Low-Acid Canned Foods
21 CFR Part 113 provides the requirements and definition of thermally processed low-acid canned foods, including the correct standard methods of processing and packing to create a commercially sterile product. Low-acid foods are defined as any foods, other than alcoholic beverages, that have a final pH that is greater than 4.6 and a water activity that is greater than 0.85.
The specification of the different containers used during processing is defined and the correct handling and examination practices for containers are explained. 21 CFR Part 113 also specifies the processing and production controls from the start of production with product preparation to the proper record keeping and the documentation for deviations in processing.FDA Guidance
- Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (August 2017)
- Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format (November 2016)
- Guidance for Industry: Dear Manufacturer Letter Regarding Changes to FDA’s Administration of Process Filings (Forms FDA 2541a and FDA 2541c) for Acidified Foods and Low-Acid Canned Foods (January 2014)
Establishment Registration & Process Filing
All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.
