Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF): Paper Submission Instructions Part V (Common Questions And Answers Concerning Registration And Process Filing Requirements)
Q. WHAT IS A LOW-ACID CANNED FOOD?
A. A low-acid canned food has the following characteristics:
Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
Receives a heat treatment for the purpose of achieving commercial sterility.
Normally stored and distributed under non-refrigerated conditions.
Q. WHAT IS AN ACIDIFIED FOOD?
A. An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under nonrefrigerated conditions.
Q. WHO MUST REGISTER WITH FDA?
A. All commercial acidified and low-acid canned food processors located in the United States and all processors in other countries who process acidified or low-acid canned food products for export to the United States must register. Importers, wholesalers, distributors, brokers, etc. are excluded from the requirement to register. However, they must ensure that processing firms they represent comply with all the applicable regulations.
Q. WHEN IS A FERMENTED FOOD NOT COVERED BY THE LOW-ACID CANNED FOOD OR ACIDIFIED FOOD REGULATIONS?
A. Fermented foods are not covered by these regulations, and thus do not need to have processes filed with FDA, if the food is naturally fermented whereby the pH of the food is reduced to 4.6 or below by the production of acid from the growth of acid-producing microorganisms. If fermentation does not lower the pH to 4.6 or below and an acidulant is added to further reduce the pH to 4.6 or below, this product would be covered by the acidified foods regulations.
Q. DO PILOT PLANTS HAVE TO REGISTER?
A. Yes, pilot plants which produce samples of acidified or low-acid canned foods for market or consumer testing within the United States must also register with FDA.
Q. IS REGISTRATION AND PROCESS FILING THE SAME FOR U.S. FIRMS AND FIRMS LOCATED IN OTHER COUNTRIES?
A. Yes, registration and process filing is the same for all commercial acidified and low-acid canned food processors located in the United States and processors in other countries. However, processors in other countries need to register and file processes only for those foods that are to be imported into the United States.
Q. IS REGISTRATlON A LICENSE OR CERTIFICATION FROM FDA?
A. No, FDA does not approve processing information or scheduled processes for acidified or low-acid canned foods, process sources, or processing plants.
Q. HOW DOES A FIRM REGISTER?
A. A processing plant registering for the first time completes a Food Canning Establishment Registration form (FDA 2541) according to the instructions in section II.
Q. HOW DOES A PARENT COMPANY WHICH OWNS ONE OR MORE SUBSIDIARY FOOD PROCESSING PLANT(S) REGISTER EACH FIRM?
A. A separate Food Canning Establishment Registration form (FDA 2541) must be submitted for each processing plant location. A separate Food Canning Establishment (FCE) number will be assigned to each.
Q. WHAT LANGUAGE SHOULD BE USED TO COMPLETE THE REGISTRATION FORM?
A. The registration form must be completed in English.
Q. WILL A FIRM BE NOTIFIED WHEN ITS REGISTRATION IS RECEIVED?
A. Yes. An FCE number will be assigned after receipt of a Food Canning Establishment Registration form FDA 2541) by FDA. The number will be furnished to the registering firm on a copy of the registration form which will be returned to the plant location/address given on the form.
Q. HOW MANY TIMES MUST A FIRM REGISTER?
A. A firm registers each processing plant location once. The firm will retain its FCE number for as long as the plant produces acidified or low-acid canned foods at the registered location.
Q. HOW DOES A FIRM CHANGE REGISTRATION INFORMATION?
A. Changes to registration information such as changes to firm name or mailing address are submitted on a Food Canning Establishment Registration form (FDA 2541). A firm going out of business or no longer producing regulated products should submit such notification to FDA by letter.
Q. IF A FIRM HAS MOVED, MUST IT RE-REGISTER?
A. Yes, a change of processing location nullifies the original FCE number since registration is based on processing location. The processing firm must complete a new Food Canning Establishment Registration form listing the new location. Under "TYPE OF SUBMISSION", check "Relocation". Enter previously assigned FCE Number in the space for "Current FCE" and complete all other spaces on the form as in an initial registration. A new FCE number will be assigned to the processing plant upon receipt of the new registration form.
Q. IF A PROCESSING ESTABLISHMENT IS SOLD, MUST THE NEW OWNER REREGISTER AND RE-FILE PROCESSES?
A. The new owner must notify FDA of the change of ownership and name change, if applicable. However, the firm will retain the FCE number previously assigned to the establishment location. In most situations, all processes to be used must be refiled and any which will not be used must be canceled. If a written agreement can be reached between the previous owner and the new owner to convey or make available all process establishment information, provide a copy of the agreement with the registration form. In these special cases refiling may not be required. The FDA LACF Coordinator will notify the new owner regarding refiling when the registration notification is made.
Q. WHAT IF A FIRM FAILS TO REGISTER?
A. Firms in the United States must register their processing establishment(s) with FDA not later than 10 days after first engaging in the manufacturing, processing, or packing of acidified or low-acid canned foods. Otherwise, the firm and/or its products may face regulatory action. Firms in other countries must register before offering any acidified or low-acid canned food products for import into the United States. Otherwise, the products will be held (detained) at the port of entry until the firm meets the registration and process filing requirements. In addition, the firm must comply with all applicable mandatory provisions of 21 CFR 108, 113 and 114.
Q. IS REGISTRATION THE ONLY REQUIREMENT FIRMS MUST MEET?
A. No, processing plants must also submit process filing forms containing scheduled process information for each acidified and low-acid canned food produced, and must meet all other requirements of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Q. CAN A FIRM REGISTER AND SUBMIT PROCESS FILING FORMS AT THE SAME TIME?
A. Yes, FDA encourages this procedure. The firm should request the appropriate form(s) from FDA and submit them with the necessary information. FDA will assign an FCE number and enter it on its copies of the process filing forms. When the firm receives its copy of the registration form with its assigned FCE number, the firm should enter that number on its file copies of all forms. All correspondence with FDA, shipping documents, etc, should include that FCE number.
Q. HOW DOES A FIRM FILE PROCESSES?
A. A firm must complete the necessary process filing form(s) for each product it produces, listing the scheduled process(es) for each.
For all processing methods except low-acid aseptic, use Form FDA 2541A.
For low acid aseptic packaging systems only, use Form FDA 2541c. Detailed instructions for completing Form FDA 2541a are contained in section III of the instructions and Form FDA 2541c is contained in Section IV.
Q. MUST A FIRM SUBMIT A SEPARATE PROCESS FILING FORM FOR EACH ACIDIFIED AND LOW-ACID CANNED FOOD?
A. Yes, FDA requires a separate process filing form for each acidified and low-acid canned food produced. In addition, a separate form must be completed for each form or style (including packing medium) receiving a different scheduled process. Further, a separate form must be completed for each container type (metal, glass, etc.). Each process filing form must list all container sizes for each product as well as other information specified by the detailed instructions contained in Section III of this booklet and the aseptic supplement. Products from other countries with unusual names should be described in detail including scientific names, part of the plant used, etc. Process filing forms must list the English name as well as the non-English name of the product as it appears on the label. For example:
Green kidney beans (flageolets) in brine
Broad beans (papdi) in brine
Q. IF A FIRM HAS CHANGED ITS PROCESSING LOCATION, WILL NEW PROCESS FILING FORMS HAVE TO BE SUBMITTED TO FDA?
A. Yes, a new registration form (FDA 2541) must be submitted, as well as new process filing forms for each acidified or low-acid canned food produced at the new plant location. A new FCE number will be assigned by FDA. The old number will no longer be valid and will not be accepted by FDA.
Q. WHEN MUST A FIRM FILE PROCESSES?
A. Processes must be filed no later than 60 days after registration and prior to packing a new product, or, in the case of firms in other countries, before importing into the United States. Registration and process filing may be done concurrently.
Q. WHAT IF A FIRM FAILS TO FILE PROCESSES?
A. If a firm in the United States fails to file processes, the firm and/or its products may face regulatory action. Firms in other countries must file processes for each acidified or low-acid canned food before offering any such product for import into the United States. Products from firms in other countries which do not have processing information on file with FDA will be held (detained) at the port of entry. Those firms must comply with the registration and process filing requirements before admission of the product into the United States will be allowed.
Q. WHERE CAN A FIRM OBTAIN SCHEDULED PROCESSES?
A. A firm should contact a process authority that scientifically establishes scheduled processes for acidified and/or low-acid canned foods. Such authorities may include trade associations, container or equipment suppliers, universities, etc. with the scientific knowledge and experience, as well as adequate facilities, to properly establish processes which will result in commercially sterile products being produced under the actual industry conditions of the process application.
Q. HOW DOES FDA HANDLE PROCESS FILING FORMS?
A. An FDA food technologist examines each process filing form for incorrect or missing information. Such forms are returned to firms for correction. Properly completed forms are further technically edited for computer entry, entered, and verified. Under no circumstances does filing of the information constitute approval of the process source, the process, or its adequacy. It is the responsibility of the processor to determine and assure the adequacy of any process before using it.
Q. WILL A FIRM BE NOTIFIED WHEN FDA RECEIVES THEIR PROCESS FILING FORMS?
A. No, because of the volume of process filing forms FDA receives, FDA will contact firms only when the scheduled process information is incomplete, or the information incorrectly filed. However, self addressed, U. S. postage marked acknowledgements prepared by the person submitting the filing forms will be returned if it appears that the forms are correctly filed.
Q. WHAT MUST A FIRM DO WHEN A PROCESS FILING FORM IS RETURNED BECAUSE OF INCOMPLETE OR INCORRECT INFORMATION?
A. Firms will receive a letter with the returned process filing form indicating the problem areas. Firms should contact their process source to obtain adequate process information, where necessary. All process information changes and additions should be made directly on the returned copy whenever possible. If completion of a new form is necessary, the old (incorrect) form should be attached to the new one and both returned to FDA.
Q. DOES FDA APPROVE A FIRM'S LOW-ACID CANNED FOOD OR ACIDIFIED FOOD PROCESSES?
A. No, FDA does not approve processes or process source authorities for low-acid or acidified foods. It is the responsibility of the processor to ascertain the adequacy of any process before using it.
Q. IF A FIRM HAS CHANGED A SCHEDULED PROCESS FOR AN ACIDIFIED FOOD OR A LOW-ACID CANNED FOOD, MUST IT REFILE?
A. Yes, a replacement process filing form must be completed if the firm makes any change to a scheduled process or any factors critical to the adequacy of the process. This includes changes to the minimum initial temperature, process time or temperature, product formulation changes which affect the scheduled process, or any other critical factor. Instructions for submitting replacements for filed processes are contained in Section III of this booklet and in the aseptic supplement.
Q. IF A FIRM IS PACKING ADDITIONAL CAN SIZES OF ACIDIFIED OR LOW-ACID CANNED FOODS, MUST PROCESS FILING FORMS BE SUBMITTED FOR THESE ADDITIONS?
A. Yes, a firm must submit a new process filing form listing all additional container sizes which will be used for each product, along with all other process information.
Q. IF A FIRM HAS STOPPED PRODUCING SOME ACIDIFIED OR LOW-ACID CANNED FOODS, SHOULD FDA BE NOTIFIED?
A. Yes, FDA should be notified in writing when acidified or low-acid canned foods are no longer produced by the firm. Detailed instructions for discontinuing or canceling previously filed processes are contained in Section III of this booklet and in the aseptic supplement.
Q. IS THERE A COST FOR FDA FORMS?
A. No. Registration and process filing forms are available at no cost to the processor. They may be obtained by printing out the forms from this website.
Q. CAN FIRMS USE PHOTOCOPIES OR COMPUTER GENERATED REPRODUCTIONS OF REGISTRATION AND PROCESS FILING FORMS?
A. These reproductions should have the same print quality and format of FDA supplied forms.