WITHDRAWN Guidance for Industry: Importer's Guide for Low-Acid Canned and Acidified Foods
2001 (Rev. 2)
Protecting Your Investment
Like many importers, you have probably invested a considerable amount of money in your low-acid canned food and acidified food imports. It makes good sense to protect your investment and to import only safe, thermally processed or properly acidified foods. Besides, that's the law. Because only legal products are permitted into the United States, it's necessary for you to know about the legal requirements enforced by FDA. This pamphlet can help you. It focuses on the necessity for processors of low-acid canned foods and acidified foods to register their establishments with FDA. These processors must also provide FDA with their products' processes. The regulations which require registration and process filing (Title 21 Code of Federal Regulations (CFR) 108.25 and 108.35) also contain other requirements.
Remember — an illegal import may be denied entry into the United States, so stop a moment and make sure that everything about your import food entry is in order.
A Question and Answer Guide
Registration of Manufacturers of Low-Acid Canned Food and Acidified Foods
Q. What foreign food processing establishments must register with FDA?
A. Each low-acid canned food and acidified food processing establishment which ships products to the United States must register with FDA. Make sure the processing establishment is registered with FDA before importing its products.
Upon receipt of a Food Canning Establishment Registration Form (FDA-2541), FDA assigns each registered processing establishment a Food Canning Establishment Number (FCE#). This number helps FDA track the firm's registration and processing records.
Q. How do I find out if the processing establishment is registered?
A. Contact the processing establishment to verify FDA establishment registration and to obtain the firm's Food Canning Establishment Number (FCE#).
Q. Can I register the processing establishment?
A. FDA recommends that the processing establishment complete the establishment registration form. In some cases, you may register the processing establishment as the firm's authorized representative. FDA requires a letter from the processing establishment authorizing you to act as its representative and to register the establishment. The letter must be enclosed with the registration forms. Before submitting the registration forms to FDA, have the processing establishment authorize all registration information.
Q. Can I obtain the LACF registration listing for all foreign processors?
A. Yes, a list of foreign processors that have completed the LACF establishment registration form is available through the Freedom of Information Act (FOIA). Instructions for how to submit a FOIA request can be found at http://www.fda.gov/foi/foia2.htm (Updated web link: Freedom of Information)
Inquiries to FDA should be sent to: Food and Drug Administration Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857.
Q. How can I tell if my imports are low-acid canned or acidified products?
A. Low-acid canned foods are products like green beans, mushrooms, and tuna fish. They are packaged in hermetically sealed containers, have a pH greater than 4.6 and a water activity greater than 0.85. Acidified foods are low-acid foods to which acid is added to reduce the pH to 4.6 or below.
Some examples of acidified foods are pickles, pimientos, and marinated artichokes. Acidified foods must also have a water activity greater than 0.85 to be included under the regulations.
FDA recommends that you fully inform yourself of the regulations for low-acid canned foods and acidified foods. If you are unsure if the product is low acid or acidified, contact the processing establishment. It has the technical information and should be able to tell you.
Q. How can I obtain information on the low-acid and acidified regulations?
A. Contact the LACF Registration Coordinator, HFS-618, Center for Food Safety and Applied Nutrition, 200 C St., SW, Washington, DC 20204 (See updated contact information below). You may send your request for a registration form by e-mail to: firstname.lastname@example.org (Updated email: email@example.com) (please include your name, company name and postal address in the e-mail request).
Q. If the processor is unable to determine if the products are low-acid or acidified, can FDA provide assistance?
A. Yes, processors may ask for FDA's help by writing to: Regulatory Food Processing and Technology Branch (HFS-617), 200 C St., SW, Washington, DC 20204 See updated contact information below.). Send the name of the product (in English), specific processing produres, the pH of each ingredient, product formula, (percentage by weight of each ingredient), and water activity.
Filing Scheduled Processes
Q. What is a scheduled process?
A. The process time and temperature, as well as any other factors (e.g., drained weight, formulation, headspace, water activity) critical to adequacy of the process, which has been established by a competent process authority and which is designed to achieve commercial sterility.
Q. For what low-acid canned food and acidified foods does the food processing establishment have to file a scheduled process?
A. Processors must file a separate scheduled process for each product and product style, and for each container size of all low-acid canned foods and acidified foods it intends to export to the United States. This must be done before shipping the products to the United States. The processor must complete the necessary forms for each product and each container type and size intended for shipment. The form used depends upon the product's process. The processing establishment can define the process and determine the correct forms to use.The forms are: Form FDA-2541a (all methods except low-acid aseptic packaging systems) Form FDA-2541c (Low-acid aseptic packaging systems). Both forms are available for viewing/downloading at http://www.cfsan.fda.gov/~comm/lacf-toc.html (Updated web link: xxxx ).
Q. Is it necessary to file the scheduled process information with FDA before I import my product?
A. Yes, complete scheduled process filing information must be on file with FDA before offering your products for import into the United States. FDA food technologists technically edit all process filing information for accuracy and completeness. This important activity requires care . Because of the many forms, it may take several weeks to complete this edit.
Q. May the importer file the scheduled process information?
A. FDA recommends that the processing establishment complete all the necessary filing forms. Completion of these forms requires knowledge of thermal processing requirements and of the scientific data relating to heat resistance of food spoilage bacteria. In some cases, you may wish to file process information as the processing establishment's authorized representative. FDA requires a letter from the processing establishment authorizing you to represent the firm and to file this information. The letter must be enclosed with the process filing forms. Before submitting the forms to FDA, please have the processing establishment authorize all process filing information. The technical nature of the process filing information, and the actual location of the processing establishment away from your office, make this communication very important.
Q. The processing establishment told me they filed a process with FDA for the product I intended to import. Why has the shipment been detained?
A. FDA food technologists examine each process filing for possible incorrect or incomplete filed process information about the process. Because of the serious nature of questionable, incomplete, or incorrectly filed processes, the forms will be returned to the firm for clarification and/or completion. Until the returned forms are found to be complete, they are not considered on file with FDA.
Q. Will I receive a certificate from FDA for the scheduled process I have filed with FDA?
A. No, FDA does not certify processes. It is the responsibility of the food processor to obtain scheduled processes established by a competent processing authority and to assure that the filed processes are followed.
Q. Are there other requirements for low-acid canned foods and acidified foods besides establishment registration and process filing?
A. Yes, imported low-acid canned foods and acidified foods are subject to all of the requirements under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. These laws require that foods be safe, clean, and wholesome, and that labeling be honest and informative.
The processing of low-acid canned foods must comply with the requirements of the Good Manufacturing Practice regulations (21 CFR Part 113). The processing of acidified foods must comply with the requirements of the Good Manufacturing Practice regulations (21 CFR Part 114).
Help to Prevent Delays
Before the shipment arrives at the port of entry, be sure to contact the nearest FDA Office (listed on the inside back cover) to obtain information about FDA's Operational and Administrative System for Import Support (OASIS), the agency's automated import system. OASIS permits FDA reviewer to evaluate and process more efficiently each import entry.
Two of the data elements used for automated entry screening in OASIS are "FDA Manufacturer" representing the site-specific location where the product is manufactured. The second element, "FDA Shipper" is the party identified on the freight bills or bills of lading. The shipper is often the same as the U.S. Customs Service invoicing party.
Low acid and acidified foods ALWAYS require evidence that they were produced in a facility that is registered with the FDA. For these products, the site-specific location must be submitted as the FDA manufacturer. The name and address of a corporate headquarters, a trading company, or other intermediate supplier is not acceptable.
Under the automated system, the import filer transmits the required shipment specific FDA data into Custom's Automated Commercial System (ACS). Within several minutes, that individual receives notification that either the shipment has been released or FDA wants to review it.
The information that the importer of record transmits to customs and to the FDA contains important information about your product and care should be taken in submitting it. Efforts when providing all required information will help prevent delays during the entry process.
Additional information on FDA import procedures may be found in FDA's Regulatory Procedures Manual available on the Internet at http://www.fda.gov/ora/compliance_ref/rpm_new2/ (Updated web link: xxxx )
Publications To Help Prevent Import Delays
- Requirements for Establishment Registration, Thermal Process Filing, and Good Manufacturing Practice for Low-Acid Canned Foods and Acidified Foods
- Reprint of regulations in Title 21, Code of Federal Regulations, Parts 108, 113 and 114.
- Procedures for Importing Foods into the United States
- Includes a flow chart listing United States food import procedures, and ways to prevent delays at the port of entry.
- FDA's Catalog of Information Materials for the Food and Cosmetic Industries
- Lists publications, audiovisuals, and displays currently available material to assist industry in complying with the laws.
- pH Control Why the Concern?
- Explains in plain, non-technical language, the importance of correct pH in acidified food processing.
You may view/download/print the publications listed above from FDA's Internet web site http://www.cfsan.fda.gov/
Direct requests for single copies of these publications and specific inquiries to:
Center for Food Safety and Applied Nutrition
Industry Activities Staff HFS-565
200 C Street, SW
Washington DC 20204
(Updated contact information:
LACF Registration Coordinator (HFS-618)
5100 Paint Branch Pkwy
College Park, MD 20740-3835)
Please include a self-addressed mailing label to expedite shipment.
FDA District Offices
- If your particular concern is not addressed, contact the Import Staff as designated by the FDA District Office in your area.
- In addition to the District Offices listed above, FDA has Resident Inspection Posts in many major cities throughout the United States. These offices can be found in the telephone directory under "U.S. Government, Food and Drug Administration."