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All About the FDA Export List

Certain countries require U.S. exporters to be listed in FDA’s export list for certain products. Without a spot on the  export list, U.S. exporters of certain food products are barred from access to applicable foreign markets. If you’re wondering whether your U.S. food export business is subject to these requirements, keep reading to learn more about the FDA’s export list.

What products are required to be on an FDA export list?

Although each country requires export lists for different products, the types of products include:

  •  Dairy
  •  Seafood
  •  Shellfish
  •  Infant formula
  •  Collagen products
  •  Gelatin products

Which countries require exporters to be listed?

Each country has their own requirements for the types of products appearing on export lists., so U.S. exporters’ eligibility may differ from one country to another. The three countries/territories that require exporters to be listed on the FDA export list for certain products are: 

  •  European Union — The EU uses certain country/territory, establishment and certificate requirements for each type of product. Products subject to regulation include dairy, seafood, shellfish, collagen and gelatin products.
  •  China — China regulates certain exporters of dairy, infant formula and seafood products.
  •  Chile — Some dairy products are subjected to regulation and must be included in the export list.

How does a U.S. exporter benefit from being on an export list?

Although the FDA does not require exporters to apply to be included in the Export Listing Module (ELM), some businesses may wish to do so in order to expand their exporting opportunities. U.S. exporters not listed in the ELM will be denied entry into certain markets.

How does a U.S. exporter apply to be on an FDA export list?

, U.S. exporters must meet certain requirements to be included on an export list. First, your business needs to be registered with the FDA and be in good standing. If your business has a record of regulatory compliance issues, the FDA may deny your petition. Lastly, you must file a petition through the ELM which includes all necessary and accurate information.

US Imports can assist your business with an export list petition

If you’re interested in securing a spot on an export list for your U.S.-based business, we can help. US Imports specialists can assist to file your petition with FDA to be included on the Export Listing Module. Our expertise can streamline the process and help open up opportunities for increased market access around the world. View pricing and more details here and let US Imports simplify the export list petition process today.

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