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  • Fda Form 2541e

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Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Process Filing for Acidified Method (Form FDA.

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How to fill out the Fda Form 2541e online

Filling out the Fda Form 2541e, used for submitting food process filings for acidified methods, can seem daunting. This guide provides step-by-step instructions to simplify the process for all users, regardless of their prior experience.

Follow the steps to accurately complete the Fda Form 2541e online.

  1. Click ‘Get Form’ button to access the Fda Form 2541e and open it in your chosen online editor.
  2. Begin with filling in the date received by the FDA in the specified format (MM/DD/YYYY), then enter your Food Canning Establishment number and Submission Identifier, following the outlined format.
  3. In Section A, provide product information: select a Food Product Group from the dropdown list or choose ‘Other’, and fill in the Product Name, form of the product, and packing medium details.
  4. Move to Section B, where you select the governing regulation that applies to your product as either acidified or voluntary. If opting for voluntary, include documentation to support your choice.
  5. Complete Section C by choosing the container type and shape from the provided options, along with the required specifics on container characteristics.
  6. In Section D, complete either the dimensions or volume of the container as instructed. You may enter the optional net weight if applicable.
  7. Section E requires you to enter details about the acidification process, including natural pH and finished equilibrium pH.
  8. In Section F, provide the source of the scheduled process along with the appropriate date.
  9. Proceed to Section G to select the process mode that applies to your product, providing any necessary additional documentation.
  10. Complete Section H by detailing how the container and interior surfaces are treated, according to the selected processing methods.
  11. Finalize the form by completing Section I with the scheduled process details, ensuring to provide any required numerical values.
  12. After reviewing all sections for accuracy, save your changes, and proceed to download or print the form for submission.

Complete your FDA Form 2541e online today to ensure your product complies with FDA regulations.

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Scheduled process: A process used to manufacture a food that will not permit the growth of microorganisms that have public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority.

Acidified foods are low-acid foods to which acids are added in order to lower pH to 4.6 or less. Examples of acidified foods include pickled vegetables and eggs. Low-acid canned foods are defined as foods that undergo a thermal process prior to being placed in a hermetically-sealed (airtight) container.

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.

Canning high-acid foods. Examples of high-acid foods include jams and jellies, pickles, and most fruits. Because there is no fear of Clostridium botulinum growth, these foods require much less heating than low-acid foods. To be safe, such foods need only to reach pasteurization temperatures.

§ 114.3 Definitions. (b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination.

A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.

Low acid foods soy, such as miso, soy beans, tofu, and tempeh. yogurt and milk. most fresh vegetables, including potatoes. most fruits. herbs and spices, excluding salt, mustard, and nutmeg. beans and lentils. some whole grains, such as millet, quinoa, and amaranth. herbal teas.

The new owner must submit a new Form FDA 2541 (Food Canning Establishment Registration), in response to which we will send the new owner a new FCE number.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232