U.S. Food & Drug Administration
Center for Food Safety & Applied Nutrition

Instructions for Establishment Registration and
Processing Filing for

Acidified and Low-Acid Canned Foods
1997

II. ESTABLISHMENT REGISTRATION (FORM FDA 2541)


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WHO MUST REGISTER

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

WHEN TO REGISTER

Low-acid canned food and acidified food processors in the United States must register with FDA not later than 10 days after first engaging in the manufacture, processing, or packing of acidified foods or of low-acid canned foods. Processors in other countries must register before offering any such products for entry into the United States. PROCESS FILING FORMS WILL BE RETURNED FROM UNREGISTERED FIRMS. However, registration and initial process filing may be done at the same time.

HOW TO REGISTER

To register with FDA, processors must complete and submit to FDA a Form FDA 2541 for each processing establishment location according to these instructions.

HOW TO COMPLETE FORM FDA 2541

Complete each required space on the form according to the following instructions. TYPE OR PRINT ALL ENTRIES LEGIBLY IN ENGLISH. The encircled numbers correspond to those on the SAMPLE REGISTRATION FORM ON PAGE 18.

  1. FOR FDA USE ONLY

    Do not make any entries in this space. FDA will assign a Food Canning Establishment (FCE) number to the establishment being registered. A copy of the registration form will be returned to you with the FCE number entered in the space labeled &qupt;:FCE No." Include that FCE number on all correspondence with FDA. It will also expedite inspection of entries into the U.S. if the FCE number is included on all shipping documents for these products.

  2. TYPE OF SUBMISSION

    Check "Initial Registration" if this processing plant has never been registered before. Leave the space for "Current FCE" number blank.

    Check "Change of Registration Information" if you are submitting changes such as the following for a previously registered firm:

    Enter the type of change and the current FCE number in the space provided.

    IF A PREVIOUSLY REGISTERED ESTABLISHMENT HAS MOVED TO A NEW LOCATION, the plant must be registered at the new location. To do so, check "Relocation (new registration required)." Enter your current Food Canning Establishment (FCE) number in the space provided. Complete all other spaces on the form as in an initial registration. FDA will assign a new FCE number and return a copy of the form as for a new registrant. The old FCE is invalid and may not be used. Submissions using the old FCE will be returned by FDA and products submitted for entry into the United States under the invalid FCE will be detained.

    NOTE: WHEN AN ESTABLISHMENT IS MOVED AND RE-REGISTERED, ALL PROCESSES TO BE USED AT THE NEW LOCATION MUST BE RE-FILED AS INSTRUCTED IN SECTION III.

  3. FOOD PROCESSING ESTABLISHMENT LOCATION

    Establishment Name

    Enter the name of your establishment as you want it to be registered. Wherever possible, use standard abbreviations such as the following:

    Inc (Incorporated)Ltd (Limited)
    Co (Company)Corp (Corporation)

    Number and Street

    Enter the address of the physical location of the establishment where your products are manufactured, processed, or packed. Abbreviations such as the following may be used:

    St (Street)Dr (Drive)Ave (Avenue)
    Rd (Road)Ln (Lane)Blvd (Boulevard)
    RR (Rural Route)

    * Do not use Post Office Boxes for the plant location.

    City and State or Province (or other Subdivision)

    Enter the appropriate location information on the line provided.

    U.S. Firms:

    Use the two-letter Postal Service abbreviation for your state.

    ZIP (or other Postal Code)

    U. S. Firms:

    Enter your 9 digit ZIP Code if one has been assigned; otherwise, enter your 5 digit code.

    Foreign Firms:

    If a postal code has been established by the postal system of your country, enter that code.

    Country

    U.S. Firms:

    Leave blank.

    Foreign Firms:

    Enter the name of the country in which your establishment is located.

    The name and address should be listed exactly as it appears on letterheads, stationary, invoices, shipping documents and labeling on products or detentions.

    Telephone No.

    U.S. Firms:

    Enter the 3 digit area code, and the 7 digit telephone number.

    Foreign Firms:

    Enter country code, city code, and telephone number

    Telefax No.

    U.S. Firms:

    Enter the 3 digit area code, and the 7 digit telefax number

    Foreign Firms:

    Enter country code, city code, and telefax number

  4. PREFERRED MAILING ADDRESS

    If you wish all correspondence from FDA to be sent to your plant location address (as entered in the block marked "Food Processing Plant Location") check "Same as Plant Location" and leave the rest of the "Preferred Mailing Address" space blank.

    If you wish all correspondence from FDA to be sent to an address different than your plant location address, enter the preferred mailing address in the spaces provided. Use the same guidelines for entries as in item (3) except that you may enter a post office (P.O.) box number instead of number and street (if applicable).

    NOTE: This preferred mailing address will be used for all FDA correspondence regarding registration and process filing. Therefore, if registration and process filing is handled by someone located in a firm's headquarters, research lab, etc., that address should be listed and all FDA mailings will be sent there.

    Enter the telephone and telefax numbers.

  5. LOW ACID AND/OR ACIDIFIED FOODS PROCESSED AT THIS LOCATION

    Enter (on a separate line) each low-acid and/or acidified food which your firm produces at this location, and check the applicable column to indicate whether it is a low-acid or acidified product. See Items 5 and 6, Section I for guidance in making this determination. The product name, form or style, and packing medium should be the same as that printed on the container label.

    Foreign Firms:

    List the English name as well as the non-English name (if applicable) as it appears on the label. For example:

    Green kidney beans (flageolets) in brine

    If necessary, attach additional forms to continue the list of products. On additional forms, complete item (3) and enter "continued" on (5) preceding the listing of additional products.

    NOTE: This information is used to help FDA to determine if the firm is required to register and file processes, and to help determine the number and type of process filing forms likely to be required.

    Do NOT submit a change to registration information just to show products which are added later, or to show discontinuance of some which were previously reported. HOWEVER, SUCH LATER ADDITIONS AND CHANGES (AS WELL AS ALL PRODUCTS LISTED WHEN INITIALLY REGISTERING) MUST BE REPORTED BY USING THE APPROPRIATE PROCESS FILING FORM ACCORDING TO THE INSTRUCTIONS IN SECTION III.

  6. PLEASE SEND THE FOLLOWING

    A different process filing form (2541c) is used for low-acid aseptic packaging systems than for other processing methods. If you aseptically process low-acid foods at this location, enter the number of process filing forms for processes you want FDA to send to you (on the line preceding "Process filing forms used for low-acid aseptic processes").

    Enter the number of forms (2541a) needed "Process filing forms used for all processing methods except for aseptic."

    Enter an "X" next to "LACF & Acidified Regulations 21 CFR 108, 113 and 114) if you need information on how to acquire these regulations.

    Enter the name, title, area code, phone number and signature of the authorized representative signing this form on behalf of your company, and the date signed. Check appropriate block to show whether the phone number is at the plant location or mailing address. If the representative is not at the plant address nor the preferred mailing address, include the location in the "Authorized Company Representative". MAIL THE REGISTRATION FORM AND ALL ATTACHED COPIES TO:

    LACF Registration Coordinator (HFS-618)
    Center for Food Safety and Applied Nutrition (FDA)
    5100 Paint Branch Parkway
    College Park, MD 20740-3835

    A copy of the registration form will be returned to you with the assigned FCE number, along with forms and/or publications you may have requested.

    Form 2541



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