Contains Nonbinding Recommendations 
 
 
Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and 
Forms FDA 2541d, FDA 2541e, FDA 
2541f, and FDA 2541g (Food Process 
Filing Forms) to FDA in Electronic or 
Paper Format: 
Guidance for Industry   
 
 
 
Additional copies are available from: 
Office of Food Safety 
Food Processing Evaluation Team, HFS-302 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(Tel) 240-402-2411 
http://www.fda.gov/FoodGuidances 
 
You may submit electronic or written comments on this guidance at any time.  Submit electronic 
comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the Docket No. FDA2013D
1622.  
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
November 2016 Contains Nonbinding Recommendations 
 
Table of Contents 
 
I. Introduction
   
II. Background
   
A. Requirement for Registration 
B. Requirement for Process Filing 
C. Voluntary Registration and Voluntary Submissions 
D. Voluntary Process for FDA Evaluation of New Processing Methods or 
New Equipment 
III. Portals for Electronic Submissions
   
A. FDAs Industry Systems (FIS) 
B. FDAs Unified Registration Listing Systems (FURLS) 
C. Relationship Between the Electronic Acidified Food/Low-Acid Canned 
Food Registration System and Food Facility Registration (FFR) 
IV. Overview of Processes for Submission of Registration and 
 
Process Filing Forms
 
A. Create an FDA Account, Register as a Food Facility, and Identify Your 
Facility as an Acidified/Low-Acid Food Processor 
B. Register as a Food Canning Establishment by Submitting Form FDA 
2541 
C. FDA Receives Form FDA 2541 
D. Establishment Contact Person Authorizes Individuals to Access the 
Electronic Acidified Food/Low-Acid Canned Food System for the Food 
Canning Establishment 
E. Submit Process Filing Forms 
V. Changes to AF/LACF Registration Information
   
A. Changing the Establishment Contact Person 
B. Changing the Mailing Address for the Food Canning Establishment 
C. Changing the Telephone Number and Email Address for the 
Establishment Contact Person, and Changing the Establishment 
Contact Person  Contains Nonbinding Recommendations 
 
D. Adding or Deleting Product Information 
E. Cancelling Registration 
F.  Relocating Commercial Processing Operations 
G. Change in Street Information via Postal Service or Local Government 
VI. How to Contact FDA or Obtain Help
   
VII. References
   
VIII. Appendices
   
  Contains Nonbinding Recommendations 
 
 
Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and 
FDA Forms 2541d, 2541e, 2541f, and 
2541g (Food Process Filing Forms) to 
FDA in Electronic or Paper Format: 
1
Guidance for Industry  
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance. 
 
 
 
I.  Introduction 
This guidance is intended for: 
  Commercial processors who manufacture, process, or pack acidified foods (AF) and/or 
thermally processed low-acid foods packaged in hermetically sealed containers 
(historically referred to as low-acid canned foods or LACF)2; and 
  Persons who are authorized to act on behalf of such commercial processors3.  
 
                                                 
1 This guidance has been prepared by the Food Processing Evaluation Team in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration. 
2 Although some hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally 
processed low-acid foods generally would not be viewed as cans, the term low-acid canned foods has been used 
for decades as a shorthand description for thermally processed low-acid foods packaged in hermetically sealed 
containers, and we continue to use that term (and its abbreviation, LACF) for the purposes of this document.   
3 Individuals who act as authorized representatives may do so for more than one commercial processor.  Table 1 
identifies the responsibilities of each type of authorized user. 
  1  Contains Nonbinding Recommendations 
 
Commercial processors who manufacture, process, or pack AF and LACF are subject to the 
registration requirements of 21 CFR 108.25(c)(1) (for AF) and 21 CFR 108.35(c)(1) (for LACF), 
as well as the process filing requirements of 21 CFR 108.25(c)(2) (for AF) and 21 CFR 
108.35(c)(2) (for LACF).  These provisions require two basic types of submissions: 
  Food Canning Establishment Registration using Form FDA 2541; and  
  Process filings using the following forms, as applicable: 
  Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method) 
  Form FDA 2541e (Food Process Filing for Acidified Method) 
  Form FDA 2541f (Food Process Filing for Water Activity /Formulation Control Method) 
  Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems) 
 
 
This guidance describes:  
  Administrative procedures relating to the registration and process filing requirements of 
21 CFR 108.25(c) (for AF) and 21 CFR 108.35(c) (for LACF);  
  Administrative procedures for voluntary registration and voluntary submissions for 
certain products manufactured, processed, or packed by a commercial processor who has 
determined that the products are not subject to the registration and process filing 
requirements of 21 CFR 108.25(c) (for AF) or 21 CFR 108.35(c) (for LACF); and  
  A voluntary process whereby, upon request, we review data and other information that 
relate to a new processing method or new equipment.  
 
This guidance addresses two basic types of submissions, described above, that are required for 
AF and LACF: 
  Food Canning Establishment Registration using Form FDA 2541 (see Appendix 10); and  
  Process filings using Forms FDA 2541d, FDA 2541e, FDA 2541f, or FDA 2541g (see 
Appendices 1 through 4, respectively).  
   
This guidance also provides general information about how to use FDAs systems for electronic 
submission of these forms.  We recommend that you submit these forms electronically and are 
issuing this guidance as a general aid to enable you to do so.  
 
This guidance does not provide detailed instructions on how to complete electronic or paper 
submissions of Forms FDA 2541, 2541d, 2541e, 2541f, and 2541g.  Such instructions are 
available elsewhere.  (See Appendix 11 for instructions for electronic submission of Form FDA 
2541, Appendix 12 for instructions for paper submission of Form FDA 2541, and Appendices 5 
through 8 for instructions for paper submission of Forms FDA 2541d, 2541e, 2541f, and 2541g).  
 
In the remainder of this guidance, you refers to: 
  Commercial processors who manufacture, process, or pack AF or LACF; 
  Commercial processors who manufacture, process, or pack products that they have 
determined are not AF or LACF, but who wish to voluntarily submit information about 
such products to FDA; and  
  Persons who are authorized to act on behalf of such commercial processors.   
 
  2  Contains Nonbinding Recommendations 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in our guidances means that something is suggested or 
recommended, but not required.  
 
 
II.  Background  
A.  Requirement for Registration 
 
A commercial processor, when first engaging in the manufacture, processing, or packing of AF 
or LACF, shall, not later than 10 days after first so engaging, register and file with FDA 
information including the name of the establishment, principal place of business, the location of 
each establishment in which that processing is carried on, the processing method, and a list of 
foods so processed in each establishment (21 CFR 108.25(c)(1) and 21 CFR 108.35(c)(1)).  You 
do so by submitting a separate Form FDA 2541 for each physical processing plant.  You may 
register electronically (using the instructions in Appendix 11) or on paper (using the instructions 
in Appendix 12).  After you register an establishment, we assign a Food Canning Establishment 
(FCE) number identifying the physical processing plant located at the address identified on Form 
FDA 2541.   
 
For example, to register one processing plant located at 123 Main Street, Camden, New Jersey 
and another processing plant located at 123 Oxford Road, Alexandria, Virginia, you would file 
two separate FDA Forms 2541 - one for the processing plant located in New Jersey and another 
for the processing plant located in Virginia.  We would assign a unique FCE number to each 
processing plant.     
 
Form FDA 2541 includes information identifying an Establishment Contact Person (ECP) for 
the establishment being registered.  An ECP should be an authorized, responsible official with 
the processing plant or with the facilitys corporate office or an individual authorized by the 
facility to act on behalf of the facility.  When a commercial processor has more than one 
establishment at distinct physical locations (e.g., in New Jersey and Virginia), a single individual 
may serve as ECP for more than one establishment.   
 
Importantly, if you use our electronic system for submitting your process filings, the ECP will 
have authority to grant additional individuals access to your electronic FCE information, and 
those individuals will be able to see any trade secret information or other confidential 
information that you include in your process filing submissions.  For this reason, we recommend 
that you take care in determining who will serve as your ECP.  For more information on how the 
ECP grants access to individuals to your electronic account, including access to any trade secret 
information or other confidential information that you include in your process filing submissions, 
see section IV.D of this guidance.    
 
  3  Contains Nonbinding Recommendations 
 
B.  Requirement for Process Filing   
A commercial processor engaged in the processing of AF shall, not later than 60 days after 
registration, and before packing any new product, provide FDA with information (using Form 
FDA 2541e) on the scheduled processes for each acidified food in each container size (21 CFR 
108.25(c)(2))4.  An analogous requirement for process filing, using either Form FDA 2541d,  
Form FDA 2541f, or Form FDA 2541g, applies to a commercial processor of LACF (21 CFR 
108.35(c)(2)).5 
 
When you submit a process filing form, you include the FCE number for the location of the 
processing plant where the product will be manufactured, processed, or packed (Appendices 1 
through 4).  Including the FCE number on the process filing form links your process filing to 
your establishment.  You may submit process filing forms either electronically or on paper. 
 
We will consider you to have complied with 21 CFR 108.25(c)(2) or 108.35(c)(2) as of the date 
on which we receive your completed process filing (Form FDA 2541d, FDA 2541e, FDA 2541f 
or FDA 2541g), whether electronically or on paper.  If your form is incompletefor example, 
because you have left some sections blank, or because you have filled in some sections in a way 
that is non-responsivewe will inform you in one of two ways.  For paper submissions, we will 
contact you using your preferred mailing address, as identified on Form FDA 2541.  We will 
treat the product identified on the form as not having complied with 21 CFR 108.25(c)(2) or 
108.35(c)(2) until we receive a completed process filing.  For electronic submissions, you will 
receive immediate feedback during the submission process to prevent blank or non-responsive 
sections on the forms.   
 
We review the submitted information about the scheduled processes for your products.  Under 21 
CFR 108.25(c)(3)(ii) and 108.35(c)(3)(ii), we may request that you provide us with any process 
and procedure information that we deem necessary to determine the adequacy of the process. 
 
A Submission Identifier (SID) identifies each process filing (Appendices 5 through 8).  The 
SID consists of (1) the year, month, and day of the month that a process filing form is created, 
and (2) a unique sequence number to identify each form when multiple forms are created on the 
same date.  The SID enables both you and FDA to quickly and accurately identify a specific 
process filing.  Because all filed process filings have a SID, it is common practice to refer to a 
filed process filing as a SID and to refer to a FCEs collection of process filings as its SIDs.  
When you use the electronic AF/LACF system to create a process filing, the system 
automatically generates a SID.  When you create a process filing using a paper form, you 
generate the SID yourself and include it on the paper form.   
 
C.  Voluntary Registration and Voluntary Submissions 
 
                                                 
4 The regulation currently specifies Form FDA 2541a.  We intend to update the regulation to specify the new form.  
5 The regulation currently specifies Form FDA 2541a (food canning establishment process filing for all methods 
except aseptic) or Form FDA 2541c (food canning establishment process filing for aseptic systems).  We intend to 
update the regulation to specify the new forms.  
  4  Contains Nonbinding Recommendations 
 
Processors who have determined that their specific food products are not acidified foods (or low-
acid canned foods) sometimes provide us with information about these products by registering 
using Form FDA 2541 and then voluntarily submitting Form FDA 2541e as a voluntary 
submission for these products.  If you conclude that a specific food product does not meet the 
definition of an acidified food at 21 CFR 114.3(b) and you choose to voluntarily submit process 
information about that product using Form FDA 2541e, we will evaluate that information to 
determine whether it is consistent with your conclusion.   
  If the conclusions of our evaluation are not consistent with yours, we may request 
additional information to help us evaluate your product or advise you that your product 
appears to be an acidified food subject to 21 CFR Part 114 and 21 CFR Part 108.   
  If the conclusions of our evaluation are consistent with yours, we will list your product in 
our paper and electronic files as a voluntary submission that is not subject to either 21 
CFR Part 113 or 21 CFR Part 114.   
  If you have an online AF/LACF account to submit and view process filings 
o
electronically, you can see this status for your product when you access your 
online account.  
  If you submitted your voluntary submission using a paper form, and do not have 
o
an online AF/LACF account, we will respond to you using the same method by 
which you submitted your request (i.e., either written or email) if you specifically 
ask us to do so.   
 
We will make available to our investigators the results of our evaluation for use during 
inspection of your facility, or when food is offered for import, to facilitate their determinations 
regarding the regulatory status of your products.       
 
If you choose to submit to FDA process information regarding a food that you conclude is not an 
acidified food, we recommend that you: 
  Register your facility using Form FDA 2541(Appendix 10) if you have not done so 
previously (e.g., because you do not also process any acidified foods or low-acid foods).  
Doing so will enable you to complete the process filing form (Form FDA 2541e), which 
requests the Food Canning Establishment (FCE) number we assign to your facility when you 
register using Form FDA 2541; and 
  Follow the instructions for submitting Form 2541e for acidified foods (Appendix 6).  These 
instructions indicate the portions of Form 2541e that are to be filled out by voluntary filers.  
 
 
D.  Voluntary Process for FDA Evaluation of New Processing Methods or 
New Equipment 
 
If you choose to do so, you may submit data and other information that relate to a new 
processing method or new equipment.  If you do so, we will review that data and other 
information as a courtesy in advance of a process filing.  If we have questions about the new 
processing method or new equipment, we will discuss them with you.  If we have no such 
questions, we will send you a letter (a No Questions Letter) to that effect.   
 
  5  Contains Nonbinding Recommendations 
 
Importantly, a No Questions Letter from us neither constitutes our approval of the method or 
system nor substitutes for a process filing required under 21 CFR 108.25(c)(2) or 21 CFR 
108.35(c)(2).  
 
III.  Portals for Electronic Submissions 
A.  FDAs Industry Systems (FIS) 
 
An electronic portal called FDA Industry Systems (FIS) provides general entry to a series of 
specific systems for electronic submissions to FDA.  To use the electronic FIS portal, follow the 
instructions in Appendix 13 to obtain an FDA Account ID and password.   
 
B.  FDAs Unified Registration Listing Systems (FURLS) 
 
FDAs Unified Registration Listing System (FURLS) is a specific component of the general FIS 
electronic portal.  Systems within the FURLS component enable persons with an FDA Account 
ID and password for the FIS electronic portal to register a facility electronically.  The two 
FURLS systems that are relevant to this document are:  
 
  Food Facility Registration (FFR); and 
  Acidified/Low-Acid Canned Foods.  
 
C.  Relationship Between the Electronic Acidified Food/Low-Acid Canned 
Food Registration System and Food Facility Registration (FFR) 
The registration requirement in 21 CFR Part 108 for FCEs that manufacture, process, or pack AF 
or LACF product is not the same as the FFR system.  The FFR system stems from the 
requirement in section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that 
domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal 
consumption in the United States must register with FDA.6 The registration requirement in 
section 415 of the FD&C Act was created by  the Public Health Security and Bioterrorism 
Preparedness Act of 2002 ( the BT Act) and amended by the FDA Food Safety Modernization 
Act (FSMA) (Pub. L. 111-353).  AF and LACF commercial processors must register with FDA 
as required in 21 CFR Part 108 using FDA Form 2541, and must also register with FDA under 
the FFR system using FDA Form 3537 as required by section 415 of the FD&C Act.  We use the 
term FFR interchangeably with the term BT Act registration. 
 
The design of the electronic AF/LACF registration system links it to the FFR system.  
Specifically, the electronic system for submission of Form FDA 2541 is limited to facilities that 
are registered as food facilities pursuant to section 415 of the FD&C Act.  Facilities that register 
                                                 
6 See the requirements in 21 CFR Part 1, subpart H (FDAs food facility registration regulations) and FDAs 
guidance entitled What You Need to Know About Registration of Food Facilities (Ref. 1) to determine whether 
you are subject to the requirement to register as a food facility pursuant to section 415 of the FD&C Act.   
 
  6  Contains Nonbinding Recommendations 
 
in the FFR system receive a facility registration number and PIN.  During the FFR process, or 
during an update to a facilitys FFR submission, you can identify your facility as an 
Acidified/Low-Acid Food Processor.   
 
The electronic AF/LACF registration system in FURLS becomes available to you if your 
registration in the FFR system identifies your facility as an Acidified/Low-Acid Food Processor.  
If your facility is registered in the FFR system, but you have not yet identified yourself as an 
Acidified/Low-Acid Food Processor, you can update your FFR information to add this 
information. 
 
If you are not required to register as a food facility under FDAs food facility registration 
regulations, and you want to access the electronic AF/LACF system, see section IV.A of this 
guidance for information about two methods for doing so.   
 
 
IV.  Overview of Processes for Submission of Registration and 
Process Filing Forms  
A.  Create an FDA Account, Register as a Food Facility, and Identify Your 
Facility as an Acidified/Low-Acid Food Processor 
 
If you want to make all submissions using paper forms, skip this step and go to section IV.B of 
this guidance. 
 
If you want to use the electronic AF/LACF system: 
  If you have not already done so, create an FDA Account for the electronic FIS portal by 
following the instructions in Appendix 13 to obtain your FDA Account ID and password.  
  If you have not already registered the establishment as a food facility in accordance with 
21 CFR Part 1 Subpart H (i.e., BT Act Registration), do so by following the instructions 
in Appendix 14 to obtain an FFR number and PIN.  During the registration process, 
identify the food facility as an Acidified Food Processor and/or Low-Acid Food 
Processor under Section 9a General Product Categories  Food for Human 
Consumption; and Type of Activity Conducted at the Facility and/or 9b General 
Product Categories  Food for Animal Consumption; and Type of Activity Conducted at 
the Facility (see Appendix 14).  It is not necessary for the person who submits the food 
facility registration in the FFR system to be the same person as the Establishment Contact 
Person (ECP) for the AF/LACF system.  For example, Mr. Smith can submit the food 
facility registration in the FFR system and Mr. Jones can be the ECP in the AF/LACF 
system.  However, Mr. Smith and Mr. Jones will each need an individual FDA Account 
and password for the FIS portal.  Refer to section II.A for the definition of an ECP. 
  If the establishment is not required to register as a food facility under FDAs food facility 
registration regulations(21 CFR Part 1 Subpart H)(i.e., BT Act Registration) , you may 
either: 
  7  Contains Nonbinding Recommendations 
 
  Follow the Instructions in Appendix 14 to register the establishment voluntarily 
o
and obtain an FFR number and PIN so that you can submit Form FDA 2541 
electronically; or 
  Follow the Instructions in Appendix 12 to submit Form FDA 2541 using a paper 
o
form; tell us that you want to access the electronic AF/LACF system when you 
send us your paper registration form, and provide us with your FDA Account ID 
for the FIS electronic portal.     
  If you already registered the establishment as a food facility and have an FFR number 
and PIN, but you have not yet identified the food facility as an Acidified Food Processor 
and/or Low-Acid Food Processor, you must update the FFR registration information (21 
CFR 1.234).  Under Section 9a General Product Categories  Food for Human 
Consumption; and Type of Activity Conducted at the Facility and/or 9b General 
Product Categories  Food for Animal Consumption; and Type of Activity Conducted at 
the Facility, check the appropriate activity type(s) as Acidified Food Processor and/or 
Low Acid Food (see Appendix 14).   
 
  After identifying the registered food facility as an Acidified Food Processor and/or Low-
Acid Food Processor, log out of your FDA account and then log back in.  After you log 
back in, the system will provide you with access to the electronic Acidified /Low Acid 
Canned Food system. 
 
 
B.  Register as a Food Canning Establishment by Submitting Form FDA 
2541  
 
We recommend that you register an establishment electronically.  To do so, follow the 
instructions in Appendix 11 to register the establishment by electronic submission of Form FDA 
2541.   
 
If you prefer to register the establishment by paper submission of Form FDA 2541, follow the 
instructions in Appendix 12 to do so.  
 
C.  FDA Receives Form FDA 2541 
 
If you use the electronic AF/LACF system to register an establishment, the electronic registration 
system will automatically assign an FCE number, display a message informing you of the 
assigned FCE Number, and send an email including a copy of the submitted Form FDA 2541 to 
the Establishment Contact Person (ECP).  If we have questions concerning your submitted 
registration information, we may contact the ECP using contact information included with the 
registration.  
 
If you register an establishment using a paper form, we will assign an FCE number and provide it 
to the Preferred Mailing Address identified on Form FDA 2541.   
  8  Contains Nonbinding Recommendations 
 
 
If you register an establishment using a paper form and also ask us to provide access to the 
electronic AF/LACF system, the ECP will need to provide FDA with the ECPs FIS Account ID.  
We will then link the electronic AF/LACF system to the ECPs FDA Account ID (see the 
discussion of the FIS portal in section III).  After we do so, the electronic AF/LACF system will 
become available to the ECP when the ECP next logs into the ECPs FDA Account.  We will 
inform the ECP when the electronic AF/LACF system is ready for use. 
 
D.  Establishment Contact Person Authorizes Individuals to Access the 
Electronic Acidified Food/Low-Acid Canned Food System for the Food 
Canning Establishment 
 
As discussed in section II.A of this guidance, we recommend that a commercial processor select 
its ECP with care, as the ECP will have authority to grant additional individuals access to the 
establishments process filing information, including trade secret information and confidential 
data.  An ECP should be an authorized, responsible official with the processing plant or with the 
facilitys corporate office, or an individual authorized by the facility to act on behalf of the 
facility.   
 
The ECP may authorize one or more individuals to access the electronic AF/LACF system for a 
specific FCE and perform designated functions related to process filing.  Doing so is not 
necessary and is at the discretion of the ECP.  Such individuals may be your employees or 
authorized third parties.7  We recommend that the ECP grant access only to individuals the ECP 
trusts with the establishments process filing information, including trade secret information and 
confidential data.  The ECP can use the electronic AF/LACF system to authorize individuals to 
perform functions related to process filing.  However, at this time only the ECP and the Super 
Authorized Representative (Super AR, described below) are authorized to perform functions 
related to registration.   
 
The ECP authorizes an individual to access the electronic AF/LACF system for a particular FCE 
by assigning a role to the individual as Super AR, an Authorized Representative (AR), or a Read 
Only Access Representative (ROAR).  A particular FCE can only have a single ECP but may 
have more than one Super AR, AR and/or ROAR.  The assigned role determines the functions 
the individual can perform electronically and when contacting FDA on behalf of the ECP.  Table 
1 shows the authorized functions that can be performed by the ECP, Super AR, AR, and ROAR. 
 
 
Table 1. Authorized Functions Associated with Assigned Roles 
 
Authorized  Establishment  Super  Authorized  Read-Only 
Functions  Contact Person  Authorized  Representative  Authorized 
(ECP)  Representative  (AR)  Representative 
(Super AR)  (ROAR) 
                                                 
7 Individuals who act as authorized third party representatives may do so for more than one commercial processor. 
  9  Contains Nonbinding Recommendations 
 
Authorized  Establishment  Super  Authorized  Read-Only 
Functions  Contact Person  Authorized  Representative  Authorized 
(ECP)  Representative  (AR)  Representative 
(Super AR)  (ROAR) 
Submit initial  Yes  No  No  No 
FCE Registration 
Form 2541 
Access the FCEs  Yes  Yes  Yes  Yes 
electronic 
AF/LACF Online 
Account  
Assign roles   Yes  No  No  No 
Assign AR to  Yes  No  No  No 
process filing 
Update FCE  Yes*  Yes*  No  No 
registration  
information  
Discuss FCE  Yes  Yes  No  No 
registration  
information with 
FDA 
Submit process  Yes  Yes  Yes  No 
filings  
Discuss process  Yes  Yes  Yes  No  
filings with FDA  
Search, print, and  Yes  Yes  Yes  Yes 
view process 
filing in the 
FCEs electronic 
AF/LACF Online 
Account 
Provide additional  Yes  Yes  Yes  No 
information to 
FDA (e.g., upon 
request) by mail, 
E-mail, or fax  
*At this time, the system only allows the ECP to update registration information electronically.  
A Super AR who needs to discuss and/or update the registration information electronically needs 
to contact FDA using the contact information provided in section VI of this guidance. 
 
E.  Submit Process Filing Forms  
 
  10  Contains Nonbinding Recommendations 
 
As described above, process filing forms can be submitted by the ECP, Super AR, or AR.  We 
recommend that you submit your process filing forms electronically.  However, you can also 
submit your process filing forms on paper.  
 
V.  Changes to AF/LACF Registration Information 
A.  Changing the Establishment Contact Person 
 
To change the ECP, contact us using the contact information provided in section VI of this 
guidance.  
 
B.  Changing the Mailing Address for the Food Canning Establishment 
 
To change the mailing address for the FCE, follow the instructions in Appendix 11 to do so 
electronically or in Appendix 12 to do so by paper submission of Form FDA 2541.   
 
C.  Changing the Telephone Number and Email Address for the 
Establishment Contact Person, and Changing the Establishment Contact 
Person 
 
To change the telephone number or email address for the ECP electronically, or to designate a 
new ECP, you may contact FDA using the contact information provided in Section VI of these 
instructions. 
 
D.  Adding or Deleting Product Information 
 
You are not required to resubmit Form FDA 2541 to tell us about new products that you are 
going to begin manufacturing, processing, or packing at an establishment that you have already 
registered.  The procedure you are required to follow to inform us about such new products is to 
submit process filing forms.  You are also not required to resubmit Form FDA 2541 to tell us 
when you no longer manufacture, process, or pack products you previously listed on the form.  
You may, however, voluntarily choose to use Form FDA 2541 to tell us when you no longer 
manufacture, process, or pack such products.  If you voluntarily choose to do so, follow the 
instructions in Appendix 12 to do so electronically or in Appendix 11 to do so by paper 
submission of Form FDA 2541.        
 
E.  Cancelling Registration 
 
You must notify us not later than 90 days after ceasing or discontinuing the manufacture, 
processing, or packing of the foods in any establishment, except that you need not do so for 
temporary cessations due to the seasonal character of production or due to temporary conditions 
  11  Contains Nonbinding Recommendations 
 
(e.g., labor disputes or fire) (21 CFR 108.25(c)(1) and 21 CFR 108.35(c)(1)).  To notify us, 
follow the instructions in Appendix 11 to cancel the registration by electronic submission, or 
follow the instructions in Appendix 12 to cancel the registration by paper submission.  
Alternatively, you may contact us using the contact information provided in section VI of this 
guidance.   
 
In the case of a change in the ownership of the establishment to another person, you should 
submit a Form FDA 2541, following the instructions in Appendix 11 for electronic submissions 
or Appendix 12 for paper submission.  A change in ownership will lead us to cancel the existing 
registration and all process filing forms submitted under the applicable FCE number.  The new 
owner must submit a new Form FDA 2541 (Food Canning Establishment Registration), in 
response to which we will assign the new owner a new FCE number.  At that point the new 
owner must submit new process filing forms for all LACF and AF products that will be 
manufactured, processed, or packed under the new ownership.  The new process filing forms will 
need to include the new FCE number.  If the new owner has any questions about the process for 
submitting new process filing forms, the new owner may contact FDA using the contact 
information provided in Section VI of this guidance.  
F.  Relocating Commercial Processing Operations   
 
If commercial processing operations are relocated (i.e., the manufacture, processing, and packing 
of foods in one establishment ceases or is discontinued and some or all of those operations are 
relocated to a new establishment), you must submit a Form FDA 2541, following the instructions 
in Appendix 11 for electronic submissions or Appendix 12 for paper submission, and your 
existing registration will be canceled.  If you notify us using the paper version of Form FDA 
2541, we will cancel the existing registration.  If you notify us using the electronic version of 
Form FDA 2541, the electronic system will allow you to cancel the registration yourself.  You 
also must register the new establishment (see 21 CFR 108.25(c)(1) and 21 CFR 108.35(c)(1)).  
Follow the instructions in Appendix 11 to register the new establishment by electronic 
submission of Form FDA 2541 or follow the instructions in Appendix 12 to register the new 
establishment by paper submission of Form FDA 2541.  We will work with you on a case-by-
case basis to determine the impact of the relocation of the facility on the SIDs you previously 
filed. 
 
G.  Change in Street Information via Postal Service or Local Government 
 
 If the postal service or local government makes a change to the address where an existing 
establishment resides and there is no physical relocation, you may follow the instructions in 
Appendix 11 to notify us by electronic submission of Form FDA 2541, or follow the instructions 
in Appendix 12 to notify us by paper submission of Form FDA 2541.  Alternatively, you may 
notify us using the contact information provided in section VI.  FDA may ask questions intended 
to assure the agency that the establishment has not physically relocated.  If you also need to 
change the FFR information, contact the FDA Industry Systems (FIS) help desk for further 
assistance (see Appendix 14.) 
 
  12  Contains Nonbinding Recommendations 
 
VI.  How to Contact FDA or Obtain Help 
You may contact us:  
  By Email at LACF@fda.hhs.gov;  
  By telephone at 240-402-2411; and 
  By mail at the address immediately below.   
 
Food and Drug Administration  
LACF Registration Coordinator (HFS-303)  
Center for Food Safety and Applied Nutrition  
5001 Campus Drive  
College Park, Maryland 20740-3835 
 
Additional information about submitting registration and process filing forms for AF and LACF 
is available in the Appendices identified in section VIII of this guidance.  
 
VII.  References 
1.  FDA. 2012. What You Need to Know About Registration of Food Facilities.  Accessible 
at 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformati
on/ucm331957.htm 
 
VIII. Appendices 
1.  FDA 2014: Form FDA 2541d. Food Process Filing for Low-Acid Retorted Method.  
Accessible at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM4655
91.pdf 
2.  FDA 2014: Form FDA 2541e. Food Process Filing for Acidified Method.  Accessible 
at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM4655
93.pdf 
3.  FDA 2014: Form FDA 2541f.  Food Process Filing for Water Activity/Formulation 
Control Method.  Accessible at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM4655
95.pdf 
4.  FDA 2014: Form FDA 2541g. Food Process Filing for Low-Acid Aseptic Systems.  
Accessible at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM4655
98.pdf 
5.  FDA 2015: Instructions for Paper Submission of Form FDA 2541d. Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/
UCM366881.pdf 
  13  Contains Nonbinding Recommendations 
 
6.  FDA 2015: Instructions for Paper Submission of Form FDA 2541e.  Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/
UCM366882.pdf 
7.  FDA 2015: Instructions for Paper Submission of Form FDA 2541f.  Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/
UCM366884.pdf 
8.  FDA 2015: Instructions for Paper Submission of Form FDA 2541g.  Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/
UCM366885.pdf 
9.  FDA 2013: Guidance for Industry: Letter Regarding Changes to FDAs 
Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified 
Foods and Low-Acid Canned Foods.  Accessible at 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor
mation/ucm378559.htm   
10. FDA 2014. Form FDA 2541. Food Canning Establishment Registration. Accessible at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM0767
78.pdf 
11. FDA. 2015.  Instructions for Electronic Submission of Form FDA 2541 (Food 
Canning Establishment Registration) for an Acidified/Low Acid Food Canning 
Establishment. Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM309486.pdf 
12. FDA 2015.  Instructions for Paper Submission of Form FDA 2541 (Food Canning 
Establishment Registration) for an Acidified/Low-Acid Food Canning Establishment.  
Accessible at 
http://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/
UCM359392.pdf  
13. FDA. Account Management.  Accessible at 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm073725.
htm 
14. FDA. Registration of Food Facilities Step-by-Step Instructions.  Accessible at 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm073706.
htm 
 
  14