- PURPOSE OF THIS BOOKLET
Federal Regulations require commercial processors of acidified foods and low-acid canned foods to be sold in the United States to register each establishment and file scheduled processes with the Food and Drug Administration for each product, product style, container size and type and processing method. See Title 21, Code of Federal Regulations, Part 108 (21 CFR 108). This booklet is designed to help processors comply with those requirements. The instructions for completing the registration and process filing forms for all processing methods except low-acid aseptic are contained in this booklet. Please read these instructions thoroughly and follow them carefully. Process filing instructions for low-acid aseptic processing and packaging systems are contained in a separate supplement which is available upon request to establishments using such systems.
This booklet also contains examples of properly completed forms as well as answers to some of the more frequently asked questions regarding registration and process filing.
Complete instructions for establishment registration and process filing are contained in this booklet as indicated below:
- Food Canning Establishment Registration (Form FDA 2541)
- Process Filing for All Processing Methods Except Low-Acid Aseptic (Form FDA 2541a)
At the end of each section is an example of a properly completed form referring to the appropriate portion of the text.
- THE NEED FOR REGULATIONS
In the early 1970's, several life-threatening botulism outbreaks occurred as a result of inadequate thermal processing of commercially prepared low-acid foods packaged in hermetically sealed containers and improper acidification of commercially prepared acidified foods. Consequently, the following regulations were published by the FDA:
21 CFR 113 (Thermally Processed Low-Acid Foods)
21 CFR 114 (Acidified Foods)
The current Good Manufacturing Practice Regulations (GMP's) for low-acid canned foods (21 CFR 113) became effective in March 1973 (revision became effective May 15, 1979). The GMP's for acidified foods (21 CFR 114) became effective in May 1979. These GMP's outline the equipment, controls, manufacturing, processing, and packing procedures which are required to ensure the production of a safe product.
The purpose of the above regulations is to protect consumers from microorganisms of public health significance (i.e., harmful bacteria or their toxins), especially Clostridium botulinum. The spores of Clostridium botulinum must be destroyed or effectively inhibited to avoid germination and subsequent production of the deadly toxin which causes botulism. This is accomplished with good manufacturing practices which must include:
- The use of thermal processes and/or other means of preservation that are properly designed by a competent processing authority to destroy or inhibit Clostridium botulinum spores;
- Proper delivery of these thermal processes and/or adequate control of other methods of preservation being used.
- Sufficient documentation that the scheduled processes are delivered through the keeping of appropriate records.
- REQUIREMENTS OF THE REGULATIONS
THIS PUBLICATION CONTAINS ONLY A SUMMARY OF THE PRINCIPAL REQUIREMENTS OF THESE REGULATIONS. LOW-ACID CANNED FOOD AND ACIDIFIED FOOD PROCESSORS AND SHIPPERS/IMPORTERS OF REGULATED IMPORTED PRODUCTS MUST TAKE STEPS TO FULLY INFORM THEMSELVES CONCERNING THE APPLICABLE REQUIREMENTS OF THESE REGULATIONS BEFORE OFFERING LOW ACID CANNED FOOD OR ACIDIFIED FOODS FOR DISTRIBUTION WITHIN OR IMPORTATION INTO THE U.S.
Food processing establishments in the United States and those which export foods to the United States are subject to regulations which require registration of the establishments and filing of scheduled processes. The registration and process filing regulation for thermally processed low-acid foods packaged in hermetically sealed containers is 21 CFR 108.35. The applicable registration and process filing regulation for acidified foods is 21 CFR 108.25, which became effective in July, 1979. 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.
Improperly processed low-acid canned foods or acidified foods present life-threatening hazards; therefore registration of those establishments which manufacture, process, or pack low-acid canned foods or acidified foods and filing of the processes they use are necessary to identify processors and to monitor compliance with the regulations, to provide for immediate application of emergency permit control should a potential public health hazard be identified.
UNDER NO CIRCUMSTANCES DOES FILING OF THE INFORMATION CONSTITUTE FDA APPROVAL OF THE PROCESS AUTHORITY, THE PROCESS, OR ITS ADEQUACY. IT IS THE RESPONSIBILITY OF THE PROCESSOR TO ASCERTAIN THE ADEQUACY OF ANY PROCESS BEFORE USING IT.
The following foods are not considered low-acid canned foods. Therefore, processors of these foods do not have to register and file processing information for these products:
- Acid foods (natural or normal pH equal to 4.6 or below)
- Alcoholic beverages
- Fermented foods (when the pH of the food is reduced to 4.6 or less by the growth of acid producing microorganisms)
- Foods processed under the jurisdiction of the meat and poultry inspection program of the United States Department of Agriculture under the Federal Meat Inspection Act and the Poultry Products Inspection Act
- Foods with water activity (aw) of 0.85 or below
- Foods which are not thermally processed
- Foods which are not packaged in hermetically sealed containers (refer to 21 CFR 113.3(j))
- Foods stored, distributed, and retailed under refrigerated conditions (product must be conspicuously labeled - e.g., Perishable, keep refrigerated)
- Tomatoes and tomato products having a finished equilibrium pH less than 4.7
The following foods are not considered acidified foods. Therefore, processors of these foods do not have to register and file processing information for these products:
- Acid foods (natural or normal pH equal to 4.6 or below)
- Acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid foods and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid food. If there is a question about whether a product is covered under the regulations, describe the product, submit a quantitative formula, list pH ranges for each ingredient and submit pH data on finished product from several production lots.
- Alcoholic beverages
- Carbonated beverages
- Fermented foods
- Foods with water activity (aw) of 0.85 or below
- Foods stored, distributed, and retailed under refrigerated conditions
- Jams, jellies, or preserves covered by 21 CFR 150.
After technical editing is completed on a filing form which has been submitted for a food which falls into one of the above categories, the form is returned to the firm with a letter indicating that process filing for that product or process (such as fermentation) is not required. The manufacturer may be required to provide data to substantiate the exclusion.
Figs, pears, pineapples or some tropical fruits with a finished equilibrium pH above 4.6 and an aw greater than 0.85 are considered low-acid canned foods. If they are thermally processed and packaged in hermetically sealed containers, they are subject to Part 113. If figs, pears, or pineapples or some tropical fruits having a normal pH prior to processing of greater than 4.6 are acidified to a pH of 4.6 or below, these products are subject to 21 CFR 108.25 and 114.
The following table illustrates the relationships between pH, water activity (aw), and current low-acid and acidified regulations. The table indicates whether a product is a low-acid or an acidified food and therefore must meet the registration and process filing requirements of FDA. To use the table, determine the finished equilibrium pH and water activity (aw) of the product. It is the relationship between pH and water activity that defines a product as either low-acid or acidified. Regardless of pH, a food product with a water activity of 0.85 or below, would not be covered by the low-acid canned food regulations or the acidified food regulations. Thus, the firm would not be required to file scheduled process information for that product.
NOTE: THIS TABLE DOES NOT APPLY TO FOODS WHICH ARE NATURALLY OR NORMALLY ACID, AS DEFINED IN THE PRECEDING PARAGRAPHS.
| Final Equilibrium pH |
Water Activity (aw) |
Registration and Process Filing Required as: | |
| Low Acid* (21CFR 108.35/113) |
Acidified** (21CFR 108.25/114) | ||
 4.6 |
0.85 | No | No |
| 4.6 |
>0.85 | No | Yes |
| >4.6 | 0.85 |
No | No |
| >4.6 | >0.85 | Yes | No |
|
> greater than * A yes under this column defines the product as low-acid, subject to the requirements of 21 CFR 108.35 and 113, and it means that the establishment must register and file scheduled process information for that low-acid product. ** A yes under this column indicates that the product is an acidified food, subject to the requirements of 21 CFR 108.25 and 114, and if so, requiring the establishment to register and file scheduled process information for that acidified product. | |||
Registration is accomplished by completing Form FDA 2541 in accordance with the instructions in Section II of this booklet. Submitting a complete registration form is required for U.S. establishments as well as establishments in other countries which export low-acid canned food or acidified food products to the United States. Process filing forms will be returned if the food canning establishment has not registered. Registration and process filing may be done at the same time.
Process filing is required for all processing establishments in the United States and those located in other countries which process acidified or low-acid canned foods for export to the United States. Filing scheduled process information is accomplished by completion of a separate process filing form for each product (Form FDA 2541a or Form FDA 2541c). See Section III for details.
PROCESS FILING FORMS ARE TECHNICALLY EDITED FOR COMPLETENESS PRIOR TO COMPUTER ENTRY. NO FORM IS CONSIDERED BY FDA TO BE FILED UNTIL TECHNICALLY EDITED. FORMS ARE RETURNED TO FIRMS FOR CLARIFICATION AND ADDITIONAL INFORMATION WHEN NECESSARY.
In order to identify each separate process filing form submitted by an establishment, a "Submission Identifier" (SID) is used. The SID enables both the firm and FDA to quickly and accurately identify a specific filing form. It is used in conjunction with a firm's Food Canning Establishment (FCE) number and consists of the year, month, and day of the month that a process filing form is submitted, and a unique sequence number to identify each form when multiple forms are submitted on the same date. The SID must be assigned by the establishment when a process filing form is prepared and is in the following format:
Where:
YY represents the last two digits of the calendar year (e.g., 98 for 1998, etc.)
MM represents the month (e.g., 02 for February, 10 for October, etc.)
DD represents the day of the month (e.g., 02, 19, 30, etc.)
SSS represents a unique sequence number to identify each form when more than one process filing form is being submitted on the same date. If only one process filing form is being submitted on a day, use 001 for the sequence number. If multiple forms are being submitted, assign a different number for each separate form (e.g., 002, 003, 004, etc.).
When a previously submitted process is being discontinued or superseded, the SIDs will clearly identify which specific submission is so affected. Specific instructions for entering SIDs are contained in the sections dealing with completion of process filing forms.
Products exported from foreign countries to the U.S. for marketing in the U.S., including both acidified and low-acid canned foods, are subject to inspection at the time of entry into the United States. Shipments which do not comply with U.S. laws and regulations WILL BE DETAINED AT THE PORT OF ENTRY. THESE PRODUCTS MUST BE BROUGHT INTO COMPLIANCE WITH THE U.S. LAWS AND REGULATIONS, DESTROYED, OR RE-EXPORTED.
Low-acid canned foods or acidified foods may be detained at the port of entry for a variety of reasons, including the following:
- Establishment is not registered
- Establishment is registered but has not filed process information for the product with the FDA
- Documentation provided with entry does not provide sufficient information to allow identification of the Food Canning Establishment (FCE) or the product.
In addition to LACF and acidified regulations (21 CFR 108.35, 108.25, 113, and 114), all other requirements of FDA's laws and regulations must be met before the products will be allowed entry into the United States. These include sanitation requirements during processing and storage, labeling, etc.
HOW TO AVOID DELAYS
Processors and exporters of low-acid or acidified foods to the U.S. can avoid delay in clearing such products for entry into the United States by ensuring that invoices, manifests, and other shipping documents include the following information:
- Name and address of the processing establishment as registered with the FDA
- Food Canning Establishment (FCE) number of the registered establishment
- Submission Identifier(s) (SID) of process filing form(s) listing process(es) filed with FDA for this product
- Product name of low-acid canned food or acidified food
product, form or style, and packing medium (as printed on
the container label and also as listed on the filing
form). For example:
Tuna (chunk style) in oil
Sardines in tomato sauce
Artichoke hearts (quartered) in brine
Mushrooms (sliced) in butter sauce
Both the English and non-English name (when applicable) should be listed as it appears on the label. For example:
Green kidney beans (flageolets) in brine
Broad beans (papdi) in brine
- Container type.
- Container dimensions for each type or size container, in inches and sixteenths of an inch. See chart in Appendix A for converting from Metric units (mm) to English units (inches and sixteenths).