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GUIDANCE DOCUMENT

CVM GFI #220 Use of Nanomaterials in Food for Animals August 2015

Final
Docket Number:
FDA-2013-D-1009
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance describes the Food and Drug Administration’s current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to help industry and other stakeholders identify potential issues related to the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

In this document, the term animal food means food for animals. This guidance is applicable to food ingredients that are intended for use in animal food and that (1) consist entirely of nanomaterials, (2) contain nanomaterials as a component, or (3) otherwise involve the application of nanotechnology.

Medicated feed contains new animal drugs approved for use in or on animal food.

This guidance does not apply to a nanomaterial form of a new animal drug or drug component (e.g., drug carrier) in medicated feed; however, it does apply to nanomaterial animal food ingredients in medicated feed.

This guidance is not intended to call into question the regulatory status of products that naturally exist in the nanoscale range or that contain incidental amounts of particles in the nanoscale range, and that have already been determined to be GRAS or approved in response to a food additive petition.

We are particularly interested in materials or end products that involve the application of nanotechnology to deliberately manipulate or control particle size in order to produce specific technical effects.

Materials or end products that naturally occur or naturally contain substances in the nanoscale range and are not further manipulated or engineered are not within the scope of this guidance. Examples of such substances include microorganisms or proteins that naturally exist at small scales.


Submit Comments

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-2013-D-1009.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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