CFSAN Constituent Update
July 16, 2012
The U.S. Food and Drug Administration (FDA) is announcing an electronic registration option to increase the speed with which 1) commercial processors that manufacture, process or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (also known as “low-acid canned foods” or “LACF”); and 2) persons who are authorized to act on behalf of such commercial processors, will be able to register their facilities with the agency using FDA Form 2541.
This new filing option is described in a guidance document titled: “Guidance for Industry – Electronic Submission of FDA Form 2541 and Administrative Procedures for Submission of FDA Form 2541a and FDA Form 2541c.” This guidance also provides general information about using FDA’s system for electronic submission of each of these forms.
FDA is also publishing instructions describing the administrative procedures for electronically submitting Food Canning Establishment registration forms (Form FDA 2541) and process filing forms (Form FDA 2541a and 2541c) required when acidified foods or low-acid canned foods are manufactured, processed or packed by a commercial processor.
Form FDA 2541, Form FDA 2541a and 2541c will continue to be accepted by paper submission.