All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA), but food facilities that work with Acidified or Low Acid canned foods are considered to be Food Canning Establishments (FCE) and need an additional registration. If an FCE does not follow FDA registration and process filing requirements, FDA may detain the facility’s Low Acid or Acidified foods at the point of entry until the products are brought into compliance, destroyed, or re-exported.
How do I know if my product is considered an acidified or low acid food?
Though there are a few exceptions, a food is usually considered to be an Acidified or Low Acid food if it is packaged in a hermetically sealed container, has a water activity of 0.85 or above, and is not stored, distributed, and retailed under refrigerated conditions. If the food has a final equilibrium pH less than or equal to 4.6, the food is Acidified. If the food has a final equilibrium pH greater than 4.6, the food is Low Acid.
How do I register as a food canning establishment?
You can register online or on paper by completing Form FDA 2541. Registration should occur within the first ten days after engaging in the manufacturing, processing, or packing of an Acidified or Low Acid canned food. Each separate processing plant needs its own FCE registration. Keep in mind that the address listed in the FCE registration must match the address listed on the establishment’s bioterrorism registration (the registration required for all food facilities). All information submitted to FDA must be in English or FDA will return the form without consideration.
Are there any other requirements for food canning establishments?
Yes. Along with the additional registration, FCEs must file scheduled process information (Form FDA 2541a) for every container type and size of each Acidified and Low Acid food product. Every process filing will have its own submission identifier (SID) to be used in conjunction with the facility’s FCE number. The SID consists of the year, month, and day that the process filing form is submitted and a unique number decided by the filer to identify each process filed on the same day. Process filings do not expire if there are no changes to the process, but any change in concentration, ingredients, processing parameters, pH, or packaging will require a new SID submission.
The scheduled processes used and filed by a food canning establishment must be established by a Process Authority, an individual or company with training and experience in thermal processing. While Registrar Corp is not a process authority, Registrar Corp FCE specialists can help you determine whether or not your product is considered an Acidified or Low Acid food and can assist with FCE registration and filing scheduled processes. Registrar Corp can also assist with the FCE process by translating the FDA 2541 forms into certain languages and converting container sizes into inches and 16ths, the appropriate units required by FDA.
Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. For assistance with FCE regulations, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from Regulatory Specialists any time at: https://www.registrarcorp.com/livehelp.
