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Korean: 한국 고객을 위한
Staff Answer
Dec 19, 2019 - 08:42 PM
Hi,
Thanks for your question. Let me answer it for you.
Anyone exporting food products from the United States requires certification from the U.S. Food and Drug Administration (FDA). FDA provides written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Interestingly, FDA only plays a part in the entire process and strongly advocates that export units follow all U.S. laws and regulations and comply with the requirements of the importing countries.
According to the official website - FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory or marketing status, based on available information at the time FDA issues the certificate (including, as appropriate, attestations provided by the person seeking the certificate).
Note:- The fact that FDA issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate.
You need to obtain the following certificates from FDA to carry out exports from United States of America -
Certificate to a Foreign Government is issued for conventional foods, food additives, infant foods etc. and is issued after the applicable requirements of the FD&C Act for marketing in the United States are met by the exporter.
Certificate of Exportability is given for conventional foods, additives and food contact substances that cannot be legally marketed within the United States but meet requirements of section 801(e) of the FD&C Act and may be legally exported. Visit the link given below to go to the website to file your online application -
https://www.fda.gov/food/food-export-...
Certificate fo Free Sale is issued for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.
The official website also clearly states that FDA issues health certificates for collagen and gelatin products intended for export to the European Union (EU) and specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries.
Please follow the steps given below to obtain the FDA certificate/s relevant to your export business -
To request these certificates, please send the following information to BulkCGExport-LM-OFS@fda.hhs.gov:
1. Business name and address. 2. Name, telephone number, and email address of contact person. 3. List of products presently shipped to the country of destination and those intended to be shipped within the next 2 years. 4. Name and address of the manufacturing and processing plant for each product 5. Names and affiliations of any Federal, State, and local governmental agencies that inspect the plant, government assigned plant identifier, such as plant number and last date of inspection. 6. A copy of the most recent (within 1 year of the date of application) inspection report issued by a State, local, or Federal public health regulatory agency and a copy of a recent laboratory analysis of the finished product as required by the foreign country. 7. A copy of the label of the product that you are sending.
In addition to the above, there are other federal agencies that provide export certificates for a range of products listed below -
Dairy/Egg products - The United States Department of Agriculture, Agricultural Marketing Service, Dairy Grading Branch (Dairy Grading Branch) offers certification services to assist in the export of dairy and related products.
Seafood products - The National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program certifies U.S. seafood products for export to any country requiring health certification. The regulations may be different for EU importers for which you need to get in touch with the federal agency.
For any further queries, you can visit the FAQ section for export certificates put together on the agency's official website. Link below -
https://www.fda.gov/food/food-export-...
Hope the answer helps. Good luck from all of us.
Thanks and regards,
go4WorldBusiness.com Team
Thanks for your question. Let me answer it for you.
Anyone exporting food products from the United States requires certification from the U.S. Food and Drug Administration (FDA). FDA provides written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Interestingly, FDA only plays a part in the entire process and strongly advocates that export units follow all U.S. laws and regulations and comply with the requirements of the importing countries.
According to the official website - FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory or marketing status, based on available information at the time FDA issues the certificate (including, as appropriate, attestations provided by the person seeking the certificate).
Note:- The fact that FDA issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate.
You need to obtain the following certificates from FDA to carry out exports from United States of America -
Certificate to a Foreign Government is issued for conventional foods, food additives, infant foods etc. and is issued after the applicable requirements of the FD&C Act for marketing in the United States are met by the exporter.
Certificate of Exportability is given for conventional foods, additives and food contact substances that cannot be legally marketed within the United States but meet requirements of section 801(e) of the FD&C Act and may be legally exported. Visit the link given below to go to the website to file your online application -
https://www.fda.gov/food/food-export-...
Certificate fo Free Sale is issued for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.
The official website also clearly states that FDA issues health certificates for collagen and gelatin products intended for export to the European Union (EU) and specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries.
Please follow the steps given below to obtain the FDA certificate/s relevant to your export business -
To request these certificates, please send the following information to BulkCGExport-LM-OFS@fda.hhs.gov:
1. Business name and address. 2. Name, telephone number, and email address of contact person. 3. List of products presently shipped to the country of destination and those intended to be shipped within the next 2 years. 4. Name and address of the manufacturing and processing plant for each product 5. Names and affiliations of any Federal, State, and local governmental agencies that inspect the plant, government assigned plant identifier, such as plant number and last date of inspection. 6. A copy of the most recent (within 1 year of the date of application) inspection report issued by a State, local, or Federal public health regulatory agency and a copy of a recent laboratory analysis of the finished product as required by the foreign country. 7. A copy of the label of the product that you are sending.
In addition to the above, there are other federal agencies that provide export certificates for a range of products listed below -
Dairy/Egg products - The United States Department of Agriculture, Agricultural Marketing Service, Dairy Grading Branch (Dairy Grading Branch) offers certification services to assist in the export of dairy and related products.
Seafood products - The National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program certifies U.S. seafood products for export to any country requiring health certification. The regulations may be different for EU importers for which you need to get in touch with the federal agency.
For any further queries, you can visit the FAQ section for export certificates put together on the agency's official website. Link below -
https://www.fda.gov/food/food-export-...
Hope the answer helps. Good luck from all of us.
Thanks and regards,
go4WorldBusiness.com Team
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