United States Regulations

Registration and Process Filing

All commercial processors, when first engaging in the manufacture, processing, or packing of low acid or acidified foods in any state must register with the FDA on Form FDA 2541 (Food Canning Establishment Registration; 21 CFR 108.25). This form must be filed not later than 10 days after the firm engages in operations.

In addition, the firm must file a scheduled process with the FDA on Form FDA 2541a not later than 60 days after registration, and before packing any new product. Firms already registered and engaged in the processing of acidified foods need only file Form FDA 2541a, for each new acidified food in each container size. Registration information and process filing forms are available from the table below. (Note: see additional regulations below this table for USDA regulated canned foods)

Low Acid Canned Food

Acidified Canned Food

Characteristics

  1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
  2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
  3. Receives a heat treatment for the purpose of achieving commercial sterility.
  4. Normally stored and distributed under non-refrigerated conditions
An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under non-refrigerated conditions.

EXEMPTIONS: Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this regulation.

Applicable Regulation

Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers Title 21 — Chapter 1, Part 113 Acidified Foods Title 21 — Chapter 1, Part 114

Instructional guides

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

Training Requirements

Sec. 113.10 Personnel. Operators of processing systems, retorts, aseptic processing and packaging systems and product formulating systems and container closure inspectors must attend a a school approved by the Commissioner…see list of “Better Process Control Schools” Sec. 114.10 Personnel. All operators of processing and packaging systems shall be under the operating supervisions of a person who has attended a school approved by the Commissioner…see list of “Better Process Control Schools”

Required Forms

Food Canning Establishment Registration (FDA 2541) Process Method Form (FDA 2541a) Food Canning Establishment Registration (FDA 2541) Process Method Form (FDA 2541a)

USDA-FSIS Canning Regulations.
Canned foods containing meat or poultry must comply with 9 CFR 318.300-311.

Guide to Food Processing Scheduled Processes (Acidified Foods)
If acidified foods are improperly processed and distributed, the health of the consumer may be adversely affected. There is no adequate way to determine the harmful nature of the foods after they have been released into marketing channels. Therefore, the U.S. Food and Drug Administration (FDA) requires evidence that acidified foods destined for interstate commerce be manufactured and handled in such a manner as to assure safety to the consumer.
North Carolina State University Department of Food Science

Guide to Inspections of Acidified Food Manufacturers
This document is intended to serve as a resource for FDA Investigators. Acidified food manufactures will find it useful for developing procedures that comply with FDA regulations.
U. S. Food and Drug Administration Office of Regulatory Affairs

Small Business Guide to FDA
Guide to FDA’s organization, procedures, policies, and regulations.
U. S. Food and Drug Administration Office of Regulatory Affairs

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
Responsibilities and precautions required of food processors.
Code of Federal Regulations Title 21 Part 110

Advisory for Retail Processing with Proper Controls and Variances for Product Safety
Guidance has been prepared in for on-site retail processing. Such retail processing can involve, but is not limited to acidifying, smoking, drying, fermenting, curing, reduced oxygen packaging, and other operations that are traditionally done at a food manufacturing plant level. This guidance is intended for retailers and regulatory personnel to help understand the controls to implement in a retail operation in order to process and sell safe food products.
Association of Food and Drug Officials

A Food Labeling Guide
A summary of the required statements that must appear on food labels.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition

Small Business Nutritional Food Labeling Exemption
Information sheet and sample form for application of small business nutritional exemption form.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition

Food Labeling – Questions and Answers – Volume 1
Provided to facilitate the advice to retail businesses process of developing or revising labels for foods other than dietary supplements.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition

Food Labeling – Questions and Answers – Volume 2
Contains FDA’s advice to retail businesses and restaurants making health and nutrient claims on their food products.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition

Guidance for Industry – FDA Nutrition Labeling Manual – A Guide for Developing and Using Data Bases
Generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled.

U.P.C Barcodes

The U.P.C. barcode is not a regulatory requirement. However, many retailers will not stock your product without it. To get a barcode, you must become a member of GS1 US Partner Connections (previously Uniform Code Council).
See gs1us.org for more information.

Basic Facts About Trademarks
How to register a trademark with the United States Patent and Trademark Office