Guidance for Commercial Processors of Acidified & Low-Acid Canned Foods
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Federal Regulations require commercial processors of shelf stable acidified foods and low-acid canned foods in a hermetically sealed container to be sold in the United States to register each establishment and file scheduled processes with the Food and Drug Administration for each product, product style, container size and type and processing method (21 CFR 108). This website contains instructions for establishment registration and process filing along with other information useful to manufacturers of these types of products.
A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.
An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85.
Guidance for Industry
Guidance documents contain nonbinding recommendations
This guidance describes administrative procedures for submissions that are required when the products manufactured, processed, or packed by a commercial processor are subject to the registration and process filing requirements of 21 CFR 108.25(c)(2) (for AF) or 21 CFR 108.35(c)(2) (for LACF). There are two basic types of such required submissions:
- Food Canning Establishment Registration using Form FDA 2541 (Appendix 1); and
- Process filings using Forms FDA 2541a (Appendix 2) and FDA 2541c (Appendix 3).
Draft Guidance for Industry: Acidified Foods September 2010
This guidance is intended for processors of acidified foods, fermented foods, and acid foods. It pertains to the current good manufacturing practice (CGMP) requirements in 21 CFR part 114 for acidified foods and to the “Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit” for acidified foods in 21 CFR 108.25 and is intended to assist commercial food processors in determining whether their food products are subject to these regulations.
The following guidance document has been withdrawn as it no longer applies:
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.
Comment on New Forms
FDA is seeking to make it easier for manufacturers of LACF to submit information about their manufacturing processes to FDA and to improve the accuracy of the information they provide. FDA is doing this by modernizing both the paper and electronic process filing forms that acidified and low-acid canned food manufacturers are required to file with the agency under 21 CFR 108.25(c)(2) and 21 CFR 108.35(c)(2). Read more about the proposed new forms.