FDA 3613e Food Export Certificate Application

Form Approved: OMB No. 0910-0498; Expiration Date: 2/28/06

Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition

Date

FOOD EXPORT CERTIFICATE
APPLICATION

1. Food Manufacturer Information
Doing business as name (If other than “Manufacturer name” to
left, and you wish this name to appear on the export certificate)

Manufacturer name

State License/Registration number

Postal Address

Contact person name
Contact phone/fax

City

Contact email

Country

State

ZIP/postal code

State

ZIP/postal code

2. Exporting Company Information (if applicable)
Export company name
State License/Registration number

Address

Contact person name

City

Contact phone/fax/or email

Country

3. Shipment Description
Product

Common Name

Manufacturer

Comments

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Continue on additional page(s) as needed.

4. Intended Destination of Shipment (Country)
Name of country

5. Send Certificate To

Manufacturer

Firm name

Other (provide the following information)

Distributor
Address

City
Contact person name

State

ZIP/postal code

Country

6. Send Certificate Via
Carrier name (U.S. Mail, FedEx, etc.)

Account number (If applicable)

7. Fees
Fees are $10 per certificate, and will be
billed upon receipt of this application.

FORM FDA 3613e (2/06)

Copies of certificate:

x
Number

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=

Total $

Fee/copy
PSC Graphic Arts: (301) 443-1090

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8. Label(s)
Attach an original or an electronic copy of any applicable product label(s). A fax copy is acceptable only if it is readable.

9. Verification

The undersigned verifies that all ingredients are approved for use by FDA or appear on the GRAS list, and each product is intended for human
consumption and is available for sale in the U.S. without restriction.
Signature

Name and Title

Date

Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition

FOOD EXPORT CERTIFICATE APPLICATION
Instructions
For Manufacturers/Distributors
1. The Manufacturer/Distributor fills out the application information describing the consignment, manufacturer (note that different processing facilities of the manufacturer may be listed on
the table describing the foods), where and how to send the certificate, optional information as needed, and applicant signature, name and date.
2. The Manufacturer/Distributor submits the application (by mail, fax,
email), along with labels as applicable. The label must be legible.

6. The Official maintains in his records an identical copy of the
signed Certificate, marked “Copy” for a period of at least two
years.
7. In the event that the Manufacturer fails to comply with the law
as stated on the Certificate, the Official will reject the application and promptly notify the Manufacturer that the Certificate
cannot be issued.

After the Certificate Has Been Issued

Manufacturer/Distributor forwards the Certificate to the
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foreign Importer and verifies that it is acceptable.
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FDA official reviews the application to be sure all the blanks

For FDA Officials
3.

are filled in properly, verifies manufacturer’s license or registration, and investigates inspection data on the listed products.
4. The Official may require an inspection prior to issuance of the
export certificate.
5. The Official prints the Certificate on watermarked Department
letterhead, assigns a unique registration number and expiration
date, signs, dates, seals and issues the Certificate as indicated.

9. If the Certificate is not acceptable, the Exporter notifies the FDA
Official that the certificate has not been accepted by the Importer, and the Official will promptly attempt to reconcile the
issue with the Importer.
10. If an original certificate is destroyed or lost, the Manufacturer/
Distributor can request an identical replacement, bearing the
unique identification number and same expiration date, to be
issued by the Official and marked “Replacement.”

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the address below.
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-550)
5100 Paint Branch Parkway
College Park, MD 20740
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays
a currently valid OMB control number.

FORM FDA 3613e (2/06)

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