territory 27
Panama 135
Papua New Guinea 44
Paraguay 99
Peru 1,033
Philippines 611
Poland 796
Portugal 887
Puerto Rico 3
Qatar 2
Reunion 21
Romania 117
Russia 1,140
Rwanda 39
Saint Barthelemy 1
Saint Helena, Ascension 3
Saint Kitts and Nevis 4
Saint Lucia 17
Saint Martin 1
Saint Vincent & Grenadines 11
Samoa 11
San Marino 5
Sao Tome and Principe 1
Saudi Arabia 58
Senegal 39
Serbia 210
Seychelles 5
Sierra Leone 20
Singapore 190
Sint Maarten 1
Slovakia 81
Slovenia 186
Solomon Islands 2
Somalia 2
South Africa 891
Spain 4,206
Sri Lanka 306
Sudan 24
Suriname 19
Swaziland 10
Sweden 157
Switzerland 337
Syria 58
Taiwan 1,672
Tajikistan 2
Tanzania 73
Thailand 1,218
Timor-Leste 5
Togo 18
Tonga 8
Trinidad and Tobago 83
Tunisia 137
Turkey 1,208
Turkmenistan 2
Turks and Caicos Islands 2
Uganda 71
Ukraine 459
United Arab Emirates 173
United Kingdom 1,465
U. S. Minor Outlying Islands 1
Uruguay 118
Uzbekistan 24
Vanuatu 8
Venezuela 160
Viet Nam 1,436
Virgin Islands 6
Virgin Islands, U.S. 2
West Bank 3
Yemen 37
Zambia 21
Zimbabwe 7
TOTAL 101,212

Nearly $130 million in food and agricultural products cross the U.S-Canada border every day. Canadian food companies must register with the United States Food and Drug Administration.

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

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