A commercial processor engaging in the manufacture, processing, or packing of acidified foods (AF) or low-acid canned foods (LACF), is required
- to register with the U.S. Food and Drug Administration
- provide information including the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on
- indicate the processing method and
- a list of foods so processed in each establishment
The registration of your domestic and or foreign establishment is required, and ITB HOLDINGS LLC is ready to assist.
▪ The product is:
- stored, distributed, and retailed under refrigerated or frozen conditions
- processed under the continuous inspection of the meat and poultry inspection program of the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act or the Poultry Products Inspection Act
- a tomato or tomato product with a finished equilibrium pH less than 4.7
- an alcoholic beverage
▪ The water activity (aw) of the finished product is less than or equal to 0.85.
Water activity (aw) is a measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded, and therefore exempt.
aw = p/p0
With :
aw = water activity (-)
p = partial pressure of water (Pa) at equilibrium with the powder at temperature T
p0 = corresponding vapor pressure of water (Pa) at temperature T
The water activity can be related to the equilibrium relative humidity (ERH) thanks to the following formula :
ERH (%) = aw * 100%
All plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation must be under the supervision of a person who has attended a Better Process Control School (BPCS).
FDA and USDA requirements to certify supervisors in acidification, thermal processing, and container closure evaluation operations during the canning of low-acid or acidified foods, are covered by the following courses.
University of California, Davis
University of Tennessee Institute of Agriculture
The Consumer Brands Association
University of Nebraska–Lincoln
Purdue University College of Agriculture
Courses Topics:
▪ FDA Regulations
▪ Microbiology of Thermally Processed Foods
▪ Principles of Acidified Foods
▪ Principles of Thermal Processing
▪ Principles of Food Plant Sanitation
▪ Food Container Handling
▪ Records and Recordkeeping
▪ Equipment, Instrumentation, and Operation for Thermal Processing Systems
▪ Still Steam Retorts.
▪ Still Retorts: Processing with Overpressure
▪ Hydrostatic Retorts
▪ Continuous Rotary Retorts
▪ Batch Agitating Retorts
▪ Aseptic Processing and Packaging Systems
▪ Closures for Double Seamed Metal and Plastic Containers
▪ Closures for Glass Containers
▪ Flexible and Semirigid Containers.
Offered in the United States and several foreign countries.
The FDA conducts inspections to ensure commercial processors of low-acid canned food (LACF) and acidified food (AF) products adhere to, among other things:
- the mandatory requirements of 21 CFR Part 108
- the LACF and AF Current Good Manufacturing Practices (CGMP) regulations under 21 CFR Parts 113 and 114
Manufacturers, exporters and importers should also expect field exams and sample analyses of LACF and AF products offered for entry.
When establishment inspections, analytical results, field exams, or other data and information demonstrate that the products were not properly manufactured to control growth and toxin production from Clostridium botulinum or other microorganisms of significance to public health, FDA may subject the commercial processor and the affected products to an Import Alert.
FDA may detain, without physical examination, shipments of identified products from firms on the Red List of an Import Alert.
- Food Canning Establishment (FCE) Registration
- Process Filing
- U.S. Agent Service
FOOD CANNING ESTABLISHMENT REGISTRATION
