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This document provides guidance for commercial processors on the registration and process filing requirements for acidified foods and low-acid canned foods with the FDA.

How to fill out guidance for industry submitting

How to fill out Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format

1. Visit the FDA website to access the Guidance for Industry materials.
2. Download Form FDA 2541 and the associated Food Process Filing Forms FDA 2541a and FDA 2541c.
3. Review the instructions provided in the guidance document carefully.
4. Gather all requisite information including facility details, types of food products processed, and process parameters.
5. Complete Form FDA 2541 with accurate establishment information, including name, address, and contact details.
6. Fill out Forms FDA 2541a and FDA 2541c with specific details about food processes, including thermal processing and equipment used.
7. For electronic submissions, ensure the forms are saved in the required format and utilize the FDA's electronic submission portal.
8. For paper submissions, print the completed forms and sign where necessary.
9. Mail the completed forms to the address specified in the guidance document.
10. Keep a copy of all submitted forms for your records.

Who needs Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

1. Food manufacturers who are establishing food canning facilities.
2. Processors of low-acid and acidified foods who must register their establishments.
3. Businesses involved in the processing of canned food products.
4. Any entity required to comply with the FDA regulations concerning food safety and processing.

People Also Ask about

Do I need to register my food product with the FDA?

If you are the owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S., you must register the facility with FDA, unless you are exempt under the Code of Federal Regulations.

What is the FDA establishment identifier number?

FEI is an acronym which stands for FDA Establishment Identifier. It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products.

What is the FDA schedule identifier number?

The FDA assigns each process filing a specific Submission Identifier (SID) unique to every product category and packing size. The SID number is 11 digits long and specific to each product type and packing size, so it is not to be mistaken for the food facility registration number, which also consists of 11 digits.

What is the FDA drug identification number?

The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States. The code is present on all prescription, over-the-counter and insulin products and labels in the U.S. The NDC serves as the FDA's identifier for drugs.

What are the FDA requirements for acidified foods?

Acidified foods are low-acid foods to which acid(s) or acid food(s) are added and which have a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85. Acid foods, those with a naturally occurring pH less than 4.6, are exempt from U.S. canning regulations.

What are the FDA guidelines for fermented foods?

Fermented foods must have an equilibrium pH value below 4.6 and meet standards that destroy bacteria, yeast, and molds to a required level. All fermented foods must have official verification from a third-party processing authority in writing. All products must be labeled properly.

What is the FCE number?

After you register an establishment, FDA assign a Food Canning Establishment (FCE) number identifying the physical processing plant located at the address provided.

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What is Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

The Guidance for Industry provides instructions on how to submit Form FDA 2541, which is the registration form for food canning establishments, as well as Forms FDA 2541a and FDA 2541c, which are necessary for food process filing. It details the requirements for both electronic and paper submissions.

Who is required to file Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

Any food canning establishment that conducts business in the United States and engages in canning of low-acid foods is required to file these forms with the FDA to ensure compliance with food safety regulations.

How to fill out Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

To fill out these forms, applicants must provide specific information about their establishment and processing methods. This includes details on the types of food processed, operational procedures, and any technological methods employed during processing. Instructions on formatting, required signatures, and submission guidelines are outlined in the guidance document.

What is the purpose of Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

The purpose of this guidance is to ensure that food canning establishments comply with FDA regulations by providing clear and consistent instructions for registration and process filing, thereby enhancing food safety and public health.

What information must be reported on Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format?

The required information includes the establishment name and address, contact information, detailed descriptions of the food products, processing methods, and thermal processes used. Additionally, any relevant operational data must also be reported to comply with FDA regulations.