Contains Nonbinding Recommendations

November 2016

This guidance is intended for:
•Commercial processors who manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”) ; and
•Persons who are authorized to act on behalf of such commercial processors .

Commercial processors who manufacture, process, or pack AF and LACF are subject to the registration requirements of 21 CFR 108.25(c)(1) (for AF) and 21 CFR 108.35(c)(1) (for LACF), as well as the process filing requirements of 21 CFR 108.25(c)(2) (for AF) and 21 CFR 108.35(c)(2) (for LACF). These provisions require two basic types of submissions:
•Food Canning Establishment Registration using Form FDA 2541; and
•Process filings using the following forms, as applicable:
•Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method)
•Form FDA 2541e (Food Process Filing for Acidified Method)
•Form FDA 2541f (Food Process Filing for Water Activity /Formulation Control Method)
•Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems)

This guidance describes:
•Administrative procedures relating to the registration and process filing requirements of 21 CFR 108.25(c) (for AF) and 21 CFR 108.35(c) (for LACF);
•Administrative procedures for voluntary registration and voluntary submissions for certain products manufactured, processed, or packed by a commercial processor who has determined that the products are not subject to the registration and process filing requirements of 21 CFR 108.25(c) (for AF) or 21 CFR 108.35(c) (for LACF); and
•A voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

This guidance addresses two basic types of submissions, described above, that are required for AF and LACF:
•Food Canning Establishment Registration using Form FDA 2541 (see Appendix 10); and
•Process filings using Forms FDA 2541d, FDA 2541e, FDA 2541f, or FDA 2541g (see Appendices 1 through 4, respectively).

This guidance also provides general information about how to use FDA’s systems for electronic submission of these forms. We recommend that you submit these forms electronically and are issuing this guidance as a general aid to enable you to do so.

This guidance does not provide detailed instructions on how to complete electronic or paper submissions of Forms FDA 2541, 2541d, 2541e, 2541f, and 2541g. Such instructions are available elsewhere. (See Appendix 11 for instructions for electronic submission of Form FDA 2541, Appendix 12 for instructions for paper submission of Form FDA 2541, and Appendices 5 through 8 for instructions for paper submission of Forms FDA 2541d, 2541e, 2541f, and 2541g).

In the remainder of this guidance, “you” refers to:
•Commercial processors who manufacture, process, or pack AF or LACF;
•Commercial processors who manufacture, process, or pack products that they have determined are not AF or LACF, but who wish to voluntarily submit information about such products to FDA; and
•Persons who are authorized to act on behalf of such commercial processors.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in our guidances means that something is suggested or recommended, but not required.

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm309376.htm