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U.S. Food and Drug Administration
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  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Registration of Food Facilities and Other Submissions
  5. Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)
  6. Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods (LACF): Electronic Submissions
  1. Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)

Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods (LACF): Electronic Submissions

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)).

Visit the FDA Industry Systems for electronic submissions.  

Form 2541/2541d/2541e/2541f/2541g
OMB Approval Numbers: 0910-0037
OMB Expiration Dates: 09/30/2017
See OMB Burden Statement

Electronic Instructions:

Video Tutorials:

Additional Information:

 

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