Resources & Steps for Acidified Processors

This guide outlines the precise steps, regulatory resources, and critical safety reminders required to safely bring your acidified food product to market.

Acidified Foods Manufacturing School - 100% Online

The Acidified Foods Manufacturing School (AFMS) is a specialized, FDA-recognized training program designed for commercial food processors, entrepreneurs, and quality control personnel who want to manufacture and sell acidified foods.

Because acidified foods carry a risk of Clostridium botulinum (botulism) if improperly processed, the US Food and Drug Administration (FDA) strictly mandates that these operations be under the supervision of a person who has successfully completed an approved course such as this one.

Process Evaluation by a Process Authority

21 CFR 114.83 / 108.25(c)(3)(i)

Have your product(s) evaluated and receive a scheduled process by a process authority. The scheduled process specifies the maximum finished equilibrium pH of the product, thermal process and other critical factors that must be controlled to assure manufacture of safe acidified foods. You can find private laboratories/individuals or many universities, like North Carolina State University, who can provide this service for you.

Initiate product testing through the Online Request Form.

Records

21 CFR 114.100 / 108.25(g)

You must decide what records are necessary to assure product safety and quality for human consumption, identify individual lots of foods in instances where questions arise as to safety or quality, aid in planning, scheduling, decision-making, and comply with governmental regulations and then, develop the necessary forms and procedures to be used. The types of records will vary with the product(s) being processed. At a minimum, critical factors stated in a scheduled process should be documented.

Example Records

Examples of Records:

  • Certifications of Personnel 21 CFR 114.10 / 108.25(f)
  • Thermal Processing 21 CFR 114.80(a)(1)
  • Equilibrated pH 21 CFR 114.80(a)(2) / 114.90
  • Container Closure/Seal Integrity Evaluation 21 CFR 114.80(a)(4)
  • Container Coding 21 CFR 114.80(b)
  • Deviations from the Scheduled Process 21 CFR 114.89
  • Calibration Records 21 CFR 114.90
  • Examinations of Raw Materials (origin & lot)
  • Examinations of Packing Material (origin & lot)
  • Examinations of Finished Products (origin & lot)
  • Cleaning and Sanitizing Compounds (origin & lot)
  • Lot Numbers and Number of Units Manufactured in Each Batch
  • Initial Distribution Records
  • Written Recall Plan 21 CFR 108.25(e)
  • HACCP Plan (Develop Food Safety Plan)

Required Equipment

You must read and follow all equipment supplier information. Purchase equipment to measure ALL critical factors as required by your scheduled process. These will include:

Potentiometric Method for Measuring Equilibrium pH

21 CFR 114.90

  • pH Meter
  • Buffers (4.0 and 7.0) for calibration
  • Distilled/Deionized water
  • Extra sensor/Electrode
  • Batteries
Method for Measuring Processing & Fill Temperature

21 CFR 114.80(a)(1)

  • Thermometer/Thermocouple (capable of being calibrated/digital)
Method for Measuring Time
  • Stopwatch (capable of being calibrated/digital)

Regulatory Steps

Federal Compliance

Current Good Manufacturing Practices

FDA Food Safety Modernization Act (FSMA)

You can find more information about Preventive Controls for Human Food Courses on our website

Registration of Food Facilities

To implement specific provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the FDA established regulations requiring that food facilities register with the agency. Food Facility Registration (FFR) provides the facility registration # and PIN. This is completed within the FDA Industry Systems. During the FFR process, or during an update to a facility’s FFR submission, you can identify your facility as an Acidified Food Processor under Section 9a.

Registration of Food Facilities

Food Facility Registration User Guide: Step-by-Step Instructions for Registration

Acidified Facility Registration

Under FDA regulations (21 CFR 108.25(c)(1)), any commercial processor starting to make, process, or pack acidified foods must register their facility. This registration requires submitting the company's name, main business office, specific facility locations, the manufacturing methods used, and a list of the foods processed at each site.

Acidified Establishment Registration provides the Food Canning Establishment (FCE) number, this number remains with physical plant location. The electronic AF/LACF registration system in FURLS becomes available to you if your registration in the FFR system identifies your facility as an Acidified Food Processor.

Section 1: Type of Submission
Section 2: Food Processing Plant Location
Section 3: Preferred Mailing Address
Section 4: Foods Processed at Location
Section 5: Establishment Contact Person

FDA Form FDA 2541 (Food Canning Establishment Registration)

Instructions for Electronic Submission of Form FDA 2541 for an Acidified/Low-Acid Food Canning Establishment

Food Process Filing for Acidified Method

Under FDA regulations (21 CFR 108.25(c)(2)), any commercial processor must register the acidified food on a scheduled process for each container size.

For each process filing, there will be a unique SID number. The SID consists of (1) the year, month, and day of the month 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.

FDA Form 2541e (Food Process Filing for Acidified Method)

Instructions for Electronic Submission of Form FDA 2541e (Food Process Filing for Acidified Method)

Adhere to the Scheduled Process

21 CFR 108.25(c)(3)

State Compliance

Contact your State Department of Agriculture to determine additional regulations/requirements.

Local Compliance

Check your local county/city/town/incorporation to determine additional regulations/requirements.

Additional Considerations