Form FDA 3613e Form FDA 3613e Food Export Certificate Application

Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/2015

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

Address

Contact person name
Contact phone/fax

City

State or Province

Contact email

ZIP/postal code

Country

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

Address

Contact person name

City

State or Province

Contact phone/fax/or email

ZIP/postal code

Country

3. Shipment Description
Product

Common Name

Manufacturer

Description/Comments

Continue on additional page(s) as needed.

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

5. Send Certificate To

Manufacturer

Firm name

Distributor

Other (provide the following information)

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 (3/12)

Copies of certificate:

Page 1 of 2

Number

x

Fee/copy

=

Total $

PSC Publishing Services (301) 443-6740

EF

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. For contacts,
refer to http://www.fda.gov/Food/InternationalActivities/Exports/
ExportCertificates/UCM151486.htm

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.
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

For FDA Officials
3. FDA Official reviews the application to be sure all the blanks
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.

8. The Manufacturer/Distributor forwards the Certificate to the
foreign Importer and verifies that it is acceptable.
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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 1 hour per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
"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 (3/12)

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