Form FDA 3613e FDA 3613e Food Export Certificate Application

Step-by-Step Instructions for the
Export Listing Module
The Export Listing Module (ELM) is an electronic system for receiving and processing requests from FDAregulated establishments that wish to be included on export lists for FDA-regulated food products.
The information provided in the ELM is used to generate export list updates for the importing countries
that require these lists. It is the establishment's responsibility to ensure that the establishment and
products for export are identified correctly on the application. It is very important that the names and
addresses of establishments on export lists reflect the records in FDA's Official Establishment Inventory.
Once listed, an establishment may edit their ELM application at any time to request an update to their
listing information. All establishments are required to update and resubmit their ELM applications every
two years to verify their listing information and indicate that they wish to continue being listed.
Establishments that do not update and resubmit their ELM applications every two years will be removed
from the lists. To ensure that the establishment receives reminder notifications prior to an application’s
expiration date, please list two contacts with accurate information for each application.

For assistance at any time, please contact the CFSAN Export Certification Team at
[email protected] or 240-402-2307.

Contents

Accessing the Export Listing Module (ELM) ........................................................................................................................... 2
Navigating the ELM Dashboard................................................................................................................................................. 6
Submitting or Editing an Application ....................................................................................................................................... 8
Appendix A: Using the Food Facility Registration in ELM ............................................................................................... 42
Appendix B: Email Notifications from the ELM ................................................................................................................... 43
Appendix C: Product, Country, and Facility Type Matrix ................................................................................................. 44

Accessing the Export Listing Module (ELM)

Figure 1: Creating an FDA Industry Systems Account

The Export Listing Module (ELM) is one of the FDA Industry Systems (FIS) and can be accessed via
https://www.access.fda.gov. Click the "Log-In" button to log in using an existing FIS account or click the
“Create Account” button to create a new FIS account.
NOTE: Every account created from the FIS home page is an "enterprise" account and each enterprise
account can create subaccounts to allow multiple people at a company to manage submissions in the FDA
Industry Systems. You may already have, or you may wish to create, a single enterprise account for all FDA
submissions related to your facility and to create subaccounts for personnel that will manage submissions
to FDA. All submissions by subaccounts will be accessible via the enterprise FIS account, which will allow
continued access to previous submissions if an employee leaves the facility. For more information on
account management, please visit review the FDA Industry Systems User Guide: Account Management.

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Figure 2: Establishing Access to the ELM for New Accounts

If you are creating a new account, click the box next to "Export Listing Module" to establish access to the
ELM. If you need detailed instructions for creating a new account, please visit Create New Account Stepby-Step Instructions.

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Figure 3: Launching the ELM from FIS

Once you log in to FDA Industry Systems, you can launch the ELM by clicking "Export Listing Module" in
the Registration and Listing Programs section. If the name of the system does not appear in green with a
checkmark in the box next to it, choose the "Update System Access" option on the left to request access to
the ELM.

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Figure 4: ELM Dashboard (for first-time users)

The ELM dashboard will display all ELM applications associated with your FIS account. First-time users
won't have any ELM applications associated with their account, so the dashboard will be empty. To start a
new application for an export list, click the "+ Enter New Application" button on the right side of the
screen. At any time, you can click on the question mark icon in the top right corner of the screen to access
step-by-step instructions for using the ELM.

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Navigating the ELM Dashboard

Figure 5: Actions on the ELM Dashboard

By default, the ELM dashboard will display all the ELM applications associated with your FIS account. You
can sort, filter, and rearrange the columns in the table below and the system will save these settings. If you
can't find one of your applications, click the "Clear User Settings" button to reset the view and display all
your applications. You can use the icons in the Action column to view, edit, or delete each application.
Click the "Action Icons" button for an explanation of each icon.
•
•
•

Select the eye icon in the action column to view an application.
Select the pencil icon to edit or renew an application. Please note that you must click through all
the screens and resubmit your application to send your edits to FDA.
Select the red X icon to request to delete an application. Please note that if you request to delete
an application with an Application Status of “Approved”, it will be removed from the export list.

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Dashboard Column Controls
Each column in the table has tools that can help you navigate your ELM
applications. Hover your mouse over the column headers until you see
the hamburger (three dashes), then click on the hamburger icon to
open the column options.

Pin Column moves the selected column to its immediate left or right.
Autosize This Column expands the selected column to display the
character values within the column.
Autosize All Columns expands all columns to display all character values
within the columns.
Reset Columns resets the column display to its original (default) state.

is The Columns tab on the right side of the table
opens a side panel of all available columns and
allows you to select which columns are displayed
in the table. Checked columns will be displayed in
the table. To hide the side panel, click the Columns
tab again.

Sorting, Filtering, Searching
Information for any column can be sorted in ascending or descending
order. Click anywhere in the column header to sort by descending
order (represented by an arrow pointing down). Click the column
header again to sort in ascending order (arrow pointing up). Click a
third time to clear the sorting.
To filter for specific information
within a column, type into the field
below the column header (see left)
or click the filter icon to select
options from a dropdown menu
(see right).

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Submitting or Editing an Application
Figure 6: Product and Country/Region

When submitting a new application, the first screen will prompt you to identify the Product Type and
Country/Region of the export list for which you wish to apply. After making your selection, click the blue
“Next” button at the bottom of the screen to proceed with the application.
When editing an existing application, you will not see this screen and cannot edit this information. If you
need to apply for a different export list, return to the ELM home page and submit a new application.

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Figure 6.1: Product and Country/Region for Shellfish Applications

If you select Shellfish as the Product Type and the European Union (EU) as the Region, the facility must
appear on the Interstate Certified Shellfish Shippers List (ICSSL). After making your selection, click the blue
“Next” button at the bottom of the screen to proceed with the application.

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Figure 7: Identifying the Facility for Listing

For most applications, you may identify the facility for listing by selecting a Food Facility Registration (FFR)
associated with your FIS account, entering an FDA Establishment Identifier (FEI Number), or entering a
DUNS number.
Please note: The ELM will auto-populate your name and address for listing from FDA records based on the
way that you identify the facility. Most firms prefer to use the Food Facility Registration, which allows you
to have complete control over the name and address that gets populated on your ELM application. If you
do not see a Food Facility Registration option, that means there are no registrations associated with your
FIS account. For more information, please see Appendix A: Using the Food Facility Registration in ELM.
•

•

If you use an FFR to identify the facility on the application, the ELM will pull in the "Facility Address"
from section 2 of the FFR. The facility address in the FFR is supposed to be the physical location of
the facility. You will be able to select any name associated with the FFR as the name for listing the
facility on the export list.
If you use the FEI or DUNS to identify the facility on the ELM application, the ELM will pull the
"Physical Address" associated with the facility's record in FDA's Official Establishment Inventory.
This may or may not match the facility address in the FFR. (Seafood vessels will also have the
option of selecting the "Mailing Address" associated with the facility's record in FDA's Official
Establishment Inventory.) The ELM will pull the legal name of the facility from Official Establishment
Inventory, but you will have the option of specifying another name for listing.

For shellfish facilities that are included on the Interstate Certified Shellfish Shippers List (ICSSL), please see
Figure 7.1 State and Certificate Information.
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Figure 7.1: ICSSL State and Certificate Information for Shellfish Facilities

Facilities applying for inclusion on the EU shellfish list must be included on the Interstate Certified Shellfish
Shippers List (ICSSL) and will be prompted to identify the state where the facility is located and the
certificate number from the ICSSL.
You may visit https://www.cfsanappsexternal.fda.gov/scripts/shellfish/sh/shellfish.cfm to search for your
certificate number. Note: If your ICSSL certificate number contains one or more leading zeroes (e.g., a zero
as the first digit), you must enter those zeroes to find the record for your facility.

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Figure 7.2: Identifying the Facility for Listing for Shellfish Firms

You may identify a shellfish facility for listing by selecting a Food Facility Registration (FFR) associated with
your FIS account, entering an FDA Establishment Identifier (FEI Number), entering a DUNS number, or
using the previously-provided ICSSL information.
Please note: The ELM will auto-populate your name and address for listing from FDA records based on the
way that you identify the facility. See Figure 7: Identifying the Facility for Listing for more information on
the FFR, FEI, and DUNS options. If this facility is also included on other exports lists, you should choose the
same option to identify the facility on the ELM applications for all export lists.

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Figure 7.3: Identifying the Facility with the Food Facility Registration

If you choose to identify the facility for listing by the Food Facility Registration, the system will display a list
of all registered food facilities associated with your FDA Industry Systems account. Select the correct facility
for your application and click the blue “Next” button at the bottom of the screen to proceed with the
application.
If you represent a food facility, but do not see an option to identify this facility by the Food Facility
Registration, you may associate this facility with your account if you have the facility’s Food Facility
Registration number and PIN. To do this, exit the ELM and click on the “Food Facility Registration” link
from the FIS home page. Once the Food Facility Registration module opens, select “Link Registration to
your Account” on the left side of the screen and enter the facility’s Food Facility Registration number and
PIN. For help with the Food Facility Registration system, please visit Online Registration of Food Facilities.
Once you have successfully linked your Food Facility Registration to your FIS account, you can return to
the ELM and use the Food Facility Registration to identify the facility.

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Figure 7.4: Identifying the Facility with the FEI Number

If you choose to identify the facility for listing by FEI number, enter the FEI number and click the blue
“Next” button at the bottom of the screen to proceed with the application. If you receive an error message,
please contact [email protected] for assistance.
If you do not know the FEI number for your facility, you can contact
[email protected] or visit the FDA FEI Portal. The FEI Portal allows a user to look up
an FEI number based on a firm name and address.

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Figure 7.5: Identifying the Facility with the DUNS Number

If you choose to identify the facility for listing by the DUNS number, enter the DUNS number and click
Next.
You may visit https://fdadunslookup.com/ to search for or request a valid DUNS number. Note: DUNS
numbers contain 9 digits. If your DUNS number contains a leading zero (i.e., a zero as the first digit), you
must enter that zero to find the record(s) for your facility.
If there are multiple facilities associated with the DUNS number, you will have the option to select the
correct name and address. If there are multiple records with the same or similar names/addresses, you
may contact [email protected] for assistance in choosing the correct record. Click the
blue “Next” button at the bottom of the screen to proceed with the application.

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Figure 7.6: Identifying the Facility with the Interstate Certified Shellfish Shippers List (ICSSL)

If you choose to identify the facility for listing by the Interstate Certified Shellfish Shippers List (ICSSL)
number, select the ICSSL option and click Next.
This option is for shellfish facilities only and will use the information provided in the State and Certificate
Information section to populate the name and address for listing from the name and address on the ICSSL;
please see Figure 7.1 State and Certificate Information.

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Figure 8: Existing Application Error

The system will not allow you to submit a duplicate application for a facility for the same product type and
country/region. You will see an error message if you try to select a facility for which there is already an
application for the product type and country/region.
If you receive an error message that directs you to the ELM home page, return to the ELM home page and
look for the existing application that is associated with your FIS account.
If the existing application is not associated with your FIS account, please contact
[email protected] for assistance and provide the existing application number.

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Figure 9: Parent Company Name/Address Information

After identifying the facility, the Business Information page will display. If you identified the facility using a
Food Facility Registration, this section is prepopulated from the Parent Company section of the Food
Facility Registration (FFR) module. If you used an FEI number, a DUNS number, or ICSSL information, this
section is not prepopulated and you may enter this information. The Doing Business As field is optional
regardless of how you identify the facility.

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Figure 10: Main Contact Information

The Main Contact Information is prepopulated from your FDA Industry Systems account. You may edit this
information if needed. Notifications about this application will be sent to this email address.
For more information about managing your FIS account, please visit FDA Industry Systems Account
Management Guide.

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Facility Information for Listing
Figure 11: Facilities Identified by FFR

Facility Type
If the "Facility Type" is not prepopulated on your application, you must select a "Facility Type" from the
dropdown menu. The options will vary based on the product type and country/region associated with your
application. The "Facility Type" selection affects how the facility is listed on the export lists, so please see
Appendix B for a list of "Facility Type" options and the associated designations for export lists.
Name and Address for Listing
If your application is approved, the "Name for Listing" and the address in this section will be included on
the export list. Please confirm that these fields are accurate before proceeding with the application.
Name for Listing
If you identified the facility using a Food Facility Registration (FFR), you will have the option of selecting
any name associated with your FFR as the "Name for Listing". If you do not see the name with which you
wish to be listed, you may update your FFR to edit an existing name in the FFR or provide an "Alternate
Trade Name". If you need to edit your FFR, save the ELM application as a draft and exit the application,
then update your FFR and return to the ELM to finish your draft application.
Address for Listing
If you identified the facility using a Food Facility Registration (FFR), the address for listing will be
prepopulated with the facility address from section 2 of the FFR. If the address that appears in the ELM is
incorrect, you should update the facility address in section 2 of the FFR before continuing with your ELM
application. To edit your FFR, save the ELM application as a draft and exit the application, then update the
FFR and return to the ELM to finish the draft application.

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Figure 12: Facilities Identified by FEI or DUNS Number

Facility Type
If the "Facility Type" is not prepopulated on your application, you must select a "Facility Type" from the
dropdown menu. The options will vary based on the product type and country/region associated with your
application. The "Facility Type" selection affects how the facility is listed on the export lists, so please see
Appendix A for a list of "Facility Type" options and the associated designations for export lists.
Name and Address for Listing
If your application is approved, the "Name for Listing" and the address in this section will be included on
the export list. Please confirm that these fields are accurate before proceeding with the application.
Name for Listing
If you identified the facility using a FEI or a DUNS number, the "Firm Name" and "Name for Listing" field
will be prepopulated with the legal firm name that FDA has on record for your facility. You may edit the
“Name for Listing” field if you wish to be listed by another name.
Address for Listing
If you identified the facility using a FEI or a DUNS number, the address for listing will be prepopulated with
the physical address associated with the facility's record in FDA's Official Establishment Inventory. If the
physical address that appears in the ELM is incorrect, please save the application as a draft and contact
[email protected] to request an update to the facility's record in FDA's Official
Establishment Inventory. You can continue with your ELM application once the facility's record has been
updated to reflect the correct physical address.

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Figure 12.1: Address Options for Seafood Vessels

If you identified the facility using a FEI or a DUNS number and you select Freezing Vessel or Factory Vessel
as the "Facility Type", you may choose to be listed with either the physical address or the mailing address
associated with the facility's records in FDA's Official Establishment Inventory. Click on the "Choose Facility
Address for Listing" option to select an address for listing.

If either the physical address or the mailing address that appears in the ELM is incorrect, please save the
application as a draft and contact [email protected] to request an update to the
facility's record in FDA's Official Establishment Inventory. You can continue with your ELM application once
the facility's record has been updated to reflect the correct address.
Please note that there is no option to select a mailing address if you use the FFR to identify the facility. If
you wish to list a vessel with a mailing address, you must use the FEI to identify the facility.

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Figure 13: Facilities Identified by ICSSL Certificate Number

Facility Type
For ICSSL facilities, the facility type is automatically populated based on the ICSSL activities for which the
facility is certified. You must indicate whether the facility also exports processed shellfish products. The
"Facility Type" selection affects how the facility is listed on the export lists. See Appendix A for a list of
"Facility Type" options and the associated designations for export lists.
Name and Address for Listing
The name and address for listing fields are automatically populated from the ICSSL.

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Figure 14: Inspection Details

The Inspection Details section is optional. If your facility has been inspected by FDA, you do not need to
complete this section. If your facility has not been inspected by FDA, providing the details for your most
recent inspection will prevent delays in the application review process. The inspection report must clearly
identify the name and address of the facility for which you are applying, the inspecting agency, the
purpose of the inspection, and the inspection result.
Select the “Browse” button to find the document you wish to upload. You may attach a document in jpeg.,
jpg, doc., docx., txt., xls., xlsx., pdf., gif., and rtf format. After you have selected the document, click the
“Upload” button. If the document was successfully uploaded, you will see a confirmation message. Click
the blue “Next” button at the bottom of the screen to proceed with the application.

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Figure 15: Additional Documents

Use the Additional Documents section to upload any additional documents that are required for review of
your application. Select the “Browse” button to find the document you wish to upload. You may attach a
document in jpg., jpeg., doc., docx., txt., xls., xlsx., pdf., gif., and rtf format. After you have selected the
document, click the “Upload” button. You will see a confirmation message if the document was
successfully uploaded.
For most applications, no additional documents are required. Some circumstances in which you may need
to upload additional documentation include:
•

•

•

If you wish to be listed with an approval number that differs from FDA's general policy for approval
numbers, you may upload a letter that includes the firm's name, address, current approval number
(if applicable), and the desired approval number. For more information about approval numbers,
visit Online Applications for Export Lists.
For the China seafood export list, upload an audit letter or other evidence of third-party
certification in this section. For more information, visit Seafood Exports to the European Union and
China.
For the European Union (EU) Collagen and Gelatin export lists, upload laboratory results in this
section. For more information, visit Collagen and Gelatin Exports to the European Union.

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Figure 16: Additional Contact Information

You may identify an additional contact to receive updates about this application. To ensure that your
company receives system notifications and that FDA can contact your firm if needed, we strongly
recommend that you identify a second contact to receive notifications about this application in addition to
the main contact identified on the first page of the application. You may wish to use a general phone
number and email address to ensure that FDA can reach somebody at your facility about this application.
Click the blue “Next” button at the bottom of the screen to proceed with the application.

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Product Information
The fields on the product information screens will vary depending on the product type and country/region
selected.

Figure 17: EU Dairy Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.

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Figure 18: China Dairy Product Information

Enter all required information. Select from the product category dropdown the option that best describes
your product. If you have question regarding the product category please reference the AQSIQ
Implementation Catalogue. Click the blue “Next” button at the bottom of the screen to proceed with the
application.

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Figure 19: Chile Dairy Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.

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Figure 20: China Seafood Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.
Note: If you indicate that one of your products is an aquaculture product, this will be indicated on the
China list with an "A" in the Remarks column. If you indicate that one of your products is a bivalve mollusk
product, this will be indicated on the China list with a "BMS" in the Remarks column.

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Figure 21: EU Seafood Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.
Note: If you intend to export aquaculture products, you must indicate that on your application so that your
EU listing contains an "Aq" in the Remarks column.

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Figure 22: EU Shellfish Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.

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Figure 23: Infant Formula China Product Information

Enter all required information. The Infant Formula Number (IFN) is required for review of the export list
application. Please reference the AQSIQ Implementation Catalogue for questions regarding the Infant
Formula Type. Click the blue “Next” button at the bottom of the screen to proceed with the application.

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Figure 24: EU Collagen Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.
Note: If you indicate that the animal origin of the product is "Fish", you must indicate whether the product
was derived from aquaculture products. If you intend to export collagen derived from aquaculture
products, you must indicate that on your application so that your EU listing contains an "Aq" in the
Remarks column.

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Figure 25: EU Gelatin Product Information

Enter all required information. Click the blue “Next” button at the bottom of the screen to proceed with the
application.
Note: If you indicate that the animal origin of the product is "Fish", you must indicate whether the product
was derived from aquaculture products. If you intend to export collagen derived from aquaculture
products, you must indicate that on your application so that your EU listing contains an "Aq" in the
Remarks column.

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Figure 26: Product List

When you add a product to the application, you'll see a Product List page with all the products associated
with the application.
To add additional products to your application, click the "+ Add Product" button. To edit information for a
product, click on the pencil icon. To remove a product from the application, click on the X icon.
Click the blue “Next” button at the bottom of the screen to proceed with the application.

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Figure 27: Application Review

Please review all the information you provided on your application on the Application Review page. If you
need to correct or update any information, click the "Edit" button in the relevant section of the application.
Click the blue “Next” button at the bottom of the screen to proceed with the application.

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Figure 28: Signature Page

Review the statement on the signature page and if you agree, check the box labeled "I Agree." Click the
blue “Submit” button at the bottom of the screen to submit the application to FDA.

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Figure 29: Confirmation Page for New Applications

Once you submit your application, you will see a confirmation page and receive an application number.
Keep this number for future inquiries about your application.

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Figure 30: Confirmation Page for Draft Applications

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Figure 31: Confirmation Page for Edited Applications

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Appendix A: Using the Food Facility Registration in ELM
If you choose to identify the facility using the Food Facility Registration (FFR), the ELM will display a
list of all registered food facilities associated with your FDA Industry Systems (FIS) account. If your
account is only associated with one registered food facility, the system will automatically select that
facility and move to the next screen.
If you represent a food facility but do not see an option in the ELM to identify the facility by the
FFR, you can associate this facility with your account using the facility’s FFR number and PIN. To do
this, click on the “Food Facility Registration” link from the FIS home page. Once the Food Facility
Registration system opens, select “Link Registration to your Account” on the left side of the screen
and enter the facility’s Food Facility Registration number and PIN. When you log back into the ELM,
you should have access to this facility.
Once you have selected the facility for the application, you will be able to choose any name on the
FFR as the "Name for Listing." If you do not see the name with which you would like to be listed in
the dropdown, you can save your ELM application as a draft, log in to the Food Facility Registration
system, add the name with which you would like to be listed in the “Alternate Trade Names”
section, and then go back to the ELM to complete your application.
The ELM will pull the facility address from the FFR as the address for listing. If this address is
incorrect, you can save your ELM application as a draft, log in to the Food Facility Registration
system, correct the facility address, and then go back to the ELM to complete your application.

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Appendix B: Email Notifications from the ELM

The ELM sends the following email notifications to the email addresses for the contacts on the
application. FDA strongly recommends that applicants identify two different contacts to receive
notifications about ELM applications.

Notifications about Submissions
•
•
•

Draft Application Saved
Application Received
Edit/Biennial Update Received

Notifications about Changes in Application Status
•
•
•
•
•

Application Approved
Application Returned for Action
Application not Deleted
Application Rejected or Deleted
Application Expired

Reminder Notifications
•
•
•
•

Draft Application Reminder
Biennial Update Reminder (6 months prior to expiration)
Biennial Update Reminder (3 months prior to expiration)
Biennial Update Reminder (1 month prior to expiration)

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Appendix C: Product, Country, and Facility Type Matrix
Product Type

Country

Facility Type Options

Activities Designation for Country Lists

Shellfish
Shellfish

European Union (EU)
European Union (EU)

Repacker*
Reshipper*

IP
IP

Collagen
Dairy
Dairy
Dairy
Dairy
Dairy
Dairy
Gelatin
Infant Formula
Seafood
Seafood
Seafood
Seafood
Seafood
Seafood
Seafood
Seafood
Seafood
Shellfish

Shellfish
Shellfish

European Union (EU)
Chile
Chile
China
China
European Union (EU)
European Union (EU)
European Union (EU)
China
China
China
China
China
European Union (EU)
European Union (EU)
European Union (EU)
European Union (EU)
European Union (EU)
European Union (EU)

European Union (EU)
European Union (EU)

Processing Plant
Co-packer
Processing Plant
Co-packer
Processing Plant
Co-packer
Processing Plant
Processing Plant
Processing Plant
Cold Stores
Factory Vessel
Freezing Vessel
Processing Plant
Broker
Cold Stores
Factory Vessel
Freezing Vessel
Processing Plant
Depuration Processor*

Shell Stock Shipper*
Shucker-Packer*

PP
N/A
N/A
PP
PP
PP
PP
PP
PP
CS
FV
ZV
PP
PP (with O! in the Remarks column)
CS
FV
ZV
PP
PC, IP

IP
IP

* For facilities on the Interstate Certified Shellfish Shippers List (ICSSL), the facility type will automatically populate based on the ICSSL activities
for which the facility is certified.

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