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GUIDANCE DOCUMENT

Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications September 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2007-D-0207
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

This guidance will assist submitters of food additive petitions (FAPs), food contact notifications (FCNs), generally recognized as safe (GRAS) notices (GRNs), and threshold of regulation (TOR) exemption requests in providing data to demonstrate that an antimicrobial agent (defined in Section II.A, below) achieves its intended technical effect in or on food or food contact articles.  Also, this guidance discusses microbiological data that may be necessary to demonstrate that an antimicrobial agent is safe for the intended use and achieves its intended effect.  This guidance replaces a guidance previously issued as “Microbiological Considerations for Antimicrobial Food Additive Submissions” (September 2007; Revised June 2008) by expanding the scope to include GRNs, by using more consistent terminology, and by eliminating portions of the guidance that reiterate information about regulatory processes addressed in regulations or other guidance documents.

Given the complexity and variety of antimicrobial agents and the diverse conditions of use, no single document can anticipate and address all microbiological issues.  Therefore, this guidance is intended to answer common questions associated with microbiological data needed to establish that an antimicrobial agent accomplishes the intended technical effect and is safe for use in or on food or food contact articles.  We recommend that you discuss any proposed experimental protocols with FDA before initiating them to ensure that the data will address our safety questions, including those related to achieving the intended technical effect.[2] In addition, we recommend that you meet with us early during development of your products to avoid studies that may be unnecessary or that may fail to address all issues.

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 FDA guidances means that something is suggested or recommended, but not required.

[1] This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 

[2] “We,” “us,” and “our” refers to FDA.  “You,” “I,” and “my” refer to the responsible person (developer, sponsor, or proponent) who conducts a food safety evaluation and submits such information to FDA.

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All written comments should be identified with this document's docket number: FDA-2007-D-0207.

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