Instructions - Acidified and Low-Acid Canned Foods

1997

Instructions for Establishment Registration and Processing Filing for
Acidified and Low-Acid Canned Foods

Table of Contents

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)

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)