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U.S. Department of Health and Human Services

Food

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Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF): Paper Submissions

 

Forms


The Food and Drug Administration is seeking to make it easier for manufacturers of acidified and low-acid canned foods (LACF) to submit information about their manufacturing processes to FDA and to improve the accuracy of the information they provide. FDA is doing this by modernizing both the paper and electronic process filing forms that acidified and low-acid canned food manufacturers are required to file with the agency under 21 CFR 108.25(c)(2) and 21 CFR 108.35(c)(2).
 

Draft Forms


Draft Instructions


 

Instructions

Also available en español (Spanish).

I. Background and Introduction
  1. Purpose of This Booklet
  2. The Need for Regulations
  3. Requirements of the Regulations
  4. Reasons for Registration and Process Filing Requirements
  5. Foods Not Covered Under the Low-Acid Canned Foods Regulations (21 CFR 108.35 and 113)
  6. Foods Not Covered Under the Acidified Foods Regulations (21 CFR 108.25 and 114)
  7. Special Cases
  8. Relationship Between pH, Water Activity, and Low-Acid Canned Food or Acidified Food Regulations
  9. Registration of Low-Acid Canned Food and Acidified Food Processing Establishments
  10. Filing Low-Acid and Acidified Food Scheduled Process Information
  11. Submission Identifier
  12. Important Information for Processing Plants in Other Countries

 

II. Establishment Registration - Form FDA 2541 (PDF:300 KB) 

 

III. Process Filing for all Processing Methods Except Aseptic  - Form FDA 2541a
  • Part A - Product
  • Part B - Processing Method
  • Part C - Critical Factors
  • Part D - Scheduled Process
  • Multiple Step Processes
  • Special Instructions for Hydrostatic Processes In Which Infeed and Exit Leg Times and Temperatures Are a Part of the Process

 

IV. Process Filing for Aseptic Packaging Systems - Form FDA 2541C

 

V. Common Questions and Answers Concerning Registration and Process Filing Requirements

 

VI. Glossary of Terms

 

APPENDIX A - Metric (mm) to English (inches and sixteenths)Container Dimension Conversion Chart

 

APPENDIX B - Temperature Conversion Chart Celsius to Fahrenheit (nearest whole degree)