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Center for Food Safety & Applied Nutrition Instructions for Establishment Registration and |
A. A low-acid canned food has the following characteristics:
2) Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
3) Receives a heat treatment for the purpose of achieving commercial sterility.
4) Normally stored and distributed under non-refrigerated conditions.
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.
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.
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.
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 FD
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.
A. No, FDA does not approve processing information or cheduled processes for acidified or low-acid canned foods, process sources, or processing plants.
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 of this booklet.
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.
A. The registration form must be completed in English.
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 mailing address given on the form.
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.
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.
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.
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.
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.
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.
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.
A. A firm must complete the necessary process filing form(s) for each product it produces, listing the scheduled process(es) for each.
2) For low acid aseptic packaging systems only, use Form FDA 2541c. Detailed instructions for completing Form FDA 2541a are contained in section III of this booklet and in a separate supplement for Form FDA 2541c.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A. No. Registration and process filing forms are available at no cost to the processor. They may be obtained from the LACF Registration Coordinator, whose address is given at the end of sections I and III of this booklet and the aseptic supplement (which is provided on request to firms who use or plan to use aseptic system).
A. These reproductions should have the same print quality and format of FDA supplied forms.