Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format: Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled "Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry." This guidance describes the administrative procedures to be used by commercial processors that 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"). These changes include new registration and food process filing forms and a new "smart form" system for electronic submission of the process filing forms. Registration and process filing are required by the AF and LACF provisions of our regulations. This guidance also provides general information about how to use FDA's systems for electronic submission of the applicable forms. In addition, this guidance describes administrative procedures for voluntary registration and voluntary submissions when a commercial processor has determined that its product is not an acidified food or a low