FDA Publishes Antimicrobial Food Additive Guidance

FDA has posted a guidance document on “Microbiological Considerations for Antimicrobial Food Additive Submissions.” The document addresses substances that are and are not considered food additives, and then provides an overview of antimicrobial food additives, illustrating best practices along the way.

This guidance document, as noted in its introduction, is directed at questions regarding microbiological data requirements for food additive petitions, food contact notifications, and threshold of regulation requests that are unique to the use of antimicrobial food additives and food-contact substances. This guidance will assist petitioners and notifiers in designing studies to determine whether an antimicrobial food additive achieves its intended technical effect. Also, this guidance discusses microbiological data that may be necessary to demonstrate that an antimicrobial agent will be safe for the intended use.

For complete details, see the document on FDA’s website.