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Take you to quickly understand the US FDA food business registration requirements

 Last Update: 2022-08-16
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The United States is the world's largest importer of agricultural products, and its main management agency for imported food is the United States Food and Drug Administration (hereinafter referred to as " FDA .
The agency manages the registration of food companies in accordance with a series of federal regulations in the United States: the production, processing, packaging, and warehousing companies of human or animal food in the United States and exported to the United States must register their company information on the FDA's websi.
Food will be detained or denied entry at the port of ent.

There are many food companies in China whose products are exported to the United Stat.
In order to help Chinese food companies exporting to the United States better understand the process of registration of food companies in the United States and the issues that need to be focused on, to avoid the risk of product being detained due to registration problems, and to ensure that our food To enter the United States more smoothly and smoothly, here is a brief introduction to the requirements of the US FDA related food business registration regulatio.

01 Basis for registration regulations

.

Food, Drug, and Cosmetic Act (21 USC 350d)

Food Safety Modernization Act (FSMA) (P.
.
111-353)

The Public Health Security and Bioterrorism Preparedness Response Act of 2002 (referred to as the Bioterrorism Act) (P.
.
107-188)

02 Registered business scope

All companies producing, processing, packaging, and warehousing human and animal food in the United States and exported to the United States must be registered with the FDA, except for companies that meet the registration exemption requiremen.

03 Registration exemption

Most farms, retail food establishments, restaurants, non-profit food businesses, fishing boats, and businesses regulated only by the United States Department of Agriculture (USDA) are exempt from registrati.

There are many situations involved in exempted enterpris.
For specific situations that can be exempted from registration, you can download and refer to Chapter B of the "Guidelines for Industry: Questions and Answers on Food Business Registration (7th Edition)" issued by the US FDA to determine whether it is within the scope of exemption from registrati.

(Download URL: https://

If you are not sure about your own judgment, the company can contact the FDA to avoid the product being detained due to the wrong judgment that the company is not register.

04 Registration time requirements

Initial registration

It must be registered before the establishment's manufacturing, processing, packaging or storage activities beg.

　　 Re-register

　　It should be submitted as required between October 1st and December 31st of each even-numbered ye.

　　This should be done within 60 calendar days of any change in any required information by the owner, operator or responsible agent of the busine.

　　 Cancellation of registration

　　It should be done within 60 calendar days of the cause of cancellation by the owner, operator or responsible agent of the business, or someone authorized by one of th.

　　05 Introduction to the registration process

　　Registration URL: https://

　　New users need to register first, fill in specific information, and set a login password, which must be a combination of letters (must be a combination of uppercase and lowercase), numbers, and special symbo.

After successful registration, the system will automatically assign a login .

　　 Account management page

　　On the account management page, users can modify account information, reset passwords, add registered categories, create a sub-account, delete sub-accounts, and activate sub-accoun.

　　Click "Food Facility Registration" to enter the main page of business registrati.

　　 Food business registration main page (FFR MAIN MENU)

　　There are a total of 10 modules on the main page of the enterprise registration, and we often use three modules (in the black box):

　　Food business registration (Register a Food Facility), registration information update (Update Facility Registration), registration information cancellation (Cancel Registratio.

　　Click Register a Food Facility to enter the food establishment registration module pa.

　　 Food business registration module page

　　The registration information module page has a total of 12 parts, which can be filled by clicking the title bar one by o.

The system will judge the content filled in each part with built-in conditio.

After the match is successful, you can enter the next part to fill.

　　 Submit the registration page

　　After filling in all the registration information, please check and confirm carefully, and then click the "submit" button to submit the registration informati.

　　After submitting, wait for the agent to confi.

When the agent fills in the relevant confirmation code, the system will give the registration number (Registration Number) and PIN co.

　　The Registration Number is the number assigned by the FDA to the registered company; the PIN code is an identification code, which is a mixed string of letters and numbers, and can also include special characte.

　　Enterprises need to keep the above information properly and do not disclose it to othe.

　　06 Description of registration information

　　 The required parts of the registration information are:

　　●Enterprise registration type;

　　●Enterprise name, address, telephone and email information (163, 126, QQ and company email are recommended not to be used for enterprise email), enterprise unique identification code (UFI code, Dun & Bradstreet code);

　　●Confirmation of enterprise emergency contact information;

　　●The name, address, email address and telephone number of the foreign company's.

agent;

　　●Applicable business food categories;

　　●Applicable enterprise processing category;

　　●Confirmation of the name and address information of the owner, operator, responsible agent or entity of the registered enterprise;

　　●Declare that the submitted information is true and accurate and that the person submitting the registration information has been authorized;

　　● Commitment that FDA can inspect businesses when and in the manner permitted by the Food, Drug, and Cosmetic A.

　　 The optional parts of the registration information are:

　　●Telephone, fax, and mail to the priority mailing address (if different from the business address);

　　●Fax and mail of the head office (if there is a head office);

　　● the fax number of the.

agent of the foreign business;

　　●Enterprise emergency contact name, position and other information;

　　● (if the business is seasonal) the approximate date of operati.

　　07 Registration Notes

　　 When filling in the second part of the registration information, it is mandatory to fill in the unique enterprise identification code (UFI) co.

This is an item that the US FDA has mandated to fill in since October 1, 202

　　At present, the UFI recognized by the US FDA is only the Dun & Bradstreet co.

Therefore, enterprises should log in to Dun & Bradstreet's website in advance to register and obtain their unique identification code (Deng & Bradstreet cod.

　　Dun & Bradstreet (Data Universal Numbering System) is a 9-digit global coding system, which is equivalent to an enterprise's identification code (like a personal ID card), and is widely used in enterprise identification, collection and query of business informati.

　　Dun & Bradstreet code registration login website: https://

　　There are free registration channels and paid express registration channels to choose from for this registrati.

　　 If the products exported to the United States are low-acid canned or acidified food, in addition to the above food enterprise registration, the enterprise must also register FCE (Food Canning Establishment) and SID (Submission Identifier) in accordance with FDA's 21 CFR108 requiremen.

(For details, please refer to the Customs Hotline 12360 "Guidelines for Registration of Low-acid Canned and Acidified Foods Exported to the United States.

　　Contributors: International Inspection and Quarantine Standards and Technical Regulations Research Center of the General Administration of Customs (and the WTO/TBT-SPS National Notification and Consultation Center of the People's Republic of China), Xiamen Customs

　　The United States is the world's largest importer of agricultural products, and its main management agency for imported food is the United States Food and Drug Administration (hereinafter referred to as " FDA .

The agency manages the registration of food companies in accordance with a series of federal regulations in the United States: the production, processing, packaging, and warehousing companies of human or animal food in the United States and exported to the United States must register their company information on the FDA's websi.

Food will be detained or denied entry at the port of ent.

US Food FDA Regulations

　　There are many food companies in China whose products are exported to the United Stat.

In order to help Chinese food companies exporting to the United States better understand the process of registration of food companies in the United States and the issues that need to be focused on, to avoid the risk of product being detained due to registration problems, and to ensure that our food To enter the United States more smoothly and smoothly, here is a brief introduction to the requirements of the US FDA related food business registration regulatio.

export food

　　01 Basis for registration regulations

　　.

Food, Drug, and Cosmetic Act (21 USC 350d)

　　 Food Safety Modernization Act (FSMA) (P.

.

111-353)

　　 The Public Health Security and Bioterrorism Preparedness Response Act of 2002 (referred to as the Bioterrorism Act) (P.

.

107-188)

　　02 Registered business scope

　　03 Registration exemption

　　There are many situations involved in exempted enterpris.

For specific situations that can be exempted from registration, you can download and refer to Chapter B of the "Guidelines for Industry: Questions and Answers on Food Business Registration (7th Edition)" issued by the US FDA to determine whether it is within the scope of exemption from registrati.

　　(Download URL: https://

　　If you are not sure about your own judgment, the company can contact the FDA to avoid the product being detained due to the wrong judgment that the company is not register.

　　04 Registration time requirements

　　 Initial registration

　　It must be registered before the establishment's manufacturing, processing, packaging or storage activities beg.

　　 Re-register

　　It should be submitted as required between October 1st and December 31st of each even-numbered ye.

　　This should be done within 60 calendar days of any change in any required information by the owner, operator or responsible agent of the busine.

　　 Cancellation of registration

　　It should be done within 60 calendar days of the cause of cancellation by the owner, operator or responsible agent of the business, or someone authorized by one of th.

　　05 Introduction to the registration process

　　Registration URL: https://

　　 Account management page

　　On the account management page, users can modify account information, reset passwords, add registered categories, create a sub-account, delete sub-accounts, and activate sub-accoun.

　　Click "Food Facility Registration" to enter the main page of business registrati.

　　 Food business registration main page (FFR MAIN MENU)

　　There are a total of 10 modules on the main page of the enterprise registration, and we often use three modules (in the black box):

　　Food business registration (Register a Food Facility), registration information update (Update Facility Registration), registration information cancellation (Cancel Registratio.

　　Click Register a Food Facility to enter the food establishment registration module pa.

　　 Food business registration module page

　　 Submit the registration page

　　After filling in all the registration information, please check and confirm carefully, and then click the "submit" button to submit the registration informati.

　　After submitting, wait for the agent to confi.

When the agent fills in the relevant confirmation code, the system will give the registration number (Registration Number) and PIN co.

　　Enterprises need to keep the above information properly and do not disclose it to othe.

　　06 Description of registration information

　　 The required parts of the registration information are:

　　●Enterprise registration type;

　　●Confirmation of enterprise emergency contact information;

　　●The name, address, email address and telephone number of the foreign company's.

agent;

　　●Applicable business food categories;

　　●Applicable enterprise processing category;

　　●Confirmation of the name and address information of the owner, operator, responsible agent or entity of the registered enterprise;

　　●Declare that the submitted information is true and accurate and that the person submitting the registration information has been authorized;

　　● Commitment that FDA can inspect businesses when and in the manner permitted by the Food, Drug, and Cosmetic A.

　　 The optional parts of the registration information are:

　　●Telephone, fax, and mail to the priority mailing address (if different from the business address);

　　●Fax and mail of the head office (if there is a head office);

　　● the fax number of the.

agent of the foreign business;

　　●Enterprise emergency contact name, position and other information;

　　● (if the business is seasonal) the approximate date of operati.

　　07 Registration Notes

　　Dun & Bradstreet code registration login website: https://

　　There are free registration channels and paid express registration channels to choose from for this registrati.

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