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.