The FDA issues different types of export certificates for different food products. For conventional foods, food additives, food contact substances, and infant formula, the FDA issues the Certificate to a Foreign Government (CFG) or the Certificate of Exportability (COE). The CFG is available for products that meet the applicable requirements of the FD&C Act for marketing in the United States. The COE is available for products that may not be sold in the United States but meet the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The CFG and the COE have the same general format but have different titles and attestations.
For dietary supplements, medical foods, and foods for special dietary use, the FDA issues the Certificate of Free Sale (COFS). This certificate does not make statements about the regulatory status of the products or establishments involved in their production. The certificate includes the following documents:
- Certificate of Free Sale,
- If applicable, a separate Certificate of Free Sale Product List
- Supplemental letter addressed to “To Whom It May Concern”
- If applicable, a separate product list to accompany the supplemental letter
For the CFG and COE, the FDA provides several options for industry to customize the information displayed on the certificates to meet importing country certification requirements. This customization is limited to the CFG and COE and does not apply to the format for the COFS.
- Format of CFG and COE Issued on or after June 29, 2020
- Format of CFG and COE Issued before June 29, 2020
- Format of COFS
Format of CFG and COE Issued on or after June 29, 2020
key features numbered and explained below
- The title indicates that the certificate covers either food for human consumption (for conventional food, seafood, food additives, and infant formula) or food contact substances, which are not intended to be consumed.
- A subtitle of "Certificate of Free Sale" can be requested on the CFG. This is optional and does not appear on all certificates. The COE is not available with a "Certificate of Free Sale" subtitle.
- Certificates include the name and address of at least one entity involved in the export of products covered by the certificate. Requestors may specify the names and addresses of no more than two entities to print on the certificate, including:
- Certificates will include the name of all products covered by the certificate. Requestors may specify up to four additional product information fields to be printed on the certificate, including:
- Schedule B/HTS number
- Scientific or chemical name
- Product description
- Production date
- Expiration date
- Type of packaging
- Unit of measure
- Lot number
- Requestors may specify additional information to be printed on the certificate, including:
Format of CFG and COE Issued BEFORE June 29, 2020
All the options indicated above were also available for certificates issued prior to June 29, 2020. FDA asks that importing countries continue to accept certificates issued prior to June 29, 2020 until the certificates expire.
Sample Food Export Certificate Issued BEFORE June 29, 2020
Format of COFS