A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods (AF) or low-acid canned Foods (LACF) shall register and file with FDA information including the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method, and a list of foods so processed in each establishment (21 CFR 108.25(c)(1) and 21 CFR 108.35(c)(1)). A commercial processor engaged in the processing of AF shall provide FDA with information, using Form FDA 2541a, on the scheduled processes for each acidified food in each container size (21 CFR 108.25(c)(2)). An analogous requirement for process filing, using either Form FDA 2541a or Form FDA 2541c, applies to a commercial processor that manufactures, processes, or packs LACF (21 CFR 108.35(c)(2)).
Visit the FDA Industry Systems for electronic submissions.
OMB Approval Numbers: 0910-0037
OMB Expiration Dates: 2-28-2015
See OMB Burden Statement
Below are resources for registration and process filing:
- Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format July 2012
- Instructions for Electronic Submission of Form FDA 2541 (Food Canning Establishment Registration) for an Acidified/Low-Acid Food Canning Establishment (PDF: 1.2MB) September 2012
- Instructions for Electronic Submission of Forms FDA 2541a and FDA 2541c (Process Filing Forms for Acidified and Low-Acid Foods) (AF/LACF), Authorizing Access to the Electronic AF/LACF System, and Searching Process Filings (PDF: 1.3MB) September 2012