Due to increased telework to mitigate COVID19, there will be an increased delay in processing paper submissions. It is recommended that whenever possible you submit registrations and process filings electronically. If you need additional assistance please send an e-mail to LACF@FDA.HHS.GOV with your issue stated in the subject line.
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 2541e, 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 2541d, 2541f or Form FDA 2541g, applies to a commercial processor that manufactures, processes, or packs LACF (21 CFR 108.35(c)(2)).
- Forms and Instructions for Paper Submission of Establishment Registration and Process Filing
- Instructions for Electronic Submission of Establishment Registration and Process Filing
Title 21, Code of Federal Regulations
- 21 CFR
Title 21, Food and Drug Administration.
- 21 CFR 108
Acidified foods; Thermal processing of low-acid foods packaged in hermetically sealed containers.
- 21 CFR 110
Current good manufacturing practice in manufacturing, packing, or holding human food.
- 21 CFR 113
Thermally processed low-acid foods packaged in hermetically sealed containers.
- 21 CFR 114