U.S. FCE REGISTRATION

U.S. FCE (Food Canning Establishment) Registration is a mandatory registration with the FDA (Food and Drug Administration) for establishments that manufacture low-acid canned foods (LACF) or acidified foods (AF) in the United States and engage in interstate commerce of these products.

What is the Purpose of FCE Registration?

The primary purpose of this registration is to ensure food safety and protect public health. Low-acid and acidified foods, if not properly processed, can create a suitable environment for the growth of Clostridium botulinum, a bacterium that can cause botulism, a potentially fatal food poisoning.

Which Foods are Covered?

• Low-Acid Canned Foods (LACF): Foods with a pH greater than 4.6 and a water activity (aw) greater than 0.85 that have been thermally processed and packaged in hermetically sealed containers. Examples: canned vegetables, soups, meats.

• Acidified Foods (AF): Foods to which acid or acid foods are added to reduce the pH to 4.6 or below. Examples: pickles, brined vegetables, some sauces.
  
  

Who Must Register for FCE?

• All establishments that manufacture the low-acid canned foods or acidified foods defined above and introduce these products into interstate commerce (i.e., for sale in multiple U.S. states or internationally).

• All firms, including foreign manufacturers, that export such products to the United States.

Importance of FCE Registration:

• Legal Requirement: It is illegal to introduce low-acid canned foods or acidified foods into interstate commerce without FCE registration, and doing so can result in severe penalties.

• Food Safety: The registration process allows the FDA to inspect establishments and their products, minimizing food safety risks.

• Consumer Health: Helps prevent food poisoning outbreaks, such as botulism.

• Market Access: Without FCE registration, it is not possible to sell these types of products in the U.S. market.