The U.S. Food & Drug Administration issued on Aug. 4 a final guidance for industry, "Use of Nanomaterials in Food for Animals," that is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.
According to FDA, this guidance is applicable to food ingredients intended for use in animal food that (1) consist entirely of nanomaterials, (2) contain nanomaterials as a component or (3) otherwise involve the application of nanotechnology.
This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient, FDA said. This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP.
At this time, FDA said it is not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).
Nanotechnology is an emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers — particles so small that they cannot be seen with a regular microscope. These particles can have chemical, physical and biological properties that differ from those of their larger counterparts, and nanotechnology has a broad range of potential applications.
Although this guidance has been finalized, comments can be submitted at any time. To submit comments to the docket by mail, use the following address, and be sure to include docket number FDA-2013-D-1009 on each page of the written comments.
Division of Dockets Management
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852