(+1) 718-5225575

FCE [Food Canning Establishment] registration with the FDA is required to export to the United States long shelf-life food specialties, such as tuna in oil, peeled tomatoes, preserves and canned products

In addition to the FCE registration it is also necessary to obtain a prior import authorization [SID procedure]. The authorization procedure discusses the product sterilization process

Exporting Shelf Stabilized Food Products to the United States

ExportUSA helps companies obtain the FCE certification registration and to request SID prior authorization in order to export and sell canned tuna in oil or water, canned peeled tomatoes, sauces, preserves, truffles, mushrooms and, more in general, all canned and long-life products to the United States of America

The technical term the FDA uses to define products that need prior approval, known as ìSIDî, is: ìLow Acid Canned Foods (LACF)/Acidified Foods (AF)î or canned food products with low acidity and artificially acidified food products

LACF and AF refer to:

A food product with low acidity is any food product [except wine and alcoholic beverages] whose final equilibrium PH is greater than 4.6, or whose "activity water is greater than 0.85" [an example of a product with low acidity, but with "activity water" lower than 0.85 is jam, since high sugar contents drastically reduce the activity water level]. An artificially acidified food product is a product that is naturally low in acidity but whose final equilibrium PH has been reduced with the addition of acidifiers. Or, a food product whose "activity water" level has been brought below 0.85.

Empirical test to understand if we are dealing with a food product that requires SID certification and FCE registration for import into and marketing in the United States

  • Is the food product in question stored at room temperature?
  • Is the food product stored in a hermetically sealed container in metal cans, glass bottles or containers, jars, plastic containers, plastic bags?
  • Is the final pH equilibrium value greater than 4.6? Is the "activity water" level of the finished product greater than 0.85?

If the answer was "Yes" to all of the above questions then you need to complete an FCE registration for your company with the FDA and submit your products for SID Preemptive Certification for import to and sale in the United States.

Food products often exempt from the SID authorization procedure

Generally, the following food products do not fall outside of the SID requirement:

  • Alcoholic products and wine
  • Sodas
  • Jams
  • Fermented foods

The Food and Drugs Administration (FDA) requires manufacturing companies and exporters to complete an FCE [Food Canning Establishment] registration to export long shelf-life food products, including aseptically sealed, canned and/or low acidity products, and/or those with added acidifiers, intended for the US market.

Importing food products to the United States

Manufacturing companies must submit to the FDA all the documentation relating to food product sterilization procedures

These practices are known as "Process Filing", and each is assigned a specific Submission Identifier (SID)

Examples of products that require an FCE registration and SID filing are, in the case of export to the United States, canned tuna in oil or in water, sauces, preserves, truffles, mushrooms and many other canned and long shelf-life food products.

To prevent the FDA from rejecting or blocking the import of canned, tinned, glass, or other long shelf-life foods into the United States, the company must be FCE registered and all procedures must be documented with the FDA.

If your company wishes to export long shelf-life products to the US, ExportUSA offers a range of services that also include assistance with FCE registration procedures and SID import permits for FDA purposes.

If your company does not have an FDA-FCE registration

Thanks to its long experience in exporting food products to the US, ExportUSA can assist you with:

  1. FCE Registration;
  2. Requesting import authorization through the SID procedure;
  3. Obtaining FCE-SID certificates to confirm to the company's customers that the product has been registered with the FDA.
  4. Offering linguistic assistance

If your company already has an FCE registration with the FDA

ExportUSA suggests opting for one of the two following services offered:

  1. Consultancy for new FDA SID Filing Guidance
    Assistance in the completion of SID-related forms, making sure that they have been accurately and thoroughly filled out and that the required formatting has been complied with.
  1. FDA SID certification and administrative requirements

If you believe that your company may be exempt from FDA FCE registration and SID pre-clearance process requirements

Related articles

Export Food Safety Plan USA

Differences between the HACCP manual and the HARPC manual for importing to America

Differences between the HACCP plan and the Food Safety Plan [HARPC plan] required by the FDA under the FSMA legislation on the safety of food products to be exported to the United States of America