The
Food and Drug Administration's Center for
Veterinary Medicine
is implementing a voluntary pilot program to accept and
review
GRAS
(generally recognized as safe) notices for animal feed
ingredients directly from manufacturers.
The
new program
will allow feed producers (deemed "notifiers" in the
program) to inform the FDA that they determined the use of
their ingredients are GRAS, instead of the prior system when
producers asked the FDA to confirm that the ingredients' use
was GRAS.
The GRAS notices manufacturers can submit should include a
GRAS exemption claim that contains the following:
- A succinct description of the ingredient containing
chemical, toxicological, and, if applicable, microbiological
characteristics;
- The applicable conditions of use including what food it
will be used in; levels of use in such foods, the purposes
for which the ingredient is used, and the specific animal
species intended to consume the ingredient;
- And the basis for the GRAS determination (scientific
procedures or common use in food).
The FDA will then evaluate whether the submitted notice
provides a sufficient basis for a GRAS determination.
The agency strongly encourages potential participants to
contact the
CVM's Division of Animal Feeds
prior to submitting notices to discuss their submission
plans.
