24/7 Live Chat Call Us

National Canned Food Month: History & Top Facts about FDA FCE Regulations

February has been deemed National Canned Food Month in the United States.  Food canning spurred from a reward of 12,000 francs offered by Napoleon in 1795 to anyone who could offer an improved method of preserving food for his army.  Frenchman Nicolas Appert claimed the prize when he discovered that applying heat to foods in sealed glass bottles improved their shelf life.  Appert’s discovery led to our current food preservative method of canning. In the 1810’s, a skilled worker could produce an average of four cans in one day.  Today, advanced machinery can produce about 400 cans per minute.

Several life-threatening Clostridium botulinum outbreaks occurred in the early 1970’s due to inadequate canning processing.  As a result, the U.S. Food and Drug Administration (FDA) implemented regulations specifically for thermally processed low-acid and acidified foods.  Registrar Corp is joining in the celebration of over 200 years of food canning by publishing a list of the top 10 things to know about FDA regulations for food canning establishments (FCE).

  1. FCEs must have two separate registrations: a food facility registration (FFR) and an FCE registration.  The two registrations are linked, and a facility’s name, physical address, and preferred mailing address are required to be listed identically in both.
  2. All documentation submitted to FDA, such as a registration, a process filing (SID), or a specialized study or report, must be in English. Otherwise, FDA may return the documentation.
  3. Separate SIDs should be submitted for each size, packaging type, and flavor of a product.
  4. An FCE should not ship any low acid or acidified foods to the US until its SIDs have been reviewed and filed by FDA.  If shipments are sent without having valid SID numbers for the products, the shipments are subject to detention.
  5. Once an SID is filed, it’s important to follow that process.  If a product’s parameters (for example, its ph, dimensions, ingredients, etc.) don’t match what it is on file, the product may be detained by FDA.  FDA will also check whether SIDs match the process at the plant when the agency conducts a facility inspection.
  6. SIDs should be included with Prior Notice submissions.  Prior Notice must be filed for every shipment of food sent to the US.
  7. When shipping a canned food that is excluded from FCE regulations to the US, it’s a good idea to include documentation within the shipment that proves the exclusion.  This can help avoid potential detention of the shipment.
  8. A facility must notify the FDA Low-Acid Canned Food Coordinator of any changes to the facility’s mailing address, physical location, company name, or facility contact person so that its FCE registration can be updated. In certain cases, a new FCE registration may be required.
  9. If a facility has a change of ownership or change of physical location, it will need a new FCE registration. The facility will have to submit new SIDs as well.
  10. Low-acid canned food and acidified food regulations apply to any hermetically sealed foods, not just foods in cans. Examples of other types of containers that may be included are glass, plastic, and pouches.

Registrar Corp is an FDA compliance firm that helps Food Canning Establishments comply with U.S. FDA regulations.  Registrar Corp can register an FCE with FDA and submit its process filings quickly and properly.  Registrar Corp can also help prepare the documentation to include in shipments of products excluded from FCE regulations.  For more information about FDA’s requirements for FCEs or how Registrar Corp can assist, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/LiveHelp.