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Food Canning Establishment (FCE) Registration
Because foods without adequate acidity may allow the growth of
microorganisms that cause foodborne illness, the FDA requires commercial processors of shelf stable acidified foods
and low-acid canned foods in a hermetically sealed container to be sold in the United States to
■ register each establishment
■ and file scheduled processes for each product, product style, container size and type and processing method.
Failure to comply with these requirements can result in detention of specific shipments or may result in a decision to refuse admission of all products produced by a processor.
Wholesalers, importers, distributors, brokers, are not required to register and file processes. However, they must ensure that manufacturing firms they represent or buy from comply with all registration and process filing requirements.
A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.
An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85.
If the raw or initial product has a pH above 4.6 it is considered a low acid food. If the pH is below 4.6 then the food is classified as an acid food. Acidified foods are low acid foods to which acid or acid ingredients are added to produce a final equilibrium pH of 4.6 or below.
Equilibrium pH means the final pH measured in the acidified food after all the components of the food have achieved the same acidity.
Is the product stored, distributed, and retailed under refrigerated or frozen conditions? If yes, the product is not covered. Refrigerated or frozen foods do not fall under pH control regardless of pH or water activity.
■ Food Facility Registration
■ Food Canning Establishment (FCE) Registration
■ Process Filing (SID)
■ U.S. Agent
■ Electronic Submissions
Submission Identifier - SID numbers (SIDs) must be submitted as Affirmation of Compliance (AofC) codes when importing acidified foods and low-acid canned foods into the United States.
should verify that their suppliers FCE registration is current.
Initial Registration Fee
Foreign Supplier Verification Program (FSVP)
If your company is importing, FSVP is required.
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Food Canning Establishments (FCE)
Scheduled Process Identification (SID - Submission Identifier)
Are subject to the FDA regulations
■ canned vegetables, mushrooms, some fruits
■ fish and acidified products
stabilized by heat sterilization treatment (pasteurization of acidified product),
whether exported or manufactured locally.
These products are low acid, pasteurized,
sterilized or acidified and presented in
■ metal tins & cans
■ canisters, drums, pails,
■ buckets, jars, bottles,
■ flexible pouches or tetra paks.
Anyone wishing to can low-acid foods must use certified equipment, have received proper training at a “Better Process Control School” and keep extensive records as specified by federal regulations.
Better Process Control School (BPCS)
■ course approved by the Food and Drug Administration as well as the United States Department of Agriculture
■ for processors of acidified and low acid canned foods
■ offered online, 2 day workshop (acidified only) or a 3 1/2 day workshop for the entire course.
■ Participants must pass the exams with a score of 70% or higher to become BPCS certified
1. Food Microbiology of Canning
2. Food Container Handling
3. Food Plant Sanitation
4. Records for Production Protection
5. Principles of Thermal Processing
6. Process Room Instrumentation, Equipment, and Operation.
The canning process must be reviewed and certified by a Recognized Process Authority.
A Recognized Process Authority is any person recognized to have the training, experience and equipment needed to determine or verify the sufficiency of a thermal process. This person serves as an independent information resource for both the processor and regulatory agencies. Recognized Process Authorities may be affiliated with private companies, universities or trade organizations.
Low-acid does not refer to acid foods with a low pH. Low-acid refers to a lower acid concentration than that of acid foods.
Because pH scale is inverse, the pH of low-acid foods is higher than that of acid foods.
Canned low-acid foods must be pressure-cooked at high temperatures for long periods of time.
Temperatures of 240°F (115.6°C) or greater are commonly used and process times may range from 20 minutes to several hours.
Most vegetables, meat and poultry foods fall into the low-acid food category.
Acid foods are foods that have a natural pH of 4.6 or below.
Processors of acid foods are not required to register and file information about their establishment(s) and foods they process or to provide information on scheduled processes for their foods.
Examples of acid foods include :
■ apples, oranges, and lemons (as well as the juices expressed from these fruits), rhubarb, peaches, grapes, cherries, plums.
■ standardized and nonstandardized food dressings (such as mayonnaise) and condiment sauces (such as ketchup) that have a natural pH of 4.6 or below
■ Tomatoes and tomato products with a finished equilibrium pH that is 4.7 or above are low-acid foods subject to requirements for low-acid foods when those foods are intended for use in hermetically sealed containers.
Therefore, tomatoes and tomato products with a finished equilibrium pH greater than 4.6, but below 4.7, do not meet the definitions of acid foods, acidified foods, or low-acid foods.
Examples of high-acid foods include jams and jellies, pickles and most fruits.
Because there is no fear of Clostridium Botulinum growth, these foods require much less heating than low-acid foods. To be safe, such foods need only to reach pasteurization temperatures.
For foods with a pH value of 3.5 or less: 175°F (79.5°C) is a sufficient pasteurization temperature.
Foods with a pH range between 3.5 and 4: pasteurization temperature of 185°F (85°C) is recommended.
Foods with a pH range of 4 to 4.3: recommended pasteurization temperature rises to 195°F (90.5°C).
Foods with a pH value of 4.3 to 4.5: recommended pasteurization temperature of 210°F (99°C.
Acidified foods are low-acid foods to which acid(s) or acid food(s) are added; they have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below.
Examples of foods that may be acidified foods include :
■ pickled beets, cocktail onions, and cherry peppers (normally pickled by the addition of acid)
■ Red bell peppers treated in an acid brine
■ Some pears and tropical fruits that have a natural pH greater than 4.6 and are acidified to a pH of 4.6 or below
■ Fermented green olives subjected to processes (such as lye treatment or washing with low-acid foods) that raise the pH above 4.6, with subsequent addition of acid or acid foods to reduce the pH to 4.6 or below
■ Tomato salsa made from tomatoes with a pH of 4.6 or below and low-acid ingredients, when the amount of low-acid ingredients is not a small amount and/or the resultant finished equilibrium pH differs significantly from that of the predominant acid or acid food
■ Cold-pack pickles that are subjected to the action of acid-producing microorganisms but require the addition of acid or an acid food to achieve a pH of 4.6 or below.
Carbonated beverages and foods that are stored, distributed, and retailed under refrigeration are excluded.
Jams, jellies, and preserves are excluded.
A food containing both acid food(s) and low-acid food(s) may or may not be covered as an acidified food.
A process schedule is designed by a process authority to deliver a “commercially sterile” (FDA) or “shelfstable” (USDA) food product.
The Process Schedule describes acidification, preservatives, packaging and the application of heat or cooking used to eliminate microorganisms in the product handled under non-refrigerated conditions.
Two values are always mentioned regarding microbial food safety: pH and water activity
The microbial quality of the final food product is determined by collecting a sample and performing bacterial counts such as aerobic plate count, E.coli, coliforms, yeast and mold counts. The stability (change in water activity or acidity) of the food once canned is another measure of product safety.
Water activity, a term most people are not familiar with, refers to the water in a food that is available for microbial growth.
Based on regulations, if a food has a value of 0.85 or below, it is classified as non-hazardous, because there is not enough free water to allow the growth of pathogens.
The value of Water Activity is different than the moisture content (% water) in a food product.
The moisture content is the total moisture, that is, the amount of bound plus free water present in the sample.
Water Activity provides a measurement of the free moisture and is usually expressed as aw or percentage Equilibrium Relative Humidity (%ERH).
The cooking step in making a food product is called a thermal process. A thermal process is established by understanding the food microbiology and processing method for the specific food that is canned. Food spoilage microorganisms are present throughout the environment, packaging containers and ingredients. High temperature kills microorganisms present in food, and the hermitically sealed container prevents re-contamination.
As an example, scheduled process is required for each of the following product container sizes for the following acidified foods and package:
Green Olive and Pimento Cheese Dip in 4 oz glass jars
Green Olive and Pimento Cheese Dip in 7 oz glass jars
Chipotle Cheese Dip in 4 oz glass jars
Chipotle Cheese Dip in 7 oz glass jars
Artichoke Leaf Cheese Dip in 7 oz glass jars
Raspberry Jalapeno Cheese Dip in 7 oz glass jars
Chocolatey Cherry Amaretto Cheesecake Fondue in 4 oz jars.