Industry may request most types of FDA-issued export certificates for food products through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS). CFSAN eCATS is one of the FDA Industry Systems available at https://www.access.fda.gov. CFSAN eCATS has different modules for different types of export certificates. Please visit the links below for step-by-step instructions for applying for export certificates.
OMB Approval Number: 0910-0793
OMB Expiration Date: 8/31/2021
CFSAN eCATS Module
Industry may request the “Certificate to a Foreign Government” and the “Certificate of Exportability” via the CFSAN eCATS module. These certificates are available for conventional foods, food additives, food contact substances, and infant formula.
Tips for Complete Applications via CFSAN eCATS
FDA is able to process complete applications much more quickly than applications for which we need to request additional clarifying information. You may wish to review the following tips to ensure that you submit a complete application.
- All product labels and supporting documentation should be in English or accompanied by an English translation.
- There should be a clear link between the manufacturer and the products listed on the application. If the product label does not include the name and address of the manufacturer, you may upload supporting documentation via the “Additional Documents” section to demonstrate the link between the products and the manufacturer (e.g., a signed letter from the manufacturer on company letterhead).
- If the manufacturing facility has not been inspected by FDA, you may upload an inspection report from another federal, state, or local regulatory agency via the “Additional Documents” section to demonstrate compliance with applicable U.S. requirements.
- For food additives and food contact substances, if the product label does not clearly state the ingredients or substances used to produce the final product, you may upload specification sheets or other documentation via the “Additional Documents” section to demonstrate a link between the product and the applicable FDA authorizations.
Certificate Application Process (CAP) Module
Industry may request the “Certificate of Free Sale” via the Certificate Application Process (CAP) Module. These certificates are available for dietary supplements, medical foods, and foods for special dietary use.