Registration and Process Filing
When first engaging in the manufacture, processing, or packing of acidified foods in any state, a commercial processor must register with the FDA on Form FDA 2541 (Food Canning Establishment Registration; 21 CFR 108.25). This form must be filed no later than ten (10) days after the firm engages in operations.
In addition, the firm must file a scheduled process with the FDA on Form FDA 2541e no later than 60 days after registration and before packing any new product. These forms are available from FDA. Firms already registered and engaged in the processing of acidified foods need only file Form FDA 2541e, for each new acidified food in each container size. Registration and process filing are done electronically.
An FDA guidance document titled, Instructions for Electronic Submission of Form FDA 2541 (Food Canning Establishment Registration) for Acidified/Low-Acid Food Canning Establishment (2017) can be found here, www.fda.gov/media/83914/download
Portals for Electronic Submissions:
- FDA's Industry Systems (FIS) - general entry to specific FDA systems (FIS Website) https://www.access.fda.gov/
- FDA's Unifies Registration Listing Systems (FURLS) - Once registered if FIS, you can then use FURLS to register your facility (general food facility registration under the Bioterrorism Act, FFR) and register as an Acidified or Low Acid Canned Foods manufacturer (AF/LACF) using FDA Form 2541
The processor must fulfill all of the requirements for registration, as well as mandatory portions of 21 CFR 114, namely:
114.10 - Personnel
114.80 (a) (1) and (2), and (b) - Processes and controls
114.83 - Establishing scheduled processes
114.89 - Deviations from scheduled processes 114.100 (b), (c), and (d) – Records
The scheduled process must include information essential to produce a safe product, including the maximum equilibrium pH, and other critical factors, such as heat processing, and preservatives used, and their levels as appropriate.
Processes and Controls
The manufacturer must employ process and control procedures to ensure that the finished foods do not present a public health hazard. Acidified foods must have a finished equilibrium pH of 4.6 or lower, achieved within the time designated in the scheduled process (if such time is determined by the process authority to be a critical factor). Furthermore, a pH of 4.6 or lower must be maintained in all finished products. While pH 4.6 or lower is adequate to prevent growth and toxin production by Clostridium botulinum, it may not be adequate to prevent growth of other microbial pathogens. Thus, acidified foods must be thermally processed to an extent that is sufficient to destroy the vegetative cells of microbes of public health significance and those of non-health significance that can grow in the product under the conditions in which it is stored, distributed, and held by the consumer. Approved preservatives may be used instead of heat to prevent growth of non-pathogenic microorganisms. The product must be tested to insure an equilibrium pH of 4.6 or lower and the results recorded.
Procedures for Acidification
It is important to remember that "acidified foods" are low-acid foods to which acids or acid foods have been added to obtain a finished equilibrium pH of 4.6 or below. Sufficient acid must be added to ensure that pH 4.6 or lower is achieved after all of the components in the finished product have reached equilibrium. The following example procedures to properly acidify foods are mentioned in the regulation:
- Direct acidification of individual containers
- Direct batch acidification
- Blanching in an acidified solution
- Immersion of blanched products in an acid solution
- Addition of an acid food to a low-acid food
Regardless of the acidification method used, it is important to establish if there are any critical factors for proper acidification, and if so, document their control during production.
In all instances, when one or more containers of a given lot of acidified food is found to have an equilibrium pH above 4.6, it must be concluded that there has been a deviation from the scheduled process for the entire lot.
Whenever the pH of any single container of a given lot of food approaches pH 4.6, a large number of containers should be sampled to ensure that none exceeds this critical value. A processor of acidified foods must promptly report to FDA any instance of spoilage, process deviation, or contamination with microorganisms, the nature of which has potential health-endangering significance where any lot of such food has in whole or in part entered distribution in commerce.
Whenever deviations from scheduled processes occur, re-working the entire lot according to a scheduled process should be quickly and carefully considered. While in many cases, such deviations may not result in any public health hazard, they may have pronounced effects on the quality of the product. For example, if records indicate a malfunction in a pasteurizer during a given period and if pasteurization is in the scheduled process filed, all product that may have been pasteurized during that period should be immediately reprocessed according to the scheduled process. Failure to control other factors specified in the scheduled process, such as maximum pH, titratable acidity, salt and sugar concentrations, preservatives, or drained weights of the finished products, are deviations, and the affected product must be set aside for evaluation or reprocessed according to pre-planned corrective action. Products with low-vacuum or improper seals shall be treated similarly.
Records of all departures from scheduled processes must be maintained in a separate file for three years.
Publication date: July 31, 2022
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