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Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions June 2008

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

The Food and Drug Administration (FDA) is responsible for prescribing the conditions of safe use of food additives under section 409 of the Federal Food, Drug, and Cosmetic Act (the Act). To evaluate the safety of food additives and determine their conditions of safe use, the agency uses the food additive petition (FAP) process and the food contact notification (FCN) process. In addition, FDA may, upon request, exempt from regulation as a food additive those substances used in food-contact articles (also known as food contact substances) that migrate into food at levels that are below the threshold of regulation (TOR). This guidance is directed at questions regarding microbiological data requirements for FAPs, FCNs, and TOR 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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