Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)

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)).