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Everything you need to know about FDA registration.

Discover all the useful information you need to know before you start your registration process.

What is the FDA registration form?

The FDA registration form is a mandatory form for all businesses who wish to export their products to the United States. It contains general information on the company and facilities to register in order to be able to proceed with registering an agri-food company.

Why register your company?

The FSMA (Food Safety Modernization Act) makes it mandatory for food companies who wish to export their products to the United States to register with the FDA beforehand. The company must then appoint a US Agent to serve as an intermediary between the company and the FDA.

The main steps to remember

Euroconsultants takes care of the administrative process with the FDA (obtaining an FDA registration number, researching the DUNS number), as well as the preliminary steps to exporting to the United States (determining the FDA Product Code, PriorNotice of Imported Foods). All of this is included in the agent’s services.

Step 1

Fill out the online questionnaire by following each step precisely

Step 2

Upon receipt of your request, we will proceed with registering your company

Step 3

We will send you a copy of the registration with your FDA registration number as well as your DUNS number within 24 hours

Step 4

We will also send you an agent contract to be signed and returned to us

Do you have any questions?

Here are some concepts and other questions you may have regarding your company's FDA registration.

More questions in mind? Contact us

What is the DUNS number?

Since the end of 2020, the FDA has made it mandatory for companies to obtain an additional ID for physical production or storage facilities: the DUNS number (Data Universal Numbering System).

The DUNS ID is a 9-digit number, assigned to every company or physical production or storage facility. Each facility must have a DUNS number. A company with several facilities will have several DUNS numbers, one for each facility.

In regard to French companies, the DUNS ID number is linked to the 14-digit SIRET number of each facility.

In regard to the wine industry, the FDA considers that every registered Château is a separate facility and must have its own DUNS number (and therefore its own SIRET).

In regard to farm operators who do not have a SIRET number, they can request one from the Chamber of Agriculture (Center forBusiness Formalities).

Ensuring the information in the DUNS / SIRET database is consistent with FDA registration, down to the last dot, is absolutely essential. For example, if one of the addresses contains the terms“Business district” and the abbreviation “BD” is entered in the registration, the FDA computer system will reject the registration for non-compliance.

Are there additional fees for renewing FDA registration?

We will proceed with renewing your company’s registration at no extra cost. Renewal is mandatory every two years in even-numbered years. Euroconsultants can also issue, free of charge, a private registration certificate, often requested by the American client.

Who must register?

Production facilities (defined as the last substantial processing step prior to export) and packaging and storage establishments.

For example, in regard to Comté, the traditional dairies known as “fruitières” must be registered, but not the farmer-members. In regard to wines, cellars and bottling must be registered.

 

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