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U.S. Department of Health and Human Services

Food

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Food Export Certificate Application Step-by-Step Instructions

September, 2012

Return to Online Certificate Application Process

Table of Contents

  1. Enter a Food Export Certificate Application
  2. Navigation
  3. Section 1 Food Manufacturer Information
  4. Section 2 Exporting Company Information
  5. Section 3 Shipment Description
  6. Section 4 Intended Destination of Shipment (Country)
  7. Section 5 Send Certificate To
  8. Section 6 Send Certificate Via
  9. Section 7 Fees
  10. Section 8 Labels
  11. Section 9 Verification
  12. Review Screen

   

Enter a Food Export Certificate Application

 

After you log into the FDA Industry Systems page, you will need to select the "Certificate Application Process" option from the list of systems available on the FURLS Home Page. See Figure 1 below.

Figure 1:
A picture of the FURLS Homepage 

 

Once you have selected "Certificate Application Process", you will navigate to the CAP main menu. To begin the application process, select "Enter New Application" from the list of options After you have entered an application, you may choose to Modify an existing application (when applicable), Search for an existing application, or Print an application from the main menu. See Figure 2 below.

Figure 2:
A picture of the CAP main menu page 

 

 

After selecting the “Enter New Application” option, the system will display all applications that have been saved but not submitted as shown in Figure 3. These saved applications will be in a “Draft” status until you submit the application.

  • If you wish to continue working on an application that has been saved, select the application radio button and click on “Complete Draft Application”.
  • If you wish to copy an existing application, select “Clone Application”. Please refer to Create an application based on the existing application section under the Modify Application of this document.
  • If you wish to create a new application, click on the “Enter New Application”.

Figure 3:
A picture of the list of applications in a draft status.  The user can choose to enter a new application or to select a previously saved drafted application to complete the draft application.  The user can also click on the clone application to copy an existing request 

 

The Center for Food Safety and Applied Nutrition (CFSAN) issues multiple Export Certificates based on the firm’s product type. When creating a new application, you will need to first select which certificate type you are requesting as shown in Figure 4.

Figure4:
A picture of the certificate type dropdown list.  The user must select a certificate type from the dropdown list 

 

It is important that you select the correct certificate type for the product or products you are exporting. Failure to do so will result in the immediate rejection of the application. If you are unsure as to which certificate type to select, click on the red question icon located next to the certificate type list. The system will display a description of each certificate type as shown in Figure 5 below:

Figure 5:
A picture with a description of all certificate types when the user clicks on the question mark help icon. 

 

Landfood: Conventional foods for human consumption are foods that are not seafood, infant formula, or dietary supplements.

Seafood: All aquatic animal life, other than birds and mammals, which is used as food for human consumption. For example, in addition to fresh and saltwater finfish and crustaceans, this applies to echinoderms such as sea cucumbers and sea urchins; reptiles such as alligators and turtles; amphibians such as frogs; and to all mollusks, including land snails (escargot). It also applies to extracts and derivatives of fish, such as eggs (roe), oil, cartilage, and fish protein concentrate, products that are mixtures of fish and non-fish ingredients, such as tuna sandwiches and soups.

Food Additive: This certificate type applies to any substance the intended use of which results or may reasonably be expected to result in its becoming a component or otherwise affecting the characteristic of any food.

Food Contact Substances: This certificate type applies to any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.

Dietary Supplements: The term "dietary supplement" is defined in the Federal Food Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994, as a product (other than tobacco) intended to supplement the diet that bears or contains a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above ingredients (21 U.S.C. 321(ff)(1)). Moreover, to be a dietary supplement, a product must be intended for ingestion in a form described in 21 U.S.C. 350(c)(1)(B)(i) or comply with 21 U.S.C. 350(c)(1)(B)(ii), must not be represented as conventional food or as a sole item of a meal or the diet, and must be labeled as a dietary supplement (21 U.S.C. 321(ff)(2)). The definition excludes an article that is authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such authorization marketed as a dietary supplement or as a food (21 U.S.C. 321(ff)(3)(B)(ii)).

Infant Formula: Infant formula is defined by section 201(z) of the act, 21 USC 321(z), as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk." The term "infant" is defined as "persons not more than 12 months old" (21 CFR 105.3). Toddler formulas are not considered infant formulas unless they are also intended for children of less than one year of age; in that case they will be regulated as infant formula. A medical food that is also an infant formula will be regulated as an infant formula. Human milk fortifiers are considered to be infant formula. Foods intended for infants such as juices, pureed baby food and baby cereals are regulated as foods not as infant formula.

Medical Foods: The Orphan Drug Amendments of 1988 enacted, for the first time, a statutory definition of medical food. The term medical food means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick patients are not medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition's specific dietary management.FDA established criteria that clarify the statutory definition of a medical food at 21 CFR 101.9(j)(8). A food is a medical food and is exempt from the nutrition labeling requirements of 21 CFR 101.9 only if: (i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube; (ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; (iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation; (iv) It is intended to be used under medical supervision; and (v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Food for Special Dietary Use: In the Federal Register of November 22, 1941 (6 FR 5921), FDA promulgated a regulation stating that the term special dietary uses'', as applied to food for man, means particular (as distinguished from general) uses of food, and that it means, among other things, uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of disease, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight. This part of the regulation remains unchanged in current Sec. 105.3(a)(1) (21 CFR 105.3(a)(1)). The statutory definition of special dietary use in section 411(c)(3) of the act (21 U.S.C. 350(c)(3)) was added in 1976 (Pub.L. 94-278).§ 105.3 Definitions and interpretations. The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter "the act") shall be applicable with the following additions:(a)(1) The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows: (i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight; (ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood; (iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use.

For certain certificate types, you will be required to enter the Bioterrorism Food Facility Registration Number and PIN in order to verify your eligibility to obtain a certificate as shown in Figure 6. This information directly corresponds to your Food Facility Registration. If you have not registered your facility and have selected a certificate type that requires the Registration Number and PIN, you will need to register your facility in the Food Facility Registration Module (FFRM) before entering an application in CAP. If you do not know your Registration Number and PIN or have any questions regarding your registration, please contact the FDA Industry Systems Help Desk.

Figure 6:
A picture of the system prompting the user to enter the mandatory Bioterrorism Food Facility Registration Number and PIN in order to verify the eligibility to obtain a certificate based on the certificate type selected 

 

Some certificate types do not require you to enter the Registration Number and PIN as shown in Figure 7. However, if you have registered your facility and have received the Registration Number and PIN, enter the information to speed up the application process.

Figure 7:
A picture of the system prompting the user to optionally enter the Bioterrorism Food Facility Registration Number and PIN in order to verify the eligibility to obtain a certificate based on the certificate type selected 

 

Navigation

At the top of every page in CAP (Figure 8 below), a status bar will track your progress through each step of the online application process.

Figure 8:
A picture of the status bar when a user is on a specific Step of the application process 

 

A "Get Help" icon, located at the top right of each step, will provide page specific help. For an overview of all help files available, please refer to the FDA Industry Systems Index of Help Pages. The "FURLS HOME" link, located the top right corner of each page, will take you to the FURLS Home Page. The "CAP HOME" link, located below the “FURLS HOME” link, will take you to the Certificate Application Process Home Page (Refer to Figure 1). To log out of the system, select "FURLS HOME" and click on logout.

At the top and bottom of each screen are four navigation buttons as shown in Figure 9.

Figure 9:
A picture of the navigation buttons 

 

  • Back to Step XX - Go back one screen and continue entering application information. Information entered on the current screen will NOT be saved.
  • Continue - Go to the next screen and continue entering application information.
  • Cancel & Start Again - The system will return you to the screen where you enter your Registration Number and PIN. Any information you have entered will NOT be saved.
  • Save & Exit - Information entered up to this point will be saved. The system will provide you with an application number and your application will be in a “Draft” status in the system for 60 days. After 60 days the application will be deleted from the system. When you log into the CAP system, any applications that are in a “Draft” status will be displayed after selecting the “Enter New Application” option from the main menu.

Section 1 - Food Manufacturer Information 

This section is required. Some fields are automatically populated based on the information in your Food Facility Registration Number and PIN and cannot be edited in CAP.

If the information is incorrect, please login to the Food Facility Registration Module and follow the directions on how to update your facility information.

If you would like to use a different facility, please logout of CAP and login with the Registration Number and PIN which belongs to the facility for which you are applying for this certificate.

Fields marked with an asterisk (*) are mandatory.

NOTE: The contact person name (First and Last) and contact phone number fields are required if you do not fill out Section 2.

The contact email address must be entered in order for you to complete the application. See Figure 10 below.

Figure 10:
A picture of the Food Manufacturer Information of Section 1 of the Certificate Application Process 

 

Section 2 - Exporting Company Information 

This section is optional. However, if you choose to enter this information, the fields below marked with an asterisk are required.

NOTE: If you choose to fill out Section 2 and decide the information is not what you wanted, you may click on the “Clear” button to remove the information from section 2.

***Export Company Name - The name of the company which will be exporting the product on the certificate.

State License/Registration Number - The Food Facility Registration Module (FFRM) registration number for the Export Company.

***Country - The country in which the Exporting Company is located.

***Address Line 1 - The physical location of the facility that is the export company. This is normally a street address, but may be some other physical/geographical designation used in rural locations.

Address Line 2 - The second address line if applicable.

***Zip Code - The Zip Code (domestic) or Postal Code (foreign) in which the export company is located.

***City - The city in which the export company is located.

***State - The state in which the export company is located.

***Contact Person Name - The Exporter’s Contact Name

***Contact Phone - The Exporter’s telephone number

Contact Phone Fax - The Exporter’s fax number if applicable.

***Contact Email - The Exporter’s email address

NOTE: If you are filling in the export company information, the system will validate the address based on the zip code entered. If there are alternate street addresses (I.e., St., Street, Ave., Avenue, etc…) the system will provide you with the preferred match. You may accept or reject the recommended address and city. See Figure 11 below.

Figure 11:
A picture of the Exporting Company Information of Section 2 of the Certificate Application Process 

  

Section 3 - Shipment Description

This section is required. See Figure 12 below.

NOTE: You must add at least one product to the application.

Figure 12:
A picture of the Shipment Description of Section 3 of the Certificate Application Process. 

To add products, select either the “Add Product” or choose the Upload File button.

Enter the following information for the following certificate types:

  • Landfood
  • Seafood

 

Add Product:

*Product - Enter the product description such as Jinny dill potato chips, or Dryer chocolate cake mix.

*Common Name - Enter the common name for the product. In the example above, Jinny dill potato chips, would be entered as “potato chips”.

*Manufacturer - This will be automatically populated with the manufacturer name that was entered in Section 1 of the form. This field cannot be edited.

Scientific Name - If the certificate type is seafood, this field is required. This field should contain the scientific name for a seafood product. For example - S. brevirostris for Rock Shrimp.

Description/Comments - Include information about the product pertaining to the weight or packaging, such as “13 cases @150 lbs”. This field may also be used to show a product and the primary ingredient, such as “potato chips with dill”.

Weight - If the certificate type is seafood, this field is required. Enter the weight of the seafood product. Only numerical values are allowed.

Weight Unit - If the certificate type is seafood, this field is required. Enter the weight unit for the weight entered for the seafood product. The options are gram, kilogram, pound and ounce.

See Figure 13 below.

Figure 13:
A picture of the Product Information of Section 3 for a seafood certificate type 

Enter the following information for the following certificate types – See Figure 14 below:

  • Food Additive
  • Food Contact Substance
  • Dietary Supplements
  • Infant Formula
  • Medical Foods
  • Foods for Special Dietary Use

 

Add Product:

*Product - Enter the product trade name or other identifier

*Common Name - Enter the common or usual name for the product.

*Manufacturer - This will be automatically populated with the manufacturer name that was entered in Section 1 of the form. This field cannot be edited.

Description/Comments - Include information about the product.

Figure 14:
A picture of the Product List of Section 3 for all certificate types other than seafood. 

When you have completed entering the product information, the system will return to Section 3 (see Figure 15 below) where you can choose to add additional products, edit existing products, remove a product, or add additional products using the upload file feature.

Figure 15:
A picture of an example of adding an additional product to the shipment description section. 

 

Edit Product:
To edit a product, select the radio button next to the product you wish to edit. Then choose the “Edit Product” button. The system will re-display the product entry screen and allow you to edit any of the fields displayed with the exception of the Manufacturer.

Remove Product:
To remove a product, select the radio button next to the item you wish to remove. Then choose the “Remove Product” option. The system will display the product information (see Figure 12). Choose the “remove product” button to remove that item from the product list. You may also select “Back” button if you do not wish to remove the product from your product list.

Upload File
If you have a large list of products, you may choose to upload a file rather than manually entering each product. The system provides a hyperlink to download a template which is in a format that must be used to upload your products.

To download the template file, first select the “Upload File” button. Then click on the “here” hyperlink to download the template file. See Figure 16 below.

The system will display a pop-up box with an option to automatically open the file with Microsoft Excel. You may choose to open the file with other applications (such as Microsoft Word) but it is recommended you use Microsoft Excel. You may also choose to save the file to your computer. The file will be saved to your default download location defined in your browser.

Figure 16:
A picture of the uploading products from a product template file.  The computer screen displays the upload feature if the user chooses to upload the product accessories.  The system provides a hyperlink to open the product template excel file where the user can use to upload the products.  When complete the user can browse and upload the product file. 

Additional directions / rules have been provided in the product template excel file. Please adhere to the following rules or the system will not accept the upload:

  1. Rows 1 and 2 must not be deleted.
  2. Please do not separate products with any blank rows.
  3. Please do not go over the maximum character limit for specified columns. See product template file header section for exact character limitations.
  4. Product Name and Common Name are mandatory cells.
  5. For Certificate Type Seafood, Scientific Name and Weight and Weight Unit columns are mandatory cells.
  6. Please do not delete the “Do not delete” worksheet.

 

Add / Update the product template with your products and related information and upload it to the system. After you have browsed to the location of your file, choose the “Upload” button. When you have completed adding the list of products, select the “Continue” button to the next step.

Section 4 - Intended Destination of Shipment (Country) 

This section is required. 

*NAME OF COUNTRY or COUNTRIES - Select one or more countries to indicate where the product(s) will be shipped. See Figure 17 below.

Figure 17:
A picture of the Intended destination of Shipment of section 4.  The user can select one or multiple countries for the intended destination of shipment 

Section 5 - Send Certificate To 

This section is required.

In this section, you will be able to determine where the certificate(s) will be mailed. There are three options to choose from shown in Figure 18.

  • Manufacturer - The same address provided in Section 1 of the application
  • Distributor - The same address provided in Section 2 of the application
  • Other – An address other than the Manufacturer or Exporter Address

Figure 18:
A picture of the Send Certificate to of section 5.  The user can select the manufacturer, distributor, or other checkbox.  If the user selects other, the user must complete the firm name and address fields 

For Certificate Type: Seafood
You will be able to select from the following combinations in Section 5:

  1. Select one option (Manufacturer, Distributor, or Other); or
  2. Select Manufacturer and Distributor; or
  3. Select Manufacturer and Other

 

For all other Certificate Types, you will only be able to select one option; Manufacturer, Distributor, or Other.

NOTE:

  • If you select the Distributor option, the system will auto-populate the address fields in section 5. These fields will not be editable.
  • If you selected the Manufacturer option but you did not enter the Contact Name and Phone Number in Section 1, you will not be able to proceed with the application process. You can go back to Section 1 of the application and enter the Contact Name and Phone Number or you can select Distributor or Other as an option.
  • If you did not enter any information in Section 2 (Exporter Information), the Distributor option will not available.

 

 

Section 6 - Send Certificate Via

This section is required.
 

You will need to select the Carrier Name. If you have selected a Carrier other than US Mail, you will need to provide the Account Number for that specific Carrier. See Figure 19 below.

NOTE: Based on the certificate type selected, the Carrier Name list may change.

Figure 19:
A picture of the Send Certificate Via of section 6.  The user can select the Carrier Name for the delivery method 

Section 7 - Fees

This section is required.
 

Please enter the number of certificates you are requesting. The total amount will be auto-calculated. See Figure 20 below.

Figure 20:
A picture of the Fees section 7.  The user enters the number of certificates and the system calculates the total cost 

 

Section 8 - Labels

The Certificate Application Process requires you to attach at least one label to each product if the certificate type you selected is one of the following:

  • Landfood
  • Food Additive
  • Food Contact Substance
  • Dietary Supplements
  • Infant Formula
  • Medical Foods
  • Foods for Special Dietary Use

 

You have the option to attach labels only for the Seafood certificate type. However, not attaching a label may delay the application process time.

You may upload images of your labels using any of the following formats: jpg, doc, docx, txt, xls, xlsx, pdf, gif or rtf. See Figure 21 below.

Figure 21:
A picture of the Labels section 8.  The user has the option to upload labels for each product 

For each product, select the “Browse” button to search for the location (on your computer or external device) of the images of your labels. Select the filename that corresponds to your label file and click on the “Upload” button.

The system will display the file name and file size at the bottom of section 8. The file size is displayed as there is a 50 Megabyte (MB) total limitation for all files uploaded per application. See Figure 22 below.

Figure 22:
A picture of the uploaded Labels hyperlink section 8.  The system displays the hyperlink and file size after a label file has been uploaded 

You will also have the ability to remove a label associated to a product. Click on the Add/Remove Label button after selecting the product as shown in Figure 23.

Figure 23:
A picture of the uploaded Labels hyperlink section 8.  The user has the ability to add/ remove a label associated to/from a product 

Once all labels have been uploaded for each product, click on “Continue” to proceed to the next section.

NOTE: You will not be able to proceed until each product has at least one attached file.

 

Section 9 - Verification

This section is auto-populated with the contact information associated to the account used to log into the CAP application. You must read the verification statement and select the “I Agree” checkbox in order to continue with the application process. See Figure 24 below. If this information is incorrect, you will need to Save & Exit the application and make the necessary updates to your Online Administration Account.

Figure 24:
A picture of the Verification section 8.  The system auto-populates the Name and Title fields from OAA.  The user must click on the “I agree” checkbox to proceed 


 

 

Click on “Continue” to proceed to the Final Review Screen.

Review Screen

The system will display the entire application broken out by section. See Figure 25 below. You may choose to modify a section by clicking on the adjacent “Edit” button. The system will re-display the data entry screen corresponding to your chosen section. You may update each section as needed. Select the “Review Changes” button to return back to the Review Screen. The application will now display the changes.

NOTE: If you add more products in section 3, the system will not display the “Review Changes” button. You will need to proceed to the next sections accordingly and attach at least one label to the new product or products in section 8.

 

Figure 25:
A picture of the final review page.  The computer screen displays each section of the application including all information entered by the user for review.  The user will be able to edit each section and make any updates.  The user must click on the Submit button to officially send it to the FDA for review 

In the Review Screen, you will also have the option to print your application before submission. Select the “Print Application” button located at the bottom of the Review Screen. A new browser window will open which will allow you to print the application as shown in Figure 26 below. When you are finished, close the smaller browser pop-up window in order to return to the CAP application.

Figure 26:
A preview of the application when the user clicks on “Print Application”. 

When you are ready to submit your application, click on the “Submit” button also located at the bottom of the Review Screen. The system will display a message that your application has been successfully submitted. See Figure 27 below. The system will provide you with an application number. Please save this application number for future reference. The application number will be needed to check the status of your application.

NOTE: You will also receive an email notification (sent to the email address or addresses you provided in section 1 and or section 2 of the application) with the application number and a successful submission message.

Figure 27:
A picture of the confirmation page.  The computer screen displays a successful confirmation page including the application number