Food Canning Establishment Registration and Process Filing are required for Acidified and Low-Acid Canned Foods.
A commercial processor engaging in the manufacture, processing, or packing of acidified foods (AF) or low-acid canned foods (LACF) must register and file with the FDA, by providing the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method, and a list of foods processed in each establishment.
Whether food should be processed in a pressure canner or boiling-water canner to control botulinum bacteria depends on the acidity of the food.
Food Facility Registration (FFR) is not Food Canning Establishment (FCE) Registration, and obviously, the requirements are different.
Low-acid Foods have pH values higher than 4.6, and include:
▪ red meats
▪ all fresh vegetables except for most tomatoes.
Most mixtures of low-acid and acid foods also have pH values above 4.6 unless their recipes include enough lemon juice, citric acid, or vinegar to make them acid foods.
However, Acid Foods have a pH of 4.6 or lower such as:
▪ marmalades, and fruit butters.
Commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers must have a current procedure and plan for:
- effecting recalls of any product that may be injurious to health
- identifying, collecting, warehousing, and controlling the product
- determining the effectiveness of such recall
- notifying the Food and Drug Administration of any such recall
- implementing such recall program.
Manufacturers must use certified equipment, have received proper training at a “Better Process Control School” (BPCS), and keep extensive records as specified by federal regulations.
Foreign companies must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the establishment and the FDA. The U.S. Agent is authorized to register any facility.
The Food and Drug Administration will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
Since the registration of your domestic and or foreign establishment is required, ITB HOLDINGS LLC is ready to assist. But, your company must provide:
- processing method
- type of retort or other thermal processing equipment employed
- minimum initial temperatures
- times and temperatures of processing
- sterilizing value (Fo)
- or other equivalent scientific evidence of process adequacy
- critical control factors affecting heat penetration
- source and date of the establishment of the process
- for each such low-acid food in each container size.